U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 0 5

Silver Spring, MD 20993

www.fda.gov

July 10, 2019

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Yanhong Bai

Manager Regulatory Affairs

Mindray Building, Keji 12th Road South

Hi-tech Industrial Park, Nanshan

Shenzhen, 518057, P.R. China

Re: K190011

Trade/Device Name: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia Detector and Alarm (including ST-Segment Measurement and Alarm)

Regulatory Class: Class II

Product Code: MHX, DQA, DRT, DSI, DSK, DXN, FLL, MLD, DPZ, CCK, CBQ, CBS, CBR, CCL,

DSB, DXG, OLW, DSJ, KOI, GXY

Dated: June 6, 2019

Received: June 10, 2019

Dear Yanhong Bai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced

above and have determined the device is substantially equivalent (for the indications for use stated in the

enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the

enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance

with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a

premarket approval application (PMA). You may, therefore, market the device, subject to the general

controls provisions of the Act. Although this letter refers to your product as a device, please be aware that

some cleared products may instead be combination products. The 510(k) Premarket Notification Database

located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

product submissions. The general controls provisions of the Act include requirements for annual registration,

listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We

remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be

subject to additional controls. Existing major regulations affecting your device can be found in the Code of

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements

concerning your device in the Federal Register.

K190011 - Yanhong Bai Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA

has made a determination that your device complies with other requirements of the Act or any Federal

statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-

mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including

information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-

devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Goodsell

Assistant Director

DHT2A: Division of Cardiac

Electrophysiology, Diagnostics

and Monitoring Devices

OHT2: Office of Cardiovascular Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

for

FORM FDA 3881 (7/17) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

510(k) Number (if known)K190011

Device NamePassport Series Patient Monitors (including Passport 12m，Passport 17m and T1)

Indications for Use (Describe)Passport 12m and 17m Patient Monitors: The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only; • ST Segment analysis of Mindray algorithm is intended for adult patients only; • C.O. monitoring is restricted to adult patients only; • ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. T1 Patient Monitor: The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients; • ST Segment analysis of Mindray ECG algorithm is intended for adult patients only. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (7/17) Page 2 of 2

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov

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MINDRAY©PROPRIETARY Page 1 of 26 Patient Monitors

510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Passport Series Patient Monitors is provided below.

Device Common Name: Patient Monitor

Device Proprietary Name: Passport Series Patient Monitors (Passport 12m, Passport 17m and T1)

Submitter

Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China Tel: +86 755 8188 8998 Fax: +86 755 2658 2680

Contact

Ms. Yanhong Bai Manager Regulatory Affairs Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P.R. China Tel: +86 755 81885635 Fax: +86 755 26582680 E-mail: baiyanhong@mindray.com

Date Prepared

December 31, 2018 Classification Regulation

21 CFR 870.1025, Class II, Arrhythmia detector and alarm (including ST-segment measurement and alarm)

Panel

Cardiovascular

MINDRAY©PROPRIETARY Page 2 of 26 Patient Monitors

Classification Regulation, Classification Name and Product Codes:

Product Code

Regulation Number

Panel Regulation description Device Common Name

Primary MHX 21 CFR

870.1025 Cardiovascular Arrhythmia detector and

alarm (including ST-segment measurement and alarm)

monitor, physiological, patient(with arrhythmia detection or alarms)

Secondary Product Code

Regulation Number

Panel Regulation description Device Common Name

DSI 21 CFR 870.1025

Cardiovascular Arrhythmia detector and alarm (including ST-segment measurement and alarm)

detector and alarm, arrhythmia

MLD 21 CFR 870.1025

Cardiovascular Arrhythmia detector and alarm (including ST-segment measurement and alarm)

monitor, st segment with alarm

DRT 21 CFR 870.2300

Cardiovascular Cardiac Monitor (including cardiotachometer and rate alarm)

monitor, cardiac (incl. cardiotachometer & rate alarm)

DXN 21 CFR 870.1130

Cardiovascular Noninvasive blood pressure measurement system

system, measurement, blood-pressure, non-invasive

DSK 21 CFR 870.1110

Cardiovascular Blood pressure computer computer, blood-pressure

FLL 21 CFR 880.2910

Cardiovascular Clinical electronic thermometer

thermometer, electronic, clinical

DQA 21 CFR 870.2700

Cardiovascular Oximeter oximeter

DPZ 21 CFR 870.2710

Cardiovascular Ear oximeter oximeter, ear

CCK 21 CFR 868.1400

Anesthesiology Carbon dioxide gas analyzer

analyzer, gas, carbon-dioxide, gaseous-phase

CBQ 21 CFR Anesthesiology Enflurane gas analyzer analyzer, gas, enflurane,

MINDRAY©PROPRIETARY Page 3 of 26 Patient Monitors

868.1500 gaseous-phase (anesthetic concentration)

CBS 21 CFR 868.1620

Anesthesiology Halothane gas analyzer analyzer, gas, halothane, gaseous-phase (anesthetic conc.)

CBR 21 CFR 868.1700

Anesthesiology Nitrous oxide gas analyzer analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.)

CCL 21 CFR 868.1720

Anesthesiology Oxygen gas analyzer analyzer, gas, oxygen, gaseous-phase

DSB 21 CFR 870.2770

Cardiovascular Impedance plethysmograph

plethysmograph, impedance

DXG 21 CFR 870.1435

Cardiovascular Single-function, preprogrammed diagnostic computer

computer, diagnostic, pre-programmed, single-function

OLW 21 CFR 882.1400

Neurology Electroencephalograph index-generating electroencephalograph software

DSJ 21 CFR 870.1100

Cardiovascular Blood pressure alarm alarm, blood-pressure

KOI 21 CFR 868.2775

Anesthesiology Electrical peripheral nerve stimulator

stimulator, nerve, peripheral, electric

GXY 21 CFR 870.1320

Neurology Cutaneous electrode. electrode, cutaneous

Primary Predicate Device: K152902 - Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1) Shenzhen Mindray Bio-Medical Electronics Co., Ltd K170876 - Passport Series Patient Monitors (Passport 12m and Passport 17m) Shenzhen Mindray Bio-Medical Electronics Co., Ltd Secondary Predicate Device: K182075 -BeneVision N Series Patient Monitors

Shenzhen Mindray Bio-Medical Electronics Co., Ltd K171292 - A7 Anesthesia System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd

Indications for Use:

MINDRAY©PROPRIETARY Page 4 of 26 Patient Monitors

Passport 12m and 17m Patient Monitors:

The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only;

ST Segment analysis of Mindray algorithm is intended for adult patients only; C.O. monitoring is restricted to adult patients only; ICG monitoring is only for use on adult patients who meet the following

requirements: height: 122 to 229cm, weight: 30 to 155kg.

The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

T1 Patient Monitor:

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;

ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.

MINDRAY©PROPRIETARY Page 5 of 26 Patient Monitors

The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

Device Description: The subject Passport Series Patient Monitors includes three monitors:

Passport 12m Patient Monitor Passport 17m Patient Monitor T1 Patient Monitor

All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters. The Passport 12m and 17m Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor. The T1 patient monitor is one of the available modules that can be plugged into the Passport 17m or 12m monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17m and 12m. Substantial Equivalence: Comparison of Indications The indications for use of the subject devices have not changed in this 510(K). Indications of the predicate device (Passport 12m and 17m Patient Monitors K170876,T1 Patient Monitor K152902) and the subject device (Passport 12m,Passport 17m and T1)) are the same. Comparison of Technological Characteristics The table below compares the key technological feature of the subject devices to the primary predicate device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902). The features in grey are the features that have been modified since their previous clearances and that are the subject of this 510(k). Device Comparison Table (Compare with Passport 12m and 17m Patient Monitors K170876,T1 Patient Monitor K152902)

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nt M

onito

rs

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Res

pira

tion

rate

(R

esp)

Use

s th

e M

PM (

Mul

ti Pa

ram

eter

Mod

ule)

to

mea

sure

the

ch

ange

in im

peda

nce

mea

sure

d ac

ross

the

thor

ax to

det

erm

ine

the

resp

iratio

n ra

te.

Sam

e

Tem

pera

ture

(T

emp)

Use

s the

MPM

(Mul

ti Pa

ram

eter

Mod

ule)

to m

easu

re c

ore

and

skin

tem

pera

ture

. T

he p

atie

nt m

onito

r ca

n m

onito

r tw

o te

mpe

ratu

res s

imul

tane

ousl

y us

ing

ther

mal

ly se

nsiti

ve re

sist

ors

(ther

mis

tors

).

Sam

e

Puls

e ox

ygen

sa

tura

tion

(SpO

2)

Use

s the

MPM

(Mul

ti Pa

ram

eter

Mod

ule)

or t

he S

pO2

mod

ule

to m

easu

re th

e am

ount

of o

xyge

nate

d ha

emog

lobi

n an

d pu

lse

rate

by

mea

surin

g th

e ab

sorp

tion

of se

lect

ed w

avel

engt

hs o

f lig

ht.

Is c

ompa

tible

with

the

follo

win

g 3

mod

ules

to m

easu

re o

xyge

n sa

tura

tion:

M

indr

ay S

pO2 M

odul

e

Mas

imo

SpO

2 Mod

ule

N

ellc

or S

pO2 M

odul

e

Sam

e

MIN

DR

AY©PR

OPR

IETA

RY

Page

10

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Puls

e ra

te (P

R)

PR fr

om M

indr

ay S

pO2

Mea

sure

men

t ran

ge: 2

0 to

254

bpm

A

ccur

acy:

±3 b

pm

PR fr

om M

asim

o Sp

O2

Mea

sure

men

t ran

ge: 2

5 to

240

bpm

A

ccur

acy:

±3 b

pm (m

easu

red

with

out m

otio

n)

±5 b

pm (m

easu

red

with

mot

ion)

PR

from

Nel

lcor

SpO

2 M

easu

rem

ent r

ange

: 20

to 3

00 b

pm

Acc

urac

y:20

to 2

50 b

pm: ±

3 bp

m

251

to 3

00 b

pm, n

ot sp

ecifi

ed

PR fr

om IB

P M

easu

rem

ent r

ange

: 25

to 3

50 b

pm

Acc

urac

y:±1

bpm

or ±

1%, w

hich

ever

is g

reat

er

PR fr

om N

IBP

M

easu

rem

ent r

ange

: 40

to 2

40 b

pm

Acc

urac

y: ±

3 bp

m o

r ±3%

, whi

chev

er is

gre

ater

PR fr

om M

indr

ay S

pO2

Sam

e PR

from

Mas

imo

SpO

2 Sa

me

PR fr

om N

ellc

or S

pO2

Sam

e PR

from

IBP

Sam

e PR

from

NIB

P

Mea

sure

men

t ran

ge: 3

0 to

300

bpm

A

ccur

acy:

Sam

e

MIN

DR

AY©PR

OPR

IETA

RY

Page

11

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Non

-inva

sive

bl

ood

pres

sure

(N

IBP)

Mea

sure

men

t ran

ge:

A

dult:

Sy

stol

ic: 4

0-27

0 m

mH

g

Dia

stol

ic: 1

0-21

0 m

mH

g

Mea

n:20

-230

mm

Hg

Pe

diat

ric:

Syst

olic

:40-

200m

mH

g

D

iast

olic

:10-

150m

mH

g

M

ean:

20-1

65m

mH

g N

eona

te:

Syst

olic

:40-

135

mm

Hg

D

iast

olic

:10-

100m

mH

g

Mea

n:20

-110

mm

Hg

Acc

urac

y:

Max

mea

n er

ror:

±5 m

mH

g M

ax st

anda

rd d

evia

tion:

8 m

mH

g

Mea

sure

men

t ran

ge:

A

dult:

Sy

stol

ic: 2

5-29

0 m

mH

g

Dia

stol

ic: 1

0-25

0 m

mH

g

Mea

n:15

-260

mm

Hg

Pe

diat

ric:

Syst

olic

:25-

240m

mH

g

D

iast

olic

:10-

200m

mH

g

M

ean:

15-2

15m

mH

g N

eona

te:

Syst

olic

:25-

140

mm

Hg

D

iast

olic

:10-

115

mm

Hg

M

ean:

15-1

25 m

mH

g A

ccur

acy:

Sa

me

Inva

sive

bl

ood

pres

sure

(IB

P)

Use

s the

MPM

(Mul

ti Pa

ram

eter

Mod

ule)

or t

he IB

P M

odul

e to

mea

sure

inva

sive

blo

od p

ress

ure.

The

mon

itor c

an m

onito

r up

to 8

inv

asiv

e bl

ood

pres

sure

s an

d di

spla

ys s

ysto

lic, d

iast

olic

an

d m

ean

pres

sure

s an

d a

wav

efor

m

for

each

pre

ssur

e.

Supp

orts

the

PPV

func

tion.

Sam

e

MIN

DR

AY©PR

OPR

IETA

RY

Page

12

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Puls

e Pr

essu

re

Var

iatio

n (P

PV)

Supp

orte

d fe

atur

e of

IBP

Sam

e

Car

diac

ou

tput

(C

.O.)

The

tem

pera

ture

cha

nge

is d

ispl

ayed

as

a cu

rve

in t

he C

.O.

split

scr

een,

and

the

m

onito

r ca

lcul

ates

the

C.O

. val

ue fr

om th

is cu

rve.

The

mon

itor

is c

apab

le o

f st

orin

g 6

mea

sure

men

ts.

Not

supp

orte

d Sa

me

Sam

e

Con

tinuo

us

card

iac

outp

ut

(CC

O)

CC

O/S

vO2

inte

rfac

e m

odul

e is

used

to

in

terf

ace

with

Ed

war

ds

Vig

ilanc

e II

mon

itor

/ V

igile

o M

onito

r w

hich

m

easu

res

cont

inuo

us c

ardi

ac o

utpu

t (C

CO

) , m

ixed

ven

ous

oxyg

en s

atur

atio

n (S

vO2)

and

cent

ral v

enou

s ox

ygen

sa

tura

tion

(Scv

O2).

Not

supp

orte

d Sa

me

Sam

e

Cen

tral

veno

us

oxyg

en s

atur

atio

n (S

cvO

2)

ScvO

2 m

odul

e is

used

to

mea

sure

cen

tral

veno

us o

xyge

n sa

tura

tion

(Scv

O2).

N

ot su

ppor

ted

Sam

e Sa

me

MIN

DR

AY©PR

OPR

IETA

RY

Page

13

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Car

bon

diox

ide

(CO

2)

Is c

ompa

tible

with

the

follo

win

g 3

mod

ules

to m

easu

re c

arbo

n di

oxid

e:

Side

stre

am C

O2 M

odul

e

M

icro

strea

m C

O2 M

odul

e

Mai

nstre

am C

O2 M

odul

e C

O2

mon

itorin

g is

bas

ed o

n ca

lcul

atio

ns f

rom

m

easu

ring

the

abso

rptio

n of

inf

rare

d (IR

) lig

ht o

f spe

cific

wav

elen

gths

usi

ng

a ph

otod

etec

tor.

Side

stre

am C

O2

2.0

mod

ule

is

adde

d,

the

func

tiona

lity

and

perf

orm

ance

is

sa

me

with

Si

dest

ream

CO

2 1.

0 m

odul

e.

The

othe

r m

odul

es

and

spec

ifica

tions

rem

ains

the

sam

e.

Sam

e

Ane

sthe

tic

gas

(AG

)

Is c

ompa

tible

with

the

follo

win

g 2

mod

ules

to

mea

sure

Ane

sthe

tic g

as:

3-

slot

AG

Mod

ule

2-

slot

AG

Mod

ule

The

AG

mod

ule

anal

yzes

gas

sam

ples

from

th

e pa

tient

and

cal

cula

tes

CO

2, O

2, N

2O

and

AA

wav

es a

nd re

late

d nu

mer

ics,

airw

ay

resp

irato

ry

rate

, an

d M

AC

(m

inim

um

alve

olar

con

cent

ratio

n).

Supp

orts

the

3-sl

ot A

G m

odul

e.

Not

supp

orte

d Su

ppor

t Sa

mpl

e G

as R

ecyc

ling

feat

ure

for A

G m

odul

e Sa

me

MIN

DR

AY©PR

OPR

IETA

RY

Page

14

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Impe

danc

e ca

rdio

grap

h (IC

G)

U

ses

the

ICG

M

odul

e to

m

easu

re a

pat

ient

’s

hem

odyn

amic

sta

tus

usin

g a

non-

inva

sive

m

etho

d ba

sed

on

thor

acic

el

ectri

cal

bioi

mpe

danc

e (T

EB) t

echn

olog

y.

Not

supp

orte

d Sa

me

Sam

e

Bis

pect

ral

inde

x (B

IS)

Mea

sure

d pa

ram

eter

s: E

EG,

BIS

, B

IS L

, B

IS R

N

ot su

ppor

ted

Sam

e Sa

me

Res

pira

tion

mec

hani

cs (R

M)

M

easu

res

resp

iratio

n m

echa

nics

fo

r ad

ults

, pe

diat

rics

and

infa

nts.

Not

supp

orte

d Sa

me

Sam

e

MIN

DR

AY©PR

OPR

IETA

RY

Page

15

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

NM

T

Use

s the

NM

T m

odul

e to

mon

itor o

bjec

tive

neur

omus

cula

r tra

nsm

issi

on.

It ev

alua

tes

mus

cle

rela

xatio

n of

pat

ient

s un

der

neur

omus

cula

r bl

ock

by m

easu

ring

the

stre

ngth

of

m

uscl

e re

actio

n af

ter

elec

trica

lly s

timul

atin

g th

e de

dica

ted

mot

or

nerv

e.

Not

supp

orte

d Sa

me

Sam

e

MI N

DR

AY©PR

OPR

IETA

RY

Page

16

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

clea

ning

an

d di

sinf

ectin

g ag

ents

List

of a

gent

s

Sodi

um h

ypoc

hlor

ite b

leac

h H

ydro

gen

pero

xide

Is

opro

pano

l R

ely+

On

TMV

irkon

1-

Prop

anol

Pe

rfor

m

Mor

e ag

ents

are

add

ed

Met

rex

Cav

iCid

e1™

Vire

x I

I 256

Vire

x T

B

Alp

et D

2 Su

rfac

e Sa

nitiz

ing

Wip

es

Clo

rox

Dis

patc

h

Hos

pita

l C

lean

er

Dis

infe

ctan

t To

wel

s with

Ble

ach

Clo

rox

Hea

lthca

re B

leac

h G

erm

icid

al W

ipes

C

loro

x H

ealth

care

H

ydro

gen

Pero

xide

C

lean

er

Dis

infe

ctan

t Wip

es

Div

erse

y O

xivi

r T

B W

ipes

M

etre

x Ca

viW

ipes

™

PDI S

ani-C

loth

AF3

Ger

mic

idal

Dis

posa

ble

Wip

e PD

I San

i-Clo

th B

leac

h G

erm

icid

al D

ispo

sabl

e W

ipe

PDI S

ani-C

loth

HB

Ger

mic

idal

Dis

posa

ble

Wip

e PD

I San

i-Clo

th P

lus G

erm

icid

al D

ispo

sabl

e C

loth

PD

I Sup

er S

ani-C

loth

Ger

mic

idal

Dis

posa

ble

Wip

e V

IRA

GU

AR

D H

ospi

tal S

urfa

ce D

isinf

ecta

nts

MIN

DR

AY©PR

OPR

IETA

RY

Page

17

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Supp

ort

new

M

asim

o Sp

O2

acce

ssor

ies

Not

supp

orte

d

Add

ed:

040-

0033

78-0

0 R

D S

ET M

D 1

4-05

, PC

5 ft

04

0-00

3379

-00

RD

SET

MD

14-

12,

Patie

nt C

able

12

ft

040-

0033

10-0

0 8p

in m

asim

o C

able

RD

SET

04

0-00

3426

-00

LNC

S to

RD

Ada

pter

04

0-00

3381

-00

RD

to L

NC

Ada

pter

Cab

le

040-

0033

76-0

0 R

D

SET

DC

I, A

dult

Reu

sabl

e Se

nsor

04

0-00

3377

-00

RD

SET

DC

I, Pe

diat

ric R

eusa

ble

Sens

or

040-

0033

80-0

0 R

D

Set

TC-I

SpO

2 R

eusa

ble

Tip-

Clip

Ear

Sen

sor,

3ft

040-

0033

82-0

0 R

D S

ET A

dhes

ive

Sens

or

040-

0033

83-0

0 R

D S

ET P

DT

Adh

esiv

e Se

nsor

04

0-00

3384

-00

RD

Set

Infa

nt A

dhes

ive

Sens

or

040-

0033

85-0

0 R

D S

et N

eo A

dhes

ive

Sens

or

040-

0033

86-0

0 R

D S

et N

eoPt

Adh

esiv

e Se

nsor

04

0-00

3387

-00

RD

Se

t N

eoPt

-500

N

on-a

dhes

ive

sens

or

Supp

ort n

ew E

CG

ac

cess

orie

s N

ot su

ppor

ted

Add

ed

040-

0035

28-0

0 EC

G

cabl

e,

12-le

ad,

defib

rilla

tion-

proo

f, A

HA

MIN

DR

AY©PR

OPR

IETA

RY

Page

18

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Supp

ort n

ew C

O2

acce

ssor

ies

Not

supp

orte

d

Add

ed:

100-

0001

38-0

0 D

RYLI

NE

PRIM

E G

as S

ampl

ing

Line

With

Airw

ay A

dapt

er, A

dult/

Pedi

atric

10

0-00

0139

-00

DRY

LIN

E PR

IME

Gas

Sam

plin

g Li

ne W

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10

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DRY

LIN

E PR

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ith A

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, Adu

lt 10

0-00

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al

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, Ped

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as

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0001

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0 D

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c 10

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as

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g Li

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0001

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0 D

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NE

PRIM

E W

ater

Tra

p M

ini

MIN

DR

AY©PR

OPR

IETA

RY

Page

19

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Impr

ove

the

SpO

2/C

O2/

BIS

si

gnal

co

rd

resi

stan

ce

to

dam

age

Not

supp

orte

d Su

ppor

ted

Not

e: T

1 do

esn’

t sup

port

BIS

mod

ule

Cor

rect

ed

an

issu

es

whe

re

NIB

P m

isre

porte

d “N

IBP

Exce

ssiv

e M

otio

n” a

fter

49

days

of r

unni

ng

Not

supp

orte

d Su

ppor

ted

MIN

DR

AY©PR

OPR

IETA

RY

Page

20

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

The

End

tidal

(Et)

and

Frac

tion

of

insp

ired

(Fi)

num

eric

s fo

r an

esth

etic

ag

ent

(AA

) ph

ysio

logi

cal

alar

ms

are

trigg

ed

only

w

hen

the

mon

itore

d pa

ram

eter

val

ue is

hi

gher

th

an

the

high

al

arm

lim

it or

is

low

er t

han

the

low

al

arm

lim

it

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supp

orte

d Su

ppor

ted

Sam

e

Exte

nd th

e se

tting

ra

nge

of

low

al

arm

lim

it of

Et

O2

Not

supp

orte

d Su

ppor

ted

Sam

e

MIN

DR

AY©PR

OPR

IETA

RY

Page

21

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Supp

ort

the

non-

over

lapp

ing

rela

tions

hips

of

al

arm

lim

it se

tting

of

ph

ysio

logi

cal

alar

ms

Not

supp

orte

d Su

ppor

ted

Supp

ort

re-a

larm

ing

afte

r a

phys

iolo

gica

l al

arm

is re

set

Not

supp

orte

d Su

ppor

ted

Supp

ort

pass

wor

d pr

otec

tion

for

acce

ssin

g th

e A

larm

Se

tup

men

u

Not

supp

orte

d Su

ppor

ted

Supp

ort

auth

oriz

atio

n of

th

e us

er

via

the

LDA

P

Not

supp

orte

d Su

ppor

ted

Supp

ort

the

Faci

lity

info

rmat

ion

of

patie

nt m

onito

r

Not

supp

orte

d Su

ppor

ted

MIN

DR

AY©PR

OPR

IETA

RY

Page

22

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Supp

ort t

he R

oom

N

o.

info

rmat

ion

of p

atie

nt m

onito

r N

ot su

ppor

ted

Supp

orte

d

Supp

ort

the

Vis

it N

umbe

r in

th

e pa

tient

de

mog

raph

ics

Not

supp

orte

d Su

ppor

ted

Supp

ort

prin

ting

of t

he a

rrhy

thim

a se

tting

s in

repo

rts

Not

supp

orte

d Su

ppor

ted

Cha

nge

the

fact

ory

defa

ult

setti

ng o

f pr

inte

r pa

per s

ize

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supp

orte

d Su

ppor

ted

Supp

ort t

o di

spla

y th

e M

AC

add

ress

of

pat

ient

mon

itor

Not

supp

orte

d Su

ppor

ted

Supp

ort

the

disp

lay

mod

e of

ST

val

ues

in t

he

para

met

er ti

le

Not

supp

orte

d Su

ppor

ted

MIN

DR

AY©PR

OPR

IETA

RY

Page

23

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Supp

ort

encr

yptio

n of

pa

tient

pr

ivat

e in

form

atio

n se

nt

to th

e ne

twor

k

Not

supp

orte

d Su

ppor

ted

Supp

ort

Laird

2.

4GH

z/5G

Hz

Wifi

mod

ule

Supp

orte

d N

ot su

ppor

ted

Sam

e Su

ppor

ted

Supp

ort

adju

stm

ent

of t

he

ST

poin

t on

m

ultip

le

disp

laye

d le

ads

Supp

orte

d N

ot su

ppor

ted

Sam

e Su

ppor

ted

Supp

ort

QT

repo

rt pr

intin

g Su

ppor

ted

Not

supp

orte

d Sa

me

Supp

orte

d

Supp

ort

NIB

P m

easu

rem

ent

on

cloc

k Su

ppor

ted

Not

supp

orte

d Sa

me

Supp

orte

d

Supp

ort

netw

ork

appl

icat

ion

trans

mis

sion

pr

iorit

y se

tting

Supp

orte

d N

ot su

ppor

ted

Sam

e Su

ppor

ted

Supp

ort E

CG

bea

t an

nota

tion

Supp

orte

d N

ot su

ppor

ted

Sam

e Su

ppor

ted

MIN

DR

AY©PR

OPR

IETA

RY

Page

24

of 2

6 Pa

tient

Mon

itors

Pred

icat

e D

evic

e (P

assp

ort 1

2m a

nd 1

7m P

atie

nt M

onito

rs

K17

0876

T1

Patie

nt M

onito

r K

1529

02)

Subj

ect D

evic

es

Feat

ure

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Pass

port

17m

Pa

sspo

rt 1

2m

T1

Supp

ort

DN

S fo

r A

DT

and

LDA

P se

rver

add

ress

N

ot su

ppor

ted

Sam

e Su

ppor

ted

Cor

rect

ed

an

issu

es

whe

re t

he

Bed

N

o.

of

the

Pass

port

12m

/17m

is

ch

ange

d af

ter

T1

is

pulle

d ou

t of

th

e m

onito

rs

Not

supp

orte

d Sa

me

Supp

orte

d

MINDRAY©PROPRIETARY Page 25 of 26 Patient Monitors

Performance Data To establish the substantial equivalence of the Passport Series Patient Monitors

(Passport 12m, Passport 17m and T1), Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.

In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.

ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 :2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests IEC 60601-2-25: 2011 (2nd edition) Particular requirements for the basic safety and essential performance of electrocardiographs IEC 60601-2-27:2011 (3rd edition) Particular requirements for the safety, including essential performance of electrocardiographic monitoring equipment ISO 80601-2-61:2011 Particular requirements for the basic safety and essential performance of pulse oximeter equipment IEC 80601-2-30:2009/AMD1:2013 Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ISO 80601-2-56:2009 (First edition) Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement IEC 60601-2-34 (Third Edition): 2011 Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment - Part

MINDRAY©PROPRIETARY Page 26 of 26 Patient Monitors

2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Substantial Equivalence Conclusion:

Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport Series devices, Passport 12m and Passport 17m (K170876) and relevant reference predicates, T1 (K152902) and relevant reference predicates, the performance testing results and conformance with applicable standards show that the Passport Series Patient Monitors (including Passport 12m, Passport 17m and T1) can be found substantially equivalent to the predicate devices.