U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 3 . 0 3 Silver Spring, MD 20993 www.fda.gov

Edan Instruments, Inc. ℅ Alice YangRegulatory Engineer Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089

Re: K180380 Trade/Device Name: iM3 vital signs monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI, DQA, DXN, FLL Dated: November 21, 2018 Received: November 27, 2018

Dear Alice Yang:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Stephen C. Browning -S5

Traditional 510(k) Submission of iM3 Vital Signs Monitor

005_5.0_Indications_for_Use 1／1

K180380

510(K) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

1. Submitter: Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen, 518122 P.R.China. Tel: +86(0755) 26858736 Fax: +1 (408) 418-4059

Contact person: Alice Yang Preparing date: December 21, 2018

2. Device name andclassification:

Device Name: Vital Signs Monitor Model: iM3 Classification Name/ Product code: 21 CFR 870.2300 Cardiac monitor (including cardiotachometer and rate alarm)/MWI 21 CFR 870.1130 Noninvasive blood pressure measurement system/DXN 21 CFR 870.2700, Oximeter/DQA 21 CFR 880.2910 Clinical electronic thermometer/FLL Regulatory Class: Class II

3. Predicate Device(s): 1) Edan Instruments, Inc, Vital Signs Monitor Model M3,K131818(Primary) 2) Edan Instruments, Inc, Patient Monitor Model V5 V6 V8, K160981(Reference)

4. Device Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). • For the Monitor mode, the user can do continuous measurement,

monitoring, alarming and manager patient data.• For the Spot mode, also call spot check mode, the user can measure

parameters quickly without creating a patient within the instrumentworkflow.

• The Round mode is designed to support hospital staff when doing ward

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rounds. The Round mode is similar as Spot mode. The difference between Round mode and Spot mode is that for one ward round, the iM3 can additionally store one ward round record automatically (the latest measurement) or manually (user can choose the measure results).

iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately.

The iM3can connect with EDAN’s MFM-CMS Central Monitoring System to display the iM3 data on a remote work station. The MFM-CMS system received FDA 510(k) clearance on June 21, 2013(K120727)

Note: Not all sensors are intended for neonatal patients. The intended population for each sensor is detailed in the section 6 below.

.

5. Indication for Use The monitor is intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments. Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP. The monitor is not intended for MRI environments. TEMP module is not intended for neonates.

6. Predicate Device Comparison

The subject device shares the same characteristics in most items with the predicate device except in the following aspects: Table 1Comparison to predicates

Item <Subject Device> iM3

<Predicate Device> M3

<Predicate Device> V5/V6/V8

K# Current Submission K131818 K160981 Intended Use

Description

The monitor is intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics

The monitor is intended to be used by qualified physicians or personnel professionally trained and it is for monitoring adults, pediatrics and neonates in hospital environments.

The monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for

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and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments.

Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP.

The monitor is not intended for MRI environments. TEMP module is not intended for neonates.

This monitor is used to monitor vital signals for patients and is suitable for use in hospital environments including out-patient department, wards and NICU.

Monitored parameters include: NIBP, SpO2, pulse rate, Quick TEMP/Infrared TEMP.

use by trained healthcare professionals in hospital environments. The monitored physiological

parameters include: ECG,

respiration (RESP), temperature

(TEMP), oxygen saturation of

arterial blood (SpO2), pulse rate

(PR), non-invasive blood

pressure (NIBP), invasive blood

pressure (IBP), carbon dioxide

(CO2), cardiac output (C.O.),

anesthetic gas (AG), bispectral

index (BIS), respiration

mechanics (RM) and impedance

cardiography (ICG).

Intended patient population

adult, pediatric and neonatal patients

adult, pediatric and neonatal patients

Same

Intended application environment

Hospital environment. Hospital environment.

Same

NIBP monitor (EDAN Module)

Principle of Operation

Oscillation Oscillation

Measurement Range

Adult Systolic 40 to 270 mmHg Diastolic 10 to 215 mmHg Mean 20 to 235 mmHg

Pediatric Systolic 40 to 230 mmHg Diastolic 10 to 180 mmHg Mean 20 to 195 mmHg

Neonate Systolic 40 to 135 mmHg Diastolic 10 to 100 mmHg

Adult Systolic 40 to 270 mmHg Diastolic 10 to 215 mmHg Mean 20 to 235 mmHg

Pediatric Systolic 40 to 200 mmHg Diastolic 10 to 150 mmHg Mean 20 to 165 mmHg

Neonate Systolic 40 to 135 mmHg Diastolic 10 to 100 mmHg

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Mean 20 to 110 mmHg Mean 20 to 110 mmHg

Accuracy

Maximum average error: ±5 mmHg Maximum standard deviation: 8 mmHg

Maximum average error: ±5 mmHg Maximum standard deviation: 8 mmHg

Resolution 1 mmHg 1 mmHg Maximum measuring period

Adult/Pediatric 120s Neonate 90s

Adult/Pediatric 120s Neonate 90s

Overpressure protection

Adult 297±3 mmHg Pediatric 245±3 mmHg Neonate 147±3 mmHg

Adult 297±3 mmHg Pediatric 240±3 mmHg Neonate 147±3 mmHg

Mode Manual, Auto, Continuous Manual, Auto, Continuous Measuring interval in AUTO Mode

1/2/3/4/5/10/15/30/60/90/120/180/240/360/480 mins

1/2/3/4/5/10/15/30/60/90/120/240/480 mins

Continuous 5min 5min PR from NIBP Measurement range 40 to 240 bpm 40 bpm to 240 bpm

Accuracy ±3 bpm or ±3.5%, whichever is greater

±3 bpm or 3.5%,

whichever is greater Resolution 1 bpm 1 bpm NIBP monitor(Suntech Module) Principle of Operation

oscillation Same

Measurement Range

Adult SYS: 40 mmHg ~ 260 mmHg DIA: 20 mmHg ~ 200 mmHg MAP: 26 mmHg– 220 mmHg

Pediatric SYS: 40 mmHg– 230 mmHg DIA: 20 mmHg– 160 mmHg MAP: 26 mmHg– 183 mmHg

Neonate SYS: 40 mmHg – 130 mmHg DIA: 20 mmHg– 100 mmHg MAP: 26 mmHg – 110 mmHg

Same

Accuracy Maximum average error: Same

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±5mmHg Maximum standard deviation: 8mmHg

Resolution 1mmHg Same

Maximum measuring period

Adult 130s Pediatric 120s Neonate 75s

Same

Overpressure protection

Adult /Pediatric <300mmHg Neonate 150mmHg

Same

Mode Manual, Auto, Continuous, Average

Manual, Auto, Continuous

Measuring interval in AUTO Mode

1/2/3/4/5/10/15/30/60/90/120/180/240/360/480 mins

1/2/3/4/5/10/15/30/60/90/120/240/480 mins

Continuous 5min Same PR from NIBP Same Measurement range 30 bpm to 220 bpm Same

Accuracy ±3 bpm or 2%,

whichever is greater

Same

SpO2 monitor (EDAN Module) Measurement Range

SpO2 0-100% Pulse Rate 25 to 300 bpm

SpO2 0-100% Pulse Rate 25 to 300 bpm

Accuracy

Saturation Adult/pediatric, non-motion conditions 70 to 100% ±2 %

0-69% unspecified Neonate

70 to 100% ±3% 0-69% unspecified

Pulse Rate Adult and Neonate 25 to 300 bpm ±2bpm (non-motion conditions)

Saturation Adult/pediatric, non-motion conditions 70 to 100% ±2 %

0-69% unspecified Neonate

70 to 100% ±3% 0-69% unspecified

Pulse Rate Adult and Neonate 25 to 300 bpm ±2bpm (non-motion conditions)

Resolution SpO2 1% Pulse Rate 1 bpm

SpO2 1% Pulse Rate 1 bpm

Sensor Emitted Light Energy: ≤15 mW

Emitted Light Energy: ≤15 mW

SpO2 monitor (NELLCOR Module) Optional Spo2 NELLCOR SpO2 module NELLCOR SpO2 module

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module TEMP monitor(EDAN quick temp module)

Measuring range Monitor mode: 25 °C ~45 °C Predict mode: 35.5 °C ~42 °C

Monitor mode: 25 °C ~45 °C Predict mode: 35.5 °C ~42 °C

Working temperature

10°C ~ 40°C 10°C ~ 40°C

Sensor type Oral /axillary /rectal Oral /axillary /rectal Adjustable range of alarm limits

35.5 °C ~42 °C 35.5 °C ~42 °C

Resolution 0.1 °C 0.1 °C

Accuracy Monitor mode: ±0.1 °C (25 °C ~ 45 °C )

Monitor mode: ±0.1 °C (25 °C ~ 45 °C )

Response time < 60 s < 60 s Update time 1 s~ 2 s 1 s~ 2 s Warm-up time <10 s <10 s Time for predicting <30 s <30 s Calibration Self-test interval: ≤5 minutes Self-test interval: ≤5 minutes Clinical Bias (-0.2 to -0.4 )°C (-0.2 to -0.4 )°C Limits of Agreement

0.49 0.49

Stability 0.14 °C 0.14 °C TEMP monitor(infrared ear temp module) Measuring range 34 °C ~ 42.2 °C 34 °C ~ 42.2 °C Working temperature

10 °C~ 40 °C 10 °C~ 40 °C

Adjustable range of alarm limits

35.5 °C~ 42 °C 35.5 °C~ 42 °C

Resolution 0.1 °C 0.1 °C Response time 1 s 1 s Measuring Mode Adjusted Mode Adjusted Mode

Clinical Accuracy

±0.2 C (0.4 °F) (35.5 °C ~42 °C ) (95°F ~107.6°F)

±0.3 C (0.5°F) (out of the range mentioned above)

±0.2 C (0.4 °F) (35.5 °C ~42 °C ) (95°F ~107.6°F)

±0.3 C (0.5°F) (out of the range mentioned above)

Response time 1s 1s Laboratory ±0.2 °C ±0.2 °C

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Accuracy TEMP monitor(Covidien F3000 quick temp module) Measuring range 30°C~43°C 30°C~43°C Prediction measurement range

35°C～43°C 35°C～43°C

Cold mode prediction measurement range

33°C～43°C 33°C～43°C

Working temperature

10°C ~ 40°C 10°C ~ 40°C

Sensor type Oral /axillary /rectal Oral /axillary /rectal Alarm range 33°C ~ 43°C 33°C ~ 43°C Resolution 0.1°C 0.1°C

Accuracy

Monitoring Mode and Predictive Mode: ±0.1 °C Quick Predictive Mode: ±0.3 °C

Monitoring Mode and Predictive Mode: ±0.1 °C Quick Predictive Mode: ±0.3 °C

Typical measurement time (after insertion into measurement site)

Oral (Quick Predictive Mode): (3~5) s (non-fever temps); (8~10) s (fever temps) Oral (Predictive Mode): (6~10) s Axillary: (8~12) s Rectal: (10~14) s Monitoring Mode (all sites): (60~120) s

Oral (Quick Predictive Mode): (3~5) s (non-fever temps); (8~10) s (fever temps) Oral (Predictive Mode): (6~10) s Axillary: (8~12) s Rectal: (10~14) s Monitoring Mode (all sites): (60~120) s

Measuring Mode Direct Mode /Adjusted Mode Direct Mode /Adjusted Mode Transient Response Time

≤30 s monitoring mode ≤30 s monitoring mode

Clinical Bias (-0.2 to -0.4 )°C (-0.2 to -0.4 )°C Limits of Agreement

0.49 0.49

Stability 0.14 °C 0.14 °C Safety Classifications Type of protection against electric shock

Class I Class I

Ingress Protection IPX1 With TEMP module: Ordinary

IPX1 With TEMP module: Ordinary

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equipment (Sealed equipment without liquid proof)

equipment (Sealed equipment without liquid proof)

The degree of RF Group 1, Class A Group 1, Class A The degree of protection against electric shock TEMP(EDAN quick temp)

BF CF

NIBP, SpO2,TEMP(Covidien quick temp \infrared ear temp )

BF BF

Electrical & Mechanical safety & Thermal safety Standards General Standards IEC 60601-1:2005 IEC 60601-1:

1988+A1:1991+A2:1995 EMC Standards IEC 60601-1-2:2014 IEC60601-1-2: 2001+A1:2004 Alarm Standards IEC 60601-1-8:2012 / Biocompatibility Standards

ISO 10993-1:2009 /

Software Standards IEC 62304:2006 / Special Standards basic safety and essential performance for patient monitor

IEC 60601-2-49: 2011 IEC 60601-2-49: 2001

NIBP IEC 80601-2-30: 2009 ISO 81060-2:2013

IEC60601-2-30:2000

SPO2 ISO 80601-2-61: 2011 ISO 9919 TEMP ISO 80601-2-56 E1112-00:2006 Power supply AC power Requirement 100-240V, 50/60 Hz 100-240V, 50/60Hz Battery Rechargeable Battery

Yes Yes

Operation characteristic Installation and use Portable Equipment

Fix Equipment (when the system is installed on Wall Mounting Bracket)

Portable Equipment Fix Equipment (when the system is installed on Wall Mounting Bracket)

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Working System Continuous operation Continuous operation Working mode Monitor, Spot, Round Monitor, Spot Physical Characteristics Weight <2.5 kg <3.5 kg

Dimensions (159±1) mm (W) × (262±1) mm (H) × (166±1) mm (D)

174 mm (L) × 235 mm (H) × 189 mm (D)

LCD 8 inches Color TFT Display touch screen

5.6 inch

LCD Resolution 800x600 pixels 640×480 pixels Environmental Specifications Temperature Working 0ºC to 40 ºC

With TEMP: +10 °C ~ +40 °C +5°C to +40°C With TEMP: +10 °C ~ +40 °C

Transport and Storage

-20 ºC to 55 ºC -20°C to +55°C

Humidity Working 15% to 95% (non-condensing) 25% ~ 80% (no coagulate) Transport and Storage

15% to 95% (non-condensing) 25% ~ 93% (no coagulate)

Atmospheric Pressure Working 86 kPa ~ 106 kPa 86 kPa to 106 kPa

Transport and Storage

70 kPa ~ 106 kPa 70 kPa to 106 kPa

Other function E-link Bluetooth Low Energy 4.0 NO Alarm indicator 3(red/yellow/blue) 3(red/yellow/blue) AC power indicator 1(green) 1(green) Battery indicator 1(green/ yellow) 1(green/ yellow) Speaker Yes Yes Recorder Yes Yes

Data Storage Trend, NIBP Measurement Review, Alarm Review, waveforms

Trend, NIBP Measurement Review, Alarm Review, waveforms

Interface USB /Network/Nurse call/ USB /Network/Nurse call/ Care and Cleaning Recommended cleaning agents

Mild neutral detergent Ethanol (75%)

Mild neutral detergent Ethanol (75%)

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Isopropanol (70%) Isopropanol (70%) Recommended types of disinfecting agents

Ethanol (75%) Isopropanol (70%)

Ethanol (75%) Isopropanol (70%)

Cleaning surface-clean the monitor with a soft cloth dampened with the cleaning solution

surface-clean the monitor with a soft cloth dampened with the cleaning solution

Disinfecting Following hospital’s policy Following hospital’s policy WI-FI IEEE 802.11b/g/n Same Frequency Band 2.4GHz ISM band Same Modulation OFDM with BPSK, QPSK,

16-QAM, and 64-QAM

802.11b with CCK and DSSS

Same

Typical Transmit Power (±2 dBm)

17 dBm for 802.11b DSSS

17 dBm for 802.11b CCK

15 dBm for 802.11g/n OFDM

Same

Touch screen

8 inch touch screen V5 12.1 inch touch screen V6 15 inch touch screen V8 17 inch touch screen

As seen in the comparison table, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

7. Performance Data:

Non-clinical data:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the iM3 Vital Signs Monitor. The system complies with

- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-8: 2006, IEC 60601-2-49: 2011, IEC 80601-2-30:2009, ISO 80601-2-56: 2009 and ISO 80601-2-61:2011 standards for safety and the IEC 60601-1-2: 2014 standard for EMC.

Coexistence testing was performed and adhere to the Radio Frequency Wireless Technology in Medical Devices guidance document recommendations.

Software Verification and Validation Testing

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Software verification and validation testing were conducted, and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”

Summary

The performance testing demonstrated that the subject devices are as safe and as effective as the predicate device.

8. Conclusion

The performance data and software verification and validation demonstrate that iM3 Vital Signs Monitor are substantially equivalent to the predicate device.

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