Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard vital signs monitor with basic data storage, display, and alarming functions. There is no mention of AI, ML, or any advanced analytical capabilities that would suggest the use of such technologies. The performance studies focus on electrical safety, EMC, and software verification/validation, not on the performance of an AI/ML algorithm.

Therapeutic

No
Explanation: The device is described as a monitor intended for monitoring, storing, reviewing, and alarming for physiological parameters. Its capabilities include displaying measuring data and producing alarms for patient care, but it does not describe any therapeutic or treatment function.

Diagnostic

No

The device is intended for monitoring, storing, and reviewing physiological parameters and generating alarms, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states it measures physiological parameters like NIBP, SpO2, PR, and TEMP, which requires hardware sensors and components. The performance studies also mention electrical safety and EMC testing, which are relevant to hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters". These parameters (NIBP, SpO2, PR, TEMP) are measured directly from the patient's body, not from a sample of bodily fluid or tissue in vitro (outside the body).
Device Description: The description reinforces that the device measures physiological parameters directly from the patient.
Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostics.

IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device measures vital signs directly from the patient, which falls under the category of patient monitoring devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The monitor is intended to be used for monitoring, storing, 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.

Product codes

MWI, DQA, DXN, FLL

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 instrument workflow.
The Round mode is designed to support hospital staff when doing ward 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)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults, pediatrics and neonates

Intended User / Care Setting

trained healthcare professionals in hospital environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical data: Electrical safety and electromagnetic compatibility (EMC) and Software Verification and Validation Testing were performed.
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 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."
The performance testing demonstrated that the subject devices are as safe and as effective as the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K131818

Reference Device(s)

K160981

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).

Summary

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December 21, 2018

Edan Instruments, Inc. % Alice Yang Regulatory 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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 (OS) 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 mediation-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,

Stephen C. Browning -S5

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K180380

Device Name iM3 vital signs monitor

Indications for Use (Describe)

The monitor is intended to be used for monitoring, storing, 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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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 and classification:	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 instrument workflow.

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

4

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)

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

1. 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:

Item
	iM3	M3	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

Table 1Comparison to predicates

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K180380 Page 3 of 11

| | 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