The Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).

The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.

The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both

Device Description

M3 and M3A Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature), in a hospital, hospital type facilities environment and intra-hospital moves. The following lists the detailed features of the subject device.

. LCD or LED display
SpO2, Pulse Rate NIBP and fast TEMP measurement .
Infrared ear temperature measurement
Nellcor or EDAN SpO2 module .
Display numeric and waveform information simultaneously .
Nurse call feature .
Built-in Lithium-ion Battery .
. Suitable for adult, pediatric and neonate patients
Visual and audible alarm .
Trend graph review and record .
USB data storage and review .
Wired and wireless network capability .

AI/ML Overview

The provided text describes the 510(k) submission for the Edan Instruments Vital Signs Monitor Models M3 and M3A. It confirms that the device is substantially equivalent to its predicate devices for non-invasive continuous monitoring of SpO2, NIBP, and temperature. However, the document does not contain specific acceptance criteria or detailed study results that prove the device meets such criteria.

The submission mentions "Verification and validation testing were conducted," and refers to "Software testing, Safety testing, Performance testing, Risk analysis, and Final validation," but it does not provide the quantitative or qualitative benchmarks used as acceptance criteria, nor does it present the results of these tests in detail.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, how ground truth was established) cannot be answered from the provided text.

Here's a summary of what can be extracted:

1. A table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria	Reported Device Performance
SpO2 Accuracy	Not specified in document	Not specified in document
NIBP Accuracy	Not specified in document	Not specified in document
Temperature Accuracy	Not specified in document	Not specified in document
General Safety	Not specified in document	Not specified in document
Software Functionality	Not specified in document	Not specified in document

Note: The document states that "Verification and validation testing were conducted" and implies these tests demonstrate substantial equivalence. However, it does not explicitly define the acceptance criteria or report the numerical results of these tests for specific performance metrics (e.g., SpO2 accuracy, NIBP accuracy, temperature accuracy).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the provided document.

4. Adjudication method for the test set

Not specified in the provided document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The device is a vital signs monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and is not mentioned in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document implies that the device's performance (standalone, as a medical device) was tested during verification and validation, but specific details or results of these standalone tests are not provided. The function of the device itself is the standalone performance, as it measures vital signs without human interpretation of raw data for diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified in the provided document. For vital signs monitors, ground truth would typically involve comparison against reference measurement devices or established clinical methods (e.g., arterial line for NIBP, highly accurate thermometer for temperature, CO-oximetry for SpO2). However, specific methodologies are not detailed here.

8. The sample size for the training set

This device is not described as an AI/ML device that requires a "training set." Therefore, this question is not applicable based on the provided text.

9. How the ground truth for the training set was established

This device is not described as an AI/ML device that requires a "training set." Therefore, this question is not applicable based on the provided text.

Summary

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KI20144

FEB 1 4 2012 510K)Summary of Safety and Effectiveness

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

Submitter:	Edan Instruments, Inc
	3/F - B, Nanshan Medical
	Equipments Park, Nanhai Rd 1019#,
	shekou, Nanshan Shenzhen,
	518067 P.R. China
	Tel: 86-755-26882220
	Fax:86-755-26882223
	Contact person: Jiang Yucai

Proprietary Name:	Vital Signs Monitor Models M3 and M3A
Classification Name:	21 CFR 870.1130 Noninvasive blood pressure measurement system
	21 CFR 870.2700, Oximeter
	21 CFR 880.2910 Clinical electronic thermometer
Product code:	DQA, DXN, FLL
Classification:	Class II
Predicate Devices:

Manufacturer	Predicate Device	510(k) #
EDAN INSTRUMENTS, INC.	M3,M3A	K102835
RADIANT INNOVATION, INC.	THP59J	K111637

M3 and M3A Vital Signs Monitor is a patient monitoring device providing the Device Description: patient with a continuous vital physiological monitoring of non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature), in a hospital, hospital type facilities environment and intra-hospital moves. The following lists the detailed features of the subject device.

. LCD or LED display
SpO2, Pulse Rate NIBP and fast TEMP measurement .
Infrared ear temperature measurement �
Nellcor or EDAN SpO2 module .
Display numeric and waveform information simultaneously .
Nurse call feature .
Built-in Lithium-ion Battery .

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. Suitable for adult, pediatric and neonate patients
Visual and audible alarm .
Trend graph review and record .
USB data storage and review .
Wired and wireless network capability .

Comparison with predicate device

Monitoring unctions	Subject device	Predicated device
SpO2	yes	yes
Pulse Rate	yes	yes
Alarm feature	yes	yes
NIBP	yes	yes
Temperature	yes	yes

Intended Use:

The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both

The following quality assurance measures were applied to the Test Summary: development of the Vital Signs Monitor Models M3 and M3A:

Software testing
· Safety testing
· Performance testing
· Risk analysis
Final validation

Verification and validation testing were conducted on the Vital Signs Conclusion: Monitor Models M3 and M3A. This premarket notification submission demonstrates that Vital Signs Monitor Models M3 and M3A is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 1 4 2012

Edan Instruments, Inc. c/o Mr. Randy Jiang Certification Engineer 3/F-B, Nanshan Medical Equipment Park, Nanhai Rd., 1019 No. Shenzhen CHINA 518067

Re: K120144

Trade/Device Name: Vital Signs Monitor, Models M3 and M3A Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Codes: DXN, DQA, FLL Dated: January 16, 2012 Received: January 18, 2012

Dear Mr. Jiang:

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 for association 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. 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.

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 i hat FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Randy Jiang

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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EXHIBIT #3

Indications for Use

510(k) Number (if known):

K120144

Device Name: Vital Signs Monitor models M3 and M3A

The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both

× Prescription Use (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sion of Cardiovascular Devices

510(k) Number K120144

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).