The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital, hospital type facilities environment and intra-hospital moves.

The Vital Signs 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

M3B Vital Signs Monitor supplies the following features:

5.7 inch LCD display .
Sp02, Pulse Rate, and Respironics CO2 measurement .
Nellcor OxiMax SpO2 .
Display numeric and waveform information simultaneously .
Nurse call .
Powerful storage capacity .
Built-in Lithium-ion Battery ●
Suitable for adult, pediatric and neonate patients .
Visual and audible alarm .

AI/ML Overview

The provided document describes the Edan Instruments, Inc. Vital Signs Monitor (Model M3B). This device is indicated for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.

However, the provided text does not contain the detailed acceptance criteria for the device's performance, nor does it present the specific study data that demonstrates the device meets such criteria. The document primarily focuses on the 510(k) summary, establishing substantial equivalence to predicate devices, and outlining the intended use and general testing performed.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states "Verification and validation testing was done on the M3B Vital Signs Monitor," but it does not specify what the acceptance criteria for SpO2 or CO2 accuracy were, nor does it report the device's measured performance against those criteria (e.g., accuracy, bias, precision for SpO2 or CO2 measurements).

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided document. The document mentions "Software testing," "Safety testing," "Risk analysis," and "Final validation" as applied measures, but it does not discuss specific test sets for performance evaluation, their sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not available in the provided document. The document does not describe any studies involving expert review for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not available in the provided document. As no specific test set involving expert review is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. This type of study typically involves human readers interpreting cases with and without AI assistance to measure performance improvement, which is not relevant for a vital signs monitor that provides direct measurements.

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

Yes, implicitly. Vital signs monitors like the Model M3B are standalone devices that provide objective measurements (SpO2, CO2, Pulse Rate). Their performance is inherently "standalone" in that they produce a numerical output based on sensor data without direct human interpretation being part of the measurement process itself. While the device's use requires clinical personnel supervision, the measurement of SpO2 and CO2 is an algorithm-only function. However, the results of such standalone performance (e.g., accuracy, precision) are not provided.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not available in the provided document. For SpO2 and CO2 monitors, ground truth is typically established using highly accurate reference methods (e.g., co-oximetry for SpO2, calibrated gas analyzers for CO2) under controlled physiological conditions. However, the document does not specify how ground truth was established for the validation of this device.

8. The Sample Size for the Training Set

Not applicable/Not available in the provided document. The Model M3B is a vital signs monitor that measures physiological parameters. It is highly unlikely to involve a "training set" in the context of machine learning. Its algorithms are typically based on established physiological models and signal processing, not on training data in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not available in the provided document. See point 8.

Summary

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Attachment A

K083821

510 (K) 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, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: 86-755-26882220Fax:86-755-26882223Responsible person: Jiang Yucai	MAY 14 2009
Official correspondent:	William Stern

Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 X27 Fax: 914 376 6111

Proprietary Name: Vital Signs Monitor (Model M3B)

Classification Name: 21 CFR 870.2700 Oximeter DQA

21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-p CCK

Predicate Devices:

Predicate devices	Capnostream 20	TidalWave SP,Model 710/715
Manufacturer	Oridion 1987Medical Ltd	Respironicsovametrix,Incorporated
K #	K060065	K032971

Device Description:

M3B Vital Signs Monitor supplies the following features:

5.7 inch LCD display .
Sp02, Pulse Rate, and Respironics CO2 measurement .
Nellcor OxiMax SpO2 .
Display numeric and waveform information simultaneously .
Nurse call .
Powerful storage capacity .
Built-in Lithium-ion Battery ●
Suitable for adult, pediatric and neonate patients .
Visual and audible alarm .

Comparison with predicate device

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Attachment A

Monitoringfunctions	M3B VitalSigns Monitor	Capnostream20	Tidal WaveSP, Model710/715
SpO2,Pulse Rate	yes	yes	yes
CO2measurement	yes	yes	yes

Intended Use:

The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.

The Vital Signs 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.

Test Summary:

The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor

Software testing
. Safety testing
. Risk analysis
. Final validation

Conclusion:

Verification and validation testing was done on the M3B Vital Signs Monitor. This premarket notification submission demonstrates that M3B Vital Signs Monitor is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAY 14 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edan Instruments, Incorporated C/o Mr. William Stern Multigon Industries, Incorporated 1 Odell Plaza Yonkers, New York 10701

Re: K083821

Trade/Device Name: Vital Signs Monitor (Model M3B) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, CCK Dated: May 5, 2009 Received: May 6, 2009

Dear Mr. Stern:

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. 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 cither 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

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Page 2- Mr. Stern

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); 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Quares

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

KO83821 . 510(k) Number (if known):

Device Name:

Vital Signs Monitor (Model M3B)

The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.

The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal psage in a hospital environment and intra-hospital moves.

The Vital Signs 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)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

y Lhuta

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k08382

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).