The H100B Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.

Device Description

H100B Pulse Oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities. The sampled signal from finger sensor is processed in the main unit and transferred into electronic signal to display the SpO2 value, pulse rate value on the LCD at the form of numeral, plethysmogram, bar graph and waveform. Data management software (Oximeter Viewer) can transferred stored data into PC for storage, review and printing. The subject device is powered by 4 pieces 1.5V AA batteries or 4 pieces 1.2V Ni-H rechargeable AA batteries. Alarm capability including audio alarm and indicator is provided when the SpO2 value is lower than the limit setup or some technical reason.

AI/ML Overview

The provided text is a 510(k) summary for the H100B Pulse Oximeter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and device performance based on a new clinical trial.

Therefore, this document does not contain the detailed information required to fill out the requested table and answer many of the specific questions. The submission primarily discusses the intended use, device description, comparison with a predicate device (PM 60 Pulse Oximeter K072581), and a general statement about "Verification and validation testing." It explicitly states that "This premarket notification submission demonstrates that H100B Pulse Oximeter is substantially equivalent to the predicate device."

Here's what can be extracted based on the limited information provided:

1. Table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. The document does not specify quantitative acceptance criteria or report performance data.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not present in the provided 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present in the provided 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not present in the provided 510(k) summary.

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

This information is not present and likely not applicable. The H100B Pulse Oximeter is not an "AI" device that assists human "readers" in a diagnostic context; it's a physiological monitoring device.

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

This information is not explicitly stated in the provided 510(k) summary. As it's a pulse oximeter, its primary function is standalone measurement and display. Performance would typically involve comparing its readings to a gold standard, not necessarily evaluating an "algorithm only" in the context of diagnostic AI.

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

This information is not present in the provided 510(k) summary. For pulse oximeters, ground truth for SpO2 measurements typically involves a co-oximeter or blood gas analyzer. The document does not specify how "verification and validation testing" was conducted.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. This type of submission does not typically detail training sets for algorithms in the way an AI/ML device would.

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

This information is not present in the provided 510(k) summary.

In summary, the provided 510(k) document is a regulatory submission focused on substantial equivalence rather than a detailed scientific study report detailing acceptance criteria and performance data from a specific clinical or technical study. It lacks the granularity of information needed to answer most of your questions.

Summary

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K092727)

DEC -- 3 2009 H100B Pulse Oximeter 510(k) Submission Section 1

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, 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
Official correspondent: _ William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 X27 Fax: 914 376 6111
H100B Pulse Oximeter Proprietary Name:
Classification Name: _ 21 CFR 870.2700 Oximeter

DQA Product code:

Classification: Class II

Predicate Devices: PM 60 Pulse Oximeter K072581 Shenzhen Mindray Bio-medical Electronics Co., LTD

Device Description: H100B Pulse Oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities. The sampled signal from finger sensor is processed in the main unit and transferred into electronic signal to display the SpO2 value, pulse rate value on the LCD at the form of numeral, plethysmogram, bar graph and waveform. Data management software (Oximeter Viewer) can transferred stored data into PC for storage, review and printing.

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H100B Pulse Oximeter 510(k) Submission Section 1

The subject device is powered by 4 pieces 1.5V AA batteries or 4 pieces 1.2V Ni-H rechargeable AA batteries. Alarm capability including audio alarm and indicator is provided when the SpO2 value is lower than the limit setup or some technical reason.

Comparison with predicate device

	Subject device	Predicated device
Monitoring functions	H100B Pulse Oximeter	PM60 Pulse Oximeter
SpO2	yes	yes
Pulse Rate	yes	yes
Alarm feature	yes	yes
Data managementsoftware	yes	yes

Intended Use: The H100B Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.

Test Summary: The following quality assurance measures were applied to the development of the H100B Pulse Oximeter:

· Software testing
Safety testing
Risk analysis
Final validation

Conclusion: Verification and validation testing was done on the H100B Pulse Oximeter. This premarket notification submission demonstrates that H100B Pulse Oximeter is substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC - 8 2009

Edan Instruments, Incorporated C/O Mr. Li Fu Consultant Shanghai MidLink Business Consulting Company, Limited Suite 8D, No. 19, Lane 999, Zhongshan Road (S-2) Shanghai, 200030, China

Re: K092727

Trade/Device Name: H100B Pulse Oximeter Regulation Number: 21CFR 870.2700 ·Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 31, 2009 Received: September 4, 2009

Dear Mr. Fu:

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 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.

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Page 2- Mr. Fu

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); 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/ReportalProblem/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,

for

Susan Runner, D.D.S., M.A. Acting Division 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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H100B Pulse Oximeter 510(k) Submission Section 1

Indication for Use

510(k) Number (if known):

H100B Pulse Oximeter Device Name:

Prescription Use (21 CFR Part 801 Subpart D) Or Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

(Division Sign-Off) · vision of Anesthesiology, General Hospital nection Control, Dental Devices

-10(k) Number: K692727

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).