The Disposable Pulse Oximeter Sensor is indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or neonatal patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments.
The Reusable Pulse Oximeter Sensors are indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or pediatric patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments.

Device Description

The proposed devices of the Pulse Oximeter Sensors (Disposable and Reusable), are used in conjunction with oximeter equipment to measure and display the arterial oxygen saturation of blood.

AI/ML Overview

The provided document is limited in detail regarding the acceptance criteria and study that proves the device meets them. It primarily focuses on substantiating equivalence to predicate devices based on safety and effectiveness, rather than providing specific performance metrics against defined acceptance criteria from a standalone study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for device performance (e.g., accuracy ranges for SpO2 or pulse rate) nor does it present a table of reported device performance against such criteria. The "Test Conclusion" section mentions "Bench tests were conducted to verify that the proposed device met all design specifications," but these specifications are not detailed or quantified in the provided text.

The closest equivalent to "acceptance criteria" discussed are the standards the device complies with, which are safety and electrical performance standards, not clinical accuracy standards.

Acceptance Criteria (Implied/Standard)	Reported Device Performance
Compliance with IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety)	Stated that "Bench tests were conducted to verify that the proposed device met all design specifications" and listed compliance with IEC 60601-1.
Compliance with IEC 60601-1-2 (Collateral Standard: Electrical equipment - Electromagnetic compatibility)	Stated compliance with IEC 60601-1-2.
Compliance with ISO 9919:2005 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use)	Stated compliance with ISO 9919:2005. This standard would typically include accuracy requirements for SpO2, but the specific performance results against these requirements are not detailed in this document.
Substantial Equivalence to Predicate Devices	Concluded "Substantially Equivalent (SE) to the predicate devices... in respect of safety and effectiveness." This implies that the device is expected to perform comparably to the predicate without explicitly stating numerical performance.

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

The document mentions "Bench tests were conducted" but does not provide any information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). Without details on a clinical accuracy study, this information is absent.

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

This information is not provided in the document as there is no mention of a clinical accuracy study that would involve expert assessment for establishing ground truth. The submission focuses on technical equivalence and compliance with general safety/performance standards.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a human-involved study or test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not mentioned or conducted according to this document. The submission is for a pulse oximeter sensor, which is a diagnostic device that outputs numerical values (SpO2 and pulse rate), not an imaging or diagnostic aid that would typically involve human readers interpreting cases with and without AI assistance.

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

The document describes "Bench tests" and compliance with standards, which can be considered standalone testing of the device's performance. However, specific details of these tests (e.g., specific accuracy values for SpO2 and pulse rate, details of controlled hypoxia studies) are not provided in this summary. For pulse oximeters, standalone performance typically involves testing against a reference oximeter during induced hypoxia studies, but the specifics of this particular device's results from such a study are not in this summary. The mention of ISO 9919:2005 implies such testing was likely performed.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation. For pulse oximeters, the ground truth for SpO2 measurements in clinical accuracy studies is typically established using co-oximetry of arterial blood samples. However, as a detailed clinical study is not summarized here, the method for establishing ground truth is not specified. For the bench tests, the ground truth would typically be established by calibrated reference equipment.

8. The Sample Size for the Training Set

This information is not applicable as the device is a pulse oximeter sensor, not an AI/ML-based algorithm that requires a "training set" in the conventional sense. The device's underlying technology and calibration would be based on physiological models and empirical data, but not referred to as an "AI training set."

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

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

In summary: The provided document is a 510(k) summary that focuses on establishing substantial equivalence through regulatory compliance and bench testing without detailing specific clinical performance acceptance criteria or the results of a dedicated clinical accuracy study. It primarily asserts that the device meets safety and basic performance criteria common to pulse oximeters and is comparable to existing predicate devices.

Summary

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Exhibit #5 510(k) Summary

JUL 1 5 2011

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K103685

Date of Submission: June 27, 2011 l.

1. Sponsor
  Beijing Rongrui-Century Science & Technology Co., Ltd. Room 105-107, Part 1, XianFeng Building, No 7 KaiTuo Road, ShangDi, HaiDian District, Beijing, 100096, P.R.China

Contact Person: Yanan Gao Position: Quality Manager Tel: +86-10-51658220 Fax: +86-10-82781761 Email: r.rui@vip.tom.com

Submission Correspondent 3. Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

1. Proposed Device Identification
  Proposed Device Name: Pulse Oximeter Sensor (Disposable and Reusable) Proposed Device Model: RSA002DN, RSJ002DA, RSJ091DI, RST063CA Classification: II Product Code: DQA Regulation Number: 21 CFR 870.2700 Review Panel: Anesthesiology

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Intended Use Statement:

The Disposable Pulse Oximeter Sensor is indicated for non-invasive spot checking and/or The Disposable Pulse Oximeter Senson saturation and pulse rate of the adult or neonatal
continuous monitoring of arterial oxygen saturation and pulse rate of the adulties, an > continuous monitoring of arterial oxygen saturation and purse facilities, and home care
patients with oximeter equipment in hospitals, hospital-type facilitics, and home care environments.
The Reusable Pulse Oximeter Sensors are indicated for non-invasive spot checking and/or The Reusable Pulse Oximeter Sensors are innution and pulse rate of the adult or pediatric
continuous monitoring of arterial oxygen saturation and pulse rate of the adulties, > continuous monitoring of arterial oxygen saturation and panso reactives, and home care environments.
Predicate Device Identification న.

Predicate Device 1

510(k) Number: K082487 JTo(K)
Product Name: SpO2 Pulse Oximeter Sensor Manufacturer: Manufacturer.
Beijing Choice Electronic Technology Co., Ltd. Beljing - 1128 Building B, Bailangyuan Fuxing Road, No. A36 Beijing, China 100039

Predicate Device 2

510(k) Number: K093853 Predicate Device Name: Model 6000CN Sensor Manufacturer: Nonin Medical, Inc. 13700 1st Ave. North Plymouth, MN 55441-5443

Device Description 6.

The proposed devices of the Pulse Oximeter Sensors (Disposable and Reusable), are used in The proposed devices of the Pulse Oximeter Sensors (Disposatio and arterial oxygen saturation of blood.

2

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Premarket Notification 510(k) Submission

rintion

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		Table 1 General Description
Model	Type	Intended Population	Matched U.S. Legally MarketedOximeter and Monitor
RSA002DN	Disposable / Wrapping	Adult (>30kg)	Nellcor N595 (K102891)
		Neonatal (<2kg)
RSJ002DA	Resuable / Finger Clip	Adult (>30kg)	Nellcor N595 (K102891)
RSJ091D1	Reusable / Finger Clip	Pediatric (3-20kg)	BLT M9000 (K100046)
RST063CA	Reusable / Finger Cot	Adult (>30kg)	BLT M7000 (K100046)

Test Conclusion 7.

Bench tests were conducted to verify that the proposed device met all design specifications as was Bench tests were conducted to verify that the proposed device. The test results demonstrated that the proposed
Substantially Equivalent (SE) to the predicate device. The test Substantially ----------------------------------------------------------------------------------------------------------------------------------------------------------------

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety, 1988;
1988; 1988; 1988; 1995; > IEC 60001
Amendment 1, 1991-11, Amendment 2, 1995;
Amendment 1, 1991-11, Amendment 2, 1993;
IEC 60601-1 Medical Electrical Equipment Part 1-2; General Requirements and Tests, 2007 IEC 60601-1 Medical Electrical Equipitient ア
Collateral standard: Electrical equipment-Particular requirements for the basic safety and
ISO 9919:2005, Medical electrical equipment-Particular requirements for the basic s A

ISO 9919:2005, Medical Cleculture of Provinces equipment for medical use.
essential performance of pulse oximeter equipment for medical use.

Substantially Equivalent Conclusion 8.

The proposed device, Pulse Oximeter Sensor (Disposable and Reusable), is determined to be The proposed device, Pulse Oximeter Sensor (DISposable and Treaters),
Substantially Equivalent (SE) to the predicate devices, SpO2 Pulse Oximeter sensor (K082487) and
Substan Substantially Equivalent (OD) 10 the 11 safety and effectiveness.
NONIN 6000CN (K093853), in respect of safety and effectiveness.
The Children (K093853), in respect of safety

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the emblem.

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

Beijing Rongrui-Century Scie. & Tech Company, Limited C/O Ms. Diana Hong General Manager Mid-Consulting Company, Limited P.O. Box 237-023 Shanghai, China 200237

JUL 15 2011

Re: K103685

Trade/Device Name: Pulse Oximeter Sensor (Disposable and Reusable) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 27, 2011 Received: June 29, 2011

Dear Ms. Hong:

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. 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.

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Page 2- Ms. Hong

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/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,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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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Premarket Notification 510(k) Submission

Project #:ML0302010Ab Exhibit #6 Indications for Use

Exhibit #6 Indications for Use

510(k) Number: K103685

Device Name: Pulse Oximeter Sensor (Disposable and Reusable)

Indications for Use:

The Disposable Pulse Oximeter Sensor is indicated for non-invasive spot checking and/or . A Fire Disposure ecommune with hospitals, hospital-type facilities, and home care environments.
The Reusable Pulse Oximeter Sensors are indicated for non-invasive spot checking and/or A I he "reasure" in also - 1 with oximeter equipment in hospitals, hospital-type facilities, and home care environments.

APRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dan Gilbert

Page 1 of 1

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

510(k) Number: K103685

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).