PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA

K103685 · Beijing Rongrui-Century Scie. & Tech. Co., Ltd. · DQA · Jul 15, 2011 · Cardiovascular

Device Facts

• Record ID: K103685
• Device Name: PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
• Applicant: Beijing Rongrui-Century Scie. & Tech. Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Pulse oximeter sensors (disposable and reusable) designed for non-invasive measurement of arterial oxygen saturation and pulse rate. Sensors interface with compatible oximeter equipment to provide continuous monitoring or spot checks. Used in hospitals, clinical facilities, and home care environments by healthcare professionals or patients. Sensors utilize optical technology to detect blood oxygenation levels; output is displayed on the host oximeter monitor to assist clinicians in patient assessment and monitoring. Benefits include real-time physiological data acquisition for patient safety.

Clinical Evidence

Bench testing only. Testing verified compliance with IEC 60601-1 (General requirements for safety) and ISO 9919:2005 (Particular requirements for the basic safety and essential performance of pulse oximeter equipment). No clinical data provided.

Technological Characteristics

Disposable (wrapping) and reusable (finger clip, finger cot) pulse oximeter sensors. Compliant with IEC 60601-1 and ISO 9919:2005. Sensing principle: optical/photoplethysmography. Connectivity: wired interface to host oximeter monitor. Regulatory class II.

Indications for Use

Indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate. Populations: Adults (>30kg), pediatric (3-20kg), and neonatal (<2kg) patients. Used in hospitals, hospital-type facilities, and home care environments with compatible oximeter equipment.

Regulatory Classification

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.

Predicate Devices

• SpO2 Pulse Oximeter Sensor (K082487)
• Model 6000CN Sensor (K093853)

Reference Devices

• Nellcor N595 (K102891)
• BLT M9000 (K100046)
• BLT M7000 (K100046)

Submission Summary (Full Text)

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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.

- 2. 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: [phone] Fax: [phone] Email: [e-mail]

Submission Correspondent 3. Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]

- 4. 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

יי

| | | Table 1 General Description | |
|----------|------------------------|-----------------------------|-------------------------------------------------------|
| Model | Type | Intended Population | Matched U.S. Legally Marketed<br>Oximeter 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 [phone] or [phone] 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