FINGER PULSE OXIMETER

K123801 · Shenzhen Kingyield Technology Co., Ltd. · DQA · May 28, 2013 · Cardiovascular

Device Facts

• Record ID: K123801
• Device Name: FINGER PULSE OXIMETER
• Applicant: Shenzhen Kingyield Technology Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: May 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.

Device Story

PM601 is a fingertip pulse oximeter for adult use in hospitals, clinics, or homes. Device measures blood oxygen saturation (SpO2) and pulse rate via digital blood oxygen sensing technology. Operated by user or clinician for spot-checking; not intended for continuous monitoring. Device displays %SpO2, pulse rate, and pulse strength. Powered by two AAA alkaline batteries; features automatic power-off after 8 seconds of signal loss and low voltage warning. Provides non-invasive physiological data to assist in health status assessment.

Clinical Evidence

Clinical trial performed on ten healthy volunteers per ISO 9919:2005 Annex EE.2 (invasive laboratory testing). Primary endpoint was SpO2 accuracy; results demonstrated an accuracy (Arms) of less than 3%.

Technological Characteristics

Fingertip form factor; silicone patient contact material. Powered by two AAA alkaline batteries. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 80601-2-61, and ISO 9919. Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Digital blood oxygen sensing principle.

Indications for Use

Indicated for spot-checking SpO2 and pulse rate in adults in hospital, clinic, or home settings. Not for continuous monitoring.

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

• MD300C1 Fingertip pulse oximeter (k093757)

Submission Summary (Full Text)

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## Exhibit #9 510(k) Summary

# MAY 2 8 2013

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: K123801

Prepared Date: March 01, 2013 1.

2. Sponsor

> Shenzhen Kingyield Technology Co., Ltd Bldg C, Fuhai Industrial Zone, Fuhai Road, Fuyong Town, Baoan, Shenzhen, 518103, China

Establishment Registration Number: 3007420856

Contact Person: Dacheng Gong Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent 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: Finger Pulse Oximeter Proposed Device Model: PM601 Device Common Name: Pulse Oximeter Classification Name: Oximeter

Classification: 2 Product Code: DQA

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Regulation Number: 21 CFR 870.2700 Review Panel: Anesthesiology

Indications for Use:

PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.

- ડ. Predicate Device Identification
510(k) Number: k093757 Product Name: MD300C1 Fingertip pulse oximeter Manufacturer: Beijing Choice Electronic Technology Co., Ltd

- 6. Device Description
The proposed device, Finger Pulse Oximeters PM601 is a fingertip device, which can display % SpO2. pulse rate value and pulse strength. It is based on digital blood oxygen.

Power consumption of the proposed device is low and the two originally-equipped AAA alkaline batteries can be operated continuously for 24 hours. It will automatically turned off when no signal is detected for more than 8 seconds. And low voltage warning will be displayed and battery symbol flash when battery voltage is low.

#### 7. Non-Clinical Test Conclusion

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

IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007), Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

ISO 80601-2-61:2011. Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

ISO 9919: 2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity. ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

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#### 8. Clinical Trial Conclusion

The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO9919:2005 Medical electrical equipment- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for the medical use on ten healthy volunteers.

It can be determined from the result of the clinical study that the accuracy Arms of the proposed device is smaller than 3%.

- 9. Substantially Equivalent

| ITEM | Proposed Device<br>Finger Pulse Oximeter PM601 | Predicate Device<br>MD300C1 Fingertip pulse oximeter<br>(k093757) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Product Code | DQA | Same |
| Regulation No. | 21 CFR 870.2700 | Same |
| Class | 2 | Same |
| Intended Use | PM601 Finger pulse oximeter is<br>intended for spot-checking oxygen<br>saturation in blood (SpO2) and pulse<br>rate. The pulse oximeter is used on<br>adults at hospital, clinics, and/or home.<br>Not for continuously monitoring. | Similar |
| SpO2<br>measurement<br>range | 70%-100% | Same |
| SpO2 accuracy | 70%~100%, ±3% | Same |
| PR measurement<br>range | 30-199 bpm | Similar |
| PR accuracy | ±2 bpm or ±2% MAX | Same |
| Patient Contact<br>Material | Silicone | Same |
| Electrical Safety | Comply with IEC 60601-1 | Same |
| EMC | Comply with IEC 60601-1-2 | Same |

### Table 111-1 Substantially Equivalent Comparison

The proposed device has the same classification information, similar intended use, same design principle, similar specifications and same safety performance as the predicate device. The difference in intended use and PR measurement range are discussed in the 510(k) submission documents. it is concluded that these differences will not affect the effectiveness and safety of the proposed device. And the results of bench texts and clinical trial have been conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

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The proposed device, Finger Pulse Oximeter PM601; is determined to be Substantially Equivalent (SE) to the predicate device, MD300C1 Fingertip pulse oximeter (k093757), in respect of safety and effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

### Public Health Service

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

May 28, 2013

Shenzhen Kingyield Technology Company, Limited C/O Ms. Diana Hong General Manager MID-Link Consulting Company, Limited P.O. Box 237-023 Shanghai China 200237

Re: K123801

Trade/Device Name: Finger Pulse Oximeter PM601 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 17, 2013 Received: April 29, 2013

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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 ` 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/ResourcesforYou/Industrv/default.htm.

Image /page/5/Picture/7 description: The image shows a signature and contact information. The signature is illegible, but the text next to it reads "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID." The image also contains the phrase "Sincerely yours," and the word "FOR" is at the bottom right.

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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RTA Response for k123801 - Section II Indications for Use

# Section II Indications for Use

510(k) Number: K123801 Device Name: Finger Pulse Oximeter PM601

Indications for Use:

PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring. '

&PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

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### OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

Neel J. Patel
2013.05.24 16:13:08 -04'00'

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K123801 510(k) Number:

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