PULSE OXIMETER, MODEL PM-50

K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DQA · Sep 5, 2006 · Cardiovascular

Device Facts

• Record ID: K061442
• Device Name: PULSE OXIMETER, MODEL PM-50
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.

Device Story

PM-50 is a portable, battery-powered pulse oximeter for spot-check monitoring. Device uses finger sensors emitting red and infrared light to measure arterial blood pulsation. Photodetector converts light intensity into electronic signals; circuitry processes signals to calculate SpO2 and pulse rate. Results displayed on LCD screen. Used in clinical settings by healthcare providers. Benefits include non-invasive, rapid assessment of patient oxygenation and heart rate. Modification involves addition of new disposable and reusable sensor options.

Clinical Evidence

Clinical study and laboratory testing conducted to validate performance of the PM-50 with added probes. Results demonstrate the device is as safe and effective as the predicate device.

Technological Characteristics

Portable, battery-powered pulse oximeter. Uses two-wavelength (red and infrared) pulsatile sensing principle. Includes disposable and reusable finger sensors. LCD display. Software-based signal processing.

Indications for Use

Indicated for non-invasive, spot-check monitoring of oxygen saturation (SpO2) and pulse rate in patients ranging from neonates to adults.

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

• PM-50 Pulse Oximeter (K052693)

Submission Summary (Full Text)

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# 510(K) SUMMARY

# SEP - 5 2006

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

The assigned 510(k) number is: Ko61442

### Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: [phone]

Fax: [phone]

- Contact Person: .
- Li Dongling

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

- . Date Prepared:
May 12, 2006

Name of the device:

- Trade/Proprietary Name: PM-50 Pulse Oximeter .
- 0 Common Name: Pulse Oximeter
- e Classification

21 CFR 870.2700 Oximeter, Pulse Class II 21 CFR 870.2710 Ear Oximeter, Pulse Class II

### Legally Marketed Predicate Device:

K052693 PM-50 Pulse Oximeter

MINDRAY PROPRIETARY

0026

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#### Description:

The PM-50 is a flexible, portable, battery powered Pulse Oximeter. The PM-50 Pulse Oximeter acquires the physiological signals - oxygen saturation (SpO2) and pulse rate (PR). The signals are converted into digital data and processed, and the SpO2 and pulse rate values are calculated and displayed on LCD screen.

PM-50 uses a two-wavelength pulsatile system - red and infrared light – to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin. The light source in the finger sensor emits red and infrared light, which are partially absorbed and modulated by the arterial blood pulsation at the sensor site. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The electronic signals are sent to the oximeter and processed by the oximeter's circuitry. Thereafter, the SpO₂ and pulse rate are obtained and indicated on the LCD screen.

# Statement of intended Use:

The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.

# Comparison of Technological Characteristics:

The PM-50 Pulse Oximeter employs the same functional technology as the predicate device.

#### Testing:

The device modification involved the addition of SpO2 probes for the PM-50 Pulse Oximeter. The purpose of adding these added probes is a business decision. The subject new probes are selectable by customers; we will not discontinue marketing the previously cleared probes.

Laboratory testing and clinical study was conducted to validate and verify that the PM-50 Pulse Oximeter met all design specifications and was substantially equivalent to predicate device.

The following quality assurance measures were applied to the development of the

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device:

- . Risk Analysis
- . Environmental Testing
- Function and Performance Testing
- Clinical Study .

## Conclusion:

The conclusions drawn from clinical and laboratory testing of the PM-50 Pulse Oximeter demonstrates that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the PM-50 Pulse Oximeter numbered K#052693.

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SEP - 5 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Company, Limited C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K061442

Trade/Device Name: PM-50 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 8, 2006 Received: August 9, 2006

Dear Ms. Goldstein-Falk:

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 such 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. Goldstein-Falk

,
3.

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu-Lian, Ph.D.

Chiu Lin, Ph.D. 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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#### Exhibit #E

Page 1 of

510(k) Number (if known):

Device Name: PM-50 Pulse Oximeter

Indications For Use:

The PM-50 Pulse Oximeter is a non-invasive, spot-check, oxygen saturation and pulse rate monitor. It operates only on battery power using existing PM-50 disposable and reusable sensors labeled for patients ranging from neonates to adults.

Prescription Use × (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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