PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T

K062605 · Philips Medical Systems · DQA · Nov 9, 2006 · Cardiovascular

Device Facts

• Record ID: K062605
• Device Name: PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
• Applicant: Philips Medical Systems
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The M1196A and M1196T reusable Clip sensors provide continuous, non-invasive measurement of arterial oxygen saturation (pulse rate signal and plethysmograph wave) to any SpO2 device that has passed validation testing. Either sensor can be comfortably clipped onto the finger of patients weighing > 40 kg (typically adult patients).

Device Story

Reusable SpO2 finger-clip sensors (Models M1196A, M1196T) measure arterial oxygen saturation non-invasively. Device emits red and infrared light through patient's finger; photodiode receives non-absorbed light. Signals are transmitted to a host pulse oximeter, which amplifies the signal and uses a calibration table to calculate oxygen saturation (HbO2 / [Hb + HbO2]) and pulse rate. Used in clinical settings by healthcare providers to monitor patient oxygenation status. Provides continuous plethysmograph wave and saturation data to assist in clinical decision-making and patient management.

Clinical Evidence

Clinical evaluations for accuracy were conducted using controlled hypoxia studies with healthy non-smoking adult volunteers across a saturation range of 70%-100%. Results confirmed performance and reliability characteristics consistent with the predicate device.

Technological Characteristics

Reusable clip-style pulse oximeter sensor. Sensing principle: dual-wavelength (red and infrared) LED light source and photodiode receiver. Connectivity: wired interface to host SpO2 monitoring device. Intended for patients > 40 kg. No internal software; relies on host device for signal processing and algorithm execution.

Indications for Use

Indicated for continuous, non-invasive measurement of arterial oxygen saturation, pulse rate, and plethysmograph wave in patients weighing > 40 kg (typically 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

• Philips Medical System Adult SpO2 sensor, model # M1191A (K882609, K990972, K000822, K030973, K032979)

Submission Summary (Full Text)

{0}------------------------------------------------

NOV ~ 9 2006

| Special 510(k) Premarket Notification |
|-----------------------------------------------------------|
| SpO2 Pulse Oximeter Sensor - Model Nos. M1196A and M1196T |

K062605

# PHILIPS Medical Systems

### 510(k) Summary (As required by 21 C.F.R. §807.92)

| Submitted by: | Philips Medical Systems, Inc.<br>Ultrasound and Monitoring Division / Patient Monitoring Supplies<br>3000 Minuteman Road<br>Andover, MA 01810-1099 | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--|
| Company Contact: | Mr. Rich McCleary<br>Senior Manager of Quality and Regulatory Affairs<br>Tel: [phone] | | |
| Date of Summary: | August 31, 2006 | | |
| Device Name | Philips Reusable SpO2 Sensor,<br>Models M1196A and M1196T | | |
| Common Name | SpO2 pulse oximeter sensor | | |
| Classification Name | Classification Name: | Oximeter | |
| | Regulation Number: | 21 C.F.R §870.2700 | |
| Predicate Device | Philips Medical System Adult SpO2 sensor, model # M1191A<br>Cleared for marketing via FD&C Act §510(k)# K882609, K990972,<br>K000822, K030973 and K032979. | | |
| Modifications | The modification involves a change from a soft cuff style to a clip<br>style housing design to facilitate attachment and removal from a<br>patient's finger. | | |

{1}------------------------------------------------

Device Description

The Philips SpO2 devices measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode.

The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called Ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb].

#### SpO2 = [HbO2]/([Hb]+[HbO2])

Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%), the Ratio can be related to a SpO2 value.

The devices contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value.

Intended Use

Technological characteristics

Testing

The M1196A and M1196T reusable Clip sensors provide continuous, non-invasive measurement of arterial oxygen saturation (pulse rate signal and plethysmograph wave) to any Sp02 device that has passed validation testing. Either sensor can be comfortably clipped onto the finger of patients weighing > 40 kg (typically adult patients).

The Philips Reusable SpO2 Sensors have the same technological characteristics as the legally marketed predicate devices.

Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device.

Testing involved environmental and clinical evaluations for accuracy. Hardware verification testing and cable interface verification testing were also conducted. Design verification and validation test results confirmed that the device is substantially equivalent with the identified predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2006

Mr. Rich McCleary Senior Manager of Quality and Regulatory Affairs Philips Medical Systems, Incorporated Ultrasound and Monitoring Division/Patient Monitoring Supplies 3000 Minuteman Road Andover, Massachusetts 01810-1099

Re: K062605

Trade/Device Name: Philips SpO2 Reusable Clip Sensors Models M1196A and M1196T Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 10, 2006 Received: October 11, 2006

Dear Mr. McCleary:

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.

{3}------------------------------------------------

Page 2 - Mr. McCleary

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,

hereby state,

*Shule H. Murphy, MD for C. Lin, 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

{4}------------------------------------------------

# Indications for Use

## 510(k) Number (if known): K062605

| Device Name: | Philips SpO2 Reusable Clip Sensors<br>Models M1196A and M1196T |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The M1196A and M1196T reusable Clip sensors provide<br>continuous, non-invasive measurement of arterial oxygen<br>saturation (pulse rate signal and plethysmograph wave) to<br>any SpO2 device that has passed validation testing. Either<br>sensor can be comfortably clipped onto the finger of patients<br>weighing > 40 kg (typically adult patients). |

Prescription 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 IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

NIOM ்லா Sign-Oif)

f Anesthesiology, General Hospital,
Control, Dental Devices

E (0.10 Number:

Page 1 of ____________________________________________________________________________________________________________________________________________________________________