PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T

K032979 · Philips Medical Systems, Inc. · DQA · Feb 20, 2004 · Cardiovascular

Device Facts

• Record ID: K032979
• Device Name: PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
• Applicant: Philips Medical Systems, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Philips Reusable SpO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation. M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.

Device Story

Reusable SpO2 sensors (M1191T, M1192T, M1193T) measure arterial oxygen saturation non-invasively. Sensors emit red and infrared light through tissue (e.g., finger); photodiode receives non-absorbed light. Signals are amplified and processed by a measurement device using an algorithm to calculate the ratio of oxygenated to total hemoglobin based on light absorption. Output is a saturation value derived from validated calibration tables. Used in clinical settings; operated by healthcare professionals. Provides real-time oxygen saturation data to support clinical monitoring and decision-making.

Clinical Evidence

Clinical evaluations for accuracy were conducted using controlled hypoxia studies with healthy non-smoking adult volunteers over a saturation range of 70%-100%. Testing established performance and reliability characteristics, demonstrating substantial equivalence to predicate devices.

Technological Characteristics

Reusable SpO2 sensors utilizing red and infrared LED light sources and a photodiode receiver. Measurement principle based on differential light absorption of hemoglobin and oxyhemoglobin. Features Nellcor-compatible connectors and Nellcor Rcal wavelength coding. Designed for non-invasive arterial oxygen saturation monitoring.

Indications for Use

Indicated for adult (M1191T), pediatric (M1192T), and neonatal (M1193T) patients for non-invasive acquisition of arterial oxygen saturation.

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 M1191A (K882609)
• Philips M1192A (K882609)
• Philips M1193A (K882609)
• Nellcor/Tyco Oxisensor II N-25 (M1901B) (K990972)
• Nellcor/Tyco Oxisensor II D-20 (M1903B) (K000822)
• Nellcor/Tyco Oxisensor II D-25 (M1904B) (K000822)

Submission Summary (Full Text)

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

Ka32979

. "

## FEB 2 0 2004

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

| Submitted by: | Egon Pfeil<br>Philips Medizin Systeme Boeblingen GmbH<br>Cardiac and Monitoring Systems<br>Hewlett-Packard Str.2<br>71034 Boeblingen<br>Germany | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Date of Summary: | September 19, 2003 | |
| Device Name | The Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T. | |
| Common Name | SpO2 Sensor | |
| Classification Name | Classification Name:<br>Regulation Number: | Oximeter<br>21 C.F.R §870.2700 |
| Predicate Devices | Philips M1191A, M1192A, M1193A, M1901B (Nellcor/Tyco<br>Oxisensor IITM N-25), M1903B (Nellcor/Tyco Oxisensor IITM D-20)and M1904B (Nellcor/Tyco Oxisensor IITM D-25) disposable SpO2<br>sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, and K000822, 4/6/00. | |
| Modifications | The modification involves a change to the connector from the proprietary Philips version to a Nellcor compatible connector with corresponding change in sensor wave length coding from the Philips Rtype to the Nellcor Rcal. | |
| 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 | |

The devices contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received

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

| | signals are forwarded to a measurement device that amplifies the<br>acquired signal and an algorithm that calculates the ratio and converts<br>via a validated calibration table the ratio to a saturation value. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Philips Reusable SpO2 Sensors are intended for acquiring non-<br>invasively the arterial oxygen saturation to support the measurement of<br>oxygen saturation.<br><br>M1191T is indicated for adult patients, M1192T is indicated for<br>pediatric patients, and M1193T is indicated for neonatal patients. |
| Technological<br>characteristics | The Philips Reusable SpO2 Sensors have the same technological<br>characteristics as the legally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted to<br>establish the performance and reliability characteristics of the modified<br>device.<br><br>Testing involved environmental and clinical evaluations for accuracy.<br>Hardware verification testing and cable interface verification testing<br>were also conducted. Test results showed substantial equivalence. |

:

,

{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 with three stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Mr. Egon Pfeil Regulatory Affairs Engineer Philips Medizin Ayateme Böeblingen GmbH Cardiac and Monitoring Systems, Incorporated Hewlett-Packard Str.2 71034 Böeblingen GERMANY

Rc: K032979/S2

Trade/Device Name: The Philips Reusable SpO2 Sensors M1191T, M1192T and M1193 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 27, 2004 Received: January 30, 2004

Dear Mr. Pfeil:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal above and have cetermined 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 menside commerce proces that have been reclassified in accordance with the provisions of Amendments, or to activetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvial applicions 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 WA), it may be can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device earrer publish further announcements concerning your device in the Federal Register.

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

## Page 2 - Mr. Pfeil

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisor mat i Dri o losuanse on that your device complies with other requirements Incan that I DA has made a deceminary unations administered by other Federal agencies. of the Act of ally I ederal batales and squirements, including, but not limited to: registration r od linest comply with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF RT art 807), labality systems (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) requirences as set form in the quading tontrol 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) I mis letter whilanow you to our finding of substantial equivalence of your device to a premaired predicated. - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not 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 may overnir 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/dsma/dsmamain.html

Sincerely yours,

Chuls

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 Statement

510(k) Number (if known)

Device Name: The Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T

Indications for Use: The Philips Reusable SpO2 Sensors are intended for acquiring nonindications for Use. The I milips Reasurement of support the measurement of oxygen saturation.

M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.

VAn h

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

510(k) Number: K032979

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Page __ of ___________________________________________________________________________________________________________________________________________________________________