PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A

K042306 · Philips Medizin Systeme Boeblingen GmbH · DQA · Oct 15, 2004 · Cardiovascular

Device Facts

• Record ID: K042306
• Device Name: PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Abbreviated
• 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 and pulse rate. M1131A is indicated for adult and pediatric patients.

Device Story

Philips Disposable SpO2 Sensor M1131A; non-invasive pulse oximetry sensor. Inputs: red and infrared light transmitted through tissue (e.g., finger). Operation: red/IR LEDs emit light; photodiode receives non-absorbed light; measurement device calculates ratio of oxygenated hemoglobin to total hemoglobin based on differential absorption. Output: SpO2 saturation value and pulse rate. Used in clinical settings; operated by healthcare professionals. Output displayed on compatible monitoring device to support clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Clinical evaluations conducted to establish accuracy. Testing included environmental, safety, interference, and clinical accuracy studies. Accuracy validated against controlled hypoxia studies in healthy nonsmoking adult volunteers across a saturation range of 70%-100%. Results demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Disposable SpO2 sensor; red and infrared LED light sources; photodiode receiver. Operates via spectrophotometric absorption principle. Connects to external monitoring device for signal amplification and processing. Calibration based on validated tables derived from controlled hypoxia studies.

Indications for Use

Indicated for adult and pediatric patients for non-invasive monitoring of arterial oxygen saturation (SpO2) and pulse rate.

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 M1191T (K882609)
• Philips M1192T (K990972)
• Nellcor/Tyco Oxisensor II D-20 (M1903B) (K000822)
• Nellcor/Tyco Oxisensor II D-25 (M1904B) (K032979/S2)

Submission Summary (Full Text)

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K042306

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OCT 15 2004

:

SECTION 9.0

510 (k) Summary

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

- Egon Pfeil Submitted by: Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str.2 71034 Boeblingen Germany
- August 20, 2004 Date of Summary:

The Philips Disposable SpO2 Sensor M1131A. Device Name

- SpO2 Sensor Common Name
- Classification Name: Oximeter (DQA) Classification Regulation Number: 21 C.F.R \$870.2700 Name
- Predicate Devices Philips M1191T, M1192T reusable SpO2 sensors, and M1903B (Nellcor/Tyco Oxisensor II™ D-20)and M1904B (Nellcor/Tyco Oxisensor II™ D-25) disposable Sp02 sensors cleared pursuant to K882609, 1/19/89; K990972, 4/19/99, K000822, 4/6/00, and K032979/S2, 2/20/04.

The Philips SpO2 devices measure, non-Device invasively, the arterial oxygen saturation of Description blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoqlobin. 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 nonsmoking adult volunteers over a specified saturation range (SaO2 from 100%-70%), the

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Ratio can be related to a SpO₂ value.

The devices contain a red and infrared light source and a photodiode receiving the nonabsorbed 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.

- The Philips Reusable SpO₂ Sensors are intended Intended Use for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation and pulse rate.
M1131A is indicated for adult and pediatric patients.

The Philips Disposable SpO2 Sensor has the same Technological technological characteristics as the legally characteristics marketed predicate device.

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

> Testing involved environmental, safety testing from hazard analysis, interference testing, and clinical evaluations for accuracy. Hardware verification testing was also conducted. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate device. Test results showed substantial equivalence.

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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 consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 5 2004

Mr. Egon Pfeil Regulatory Affairs Engineer Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2, 71034 Böblingen GERMANY

Re: K042306

Trade/Device Name: The Philips Disposable SpO2 Sensor M1131A Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 20, 2004 Received: August 25, 2004

Dear Mr. Pfeil:

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 approvisions of the Act. The general controls provisions of the Act include controls proviblems or a must 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 (1 wr t), ice 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 - Mr. Pfeil:

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 meall that FDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal states and reguirements, including, but not limited to: registration 1 ou must comply with an are reseling (21 CFR Part 801); good manufacturing practice alla listing (21 CF RT Fat 007), abolity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quadion 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) This letter will anow Jourse of Substantial equivalence of your device to a premiarket notification. - The PDF innults 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), If you desire specific advice for your de at [phone]. Also, please note the regulation prease condition by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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,

Susan Runner

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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## Indications for Use

510(k) Number (if known): __ The Philips Disposable SpO₂ Sensor M1131A Device Name:

Indications for Use: The Philips disposable SpO₂ Sensor is intended for non-Indications for Ober 14th oxygen saturation (SpO2) and pulse rate.

Indicated for adult/pediatric patients.

Over-The-Counter Use No_ Prescription Use yes AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of ______________________________________________________________________________________________________________________________________________________________________

Quy Suhon

(Division Sign Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K