PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.

K052377 · Philips Medizin Systeme Boeblingen GmbH · DQA · Nov 17, 2005 · Cardiovascular

Device Facts

• Record ID: K052377
• Device Name: PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
• Applicant: Philips Medizin Systeme Boeblingen GmbH
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Philips Disposable SpO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation and pulse rate.

Device Story

Disposable SpO2 sensors (M1132A, M1133A) measure arterial oxygen saturation and pulse rate non-invasively. Device emits red and infrared light through tissue (e.g., finger); photodiode receives non-absorbed light. Signal processing unit amplifies acquired signals; algorithm calculates ratio of oxygenated to total hemoglobin based on differential light absorption. Calibration curves derived from controlled hypoxia studies in healthy volunteers convert ratio to SpO2 value. 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 for accuracy conducted using controlled hypoxia studies in healthy, non-smoking adult volunteers across a saturation range of 70%-100%. Testing also included environmental, safety, and hardware verification. Results demonstrated substantial equivalence to predicate devices.

Technological Characteristics

Disposable SpO2 sensors; red and infrared LED light sources; photodiode receiver. Measurement based on differential light absorption (Ratio calculation). Calibration via validated tables derived from hypoxia studies. Connectivity via cable to host monitoring device. No specific material standards or software class details provided.

Indications for Use

Indicated for non-invasive measurement of SpO2 and pulse rate in infant patients (M1132A) and neonatal, infant, and adult patients (M1133A).

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 M1131A disposable Sp02 sensor
• M1901B (Nellcor/Tyco Oxisensor II™ N-25) (K042306, K000822, K990972)
• M1902B (Nellcor/Tyco Oxisensor II™ I-20) (K042306, K000822, K990972)

Submission Summary (Full Text)

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

- Submitted by: Egon Pfeil Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str.2 71034 Boeblingen Germany
- August 26, 2005 Date of Summary:
- Device Name Philips Disposable SpO2 Sensors M1132A and M1133A.
- Common Name SpO2 Sensor
- Classification Classification Name: Oximeter (DQA) Regulation Number: 21 C.F.R §870.2700 Name
- Predicate Devices Philips M1131A disposable Sp02 sensor, and M1901B (Nellcor/Tyco Oxisensor II™ N-25) and M1902B (Nellcor/Tyco Oxisensor II™ I-20) disposable SpO2 sensors cleared pursuant K042306, 10/15/04, K000822, 4/6/00, and K990972, 4/19/99.
- Device The Philips SpO2 devices measure, non-Description 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

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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 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.

Intended Use The Philips Disposable SpO2 Sensors are intended for acquiring non-invasively the arterial oxygen saturation to support the measurement of oxygen saturation and pulse rate.

> M1132A is indicated for infant patients and M1133A is indicated for neonatal, infant, and adult patients.

Technological The Philips Disposable SpO2 Sensors have the characteristics same technological characteristics as the leqally marketed predicate devices.

Testing Verification and validation testing activities 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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NOV 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medizin Systeme Böblingen GmbH Mr. Egon Pfeil Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard Street 2 D-71034 Boeblingen GERMANY

Re: K052377

Trade/Device Name: The Philips Disposable SpO2 Sensors MII32A and MII33A Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 26, 2005 Received: August 30, 2005

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 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 - 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 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 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

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## Indications for Use

510(k) Number (if known): The Philips Disposable SpO2 Sensors M1132A and M1133A Device Name:

Indications for Use: The Philips disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.

Indicated for adult/infant/neonatal (M1133A) and infant (M1132A) patients.

Over-The-Counter Use Prescription Use __ yes No 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)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K052377

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SIBK) Number: K052077-