PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL

K062455 · Philips Medical Systems · DQA · Nov 3, 2006 · Cardiovascular

Device Facts

• Record ID: K062455
• Device Name: PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
• Applicant: Philips Medical Systems
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Philips reusable SpO2 sensors are for multi-patient use, when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required. M1191B, M1191BL and M1191BNL sensors are indicated for use with adult patients.

Device Story

Reusable SpO2 sensors (models M1191B, M1191BL, M1191BNL) measure arterial oxygen saturation and pulse rate non-invasively. Device emits red and infrared light through human tissue (e.g., index finger); photodiode receives non-absorbed light. System calculates ratio of red to infrared light absorption to determine oxygen saturation (SpO2 = [HbO2]/([Hb]+[HbO2])). Signals are amplified and processed via algorithm using validated calibration tables derived from controlled hypoxia studies. Used in clinical settings for multi-patient monitoring. Healthcare providers use output for continuous patient status assessment; aids in clinical decision-making regarding oxygenation levels.

Clinical Evidence

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

Technological Characteristics

Reusable SpO2 sensor; red and infrared LED light sources; photodiode receiver. Measures light absorption to calculate SpO2 ratio. Connectivity via cable interface to host monitoring device. Materials modified for cuff exterior to improve durability and fit. Software-based algorithm uses validated calibration tables.

Indications for Use

Indicated for adult patients requiring continuous non-invasive arterial oxygen saturation and pulse rate monitoring.

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)

Submission Summary (Full Text)

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K062455

## PHILIPS Medical Systems

NOV - 3 2006

## 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 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Mr. Rich McCleary<br>Senior Manager of Quality and Regulatory Affairs<br>Tel: [phone] |
| Date of Summary: | August 18, 2006 |
| Device Name | Philips Reusable SpO2 Sensor,<br>Models M1191B, M1191BL and M1191BNL |
| Common Name | SpO2 pulse oximeter sensor |
| Classification Name | Classification Name: Oximeter<br>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 and K030973. |
| Modifications | The modification involves changes to the exterior cuff materials to<br>improve quality, enhance value and accommodate patients with large<br>fingers. |

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| Device<br>Description | The Philips SpO2 devices measure, non-invasively, the arterial oxygen<br>saturation of blood. The measurement method is based on the red and<br>infrared light absorption of hemoglobin and oxyhemoglobin. Light of<br>a red and infrared light source is emitted through human tissue and<br>received by a photodiode.<br><br>The measurement is based on the absorption of light, which is emitted<br>through human tissue (for example through the index finger). The<br>light comes from two sources (red LED and infrared LED) with<br>different wavelengths and is received by a photodiode. Out of the<br>different absorption behavior of the red and infrared light a so-called<br>Ratio can be calculated. The saturation value is defined by the<br>percentage ratio of the oxygenated hemoglobin [HbO2] to the total<br>amount of hemoglobin [Hb]. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | $SpO2 = [HbO2]/([Hb]+[HbO2])$ |
| | Out of calibration curves, which are based on controlled hypoxia<br>studies with healthy non-smoking adult volunteers over a specified<br>saturation range (SaO2 from 100%-70%), the Ratio can be related to a<br>SpO2 value. |
| | The devices contain a red and infrared light source and a photodiode<br>receiving the non-absorbed red and infrared light. The received<br>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 | Philips reusable SpO2 sensors are for multi-patient use, when<br>continuous non-invasive arterial oxygen saturation and pulse rate<br>monitoring are required. |
| | M1191B, M1191BL and M1191BNL sensors are indicated for use<br>with adult 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. |
| | Testing involved environmental and clinical evaluations for accuracy.<br>Hardware verification testing and cable interface verification testing<br>were also conducted. Design verification and validation test results<br>confirmed that the device is substantially equivalent with the identified<br>predicate devices. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

Mr. Rich McCleary Senior Manager, Quality & Regulatory Affairs Phillips Medical Systems 3000 Minuteman Road Andover, Massachusetts 01810-1099

Re: K062455

Trade/Device Name: Philips Reusable Sp02 Sensors Models, M1191B, M1191BL and M1191BNL Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 2, 2006 Received: October 4, 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 (sec 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. 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/cdrl/industry/support/index.html.

Sincerely vours,

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): K062455

| Device Name: | Philips Reusable SpO2 Sensors<br>Models M1191B, M1191BL and M1191BNL |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | Philips reusable SpO2 sensors are for multi-patient use,<br>when continuous non-invasive arterial oxygen saturation and<br>pulse rate monitoring are required. |

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)

lumm Solum

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

KOL:2465 510(k) Number

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