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 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.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study details for the Philips SpO2 Pulse Oximeter Sensor:

Acceptance Criteria and Study for Philips SpO2 Pulse Oximeter Sensor (Models M1196A and M1196T)

Based on the provided 510(k) summary, the device is a modified version of an existing device, with the modification being a change in housing design from a soft cuff to a clip style. The primary focus of the testing described is to demonstrate substantial equivalence to the predicate device, particularly regarding accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantitative performance metrics beyond the description of the study. However, the basis for performance evaluation is described:

Acceptance Criteria (Inferred)	Reported Device Performance
SpO2 Accuracy (across 70-100% range)	Established through "controlled hypoxia studies with healthy non-smoking adult volunteers"
Substantial Equivalence	"Design verification and validation test results confirmed that the device is substantially equivalent with the identified predicate devices."
Environmental Performance	"Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device."
Hardware and Cable Interface Verification	"Hardware verification testing and cable interface verification testing were also conducted."

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a numerical sample size. The description refers to "healthy non-smoking adult volunteers."
Data Provenance: Prospective. The studies were "controlled hypoxia studies" which are inherently prospective. The country of origin is not explicitly stated, but the submission is to the FDA in the US, suggesting the study likely took place in the US or under US regulatory guidelines.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable/not mentioned. This type of device relies on direct physiological measurement, and the "ground truth" (SaO2) in hypoxia studies is typically measured by co-oximetry of arterial blood samples, not by expert consensus.
Qualifications of Experts: Not applicable for establishing ground truth for direct physiological measurements.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is typically used for image interpretation or subjective assessments. Here, the comparison is of the device's SpO2 reading against a direct physiological measurement (SaO2 from blood gas analysis).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC study was not done. This type of study involves evaluating human readers' performance with and without AI assistance, which is not relevant for a standalone SpO2 sensor device.

6. Standalone Performance Study

Yes, a standalone study was done. The "controlled hypoxia studies" assessed the device's ability to accurately measure SpO2 against a known reference (SaO2 from arterial blood samples) in a controlled environment. The phrase "algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value" implies an algorithm-only performance.

7. Type of Ground Truth Used

The ground truth used was physiological outcome data, specifically arterial oxygen saturation (SaO2), derived from co-oximetry of arterial blood samples during the controlled hypoxia studies. This is explicitly stated as "SaO2 from 100%-70%".

8. Sample Size for the Training Set

Not explicitly stated. The "calibration curves, which are based on controlled hypoxia studies" suggest that data from these studies were used to establish the device's calibration. It is implied that the same or similar controlled hypoxia studies provided the data for both calibration (training) and validation (testing), or that a subset was used for training/calibration.

9. How the Ground Truth for the Training Set Was Established

The ground truth for establishing the calibration curves (training set) was established through controlled hypoxia studies with healthy non-smoking adult volunteers. In these studies, subjects were desaturated to various levels of arterial oxygen saturation (SaO2), and the SpO2 values from the device were correlated with directly measured SaO2 values obtained from co-oximetry of arterial blood samples. This process allows for the creation of a "validated calibration table" that relates the device's measured optical ratio to a SpO2 value.

Summary

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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.Ultrasound and Monitoring Division / Patient Monitoring Supplies3000 Minuteman RoadAndover, MA 01810-1099
Company Contact:	Mr. Rich McClearySenior Manager of Quality and Regulatory AffairsTel: (978) 659-4914
Date of Summary:	August 31, 2006
Device Name	Philips Reusable SpO2 Sensor,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 # M1191ACleared for marketing via FD&C Act §510(k)# K882609, K990972,K000822, K030973 and K032979.
Modifications	The modification involves a change from a soft cuff style to a clipstyle housing design to facilitate attachment and removal from apatient's finger.

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Device Description

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

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.

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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.

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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Indications for Use

510(k) Number (if known): K062605

Device Name:	Philips SpO2 Reusable Clip SensorsModels M1196A and M1196T
Indications For Use:	The M1196A and M1196T reusable Clip sensors providecontinuous, non-invasive measurement of arterial oxygensaturation (pulse rate signal and plethysmograph wave) toany SpO2 device that has passed validation testing. Eithersensor can be comfortably clipped onto the finger of patientsweighing > 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)

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f Anesthesiology, General Hospital,
Control, Dental Devices

E (0.10 Number:

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).