PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. by PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH

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 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.

AI/ML Overview

The provided 510(k) summary for the Philips Disposable SpO2 Sensors M1132A and M1133A includes information on the general verification and validation testing, but it does not provide specific quantitative acceptance criteria or detailed results of a study that directly proves the device meets those criteria in the format requested.

The document states:

"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."

This is a general statement of testing and conclusion of substantial equivalence, but it lacks the specific data points needed to fill out the detailed table and answer all the questions. The most relevant information regarding accuracy is the mention of "controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%)" for establishing calibration curves. However, this describes how the calibration curves were derived, not a specific performance evaluation study with acceptance criteria and results for the device itself.

Therefore, many of the requested details cannot be extracted directly from this 510(k) summary.

Information that can be extracted or inferred:

Type of Ground Truth: The calibration curves are based on "controlled hypoxia studies" with measured arterial oxygen saturation (SaO2), which can be considered a form of clinical reference standard (arterial blood gas analysis).
Sample Size for Training Set: The document mentions "controlled hypoxia studies with healthy non-smoking adult volunteers" were used to establish the calibration curves (which serve as a "validated calibration table"). The specific number of volunteers is not provided.
How Ground Truth for Training Set was Established: Through "controlled hypoxia studies" where SaO2 (arterial oxygen saturation) was measured directly from the volunteers.

Information NOT available in the provided document:

A table of specific quantitative acceptance criteria and reported device performance.
Sample size used for a test set (as distinct from the calibration/training data).
Data provenance for a test set.
Number of experts and their qualifications for establishing ground truth for a test set.
Adjudication method for a test set.
Results from a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
Specific quantitative results from a standalone performance study with acceptance criteria.

Summary based on available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in this document. The document states "Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate device," but does not detail these criteria or specific performance results for the device in a test set context.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The document describes "clinical evaluations for accuracy" but does not give a sample size for a separate test set used to validate the device.
Data Provenance: Not explicitly stated for a test set. The calibration curves were based on studies with "healthy non-smoking adult volunteers," implying prospective data. The country of origin is not specified for these studies, though the submitting company is based in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided. The document refers to "controlled hypoxia studies" for calibration curves, which typically involve trained medical staff, but does not specify the number or qualifications of experts for establishing ground truth for a device performance test set.

4. Adjudication method for the test set

Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This device is a disposable SpO2 sensor, which provides a direct measurement, not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The device itself (sensor + algorithm) makes a standalone measurement. The document states "clinical evaluations for accuracy" were done, implying a standalone performance assessment against a clinical reference. However, specific quantitative results from such a study and its acceptance criteria are not detailed.

7. The type of ground truth used

Clinical Reference Standard (Arterial Oximetry): Calibration curves were derived from "controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%)". SaO2 measured directly from arterial blood is the accepted clinical gold standard for oxygen saturation. This is the "ground truth" against which the device's SpO2 measurements are implicitly compared or from which its calibration is derived.

8. The sample size for the training set

Not provided. The document only states "healthy non-smoking adult volunteers" were used for the controlled hypoxia studies to generate calibration curves. The specific number of volunteers is not mentioned.

9. How the ground truth for the training set was established

Controlled Hypoxia Studies with SaO2 measurements: The ground truth for the calibration curves was established through "controlled hypoxia studies" where the arterial oxygen saturation (SaO2) was directly measured from the blood of healthy, non-smoking adult volunteers. This typically involves arterial blood gas sampling and analysis.

Summary

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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.

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.

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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Image /page/2/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a human figure in motion or a stylized representation of a wave or flow. The emblem is simple and conveys a sense of movement and progress.

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 (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 (301) 443-6597 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-

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).