PHILIPS M3001A MULTI MEASUREMENT SERVER

• K Number: K090360
• Device Name: PHILIPS M3001A MULTI MEASUREMENT SERVER
• Manufacturer: PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
• Date Cleared: 2009-05-04 ( 81 days)
• Product Code: DQA , DPZ
• Regulation Number: 870.2700
• Type: Special
• Panel: Anesthesiology
• Reference & Predicate Devices: K060576 , K030973 , K033715
• Predicate For: K101600

Intended Use

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment.

Device Description

The modified device Philips M3001A Multi Measurement Server is substantially equivalent to the leqally marketed M3001A Multi Measurement Server (K030973, K033715). The modification consists of the integration of the Nellcor OxiMax SpO2 measurement module which is substantially equivalent to the legally marketed Nellcor OxiMax N-600x Pulse Oximeter (K060576). The modification adds to the M3001A Multi Measurement Server the Nellcor OxiMax SpO2 measurement module as an option in order to use the full Nellcor OxiMax technology. The modification is the integration of the Nellcor OxiMax SpO2 measurement module into the M3001A with minor hardware and software adaptations. The modification leads to a compact Multi measurement Server with integrated full Nelloor OxiMax technology.

AI/ML Overview

The provided text describes the Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 measurement module. However, it does not contain a discrete "acceptance criteria" section with specified thresholds for performance metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to standards.

Here's an attempt to extract and infer information based on the provided text, structured as requested:

Acceptance Criteria and Study Details for Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 Measurement Module

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Inferred)	Reported Device Performance
SpO2 Accuracy	Within specified ranges (conforming to ISO 9919:2005)	2% to 4% RMS dependent on the Nellcor OxiMax sensor type for specified ranges
Pulse Rate Accuracy	Within specified ranges (conforming to ISO 9919:2005)	±3 bpm in the range of 25 bpm to 250 bpm
Functionality	Meets all reliability requirements and performance claims (comparable to predicate device)	"Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence."
Safety	Meets safety requirements (from hazard analysis)	"safety testing from hazard analysis" conducted.
Environmental	Withstands environmental conditions (comparable to predicate device)	"environmental tests" conducted.
System Level	Performs as expected as a complete system (comparable to predicate device)	"system level tests" conducted.
Integration	Seamless integration of SpO2 module (comparable to predicate device)	"integration tests" conducted.

Note on Acceptance Criteria: The document explicitly states "Pass/Fail criteria were based on the specifications cleared for the predicate device." While specific numerical acceptance criteria other than the accuracy ranges for SpO2 and pulse rate are not provided, it's inferred that the acceptance criteria revolved around demonstrating performance equivalent to the legally marketed predicate devices and compliance with ISO 9919:2005.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions "controlled hypoxia studies with healthy non-smoking adult volunteers" for establishing calibration curves, but it does not specify the sample size for the test set used to validate the accuracy of the final device.
• Data Provenance: The SpO2 calibration curves are based on "controlled hypoxia studies with healthy non-smoking adult volunteers." The location or country of origin for these volunteers is not specified. The nature of the study for these calibration curves is prospective, as they involve controlled studies. The verification, validation, and testing activities mentioned for the full device are likely internal tests, but no further details on their provenance are provided.

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

The document does not mention the use of experts to establish ground truth for a test set in the context of the device's performance validation. The SpO2 values are derived from a physiological principle (absorption of light and ratio of oxygenated hemoglobin) and calibrated against in vivo hypoxia studies, not expert interpretation.

4. Adjudication Method for the Test Set

Since there is no mention of experts establishing ground truth or subjective assessments, there is no adjudication method described.

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

No MRMC comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the standalone performance of the device's physiological measurements.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the information provided describes a standalone performance evaluation of the device. The accuracy of SpO2 and pulse rate, and the overall functionality, were tested without explicit human-in-the-loop interaction for interpretation or decision-making related to the device's core measurements. The SpO2 measurement is "based on the absorption of light" and calculated through "Out of calibration curves."

7. Type of Ground Truth Used

The ground truth for the SpO2 measurement accuracy relies on:

• Physiological principle: The definition of SpO2 as the percentage ratio of oxygenated hemoglobin to total hemoglobin.
• Controlled hypoxia studies: Data obtained from "controlled hypoxia studies with healthy non-smoking adult volunteers" was used to establish calibration curves, which then serve as the reference for determining SpO2 values from the light absorption ratio. This implicitly means that the actual blood oxygen levels during these controlled studies served as the ground truth for calibration curve development.

For the general functional and reliability testing, the ground truth was "specifications cleared for the predicate device" and compliance with ISO 9919:2005.

8. Sample Size for the Training Set

The document does not explicitly use the term "training set." However, the "calibration curves" for SpO2 are based on "controlled hypoxia studies with healthy non-smoking adult volunteers." The sample size for these studies (which serve as the basis for the device's internal calibration/training equivalent) is not specified.

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

The "calibration curves" (analogous to a training set for the SpO2 algorithm) were established using data from "controlled hypoxia studies with healthy non-smoking adult volunteers." In these studies, subjects are typically desaturated under controlled conditions, and their arterial blood oxygen saturation is measured directly using a co-oximeter (considered the gold standard for oxygen saturation in blood), which would serve as the ground truth. The ratio of red and infrared light absorption from the oximeter is then correlated with these direct blood oxygen measurements to create the calibration curves.

Summary

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KOC360

MAY - 4 2009

8.0 510 (k) Summary

summary of 510(k) safety and effectiveness information i s This submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this premarket notification is:

Dr. Jens-Peter Seher Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2 D-71034 Böblingen, Germany

Tel: [phone] Fax: [phone] e-mail: [e-mail]

This summary was prepared on February 09, 2009.

• 2. The name of this device is the Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 measurement module.
     Classification names are as follows:

Device Panel	Classification	Procode	Description
Cardiovascular	§870.2700, II	DOA	Oximeter
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• 3. Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment.
• 4. The modified device Philips M3001A Multi Measurement Server is substantially equivalent to the leqally marketed M3001A Multi Measurement Server (K030973, K033715). The modification consists of the integration of the Nellcor OxiMax SpO2 measurement module which is substantially equivalent to the legally marketed Nellcor OxiMax N-600x Pulse Oximeter (K060576).
• 5. The modification adds to the M3001A Multi Measurement Server the Nellcor OxiMax SpO2 measurement module as an option in order to use the full Nellcor OxiMax technology.
• 6. The modified device has the same intended use as the legally marketed predicate device. The device is intended for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.
• 7. The SpO2 measurement is based on the absorption of light, which is transmitted through human tissue (e.g. index finger). Two light sources transmit red and infrared light through the human tissue.

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The ratio of the different absorption of the red and infrared light is 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 the specified saturation ranges, the ratio determines the SpO₂ value. The measurement accuracy of SpO2 in the specified ranges is between 2% and 4% RMS dependent on the Nellcor OxiMax sensor type. The measurement accuracy of pulse rate in the range of 25 bpm to 250 bpm is ±3 bpm.

• 8. The modification is the integration of the Nellcor OxiMax SpO2 measurement module into the M3001A with minor hardware and software adaptations. The modification leads to a compact Multi measurement Server with integrated full Nelloor OxiMax technology.
• 9. The accuracy of the device was validated according to ISO 9919:2005.
• 10. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry module functionality meets all reliability requirements and performance claims.

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

Public Health Service

MAY - 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Jens-Peter Seher Philips Medizin Systeme Boblingen GmbH Hewlett-Packard-Street 2 Boblingen 70134 GERMANY

Re: K090360

Trade/Device Name: Philips M3001A Multi Measurement Server Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: April 6, 2009 Received: April 9, 2009

Dear Dr. Seher:

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 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.

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

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Page 2- Dr. Seher

and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Rumer

Susan Runner, D.D.S., MA Acting 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):

Philips M3001A Multi Measurement Server Device Name:

Indications for Use:

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment.

Prescription Use Over-The-Counter Use ves No AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

g

L. Schulten 5/14/09

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

510(k) Number: K090340

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).