(81 days)
No
The summary describes the integration of a standard pulse oximetry module into an existing multi-measurement server. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The testing focuses on standard medical device performance and safety metrics.
No
The device is described as monitoring, recording, and alarming physiological parameters, which are diagnostic functions, not therapeutic ones.
No
Explanation: The device is indicated for monitoring, recording, and alarming of physiological parameters, which places it in the category of patient monitoring devices rather than diagnostic devices. While monitoring can inform diagnosis, the primary intended use described does not involve disease detection or characterization.
No
The device description explicitly states "minor hardware and software adaptations" and describes the integration of a "Nellcor OxiMax SpO2 measurement module," which is a hardware component. The performance studies also mention system-level tests and environmental tests, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "monitoring the physiological parameters of patients" and "monitoring, recording and alarming of multiple physiological parameters". This involves directly measuring physiological signals from the patient's body (like SpO2 and pulse rate).
- Device Description: The description details the integration of a pulse oximetry module, which measures oxygen saturation and pulse rate non-invasively from the patient's tissue (e.g., finger).
- Anatomical Site: The mention of "human tissue (e.g. index finger)" confirms that the measurements are taken directly from the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, or tissue samples) in a laboratory setting, which is the defining characteristic of an In Vitro Diagnostic device.
Therefore, this device falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes
DOA, DPZ
Device Description
The modified device Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 measurement module. 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 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. 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
index finger
Indicated Patient Age Range
adult, pediatric and neonatal patients
Intended User / Care Setting
health care professionals / hospital environment and during transport inside and outside of hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The accuracy of the device was validated according to ISO 9919:2005. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
- 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: +49 7031 463-2086 Fax: +49 7031 463-2442 e-mail: jens-peter.seher@philips.com
This summary was prepared on February 09, 2009.
-
- The name of this device is the Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 measurement module.
Classification names are as follows:
- The name of this device is the Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 measurement module.
| Device Panel | Classification | Procode | Description |
|---|---|---|---|
| Cardiovascular | §870.2700, II | DOA | Oximeter |
| 74 |
-
- 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.
-
- 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 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.
-
- 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.
42
1
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.
-
- 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.
-
- The accuracy of the device was validated according to ISO 9919:2005.
-
- 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.
2
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
3
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
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