(53 days)
Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals.
X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.
The SpO2 measurement is based on the absorption of light, which is emitted through human tissue (i.e. 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 = [HbOz]/({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 70%-100%), the ratio determines the SpO2 value. The measurement accuracy of SpO2 in the range of 70% to 100% is between 2% and 4% RMS dependent on the Philips sensor type. The measurement accuracy of pulse rate in the range of 30 bpm to 300 bpm is 2% or 1 bpm (whichever is greater).
The modification is a hardware and firmware improvement and reduces the manufacturing costs.
Here's an analysis of the acceptance criteria and study details for the picoSAT IIP408 SpO2 pulse oximetry module, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Target/Specification) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (70%-100% SaO2) | 2% to 4% RMS (Root Mean Square) dependent on Philips sensor type | "the accuracy of the subject device with all Philips sensors is within the specified accuracy of 2% to 4% RMS (Root Mean Square) in the measurement range of 70% to 100% oxygen saturation compared to SaO2 reference values." |
| Pulse Rate Accuracy (30 bpm to 300 bpm) | 2% or 1 bpm (whichever is greater) | Not explicitly re-stated in the "Reported Device Performance" for the modified device, but implicitly affirmed by the statement that the modifications are "hardware and firmware improvements" and "The modified devices have the same technological characteristics as the legally marketed predicate devices." This implies pulse rate accuracy remains consistent with the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 10 volunteers
- Data Provenance: Controlled hypoxia studies with healthy non-smoking adult volunteers. Since the submitter is Philips Medizin Systeme Böblingen GmbH (Germany), it's highly likely the study was conducted in Germany or a similar Western country, but the specific country of origin is not explicitly stated. The study was prospective in nature due to it being a "controlled desaturation study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in this context.
- Qualifications of Experts: The ground truth was established by a CO-Oximeter as a reference, not human experts. CO-Oximeters are laboratory-grade instruments used for highly accurate blood gas analysis, including oxygen saturation.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by instrumental reference (CO-Oximeter) rather than human expert interpretation requiring adjudication.
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
- MRMC Study Done: No. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study Done: Yes, essentially. The accuracy of the SpO2 measurement is a direct output of the device's hardware and firmware, compared against a reference standard. There is no human "in-the-loop" for the direct SpO2 measurement process itself.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Instrumental reference – a CO-Oximeter was used to provide SaO2 (arterial oxygen saturation) reference values.
8. The Sample Size for the Training Set
- Sample Size: Not explicitly stated as a distinct "training set" in the context of machine learning model development. For traditional medical device calibration (as described here), "calibration curves" are developed. While the text mentions "Out of calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%), the ratio determines the SpO2 value," it does not specify a separate sample size for developing these curves, implying some overlap or that the 10 volunteers may have contributed to this process. It explicitly states "at least 20 data samples per volunteer" for the validation study.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: The "calibration curves" (analogous to a training process for establishing the device's core functionality) were "based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 70%-100%)." This implies that during these hypoxia studies, a reference method (likely a CO-Oximeter, similar to the validation) was used to establish the true SaO2 values against which the device's internal light absorption ratios were mapped to create the SpO2 output.
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AUG 2 9 2008
8.0 510(k) Summary
This summary of 510 (k) safety and effectiveness information is 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 Boeblingen GmbH Cardiac & Monitoring Systems Hewlett-Packard-Str. 2 D-71034 Boeblingen Germany
+49 7031 463-2086 Fax: +49 7031 463-2442 Tel: e-mail: jens-peter.seher@philips.com
This summary was prepared on June 27, 2007.
-
- The name of the device is the picoSAT IIP408 Sp02 pulse oximetry module and the SpO2 measurement module in the X2 (M3002A) Multi Measurement Module and M1020B SpO₂ Plug-in Module. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Anesthesiology andRespiratory Therapy(12624) | §870.2700, II | DQA | Oximeter |
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- Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals. X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.
-
- The modified devices have the same intended use as the legally marketed predicate devices. The devices are intended for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals. X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.
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-
- The SpO2 measurement is based on the absorption of light, which is emitted through human tissue (i.e. 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 = [HbOz]/({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 70%-100%), the ratio determines the SpO2 value. The measurement accuracy of SpO2 in the range of 70% to 100% is between 2% and 4% RMS dependent on the Philips sensor type. The measurement accuracy of pulse rate in the range of 30 bpm to 300 bpm is 2% or 1 bpm (whichever is greater).
-
- The modification is a hardware and firmware improvement and reduces the manufacturing costs.
- The modified devices have the same technological characteristics 8. as the legally marketed predicate devices.
-
- The accuracy of the device was validated with all Philips SpO₂ sensors by a controlled desaturation study with CO-Oximeter as a reference. Data of 10 volunteers and at least 20 data samples per volunteer with the data samples spread over the specified accuracy range from 70% to 100% were collected. The controlled desaturation study demonstrates that the accuracy of the subject device with all Philips sensors is within the specified accuracy of 2% to 4% RMS (Root Mean Square) in the measurement range of 70% to 100% oxygen saturation compared to SaO2 reference values. No adverse events were reported.
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- Verification testing activities were conducted to establish the performance and reliability characteristics of the new device. Testinq involved functional level tests and safety testing from the risk analysis. Clinical validation studies were also conducted. All verification and validation activities were successfully completed. The verification and clinical validation results demonstrate that modified device is substantially equivalent to predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is facing left and has a stylized design. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2008
Dr. Jens-Peter Seher Regulatory Affairs Engineer Cardiac and Monitoring Systems Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Strasse 2 D-71034 Boeblingen GERMANY
Re: K081937
Trade/Device Name: PicoSAT IIPlus SpO2 Pulse Oximetty Module, SpO2 Measurement Module in the X2(M3002A) Multi-Measurement Module and M1020B SpO2 Plug-in Module Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 22, 2008 Received: August 25, 2008
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 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 - Dr. Seher
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Khamuels Seidi, m.d. foe //
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):K081937
Device Name: picoSAT II2108 SpO2 pulse oximetry module, SpO2 measurement module in the X2 (M3002A) Multi-Measurement Module and M1020B SpO2 Plug-in Module
Indications for Use: Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of the physiological parameters arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in a hospital environment by health care professionals.
X2 (M3002A) Multi-Measurement Module is indicated for transport monitoring outside hospitals.
(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081937
Prescription Use yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (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)
§ 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).