(72 days)
Philips reusable SpO2 sensors are for multi-patient use, when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required.
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.
The provided text describes a 510(k) submission for the Philips Reusable SpO2 Sensor, Models M1191B, M1191BL, and M1191BNL. The document focuses on the substantial equivalence to a predicate device and mentions testing for performance and reliability characteristics. However, it does not provide specific acceptance criteria or the detailed study results that prove the device meets those criteria in the format requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The text states: "Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device." and "Design verification and validation test results confirmed that the device is substantially equivalent with the identified predicate devices." However, it does not specify what those performance characteristics or acceptance criteria were, nor does it present the numerical results from such tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that calibration curves are "based on controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%)." It does not specify the exact number of volunteers/patients or data points used in these studies.
- Data Provenance: The data is prospective, derived from "controlled hypoxia studies with healthy non-smoking adult volunteers." The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The ground truth for SpO2 devices is typically established through arterial blood gas (SaO2) measurements in controlled hypoxia studies. The document mentions "controlled hypoxia studies" but does not detail the methodology for establishing the ground truth or the involvement of experts in that process.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of SpO2 measurements with arterial blood gas as ground truth, a traditional adjudication method (like 2+1, 3+1 for image interpretation) is not typically applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. An MRMC study is generally relevant for AI systems involving human interpretation of medical images. For a device like an SpO2 sensor, such a study is not applicable as it does not involve human readers interpreting output from an AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, implicit in the description. The device itself (the sensor and its associated algorithm) directly measures SpO2. The device description mentions "an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value." The "controlled hypoxia studies" would be a standalone performance evaluation of the device against a physiological ground truth (arterial blood gas saturation).
7. Type of Ground Truth Used
The ground truth used is physiological measurement: arterial oxygen saturation (SaO2) obtained through "controlled hypoxia studies with healthy non-smoking adult volunteers over a specified saturation range (SaO2 from 100%-70%)."
8. Sample Size for the Training Set
The document mentions "calibration curves, which are based on controlled hypoxia studies with healthy non-smoking adult volunteers." This implies that data from these studies was used to develop or train the calibration table/algorithm. However, the exact sample size for this (what you're calling the "training set") is not specified.
9. How the Ground Truth for the Training Set Was Established
The ground truth for the "training set" (data used for calibration curves) was established through controlled hypoxia studies where volunteers' actual arterial oxygen saturation (SaO2) was likely measured through arterial blood gas analysis while their oxygen levels were varied. The document states: "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."
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PHILIPS Medical Systems
NOV - 3 2006
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 |
|---|---|
| Company Contact: | Mr. Rich McClearySenior Manager of Quality and Regulatory AffairsTel: (978) 659-4914 |
| Date of Summary: | August 18, 2006 |
| Device Name | Philips Reusable SpO2 Sensor,Models M1191B, M1191BL and M1191BNL |
| Common Name | SpO2 pulse oximeter sensor |
| Classification Name | Classification Name: OximeterRegulation 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 and K030973. |
| Modifications | The modification involves changes to the exterior cuff materials toimprove quality, enhance value and accommodate patients with largefingers. |
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| DeviceDescription | The Philips SpO2 devices measure, non-invasively, the arterial oxygensaturation of blood. The measurement method is based on the red andinfrared light absorption of hemoglobin and oxyhemoglobin. Light ofa red and infrared light source is emitted through human tissue andreceived by a photodiode.The measurement is based on the absorption of light, which is emittedthrough human tissue (for example through the index finger). Thelight comes from two sources (red LED and infrared LED) withdifferent wavelengths and is received by a photodiode. Out of thedifferent absorption behavior of the red and infrared light a so-calledRatio can be calculated. The saturation value is defined by thepercentage ratio of the oxygenated hemoglobin [HbO2] to the totalamount of hemoglobin [Hb]. |
|---|---|
| $SpO2 = [HbO2]/([Hb]+[HbO2])$ | |
| Out of calibration curves, which are based on controlled hypoxiastudies with healthy non-smoking adult volunteers over a specifiedsaturation range (SaO2 from 100%-70%), the Ratio can be related to aSpO2 value. | |
| The devices contain a red and infrared light source and a photodiodereceiving the non-absorbed red and infrared light. The receivedsignals are forwarded to a measurement device that amplifies theacquired signal and an algorithm that calculates the ratio and convertsvia a validated calibration table the ratio to a saturation value. | |
| Intended Use | Philips reusable SpO2 sensors are for multi-patient use, whencontinuous non-invasive arterial oxygen saturation and pulse ratemonitoring are required. |
| M1191B, M1191BL and M1191BNL sensors are indicated for usewith adult patients. | |
| Technologicalcharacteristics | The Philips Reusable SpO2 Sensors have the same technologicalcharacteristics as the legally marketed predicate devices. |
| Testing | Verification and validation testing activities were conducted toestablish the performance and reliability characteristics of the modifieddevice. |
| Testing involved environmental and clinical evaluations for accuracy.Hardware verification testing and cable interface verification testingwere also conducted. Design verification and validation test resultsconfirmed that the device is substantially equivalent with the identifiedpredicate devices. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2006
Mr. Rich McCleary Senior Manager, Quality & Regulatory Affairs Phillips Medical Systems 3000 Minuteman Road Andover, Massachusetts 01810-1099
Re: K062455
Trade/Device Name: Philips Reusable Sp02 Sensors Models, M1191B, M1191BL and M1191BNL Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 2, 2006 Received: October 4, 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 (sec 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/cdrl/industry/support/index.html.
Sincerely vours,
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): K062455
| Device Name: | Philips Reusable SpO2 SensorsModels M1191B, M1191BL and M1191BNL |
|---|---|
| Indications For Use: | Philips reusable SpO2 sensors are for multi-patient use,when continuous non-invasive arterial oxygen saturation andpulse rate monitoring are required. |
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)
lumm Solum
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KOL:2465 510(k) Number
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§ 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).