(72 days)
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 adults, pediatrics and neonates in patient transport and healthcare environments.
The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.
The provided text is a 510(k) summary for the Philips Medical Systems Masimo SET SpO2 module. This document focuses on establishing substantial equivalence of a new device to a legally marketed predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for the new device's specific clinical efficacy or accuracy.
Therefore, much of the requested information cannot be directly extracted from the provided text. The summary explicitly states: "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."
This indicates that the testing performed largely confirmed the new device's ability to operate similarly to the predicate under various conditions, rather than a clinical study establishing new performance benchmarks.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It does not provide specific acceptance criteria or reported device performance metrics in a table format for the new device. The focus is on equivalence, not on new performance claims.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The summary refers to "system level tests, integration tests, environmental tests, and safety testing," which are typically laboratory or engineering tests, not clinical studies with a "test set" in the context of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As noted above, the "test set" likely refers to engineering testing, not a clinical dataset requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is 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
This information is not provided. The device is an SpO2 module, which provides a physiological measurement, not an AI-powered diagnostic tool requiring human reader studies to improve interpretation. An MRMC study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a pulse oximetry module, which inherently provides a standalone measurement (SpO2, pulse rate). The summary confirms its "functionality" and "performance claims," implying its ability to provide these measurements independently. However, the exact details of standalone performance metrics are not explicitly stated beyond meeting predicate specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a pulse oximeter, "ground truth" for accuracy is typically established through controlled desaturation studies compared against arterial blood gas measurements. The provided text does not detail the type of ground truth used for specific accuracy validation, but implies it was sufficient to demonstrate equivalence to the predicate.
8. The sample size for the training set
This information is not provided. Pulse oximeters do not typically employ a "training set" in the machine learning sense. Their algorithms are based on established physiological principles and signal processing, often calibrated and validated against clinical data, but not "trained" as an AI model would be.
9. How the ground truth for the training set was established
As there is no "training set" in the AI sense for this device, how its ground truth was established is not applicable and therefore not provided.
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not a detailed clinical study report on the new device's performance metrics against specific acceptance criteria.
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8.0 510 (k) Summary
summary of 510 (k) safety and effectiveness information This 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:
Philips Medical Systems
OCT 1 8 2006
This summary was prepared on 4 August, 2006.
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- The name of this device is the Masimo SET SpO2 module for Philips and M3001A Multi-measurement Server option A03. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Anesthesiology | §868.2375, II | BZQ | Monitor, BreathingFrequency |
| 73 | §870.2700, II | DQA | Oximeter |
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- The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.
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- The new device has the same Indications for Use as the legally marketed predicate device: 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 adults, pediatrics and neonates in patient transport and healthcare environments.
-
- The new device has the same technological characteristics as the legally marketed predicate device.
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- 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/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the organization's role in public health and welfare.
OCT 1 8 2006
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems North America Company C/O Mr. Dave Osborn Programs Manager Philips Medical System 3000 Minuteman Road Andover, Massachusetts 01810
Re: K062268
Trade/Device Name: Masimo SET SpO2 Module for Philips and M3001 A Multimeasurement Server Option A03
Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 22, 2006 Received: September 26, 2006
Dear Mr. Osborn:
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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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, emphasizing the department's role and national scope.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Page 2 - Mr. Osborn
Food and Drug Administration
Please be advised that FDA's issuance of a substantial equivalence determing 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 vours.
Ching-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
Enclosure
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Indications for Use
510(k) Number (if known): 1 120(o 2260
Device Name:
Masimo SET SpO2 module for Philips and M3001A Multimeasurement Server option A03
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 adults, pediatrics and neonates in patient transport and healthcare environments.
Prescription Use Over-The-Counter Use yes 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) Page (Division Sign-Qff) Division of Anesthesiology, General Hospital Infection Control, Dental D 510(k) Number:
§ 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).