(72 days)
No
The summary describes a pulse oximetry module and its integration with existing patient monitors. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on standard physiological monitoring and integration.
No
The device is described as a pulse oximetry module intended for monitoring, recording, and alarming physiological parameters. It does not actively treat or prevent a medical condition.
No
The device is described as being for "monitoring, recording and alarming of multiple physiological parameters", rather than for diagnosing any conditions.
No
The device description explicitly states it is a "Masimo SET SpO₂ pulse oximetry module" for use in host patient monitors, indicating it is a hardware module, not software only. The performance studies also mention system level tests, integration tests, environmental tests, and safety testing, which are typical for hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring physiological parameters of patients (SpO2 in this case) in vivo (within the living body). IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a pulse oximetry module for use in patient monitors. Pulse oximetry is a non-invasive method of measuring oxygen saturation in the blood, typically done by placing a sensor on a finger or earlobe. This is an in vivo measurement.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, reagents, or any other characteristics typically associated with IVD devices.
Therefore, this device falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
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 adults, pediatrics and neonates in patient transport and healthcare environments.
Product codes
BZQ, DQA
Device Description
The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults, pediatrics and neonates
Intended User / Care Setting
health care professionals / patient transport and healthcare environments
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.)
Not Found
Predicate Device(s)
K013199, K020531, K030973, K040259
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
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.
-
- 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, Breathing |
| Frequency | |||
| 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.
-
- 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.
-
- 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.
1
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.
2
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
3
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: