(127 days)
Not Found
No
The summary describes standard SpO2 sensors and their intended use, without any mention of AI or ML technologies in the device description, performance studies, or key metrics.
No
The device is described as intended for non-invasive measurement of oxygen saturation and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device is intended for "non-invasive measurement of oxygen saturation (SpO2) and pulse rate," which are measurements used to inform a diagnosis.
No
The device description is not provided, but the intended use and performance studies clearly describe and test physical SpO2 sensors (reusable and disposable), which are 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 "non-invasive measurement of oxygen saturation (SpO2) and pulse rate." This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a disease state, condition, or physiological state based on the analysis of a sample.
- Using reagents or other materials to perform a test on a sample.
The device is a sensor that measures physiological parameters directly from the patient. This falls under the category of a medical device used for monitoring, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Philips reusable and disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.
Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T: M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.
Philips SpO2 Reusable Clip Sensor Model M1196T: M1196A and M1196T are indicated for patients > 40 kg (typically adult patients).
Philips Disposable SpO2 Sensor M1131A: M1131A is indicated for adult patients/pediatric patients
Philips Disposable SpO2 Sensors M1132A and M1133A: M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
Not Found
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
Adult, pediatric, neonatal, infant. For M1196T, > 40 kg (typically adult patients).
Intended User / Care Setting
Not Found
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 sensors functionality meets all reliability requirements and performance claims.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032979, K062605, K042306, K052377
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Ko63783
APR 2 7 2007
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:
Philips Medical Systems
This summary was prepared on 15 December, 2006.
The name of this device is the: Philips Reusable SpO₂ Sensors M1191T, M1192T, & M1193T; Philips SpO2 Reusable Clip Sensor M1196T; Philips Disposable SpO2 Sensor M1131A; Philips Disposable SpO₂ Sensors M1132A & M1133A. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Anesthesiology | |||
| 73 | §870.2700, II | DQA | Oximeter |
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- The new device is substantially equivalent to previously cleared Philips devices Philips Reusable SpO2 Sensors M1191T, M1192T, & M1193T marketed pursuant to K032979; Philips SpO₂ Reusable Clip Sensor M1196T pursuant to K062605; Philips Disposable SpO2 Sensor M1131A pursuant to K042306; as well as Philips Disposable SpO2 Sensors M1132A & M1133A pursuant to K052377.
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- The modification involves a labeling chanqe to add compatibility of the subject sensors with three existing non-Philips monitors; Nellcor's N-20 PA Portable Pulse Oximeter, Nellcor's NPB-40 Handheld Pulse Oximeter & Critikon's Dinamap Pro 400 V1.
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- The new device has the same Indications for Use as the legally marketed predicate device.
The Philips reusable and disposable SpO₂ Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.
Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T: M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.
Philips SpO2 Reusable Clip Sensor Model M1196T: M1196A and M1196T are indicated for patients > 40 kg (typically adult patients).
Philips Disposable SpO2 Sensor M1131A: M1131A is indicated for adult patients/pediatric patients
Philips Disposable SpO₂ Sensors M1132A and M1133A: M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.
1
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- 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 sensors 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 and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medical Systems, Incorporated Mr. Tapan D. Shah Regulatory Affairs Cardiac and Monitoring Systems 3000 Minuteman Road Andover, Massachusetts 01810
APR 2 7 2007
Re: K063783
Trade/Device Name: Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T Philips SpO2 Reusable Clip Sensor Model M1196T, Philips Disposable SpO2 Sensor M1131A, Philips Disposable SpO2 Sensors M1132A and M1133A Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class; II Product Code: DOA Dated: Undated Received: April 11, 2007
Dear Mr. Shah:
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 (first 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 Activity to un 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 offecting 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.
3
Page 2 -Mr. Shah
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) 276-0115. 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 yours.
Clus
Chin Liu, 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
4
Indications for Use
510(k) Number (if known):
Device Name(s): 1). Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T
2). Philips SpO2 Reusable Clip Sensor Model M1196T
3). Philips Disposable SpO2 Sensor M1131A
4). Philips Disposable SpO2 Sensors M1132A and M1133A
Indications for Use:
The Philips reusable and disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.
Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T
M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.
Philips SpO2 Reusable Clip Sensors Models M1196T
M1196T is indicated for patients > 40 kg (typically adult patients)
Philips Disposable SpO2 Sensor M1131A
M1131A is indicated for adult patients/pediatric patients
Philips Disposable SpO2 Sensors M1132A and M1133A
M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.
Prescription Use yes Over-The-Counter Use 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)
Chellato
C(k) Number
n of Anertheriology, General Hospital. on Control. Damel Davi
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