(178 days)
Not Found
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description is for standard pulse oximeter sensors/probes.
No
The device is described as an Oximeter Sensor/Probe intended for continuous or spot monitoring of non-invasive arterial oxygen saturation, which is a diagnostic/monitoring function, not a therapeutic intervention.
Yes
The device monitors non-invasive arterial oxygen saturation, which is a diagnostic measurement.
No
The device description explicitly mentions "ComSat Oximeter Sensors / ComSat Pulse Oximeter Probes," 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 "Continuous or spot monitoring of non-invasive arterial oxygen saturation." This describes a device that measures a physiological parameter directly from the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as "ComSat Oximeter Sensors / ComSat Pulse Oximeter Probes." Pulse oximeters are devices that attach to the skin (typically a finger or earlobe) to measure oxygen saturation and pulse rate non-invasively.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Laboratory analysis
Therefore, based on the provided information, the ComSat Oximeter Sensors / ComSat Pulse Oximeter Probes are medical devices for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Continuous or spot monitoring of non-invasive arterial oxygen saturation.
Product codes
74 DQA
Device Description
ComSat Oximeter Sensors
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
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
AUG 28 1997
Mr. Lane F. Beard Sensor Devices, Inc. c/o Aristo Medical USA 1801-A Airport Road Waukesha, Wisconsin 53188
K970769 Re: ComSat Oximeter Sensors Regulatory Class: II (two) Product Code: 74 DQA Dated: June 30, 1997 Received: July 1, 1997
Dear Mr. Beard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Lane F. Beard
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ComSat Pulse Oximeter Probes
Indications for Use: Continuous or spot monitoring of non-invasive arterial oxygen --------------------------------------------------------------------------------------------------------------saturation. ------------
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Cardiovascular, Respiratory, | ||
| and Neurological Devices | ||
| 510(k) Number | K970769 | |
| escription Use | ||
| er 21 CFR 80i.109) | OR | Over-The-Counter Use |
(Optional Format 1-2-96)