(232 days)
Not Found
None
No
The summary does not mention AI, DNN, or ML, nor does it describe any features or processes that typically involve these technologies (like image processing or complex data analysis beyond standard physiological monitoring).
No
The device is used for non-invasive monitoring of patient oxygen saturation and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
Explanation: The device monitors patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypoxemia or arrhythmias.
No
The summary describes a device for monitoring SpO2 and pulse rate, which typically requires a physical sensor to acquire the physiological data. The mention of "appropriate DPT accessory" further suggests a hardware component is involved. The lack of a device description prevents a definitive confirmation, but the intended use strongly implies a hardware-software system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Non-invasive monitoring of patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave." This describes a device that monitors physiological parameters directly from the patient's body, not a device that analyzes samples (like blood, urine, or tissue) outside of the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device does not perform such tests.
Therefore, this device falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
Non-invasive monitoring of patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave.
Product codes
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 and/or Neonate/Infant
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three wavy lines extending from the figure's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Mr. George Mason Sensidyne, Inc. 16333 Bay Vista Drive Clearwater, FL 33760
Re: K011974
Sensaid SpO2 Sensors (RC-NCR11-3, RC-NCR10-3, and RC-OHM20-10) Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: 74 DQA Dated: December 20, 2001 Received: December 21, 2001
Dear Mr. Mason:
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 for are navaior 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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Page 2 - Mr. George Mason
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 or any I vith 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 (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 promated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of Compliance at (201) 594-4639 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O inter goneta mall 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/dsma/dsmamain.html
Sincerely yours,
Dah Tell
Robert D. Zuckerman, M.D.
am D. Zuckermah, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K 011974
Device Name: SENSAID
Indications For Use:
Non-invasive monitoring of patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave.
pleuryShould sensors can be used for Adult, Pediatric and/or Neonate/Infant applications with the appropriate DPT accessory.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dalla teh
Division of Cardiovascular & Respiratory Devices
510(k) Number K01944
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)