K Number
K011974
Device Name
SENSAID
Manufacturer
Date Cleared
2002-02-12

(232 days)

Product Code
Regulation Number
870.2700
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Non-invasive monitoring of patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave.

Should sensors can be used for Adult, Pediatric and/or Neonate/Infant applications with the appropriate DPT accessory.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth, or training set details.

The document is a clearance letter from the FDA for a device called "Sensaid SpO2 Sensors." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information for marketing the device. It also includes the "Indications For Use" for the device, but it does not detail any performance studies or criteria related to its accuracy or efficacy.

§ 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).