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K Number
K133090
Device Name
OXICARE FINGERTIP PULSE OXIMETER
Manufacturer
DELBIO INCORPORATION
Date Cleared
2014-02-28

(151 days)

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

The Fingertip Pulse Oximeter (DB12) is used for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult patients in hospitals, physician's office, clinical settings and home care environment. The Fingertip Pulse Oximeter (DB12) is not intended for continuous monitoring.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification approval letter for the Oxicare Fingertip Pulse Oximeter, Model DB12. It confirms the substantial equivalence of the device to legally marketed predicate devices.

However, the document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document does not provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance. This document only confirms the device's substantial equivalence based on prior (unspecified) testing.
  3. Number of experts or their qualifications for ground truth establishment.
  4. Adjudication method for the test set.
  5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not typically for a simple pulse oximeter.
  6. Information on standalone algorithm performance. A pulse oximeter is a physical sensor, not an algorithm in the sense of AI.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document primarily focuses on the regulatory aspects of the device's clearance, such as its classification, regulation number, and general controls provisions of the Act. While it implies that the device has undergone testing to demonstrate its performance for "spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR)", the details of how that performance was assessed against specific criteria are not included in this FDA letter. Such details would typically be found in the manufacturer's 510(k) submission, which is not fully provided here.

§ 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).