PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

• K Number: K083351
• Device Name: PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P
• Manufacturer: COMDEK INDUSTRIAL CORP.
• Date Cleared: 2009-04-24 ( 162 days)
• Product Code: DQA
• Regulation Number: 870.2700
• Type: Traditional
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The COMDEK Portable Pulse Oximeter MD-600P offers non-invasive continuous and instantaneous monitoring, and provides users with high-level accuracy and a quick measuring response. The environments for use are hospitals, intra-hospital transport, hospital-type facilities and the home. The device is intended for use only with adults.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding the Comdek Portable Pulse Oximeter MD-600P. While it confirms the device's substantial equivalence and outlines regulatory requirements, it does not contain the detailed study information or acceptance criteria requested in the prompt.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific performance criteria or the results of a study.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, etc.: Not available in this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a medical device, not an AI algorithm.
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not applicable as this is a medical device, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable as this is a medical device, not an AI algorithm.

The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing a detailed technical study report.

Regulation Number and Section

§ 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).