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K Number
K973991
Device Name
METRON QA-510 SPO2 ANALYZER
Manufacturer
METRON U.S., INC.
Date Cleared
1998-01-16

(87 days)

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

The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.

Device Description

The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.

AI/ML Overview

This document is a 510(k) Pre-market Notification from the FDA regarding the Metron U.S. QA-510 SpO2 Analyzer. It is a regulatory approval letter and an indications for use statement. Therefore, it does not contain the detailed technical study information requested about acceptance criteria and device performance.

The document discusses:

  • Device Name: Metron U.S. QA-510 SpO2 Analyzer
  • Regulatory Class: II (two)
  • Product Code: 74 DQA
  • Indications for Use: "The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED. The QA-510 is designed to be used by trained service technicians."
  • Substantial Equivalence: The FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.

Therefore, I cannot provide the requested information about acceptance criteria and study details because this type of information is typically found in the 510(k) submission itself (which includes engineering reports, test data, and performance specifications), not in the FDA's clearance letter.

The letter confirms the device's clearance for marketing, but it does not disclose the specific performance metrics, study designs, sample sizes, or ground truth methodologies that were part of the underlying submission that led to this clearance.

§ 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).