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K Number
K021132
Device Name
UNI-PATCH ULTRASOUND COUPLING GEL
Manufacturer
THE LUDLOW COMPANY LP
Date Cleared
2002-05-15

(36 days)

Product Code
MUI
Regulation Number
892.1570
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Uni-Patch Ultrasound Coupling Gel is intended for use as the coupling medium for Ultrasound procedures on external, intact skin

Device Description

Uni-Patch Ultrasound Coupling Gel is a viscous, clear blue, water-soluble gel. Typical packaging configuration for the Uni-Patch Ultrasound Coupling Gel is 250 ml plastic bottles and 5 liter plastic containers.

AI/ML Overview

The provided text is a 510(k) summary and FDA clearance letter for the "Uni-Patch Ultrasound Coupling Gel." This document focuses on the regulatory clearance process for a medical device (ultrasound gel) based on substantial equivalence to a predicate device, rather than a study evaluating the performance of an AI-powered diagnostic device against specific acceptance criteria.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not available in the provided text. The document states:

  • "Performance FDA has not established special controls or performance standards for this device"
  • "Uni-Patch Ultrasound Coupling Gel is similar in terms of intended use and technological characteristics to predicate devices reviewed as coupling gels used to couple ultrasound device is similar with respect to indications for use and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency."

This indicates that the clearance was based on demonstrating similarity to existing, legally marketed ultrasound gels, not on a new, controlled performance study with the metrics you've outlined for AI/diagnostic devices.

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.