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K Number
K031018
Device Name
AUTOGEL PAD
Manufacturer
RICH-MAR CORP.
Date Cleared
2003-12-08

(252 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

Conductive medium for transmission of therapeutic ultrasound to tissue.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "AutoGel Pad." This document pertains to the regulatory clearance of a device based on substantial equivalence to a predicate device, rather than a de novo approval that would detail extensive performance studies against acceptance criteria.

Therefore, the input document does not contain the information requested in the prompt regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size and data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How training set ground truth was established.

This document merely states that the FDA found the "AutoGel Pad" to be substantially equivalent to a legally marketed predicate device, indicating it can be marketed for its stated "Indications For Use: Conductive medium for transmission of therapeutic ultrasound to tissue." The FDA's determination of substantial equivalence often relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, but it does not typically involve the detailed performance study reporting requested in the prompt.

§ 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.