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K Number
K984564
Device Name
ETHYL CHLORIDE DISPENSER
Manufacturer
DUKAL CORP.
Date Cleared
1999-12-02

(344 days)

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

A vapocoolant intended for topical application in management of myofacial pain, restricted motion, and muscle spasm, and for the control of pain associated with injections, minor surgical procedures and the temporary relief of minor sports injuries.

Device Description

Dispenser Containing a Vapocoolant

AI/ML Overview

This document does not contain information about the acceptance criteria and the study proving the device meets them. The provided text is a 510(k) summary for an Ethyl Chloride and Dispenser and the FDA's response regarding its substantial equivalence to a predicate device.

It includes:

  • Contact information for the submitter.
  • Date of the summary.
  • Trade name, classification, and predicate device.
  • Device description and intended use.
  • FDA's letter of substantial equivalence.
  • Detailed indications for use.

It does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size for the test set or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication method.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information on a standalone algorithm performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

N/A