LogoFDA 510(k) Search
K Number
K031036
Device Name
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
Manufacturer
GEBAUER CO.
Date Cleared
2003-07-10

(100 days)

Product Code
MLY,REF
Regulation Number
N/A
Type
Traditional
Panel
PM
Reference & Predicate Devices
K021726,K991514
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries. The Medium Spray is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.

Device Description

Gebauer's Skin Refrigerant (Mist and Medium Spray) Topical Anesthetic is a prescription device designed to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) in a mist and medium spray. This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device delivery system submitted in this application is specifically designed to deliver a medium and mist spray of the Gebauer's Skin Refrigerant (Mist Spray and Stream Spray) mixture. The medium and mist is an appropriate mode of application when users follow the labeled directions for use, cooling skin through rapid evaporation of the non-medicated volatile propellants.

AI/ML Overview

The provided text describes Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The document, primarily a 510(k) summary, focuses on establishing substantial equivalence based on:

  • Identical formulation and delivery system to Gebauer's Instant ICE (K021726).
  • Identical indications for use to Gebauer's Ethyl Chloride (K991514), with additional clarification for pre-injection anesthesia examples.

The only "performance" mentioned is a reference to: "The temperature equivalency data previously submitted in 510(k) K021726, shows that Gebauer's Instant Ice 110 Stream is equivalent to Gebauer's Ethyl Chloride® Medium (± 5.0° C) at the 95% confidence interval 80% of the time." However, details of this study are not provided in the current document, and it pertains to a predicate device's equivalency, not specific acceptance criteria for the new device itself.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text.

Summary of missing information:

  • Acceptance Criteria for Gebauer's Skin Refrigerant (Mist Spray and Medium Spray): Not stated.
  • Reported Device Performance for Gebauer's Skin Refrigerant (Mist Spray and Medium Spray): Not stated.
  • Details of the temperature equivalency study (K021726): Not provided in this document, only a high-level summary of its outcome. This study was for a predicate device.

To address your request, information specifically outlining performance acceptance criteria and a study design/results for the Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) would be needed.

N/A