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.

Summary

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K031036 1/2

JUL 1 0 2003 SECTION E 510(k) Summary June 20, 2003

Device Trade Name:	Gebauer's Skin Refrigerant (Mist Spray andMedium Spray)
Common Name	Cold Spray
Establishment Registration Number:	1519179
Classification:	I (Proposed)
Panel:	General & Restorative Surgery
Device Product Code:	89MLY
Device Classification Name:	Vapocoolant
Special Controls:	None
Manufacturer:	Gebauer Company9410 St. Catherine Ave.Cleveland, OH 44104
Contact	Amy Paukovits

Director of Regulatory Affairs (216) 271-5252, ext. 20 (216) 271-5335 Fax

Predicate Devices:

The new device's name is Gebauer's Skin Refrigerant (Mist Spray and Medium Spray), to be sold as a prescription product, which we claim is substantially equivalent to Gebauer's Ethyl Chloride® (Fine and Medium Nozzles) 510(k) K991514 and Gebauer's Instant ICE (Mist and Stream Spray) 510(k) K021726.

Description:

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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. The new device, Gebauer's Skin Refrigerant is identical in all aspects to Gebauer's Instant ICE 510(k) K021726 except that we are requesting a prescription classification for the additional indications for use of pre-injection anesthesia, minor surgery and the management of myofascial pain by using the Spray and Stretch® technique. The new device, Gebauer's Skin Refrigerant has the identical indications for use as Gebauer's Ethyl Chloride 510(k) K991514.

Intended Use of Device

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.

Technical Summary

As with both predicate devices, the cooling action experienced by the patient is caused by the evaporation of the chemical mixture from the patient's skin. The user applies pressure to the nozzle to dispense the aerosol product onto the skin. The material is contained in a can, filled under pressure, and dispensed using standard aerosol nozzle technology.

Determination of Substantial Equivalence

There is demonstrated equivalency in basic product design and technology, in indications for use, target population, and risk factors.

As stated above, the new device is identical in formulation, delivery system and packaging to Gebauer's Instant ICE, 510(k) K021726. 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. See data in 510(k) K021726, Section I Performance. The indications for use for the new device are identical to the predicate device. Gebauer's Ethyl chloride 510(k) K991514. Under the general indication for pre-injection anesthesia, we have added in parethesis some examples of the types of injections such as IV starts, and venipunture that may be performed with Gebauer's Skin Refrigerant.

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Public Health Service

JUL 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Amy J. Paukovits Director of Regulatory Affairs Gebauer Company 9410 St. Catherine Avenue Cleveland, Ohio 44104

Re: K031036

Trade/Device Name: Gebauer's Skin Refrigerant, Mist and Medium Sprays Regulatory Class: Unclassified Product Code: MLY, Refrigerant, Topical (Vapocoolant) Dated: March 28, 2003 Received: April 21, 2003

Dear Ms. Paukovits:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Amy J. Paukovits

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

W Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K031036

Device Name: Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

Muriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K031036

D-1

Regulation Number and Section

N/A