Gebauer's Ethyl Chloride (Fine and Medium Nozzles): Gebauer's Ethyl Chloride is 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 and the temporary relief of minor sports injuries. It is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.

Device Description

Ethyl Chloride (Fine or Medium Nozzle) is a prescription device consisting of a single organic chemical (Ethyl Chloride) and a precise delivery system. The chemical is selfaerosolized to deliver a pinpoint stream spray.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Gebauer's Ethyl Chloride, a vapocoolant device. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, rather than to establish new performance criteria through a study.

Therefore, the document does not contain the information requested regarding:

Acceptance criteria and reported device performance in a table.
Sample size used for the test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance study.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Instead, the document focuses on demonstrating technological equivalence to existing legally marketed predicate devices.

Here's an analysis of what the document does state concerning the comparison:

Comparison of Technological Characteristics (from {1}):

Mechanism of Action: Both the new devices (Gebauer's Ethyl Chloride Fine/Medium Nozzle) and predicate devices aerosolize Ethyl Chloride. The cooling action is caused by the evaporation of Ethyl Chloride from the patient's skin.
Active Ingredient Quality: Both new and predicate devices contain Ethyl Chloride that meets the test specifications delineated in the USP Ethyl Chloride raw material monograph.
Differences: The only difference noted is the "USP designation for the finished aerosolized product."
Raw Material: The source and grade of the raw material are identical for the predicate and new devices.

Conclusion of Substantial Equivalence (from {2} and {3}):

The FDA reviewed the 510(k) submission and determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This determination allows the device to be marketed.

In essence, for this type of submission, the "proof" the device meets acceptance criteria is the demonstration that its technological characteristics and intended use are sufficiently similar to a predicate device that has already been cleared for market. There is no new clinical or performance study conducted by the manufacturer and detailed in this document to establish novel performance metrics or acceptance criteria.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white graphic of a stylized letter 'G'. The letter is formed by a thick, rounded shape that is open on the right side. A horizontal line extends from the opening of the 'G', creating a tail-like feature. The overall design is simple and modern.

NY

K991514

510(k) SUMMARY

Establishment Name:

Gebauer Company (Manufacturer)

9410 St. Catherine Ave. Cleveland, OH 44104

Address:

Phone Number:

Fax Number:

Contact Person:

Date Summary Prepared:

Device Names:

Classification Name:

Predicate Products:

(216) 271-5252

(216) 271-0910

Denise E. Spellman (Official Correspondent)

4/28/99

Gebauer's Ethyl Chloride, Fine Nozzle Gebauer's Ethyl Chloride, Medium Nozzle

Vapocollant

Ethyl Chloride, USP Fine Nozzle Ethyl Chloride, USP Medium Nozzle Ethyl Chloride, USP 100 g Tube

Device Description:

Intended Use of Device:

Ethyl Chloride (Fine or Medium Nozzle): Ethyl Chloride is a vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections, minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), and the temporary relief of minor sports injuries. It is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.

V-1 amended 7/14/99

{1}------------------------------------------------

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Both the new devices and predicate devices aerosolize Ethyl Chloride. The cooling action experienced by the patient is caused by the evaporation of Ethyl Chloride from the patient's skin. Both new and predicate devices contain Ethyl Chloride that meets the test specifications delineated in USP Ethyl Chloride raw material monograph. The only differences between the new devices and the predicate devices is the USP designation for the finished aerosolized product. The source and grade of the raw material is identical for the predicate and new devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 16 1999

Ms. Denise E. Spellman OA/Regulatory Affairs Director Gebauer Company 9410 St. Catherine Avenue Cleveland, Ohio 44104

Re: K991514

Trade Name: Gebauer's Chloride Fine Nozzle Regulatory Class: Unclassified Product Code: MLY Dated: June 3, 1999 Received: June 9, 1999

Dear Ms. Spellman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Ms. Denise E. Spellman

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

{4}------------------------------------------------

510(k) Number (if known):	K991514
Device Name:	Gebauer's Ethyl Chloride Fine NozzleGebauer's Ethyl Chloride Medium Nozzle

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	X	OR
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(Division Sign-Off)

Division of General Restorative Devices

510(k) Number:	K991514
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II-1
amended 7/14/99Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A