GEBAUER'S CHLORIDE FINE NOZZE

K991514 · Gebauer Co. · MLY · Jul 16, 1999 · PM

Device Facts

• Record ID: K991514
• Device Name: GEBAUER'S CHLORIDE FINE NOZZE
• Applicant: Gebauer Co.
• Product Code: MLY · PM
• Decision Date: Jul 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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.

Device Story

Prescription vapocoolant device; consists of Ethyl Chloride chemical and precise delivery system (fine or medium nozzle). Operates via self-aerosolization; delivers pinpoint stream spray to skin. Cooling action achieved through rapid evaporation of Ethyl Chloride from skin surface. Used by clinicians in clinical settings for pain management and myofascial therapy. Provides immediate topical cooling to alleviate pain and improve range of motion.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and chemical composition identical to legally marketed predicate devices.

Technological Characteristics

Single organic chemical (Ethyl Chloride) in aerosol delivery system. Raw material meets USP Ethyl Chloride monograph specifications. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring topical pain control for injections, minor surgical procedures (e.g., lancing boils, abscess drainage), temporary relief of minor sports injuries, and treatment of restricted motion due to myofascial trigger points.

Predicate Devices

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

Submission Summary (Full Text)

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## 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:

[phone]

[phone]

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:

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.

#### 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

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# 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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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| 510(k) Number (if known): | K991514 |
|---------------------------|--------------------------------------------------------------------------------|
| Device Name: | Gebauer's Ethyl Chloride Fine Nozzle<br>Gebauer's Ethyl Chloride Medium Nozzle |

### Indications For Use:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR |
|------------------|---|----|
|------------------|---|----|

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number: | K991514 |
|----------------|---------|
|----------------|---------|

II-1
amended 7/14/99Over-The-Counter Use

(Optional Format 1-2-96)