(77 days)
Not Found
No
The summary describes a chemical vapocoolant and its delivery system, with no mention of AI or ML technology.
Yes
The device is intended for the temporary relief of pain associated with minor surgical procedures and sports injuries, and for the treatment of restricted motion associated with myofascial pain, indicating a therapeutic purpose.
No
Explanation: The device is described as a vapocoolant (skin refrigerant) for pain control and treatment of restricted motion, and its description focuses on its chemical composition and delivery system rather than any diagnostic function. There is no mention of it being used to detect, diagnose, or monitor a condition.
No
The device description clearly states it consists of a chemical (Ethyl Chloride) and a precise delivery system, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "vapocoolant (skin refrigerant) intended for topical application to control pain..." This describes a device used directly on the body for a therapeutic purpose (pain relief).
- Device Description: The description confirms it's a chemical delivered as a spray for topical application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body. This device is applied directly to the body for a physical effect (cooling).
N/A
Intended Use / Indications for Use
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.
Product codes
MLY
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 self-aerosolized to deliver a pinpoint stream spray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
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:
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
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 Nozzle |
| 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.
(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 |
|---|---|---|
| ------------------ | --- | ---- |
(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)