(100 days)
No
The summary describes a topical anesthetic spray and its delivery system, focusing on chemical composition and physical properties. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is intended to control pain, relieve minor sports injuries, and treat restricted motion, which are considered therapeutic benefits.
No
Explanation: The device is a topical anesthetic intended for pain control and temporary relief of minor injuries by cooling the skin. It does not diagnose any condition.
No
The device description clearly indicates a physical delivery system for a chemical mixture, 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 for topical application to the skin to control pain and provide temporary relief. This is a direct application to the body surface, not for examining specimens taken from the body.
- Device Description: The description details a spray that delivers volatile propellants to cool the skin through evaporation. This is a physical effect on the body, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
89MLY
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. 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K031036 1/2
JUL 1 0 2003 SECTION E 510(k) Summary June 20, 2003
| Device Trade Name: | Gebauer's Skin Refrigerant (Mist Spray and
Medium 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 Company
9410 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:
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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized symbol consisting of three curved lines that resemble a person's profile.
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.
3
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
4
510(k) Number (if known): K031036
Device Name: Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic
Indications For 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
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