(202 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the spray for cooling, with no mention of AI or ML technologies.
Yes.
The device is used for the "temporary relief and reduction of minor pain and swelling" from various injuries, which is a therapeutic purpose.
No
The device is described as providing "temporary relief and reduction of minor pain and swelling" by cooling the skin through rapid evaporation. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a physical device that delivers a chemical mixture in a spray form, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief and reduction of pain and swelling from injuries. This is a therapeutic or symptomatic treatment, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device description details a topical spray that cools the skin through evaporation. This mechanism of action is physical and applied externally, not a diagnostic process involving analysis of biological materials.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly intended for external application to the skin for symptomatic relief, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Clinical conditions that may respond to the cooling effect's of Gebauer's Instant Ice ™ Mist Spray are to use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries. For Gebauer's Instant Ice The Stream spray they are to use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries and muscle spasms.
Gebauer's Instant Ice TM (Mist Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.
Gebauer's Instant Ice TM (Stream Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries and muscle spasms.
Product codes (comma separated list FDA assigned to the subject device)
89MLY, MLY
Device Description
Gebauer's Instant Ice ™ (Mist Spray and Stream Spray) is an over-the-counter device to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) in a stream or mist spray. This mixture self-propels itself from the delivery system without the need for a propellant, because of the mixtures high vapor pressure. This form of delivery is an appropriate mode of application when the consumer follows the labeled directions for use, cooling skin through rapid evaporation of non-,medicated volatile propellants. 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 consumer 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Temperature equivalency data shows that Gebauer's Instant Ice ™ Stream is equivalent to Gebauer's Ethyl Chloride® Medium (± 5.0° C) at the 95% confidence interval 80% of the time and that the temperature range of Gebauer's Instant Ice TM Mist Spray and Gebauer's Instant Ice 11 Stream Spray are contained within the range of two currently marketed over-the-counter products. The 95% confidence intervals for average temperatures of Gebauer's Instant Ice ™ Stream and Mist Spray products, Mueller® Coolant Cold Spray and Cramer® Cold Spray (Premarket Notification 510(k), "device in commercial distribution before May 28. 1976 ) were calculated, and the temperature interval between the Mueller® and Cramer® products was determined. Gebauer's Instant Ice TM Mist Spray and Gebauer's Instant Ice 10 Stream Spray, while the same chemicals, have minor temperature characteristic differences, due to the physical properties of fluid dynamics and a slightly lower temperature in the mist.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
510(k) Application for Gebauer's Instant Ice ™ (Stream and Mist Spray) Koal726
1087
SECTION E 510(k) Summary May 7, 2002
| Device Trade Name: | Gebauer's Instant Ice TM (Mist Spray and Stream Spray) |
|---|---|
| Common Name | Cold Spray |
| DEC 1 2 2002 | |
| Establishment Registration Number: | 1519179 |
| Classification: | I (Proposed) |
| Panel: | General & Restorative Surgery |
| Device Product Code: | 89MLY |
| Device Classification Name: | Vapocollant (I believe this is a misspelling in the Classification Names Publication, FDA 95-4246 and should be Vapocoolant) |
| Special Controls: | None |
Manufacturer:
Gebauer Company 9410 St. Catherine Ave. Cleveland, OH 44104
Contact
Amy J. Paukovits Director of Regulatory Affairs and Quality Control (216) 271-5252 (216) 271-5335 Fax
Predicate Devices:
The new device's name will be Gebauer's Instant Ice ™ (Mist Spray and Stream Spray), to be sold as a non prescription over the counter product, which we claim is substantially equivalent to Gebauer's Ethyl Chloride® (Fine and Medium Nozzles) 510 (k) K991514 and Mueller® Coolant Cold Spray (21CFR 807.85 and Premarket Notification 510(k), "device in commercial distribution before May 28, 1976 are exempt from 510(k) submission), in distribution for over 40 years (as a non prescription cold spray) with no 510(k) number.
1
510(k) Application for Gebauer's Instant Ice ™ (Stream and Mist Spray)
escription
designed
pressure.
2012 Gebauer's Instant Ice ™ (Mist Spray and Stream Spray) is an over-the-counter device to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) in a stream or mist spray. This mixture self-propels itself from the delivery system without the need for a propellant, because of the mixtures high vapor
KO21736
This form of delivery is an appropriate mode of application when the consumer follows the labeled directions for use, cooling skin through rapid cvaporation of non-,medicated volatile propellants
Intended Use of Device
Clinical conditions that may respond to the cooling effect's of Gebauer's Instant Ice ™ Mist Spray are to use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries. For Gebauer's Instant Ice The Stream spray they are to use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries and muscle spasms.
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 consumer 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 Substantial Equivalence
There is demonstrated equivalency in basic product design and technology in indications for use, target population, and risk factors.
Temperature equivalency data shows that Gebauer's Instant Ice ™ Stream is equivalent to Gebauer's Ethyl Chloride® Medium (± 5.0° C) at the 95% confidence interval 80% of the time and that the temperature range of Gebauer's Instant Ice TM Mist Spray and Gebauer's Instant Ice 11 Stream Spray are contained within the range of two currently marketed over-the-counter products. The 95% confidence intervals for average temperatures of Gebauer's Instant Ice ™ Stream and Mist Spray products, Mueller® Coolant Cold Spray and Cramer® Cold Spray (Premarket Notification 510(k), "device in commercial distribution before May 28. 1976 ) were calculated, and the temperature interval between the Mueller® and Cramer® products was determined. Gebauer's Instant Ice TM Mist Spray and Gebauer's Instant Ice 10 Stream Spray, while the same chemicals, have minor temperature characteristic differences, due to the physical properties of fluid dynamics and a slightly lower temperature in the mist,
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines above and below them.
Public Health Service
DEC 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Amy J. Paukovits Director, Regulatory Affairs Gebauer Company 9410 St. Catherine Avenue Cleveland. Ohio 44104
Re: K021726
Trade/Device Name: Gebauer's Instant Ice Mist and Stream Sprays Regulation Name: Refrigerant, Topical (Vapocoolant) Regulatory Class: Unclassified Product Code: MLY Dated: September 12, 2002 Received: September 13, 2002
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
3
Page 2 - Ms. Amy Paukovits
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. 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 f 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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
b. Mark N. Milken
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
K021726 510(k) Number (if known):
Device Name: Gebauer's Instant Ice TM (Mist Spray and Stream Spray)
Indications For Use:
Gebauer's Instant Ice TM (Mist Spray): I Ise like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries. ·
Gebauer's Instant Ice TM (Stream Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries and muscle spasms.
(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 X
for Mark N. Milkena
Division a concent. Restorative and Neurological Devices
510(k) Number K021726
(Optional Format 1-2-96)