(201 days)
None
No
The 510(k) summary describes a topical anesthetic spray and its delivery system, with no mention of AI or ML technology in the intended use, device description, or other sections.
Yes
The device is described as a "vapocoolant" and is intended for "temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions)" and "treatment of myofascial pain caused by trigger points, restricted motion and muscle tension," which are therapeutic applications.
No
The device is a vapocoolant intended for pain control and temporary relief of minor injuries, not for diagnosing medical conditions.
No
The device description clearly states it is a delivery system for a chemical mixture, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that Gebauer's Skin Refrigerant is a topical anesthetic applied directly to the skin, mucous membranes, and minor open wounds. It works by cooling the skin through rapid evaporation.
- Lack of Sample Analysis: There is no mention of this device being used to analyze any biological samples taken from the body. Its function is purely external and physical (cooling).
Therefore, based on the provided text, Gebauer's Skin Refrigerant is a topical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. Gebauer's Skin Refrigerant controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
Product codes (comma separated list FDA assigned to the subject device)
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 (1,1,2-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 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 spray is an appropriate mode of application when users follow directions for use, cooling the 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 Skin Refrigerant (Mist Spray and Medium Spray) 510(k) K031036, except that we are requesting expanded indications for use of the product on mucous membranes and breached and compromised skin. Both the new and predicate devices are indicated for use to control pain for pre-injection anesthesia, minor surgery, and minor sports injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin, mucous membranes, minor open wounds
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): 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
K032671
lop2
MAR 1 7 2004
SECTION E 510(k) Summary August 29, 2003
Device Trade Name:
Common Name
Establishment Registration Number:
Classification:
Panel:
Device Product Code:
Device Classification Name:
Special Controls:
Manufacturer:
Contact:
Gebauer's Skin Refrigerant (Mist Spray and Medium Spray)
Cold Spray
1519179
I (Proposed)
General & Restorative Surgery
89MLY
Vapocoolant
None
Gebauer Company 9410 St. Catherine Ave. Cleveland, OH 44104
Amy Paukovits Director of Regulatory Affairs Tel: (216) 271-5252, ext. 20 Fax: (216) 271-5335
Predicate Device:
Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) 510(k) K031036
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 (1,1,2-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 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 spray is an appropriate mode of application when users follow directions for use, cooling the 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 Skin Refrigerant (Mist Spray and Medium Spray) 510(k) K031036, except that we are requesting expanded indications for use of the product on mucous membranes and breached and compromised skin. Both the new and predicate devices are indicated for use to control pain for pre-injection anesthesia, minor surgery, and minor sports injuries.
1
K032671
20F2
The Medium Spray for the new device, like the predicate medium spray device, is also indicated for the management of myofascial pain caused by trigger points, restricted motion and muscle tension by using the Spray and Stretch® technique.
Intended Use of Device
A vapocoolant (skin refrigerant) intended for topical application to skin, mucous membranes and minor open wounds. Gebauer's Skin Refrigerant controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
Technical Summary
As with the predicate device, 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
This premarket notification 510(k) "change being effected" is being submitted to expand the indications for use for Gebauer's Skin Refrigerant, Mist and Medium Stream. 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 the predicate device Gebauer's Skin Refrigerant, Mist and Medium Stream previously cleared for market under 510(k) K031036. The new device has expanded indications for use for topical application to the skin, mucous membranes and breached or compromised skin. Eoth the new and predicate devices are indicated for use to to control pain associated with pre-injection anesthesia, minor surgery and minor sports injuries. The medium stream spray for both the predicate and new device have the identical indication for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension. The expansion of the indications for use is based on FDA's Blue Book #G95-1 and ISO-10993.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Ms. Amy J. Paukovits Director of Regulatory Affairs Gebauer Company 9410 St. Catherine Avenue Cleveland, Ohio 44104
Re: K032671
Trade/Device Name: Gebauer's Skin Refrigerant (Mist Spray and Medium Stream Spray) Topical Anesthetic
Regulatory Class: Unclassified Product Code: MLY Dated: March 8, 2004 Received: March 10, 2004
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 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/dsmamain.html
Sincerely yours,
Mark N. Milliken
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K032671
Device Name: Gebaucr's Skin Refrigerant (Mist Spray and Medium Stream 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 skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. Gebauer's Skin Refrigerant controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
R. Mark A. Milliken
neral. Restorative. 0-1 and Neurological Devices
510(k) Number K032671
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