DERMAFREEZE

K992286 · Rhealm Pharmaceuticals, Inc. · MLY · Jan 21, 2000 · PM

Device Facts

• Record ID: K992286
• Device Name: DERMAFREEZE
• Applicant: Rhealm Pharmaceuticals, Inc.
• Product Code: MLY · PM
• Decision Date: Jan 21, 2000
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

DermaFreeze™ is a vapocoolant intended for topical application for the control of pain associated with minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), injections, and contusions.

Device Story

DermaFreeze is a vapocoolant spray applied topically to skin. Device functions via rapid evaporation of coolant agent, inducing localized cooling effect on skin surface. Cooling provides temporary analgesic effect, reducing pain sensation during minor surgical procedures, injections, or treatment of contusions. Used in clinical settings by healthcare professionals. Output is physical cooling of tissue; clinical benefit is pain management for patient during minor procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vapocoolant spray for topical application. Device functions via evaporative cooling principle. No electronic components, software, or complex materials described.

Indications for Use

Indicated for topical pain control during minor surgical procedures (e.g., lancing boils, incision/drainage of small abscesses), injections, and contusions.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2000

Dr. Richard Mann President RHEALM Pharmaceuticals, Inc. 258 SE 6" Avenue Suite 12 Delrav Beach, Florida 33483

Re: K992286

Trade Name: DermaFreeze Regulatory Class: Unclassified Product Code: ML Y Dated: October 22, 1999 Received: October 25, 1999

### Dear Dr. Mann:

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 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 (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 (OS) 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.

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.

{1}------------------------------------------------

#### Page 2 -- Dr. Richard Mann

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

CONFIDENTIAL

### K 992286

## DermaFreeze™ Premarket Notification

# INDICATIONS FOR USE

DermaFreeze™ is a vapocoolant intended for topical application for the control of pain associated with minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), injections, and contusions.

(Please do not write below this line, continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) X

Over-The-Counter
(Optional Form) **__**

Neo for SED
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992286

RHEALM Pharmaceutical, Inc., DermaFreeze™ 510k