FRIGIDERM FRIGISPRAY

K971216 · Dermatologic Lab & Supply, Inc. · GEH · May 29, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971216
• Device Name: FRIGIDERM FRIGISPRAY
• Applicant: Dermatologic Lab & Supply, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DELASCO Frigiderm FrigiSpray is intended to be used by Dermatologists and/or Plastic Surgeons for the following procedures. Freeze destruction on epithelial arising cryoresponsive benign, premalignant and malignant tumors, such as skin tags, verrucae, cutaneous horns, actinic keratoses, and basal cell carcinoma.

Device Story

Frigiderm FrigiSpray is a manual cryosurgical unit for dispensing liquid nitrogen. Device consists of a 0.3L vacuum flask constructed of stainless steel, brass, and teflon. Includes various size nozzles for direct spray application to skin lesions. Operated by dermatologists or plastic surgeons in clinical settings. Device enables controlled cryodestruction of benign, premalignant, and malignant skin tumors. No electronic or software components.

Clinical Evidence

No clinical data submitted; bench testing not required for this Class II device per FDA request. Safety evaluation based on database search for adverse effects of currently marketed devices.

Technological Characteristics

0.3L vacuum flask; materials: stainless steel, brass, teflon. Manual operation; no energy source required. Interchangeable nozzles for liquid nitrogen delivery.

Indications for Use

Indicated for dermatologists and plastic surgeons to perform freeze destruction of epithelial-arising cryoresponsive benign, premalignant, and malignant tumors, including skin tags, verrucae, cutaneous horns, actinic keratoses, and basal cell carcinoma.

Regulatory Classification

Identification

(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

Predicate Devices

• The Brymill Cryogun

Submission Summary (Full Text)

{0}

K971216
MAY 29 1997

# Summary of Safety and Effectiveness

May 19, 1997

I. Device Submitted: Cryosurgical unit and accessories
II. Proprietary Name: Frigiderm FrigiSpray
Common Usual Name: Cryogenic Spray
III. Predicate Device:

Frigiderm FrigiSpray marketed by DELASCO is substantially equivalent to The Brymill Cryogun manufactured by Brymill Corporation, PO Box 2392, Vernon, Connecticut 06066.

IV. Device Description:

The DELASCO Frigiderm FrigiSpray has engineered a 0.3L Vacuum Flask of stainless steel, brass and teflon for the dispensing of liquid nitrogen. The device assembly is also equipped with various size nozzles providing accessibility and a direct spray to different size lesions.

V. Intended Use:

The DELASCO Frigiderm FrigiSpray is intended to be used by Dermatologists and/or Plastic Surgeons for the following procedures.

- Freeze destruction on epithelial arising cryoresponsive benign, premalignant and malignant tumors, such as skin tags, verrucae, cutaneous horns, actinic keratoses, and basal cell carcinoma.

VI. Technological Characteristic Similarities:

The DELASCO Frigiderm FrigiSpray is similar in intended use and construction to the Brymill Cryogun. The Vacuum Canister composed of stainless steel is similar in design as well as the Nozzles for Liquid Nitrogen application.

VII. Performance Data:

No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A data base search has been performed to evaluate any adverse effects of the device which is currently marketed.

No data submitted for section 807.92 6[(b)(1)(2)(3c)]
See attached documentation for adverse effects.

Page 44

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 29 1997

Ms. Deborah Grafelman
Director of Marketing
Delasco
608 13th Avenue
Council Bluffs, Iowa 51501

Re: K971216
Trade Name: Frigiderm FrigiSpray
Regulatory Class: II
Product Code: GEH
Dated: April 1, 1997
Received: April 2, 1997

Dear Ms. Grafelman:

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 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

{2}

Page 2 - Ms. Deborah Grafelman

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

Sincerely yours,


Enclosure

{3}

510(k) Number: K971216

Device Name: Frigiderm FrigiSpray

## Indications for Use:

This product is intended to be used by Dermatologists and/or Plastic Surgeons for the following procedures.

Freeze destruction on epithelial arising cryoresponsive benign, premalignant and malignant tumors, such as skin tags, verrucae, cutaneous horns, actinic keratoses, and basal cell carcinoma.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative Devices 1971216

Prescription Use ☑ (Per 21 CFR 801.109)