VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM

K982506 · Cryosurgery, Inc. · GEH · Jan 27, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K982506
• Device Name: VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
• Applicant: Cryosurgery, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jan 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratoses, achrochordon, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna, keratoacanthoma, basal cell, bowen's disease, lentigo discreta, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi's sarcoma, and pyogenic granuloma.

Device Story

Verruca-Freeze Cryosurgery Delivery System uses a refrigerant blend (1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane) to perform cryosurgery. Device delivers cryogen to skin lesions to induce tissue destruction via freezing. Used by clinicians in office settings for dermatological procedures. System facilitates removal or treatment of various benign and malignant skin growths; benefits patient through minimally invasive lesion destruction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cryosurgical delivery system utilizing a pressurized refrigerant blend of 1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane. Manual delivery mechanism for topical application to skin lesions.

Indications for Use

Indicated for treatment of benign and malignant skin lesions including warts, keratoses, skin tags, molluscum contagiosum, age spots, dermatofibroma, keloids, granuloma, angiomas, and various carcinomas in patients requiring cryosurgical intervention.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1999

Ronald A. McDow, M.D. Medical Director CryoSurgery, Inc. Post Office Box 50035 Nashville, Tennessee 37205

Re: K982506

Trade Name: Verruca-Freeze Cryosurgery Delivery System™ Regulatory Class:II Product Code: GEH Dated: January 4, 1999 Received: January 6, 1999

Dear Dr. McDow:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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.

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Page 2 - Ronald A. McDow, M.D.

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,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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## Statements of Indications for Use

1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratoses, achrochordon, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna, keratoacanthoma, basal cell, bowen's disease, lentigo discreta, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi's sarcoma, and pyogenic granuloma.

Prescription Use
(Per 21 CFR 801.109)

patel

(Division Sign-Off) Division of General Restorative Devil 510(k) Number