HISTOFREEZER VERRUCA PLANA

K971392 · OraSure Technologies, Inc. · GEH · Oct 21, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971392
• Device Name: HISTOFREEZER VERRUCA PLANA
• Applicant: OraSure Technologies, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Histofreezer is indicated for use in the treatment of the following: Genital Warts Molluscum Contagiosum Seborrhoeic Keratosis Skin Tags Verruca Plantaris Verruca Vulgaris Verruca Plana

Device Story

Histofreezer Verruca Plana is a cryosurgical device used for the destruction of benign skin lesions. It utilizes a cryogen to freeze tissue, causing controlled necrosis of the target lesion. The device is intended for use by healthcare professionals in a clinical setting. By applying the freezing agent directly to the lesion, the device facilitates the removal of warts, skin tags, and other specified dermatological conditions. The procedure is performed in-office, allowing for rapid treatment of common skin growths without the need for invasive surgery.

Technological Characteristics

Cryosurgical device utilizing a freezing agent for tissue destruction. Form factor designed for topical application to skin lesions. Class II device.

Indications for Use

Indicated for treatment of genital warts, molluscum contagiosum, seborrhoeic keratosis, skin tags, verruca plantaris, verruca vulgaris, and verruca plana in patients requiring cryotherapy.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

R. Sam Niedbala, Ph.D., BCFE .Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799

OCT 21 1997

Re: K971392 Trade Name: Histofreezer® Verruca Plana Regulatory Class: II Product Code: GEH Dated: September 15, 1997 Received: September 16, 1997

Dear Dr. Niedbala:

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 requirements , 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 - R. Sam Niedbala, Ph.D., BCFE

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,

Aisellfo

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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Histofreezer® Verruca Plana _____________________________________________________________________________________________________________________________________

Indications For Use: Histofreezer is indicated for use in the treatment of the following:

Genital Warts Molluscum Contagiosum Seborrhoeic Keratosis Skin Tags Verruca Plantaris Verruca Vulgaris Verruca Plana

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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