HISTOFREEZER DEVICE

K982358 · OraSure Technologies, Inc. · GEH · Oct 2, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982358
• Device Name: HISTOFREEZER DEVICE
• Applicant: OraSure Technologies, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Oct 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Histofreezer® device 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 is a portable cryosurgical device used for the treatment of benign skin lesions. It functions by applying a freezing agent to the target tissue to induce localized destruction. The device is intended for use by healthcare professionals in a clinical setting. By delivering controlled cold temperatures to the lesion, the device facilitates the removal of warts, skin tags, and other specified dermatological conditions. It serves as a non-invasive alternative to surgical excision or other destructive modalities, offering a therapeutic benefit through cryotherapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable cryosurgical device utilizing a freezing agent for localized tissue destruction. Form factor designed for clinical application of cryotherapy to benign skin lesions.

Indications for Use

Indicated for treatment of benign skin lesions including 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 20850

OCT 2 1998

R. Sam Niedbala, Ph.D., BCFE Executive Vice President STC Technologies, Inc. 1745 Eaton Ave. Bethlehem, PA 18018

Re: K982358 Trade Name: Histofreezer Device Regulatory Class: II GEH Product Code: Dated: June 30, 1998 Received: July 6, 1998

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 In addition, FDA may publish further announcements action. 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 - Dr.R.Sam Niedbala

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 leqally 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,

Colin M. Witten, Ph.D., M.D.

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

K982358 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Histofreezer® Device

(Per 21

Indications For Use: The Histofreezer® device 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) | | |
|------------------------------------------|--------------------------------------------------------|---------|----------------------|
| | (Division Sign-Off) | | |
| | Division of General Restorative Devices | | |
| | 510(k) Number | 1902358 | |
| Prescription Use<br>(Per 21 CFR 801.109) | | OR | Over-The-Counter Use |