CRYOPRO MAXI AND CRYOPRO MINI

K982280 · Cortex Technology Aps · GEH · Nov 25, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982280
• Device Name: CRYOPRO MAXI AND CRYOPRO MINI
• Applicant: Cortex Technology Aps
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CryoPro® Mini and CryoPro® Maxi units are intended to be used within the fields of dermatology and plastic surgery for the treatment of cryoresponsive benign, premalignant and malignant tumors such as skin tags, verrucae, actinic keratoses and basal cell carcinoma.

Device Story

CryoPro Mini and Maxi are handheld cryosurgical units; used in dermatology and plastic surgery clinics by physicians. Devices consist of vacuum-insulated stainless steel flasks (0.35 L or 0.5 L) containing liquid nitrogen. Operation involves manual dispensing via a valve system; spray nozzles or closed contact probes attach to the valve to deliver cryogen to target tissue. Device enables controlled freezing of skin lesions; facilitates removal of benign, premalignant, and malignant tumors. No electronic or software components; purely mechanical operation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: stainless steel flask, stainless steel dispensing valve, brass valve stem, Teflon gasket. Principle: vacuum-insulated liquid nitrogen cryosurgical delivery. Form factor: handheld flask (0.35 L or 0.5 L). Energy source: none (mechanical).

Indications for Use

Indicated for treatment of cryoresponsive benign, premalignant, and malignant skin tumors, including skin tags, verrucae, actinic keratoses, and basal cell carcinoma in dermatology and plastic surgery patients.

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

• CryoGun liquid nitrogen cryosurgical system

Submission Summary (Full Text)

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

# 510(K) SUMMARY

Date: June 30, 1998

Cortex Technology ApS Submitter: Textilvaenget 1 9560 Hadsund Denmark 45 9857-4100

Trade Name of Device Submitted: CryoPro® Mini and CryoPro® Maxi

Common Name: Cryosurgical Unit and Accessories

Classification Name: Cryosurgical Unit and Accessories (21 C.F.R. § 878.4350)

Predicate Device: The CryoPro® Mini and CryoPro® Maxi cryosurgical units are substantially equivalent to the CryoGun® liquid nitrogen cryosurgical system manufactured by Brymill Corporation. To the best of Cortex's knowledge, the CryoGun® is a "pre-amendments" device.

Device Description: The CryoPro® Mini consists of a 0.35 L stainless steel vacuum insulated, stainless steel flask equipped with a stainless steel top which holds a pressure relief valve and a dispensing valve for dispensing liquid nitrogen. The dispensing valve body is made of stainless steel with a brass valve stem and sealed with a Teflon gasket.

The dispensing valve may be mounted with spray nozzles or closed contact probes of varying sizes depending on the size and nature of the area to be treated.

The CryoPro® Maxi provides a 0.5 L stainless steel vacuum insulated flask and is otherwise identical to the CryoPro® Mini unit.

Intended Use: The CryoPro® Mini and CryoPro® Maxi units are intended to be used within the fields of dermatology and plastic surgery for the treatment of cryoresponsive benign, premalignant and malignant tumors such as skin tags, verrucae, actinic keratoses and basal cell carcinoma.

Technological Characteristics and Similarities: The CryoPro® Mini and CryoPro® Maxi units are similar in intended use, design, materials and construction to the Brymill CryoGun® units. The vacuum insulated flask is similar in design and holds the same working pressure. The relief valve, the dispensing valve, spray nozzles and contact probes are also similar in intended use, materials and construction.

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

For submissions claiming substantial equivalence to a 807.87(i) device which has been classified into class III under section 513(b) of the act.. . . .

Not applicable.

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

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head with three lines forming the head and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle head. The logo is simple and recognizable, representing the department's role in public health and human services.

## NOV 2 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cortex Technology APS c/o Marsha C. Wertzberger Counsel for Cortex Technology Cortex Technology APS 1050 Conneticut Avenue NW Washington, DC 20036

Re: K982280

Trade Name: Cryopro Maxi and Cryopro Mini Regulatory Class: II Product Code: GEH Dated: October 16, 1998 Received: October 16, 1998

Dear Ms. Wertzberger:

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 legally marketed predicate 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 Ouality 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.

{3}------------------------------------------------

#### Page 2 - Ms. Marsha Wertzberger

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/dsma/dsmamain.html".

Sincerely yours,

ly

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

{4}------------------------------------------------

510(k) Nunber (if known):

CryoPro @ Maxi and CryoPro Mini Device Name:

### Indications For Use:

The CryoPro® Mini and CryoPro Maxi units are intended to be used within the fields of dermatology and plastic surgery for the treatment of cryoresponsive benign, premalignant and malignant tumors such as skin tags, verrucae, actinic keratoses and basal cell carcinoma.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEROPED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K982280 |

| Prescription Use | X | OR | Over-The-Counter Use |
|----------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)

ﺒﺔ.

02/13 '96 11:07