CRYOPEN AND ACCESSORIES

K012214 · Cimex Biotech, LLC · GEH · Apr 26, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K012214
• Device Name: CRYOPEN AND ACCESSORIES
• Applicant: Cimex Biotech, LLC
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Apr 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CryoPen is intended to be used as a Cryosurgical unit for ablative type surgical technique. The CryoPen is indicated for use on multiple organ systems, including a wide range of disease (i.e. viral, benign, pre-malignant and malignant tissue).

Device Story

CryoPen system provides tissue ablation via freezing without cryogenic liquids/gases. System comprises refrigeration unit (115 VAC) and three hand-held modules (0.4, 0.25, 0.19 inch diameters) with disposable tips. Refrigeration unit cools modules to -100 C; includes DC power source for temperature monitoring during cool-down. Used by clinicians for ablative surgical techniques. Device benefits patients by providing controlled localized tissue destruction.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Cryosurgical unit; refrigeration-based cooling to -100 C; 115 VAC power; hand-held modules in three diameters (0.4, 0.25, 0.19 inch); pure silver contact tips; disposable tips; DC power source for temperature monitoring.

Indications for Use

Indicated for use on patients requiring tissue ablation across multiple organ systems for viral, benign, pre-malignant, and malignant tissue conditions.

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

• Wallach LL100 (K803311)

Reference Devices

• Silverlon™ Contact Wound Dressing (K981299)

Submission Summary (Full Text)

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## K012214 112 510(k) SUMMARY OF SAFETY and EFFECTIVENESS

### A. General Information

| Submitter's Name | Cimex BioTech, L.C. |
|---------------------|---------------------|
| Address: | 72385 Industry Park |
| | Covington, LA 70435 |
| Telephone: | |
| Contact Person | Michael Haas, M.D. |
| Date Prepared: | July 10, 2001 |
| Registration Number | 2320472 |

### B. Device

1.

2.

3.

4.

5.

6:

| 1. | Name: | CryoPen (Model CP-010 and Accessories) |
|----|--------------|----------------------------------------|
| 2. | Trade name: | CryoPen and Accessories |
| 3. | Common Name: | Cryosurgical Unit and Accessories |

Classification Name: Unit, Cryosurgical, Accessories

II

- 4. 5. Product Code:
GEH

- Class: 6.
Regulation Number: 878.4350 7.

## Description of the Device

The CryoPen system provides a means of freezing tissue without the use of cryogenic liquids or gases. The system consists of three hand-held freezing modules, a refrigeration unit, and disposable tips. When used properly, the system will deliver effective temperature for tissue ablation.

The refrigeration component is the largest unit, and is used to lower the temperature of the CryoPen units to temperature of -100 C. It operates on 115 VAC obtained from conventional convenience outlets. The supporting housed in the refrigerator cabinet include a DC power source to indicate the temperature of the CryoPen units during cool down, and all other necessary control and electrical safety features.

There are currently three different sizes of the hand-held modules: a 0.4 inch diameter unit, a 0.25 inch diameter unit, and a 0.19 inch diameter unit.

### C. Intended Use Statement

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KOI 2214 2/2

The CryoPen is intended to be used as a Cryosurgical unit for ablative type surgical technique.

The CryoPen is indicated for use on multiple organ systems, including a wide range of disease (i.e. viral, benign, pre-malignant and malignant tissue).

### Components D.

CONTENTS:

### PART NUMBER:

(1) CryoPen Cooling System Assembly

(2) CrvoPen Module Assembly (0.4 in)

(3) CryoPen Module Assembly (0.25 in)

(4) CryoPen Module Assembly (0.19 in)

(5) Disposable tips (0.4 in)

(6) Disposable tips (0.25 in)

(7) Disposable tips (0.19)

(8) CryoPen Cool-Down Fixture Plug

CP-001100-01 CP-004300-01 CP-004200-01 CP-004100-01 CP-004302-01 CP-004202-01 CP-004102-01 CP-006001-01

#### Substantial Equivalence E.

The CryoPen System is Substantially Equivalent to the Wallach LL100 Predicate Device, approved on February 04, 1981, (reference K803311). The CryoPen and the Wallach LL100 destroy tissue using cryogenic temperatures. The contacting metal incorporated in the cryotips used with the CryoPen™, are made of pure silver, which differs from the predicate contact material of stainless steel. A predicate device using silver is K981299 Silverlon™ Contact Wound Dressing. Appropriate biocompatibility testing was performed on this predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

**APR 26 2002**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michael J. Haas, M.D. Vice President of Research and Development Cimex Bio-Tech 72385 Industry Park Covington, LA 70435

Re: K012214

Trade/Device Name: CryoPen and Accessories Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: February 22, 2002 Received: February 28, 2002

Dear Dr. Haas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 ass backed in also 1.076, the enactment date of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Michael J. Haas, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to organ finding of substantial equivalence of your device to a legally premarket nothleation: "The PDF massification 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 If you desire specific ad roo for you in vitro diagnostic devices), please contact the Office of additionally 21 OF N Far 80510 reading for questions on the promotion and advertising of your Compliance at [phone] conpliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsional Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Miriam C. Provost
for Celia Witten, Ph.D., M.D.

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

Enclosure

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## 510(k) Number:

K012214

Device Name:

CryoPen System

Indications For Use:

- Intended Use: Cryosurgical unit used for ablative type surgical ● technique
- Indications for use: Multiple organ systems, wide range of . disease, viral, premalignant and malignant tissue.

# PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription USE __ V or OVER - THE - COUNTER - USE (Optional Form 1-2-96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K012214