CRYMED CRYO-ABLATOR

K040809 · Crymed Technologies, Inc. · GEH · May 21, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040809
• Device Name: CRYMED CRYO-ABLATOR
• Applicant: Crymed Technologies, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: May 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CryMed Cryo-Ablator System is intended to be used as a cryosurgical tool for dermatology, gynecology and general surgery.

Device Story

Cryosurgical system; consists of electronic console, cryo-catheter, and liquid nitrogen tank. Operates by propelling liquid nitrogen through catheter to target site; destroys unwanted tissue via extreme cold application. Used in dermatology, gynecology, and general surgery. Physician-operated; catheter positioned via visual observation. Provides alternative to surgical resection. Benefits patient by enabling tissue destruction without traditional resection.

Technological Characteristics

Cryosurgical unit; utilizes liquid nitrogen as cryogen. System components include electronic console, cryo-catheter, and cryogen storage tank. Operates via manual control of cryogen flow to catheter tip for tissue freezing. Class II device per 21 CFR 878.4350(a).

Indications for Use

Indicated for use as a cryosurgical tool in dermatology, gynecology, and general surgery for the destruction of unwanted tissue.

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 Surgical Devices WA1000 (K813024)
• Figitronics Cryo-Plus (K811390)
• Figitronics Cryo-Surg System 5900 (K840536)
• Wallach Surgical Devices UltraFreeze (K935010)
• Cortex Technology's Cryopro Maxi and Cryopro Mini (K982280)
• CMS Cryolite (K970995)

Submission Summary (Full Text)

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## MAY 2 1 2004

#### 510(k) Safety Summary

March 22, 2004 Submitted by:

CryMed Technologies, Inc. 319 W. Timonium Road Lutherville, MD 21093 Tel. [phone] Fax [phone] Frank Majerowicz, President CryMed Technologies, Inc. Contact Person:

Name of Device

- Trade Name: CryMed Cryo-Ablator �
- Common Name: Cryosurgical Unit, Cryogenic Surgical Device .
- · Classification: Cryosurgical unit with Liquid Nitrogen, Class II [21 CFR & 878.4350(a)].

K 040809

- Establishment Registration Number: t Applied for on 3/20/04
Predicate Devices

| Device | Premarket Notification |
|------------------------------------------------------|------------------------|
| Wallach Surgical Devices WA1000 | K813024 |
| Figitronics Cryo-Plus ™ | K811390 |
| Figitronics Cryo-Surg™System 5900 | K840536 |
| Wallach Surgical Devices UltraFreeze | K935010 |
| Cortex Technology's Cryopro Maxi<br>and Cryopro Mini | K982280 |
| CMS Cryolite | K970995 |

#### Device Description

The Cryo-Ablator System is a cryosurgical device, consisting of an electronic console, cryo-catheter and cryogen tank,

The Cryo-Ablator System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a crvo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.

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#### Indications for Use

The CryMed Cryo-Ablator System is similar in form and function to the Cryomedical Sciences' CMS Cryolite, Wallach Surgical Devices WA1000 (K813024) and its UltraFreeze (K935010), Figitronics' Cryo-Plus ™ (K811390) and its Cryo-Surg™System 5900 (K840536), and the Cortex Technology's Cryopro Maxi and Cryopro Mini (K982280). The intended use for the CryMed Cryo-Ablator System is the same as those listed for the CryMed Cryo-Ablator System predicate devices.

### Technical Characteristics

The technology used by CryMed Technologies, Inc. is substantially equivalent to those of the above listed predicate devices.

### Summary

Based on the principles of operation, design, materials and intended use, the CryMed Cryo-Ablator System is substantially equilivant to devices currently marketed in the United States.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2004

Mr. Frank Majerowicz President CryMed Technologies, Inc. 319 W. Timonium Road Lutherville, Maryland 21093

Re: K040809

Trade/Device Name: CryMed Cryo-Ablator Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: March 22, 2004 Received: March 29, 2004

Dear Mr. Majerowicz:

Wc have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of 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) that do not require approval of a premarket approval application (PMA). and Oosmette . fore, market the device, subject to the general controls provisions of the Act. The I ou may , aroney mass of the Act include requirements for annual registration, listing of general vehicle profitecturing 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 complics 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 - Mr. Frank Majerowicz

This letter will allow you to begin marketing your device as described in your Section 510(k) Prins leter will and w you to over finding of substantial equivalence of your device to a legally promance noticated 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), please n you dosir of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C Provost

Celia M. 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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# Indications for Use

510(k) Number (if known):_K040809

Device Name: CryMed Cryo-Ablator from CryMed Technologies, Inc.

Indications For Use:

The CryMed Cryo-Ablator System is intended to be used as a cryosurgical tool for The Cryined Cryo-Ablator Oystem is member to matology, gynecology and general surgery.

× Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

**510(k) Number** K040809