SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

K040690 · Cryocath Technologies, Inc. · OCL · Apr 29, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040690
• Device Name: SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
• Applicant: Cryocath Technologies, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Apr 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Device Story

System comprises cryosurgical console, 10 cm cryosurgical probe, FrostByte clamp, gas tank regulator, and footswitch. Operates via Joule-Thomson effect using inert argon gas to deliver cold temperatures to target cardiac tissue. Used in minimally invasive cardiac surgery by physicians to create cryonecrosis and inflammatory response, thereby blocking abnormal electrical conduction pathways. Console powered by 120/230 VAC; controls gas flow to single-use disposable probe. Physician monitors procedure and applies probe/clamp to tissue; output is localized tissue freezing. Benefits include precise ablation of arrhythmogenic tissue.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

System utilizes inert argon gas for cryoablation via Joule-Thomson effect. Components include console, 10 cm probe, and clamp. Operates on 120/230 VAC. Single-use disposable probes. Class II device.

Indications for Use

Indicated for patients undergoing minimally invasive cardiac surgical procedures, including treatment of cardiac arrhythmias, requiring tissue freezing to block electrical conduction pathways.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• SurgiFrost® Cryosurgical System (K021010)
• CryoCare Cardiac Surgical System (K011040)
• AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190)
• Cobra Bipolar System (K023288)
• Atricure Bipolar Coagulation System (K020919)
• Cardioblate™ Radiofrequency Ablation System (K013392)

Submission Summary (Full Text)

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# 510(k) Summary

# CryoCath Technologies Inc. SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console

### 1. SPONSOR

| CryoCath Technologies Inc. | |
|----------------------------|----------------------------------------------|
| 16771 Chemin Ste-Marie | |
| Kirkland, Quebec | |
| H9H 5H3, CANADA | |
| Contact Person: | Flor del Pilar Arana, Official Correspondent |
| Telephone: | 514-694-1212 |

Date Prepared: March 12, 2004

### 2. Device Name

| Device Trade Name: | SurgiFrost® 10 cm Cryosurgical Device plus<br>FrostByte™ Clamp and Cryosurgical Console |
|------------------------|-----------------------------------------------------------------------------------------|
| Common/Usual Name: | Cryosurgical system |
| Classification Name: | Cryosurgical Unit and Accessories |
| Device Classification: | Class II |

### 3. PREDICATE DEVICES

CryoCath Technologies - SurgiFrost® Cryosurgical System (K021010)

Endocare Inc. - CryoCare Cardiac Surgical System (K011040)

CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190)

Boston Scientific - Cobra Bipolar System (K023288)

Atricure Inc. - Atricure Bipolar Coagulation System (K020919)

Medtronic Inc. - Cardioblate™ Radiofrequency Ablation System (K013392)

### 4. Device Description

The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical

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procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

## The Intended Use does not change as a result of this special 510(k) submission.

The SurgiFrost® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, Cryosurgical Console and accessories act together as a System. The system is composed of the following components:

- . Cryosurgical Control Panel and Power Cord
- Cryosurgical Console �
- Tank Carrier .
- Gas Tank Regulator and Wrench .
- Gas Hose .
- SurgiFrost® Cryosurgical Device (Single Use) ●
- . FrostByte™ Clamp (Single Use)
- . Footswitch (optional)

The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 10 cm Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.

### 5. Intended Use

The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive treatment of cardiac arrhythmias. The CryoCath SurgiFrost® System freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational

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KO40690 p.30f3

characteristics. The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness.

### 7. Performance Testing

Information submitted in this premarket notification for the SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices listed.

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a bird-like figure wrapped around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

FEB 21 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CryoCath Technologies, Inc. c/o Ms. Flor del Pilar Arana Director Regulatory Affairs 16771 Chemin Ste-Marie Kirkland, Quebec H9H 5H3, CANADA

Re: K040690

Trade Name: SurgiFrost® 10 cm Cryosurgical Device plus Frostbyte™ Clamp and Cryosurgical Console Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: II (two) Product Code: OCL Dated: April 14, 2004 Received: April 20, 2004

Dear Ms. Pilar Arana:

This letter corrects our substantially equivalent letter of April 29, 2004.

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 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) that do not require approval of a premarket approval (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 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.

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Page 2 - Ms. Flor del Pilar Arana

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.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office 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 Manufacturers, 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,

elmee

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K0466 90

Device Name: SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console

Indications For Use: The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Prescription Use X

:

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diuna Riaclune1

Jivision Sign-Off) Nivision of Cardiovascular Devices

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310(k) Number_K040690