CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12

K041890 · Cryocor, Inc. · OCL · Sep 22, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041890
• Device Name: CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
• Applicant: Cryocor, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Sep 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CryoCor Model 1255 Surgical Probe is intended to be used for the treatment of cardiac diseases, such as arrhythmia, by the application of extreme cold in order to ablate (destroy) electrically abnormal cardiac and vascular tissue. The Probe is part of a Cryoablation System, which includes a control console and a Probe/console interface. The Probe will be used under direct visualization to perform cardiac ablation procedures in the cardiac surgical setting. The intent of the device will be to treat patients either concomitant with or using techniques widely used in cardiac surgery, including thoracotomy or minimally invasive (MICS) techniques.

Device Story

Single-use, disposable cryosurgical probe; interfaces with Cryoablation console; uses N2O cryogen; employs Joule-Thomson effect to induce cryonecrosis; blocks electrical conduction in cardiac/vascular tissue. Used in cardiac surgical settings (thoracotomy or MICS); operated by surgeons under direct visualization. Probe handle allows torque and articulation segment deflection for precise tip placement. Output is localized tissue ablation; assists surgeons in treating cardiac arrhythmias. Benefits include targeted destruction of abnormal tissue.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1. Sterilization validated via E-beam radiation.

Technological Characteristics

Single-use cryosurgical probe; N2O cryogen; Joule-Thomson effect cooling; articulation segment for tip positioning; E-beam radiation sterilization; biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for patients undergoing thoracic surgery requiring ablation of arrhythmic cardiac tissue.

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.

Submission Summary (Full Text)

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SEP 2 2 2004

K041890 p. 1 of 2

# 510(k) Summary of Substantial Equivalence

| Date Prepared | September 16, 2004 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Submitter<br>Address | CryoCor, Inc.<br>9717 Pacific Heights Blvd.<br>San Diego, Ca 92121 |
| Contact<br>Phone<br>Fax<br>E-Mail Address | Jami Miller<br>Regulatory Affairs Specialist<br>858-909-2231<br>858-909-2350<br>[e-mail] |
| Device Trade Name/ Model Numbers | 1255 Series Surgical Probe:<br>Model 1255-15-12 |
| Device Common Name | Cryosurgical Probe |
| Device Classification Name | Cryosurgical unit and accessories |
| Classification Regulation | Class II, C.F.R. Section 878.4350 |
| Product Code | GEH |

# Device Description

The CryoCor Model 1255 Surgical Probe is a single-use, disposable device that interfaces with the Cryoablation console and delivers Cryoablation therapy to the target tissue, using N2O as a cryogen and employing the Joule-Thomson effect to cause a block of electrical conduction through tissue through cryonecrosis. Placement of the Probe tip is accomplished under direct visualization by manipulation of the Probe handle (applying torque to the shaft and/or deflecting the articulation segment). The Breva Model Series may include multiple articulation lengths and multiple tip lengths. The first model of the Breva Model Series to be commercialized will be the Breva 1255-15-12 (i.e. 5cm articulation length, 15 mm tip length, and 12cm shaft length).

# Intended Use

The CryoCor Model 1255 Surgical Probe is intended to be used for the treatment of cardiac diseases, such as arrhythmia, by the application of extreme cold in order to ablate (destroy) electrically abnormal cardiac and vascular tissue. The Probe is part of a

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Cryoablation System, which includes a control console and a Probe/console interface. The Probe will be used under direct visualization to perform cardiac ablation procedures in the cardiac surgical setting. The intent of the device will be to treat patients either concomitant with or using techniques widely used in cardiac surgery, including thoracotomy or minimally invasive (MICS) techniques.

## Substantially Equivalent Devices

The physical characteristics, the intended use, and the mode of use of the Model 1255 Surgical Probe are similar to the predicate device.

### Test Summary

#### Performance Testing

Bench testing confirmed that the Model 1255-15-12 Surgical Probe met its design and performance requirements.

#### Biocompatibility Information

Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible.

#### Sterilization Validation

The Model 1255-15-12 Surgical Probes are sterilized using a validated E-beam radiation sterilization cycle.

## Conclusion

CryoCor, Inc. considers the Model 1255-15-12 Surgical Probe to be substantially equivalent to their legally marketed predicate device based on the data and information presented within this application.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is presented in black and white.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cryocor, Inc. c/o Ms. Jami Miller Regulatory Affairs Specialist 9717 Pacific Heights Blvd. SanDiego, CA 92121

Re: K041890

Trade Name: Cryocor Model 1250 ("Breva") Series Surgical Probes Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: II (two) Product Code: OCL Dated: August 05, 2004 Received: August 09, 2004

Dear Ms. Miller:

This letter corrects our substantially equivalent letter of September 22, 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. Jami Miller

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 vours.

Eemee

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: K041890

Device Name: CryoCor Model 1250 ("Breva") Series Surgical Probes

Indications for Use:

The CryoCor Model 1250 ("Breva") Series Surgical Probes are intended to be used in thoracic surgery, specifically for the ablation of arrhythmic cardiac tissue.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bumima
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number k041890