ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)

K121507 · AtriCure, Inc. · GEH · Jun 6, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121507
• Device Name: ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
• Applicant: AtriCure, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jun 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a nonsterile, reusable device-used with the Crvo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.

Device Story

AtriCure Cryo Module System (ACM) is an electro-mechanical and pneumatic cryosurgical unit. It delivers Nitrous Oxide to sterile, single-use cryo-ablation probes (Cryo1 or cryolCE). The system freezes target cardiac tissue to block electrical conduction pathways via cryonecrosis or inflammatory response. Used by clinicians in surgical settings. The ACM unit is non-sterile and reusable; probes are sterile and single-use. The system provides a controlled cryogenic energy source to create lines of ablation for treating cardiac arrhythmias.

Clinical Evidence

Bench testing only. Testing included design verification, validation, and software validation to confirm conformance to product specifications and international standards (UL 60601-1, IEC 60601-1-2, ASTM F882-84).

Technological Characteristics

Electro-mechanical and pneumatic cryosurgical system. Energy source: Nitrous Oxide. Materials: Biocompatible per ISO 10993-1. Standards: UL 60601-1, EN 60601-1, IEC 60601-1-2, EN 55011, ASTM F882-84. System consists of reusable ACM console and single-use sterile probes.

Indications for Use

Indicated for the cryosurgical treatment of cardiac arrhythmias in patients requiring cardiac ablation.

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

• AtriCure Cryo Module System (ACM, Cryo1, and cryolCE) (K112072)

Reference Devices

• frigitronics CCS-200 Cardiac Cryosurgical System (K811390)

Submission Summary (Full Text)

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## K121507 P1/2

## ATRICURE Cryo Module System 510(k) SUMMARY

## General Information

| Date Compiled | May 8, 2012 |
|----------------|-------------------------------------------------------------------------------------------------------------|
| Classification | Class II |
| Product Code | GEH, 21 CFR 878.4350 |
| Trade Name | AtriCure Cryo Module System (ACM, Cryo1, and cryolCE) |
| Manufacturer | AtriCure, Inc<br>6217 Centre Park Drive<br>West Chester, OH 45069<br>[phone]<br>[phone] (fax) |
| Contact | James L. Lucky<br>VP of Quality Systems and Regulatory Affairs |

## Indications for Use

The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a nonsterile, reusable device-used with the Crvo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.

## Cleared Device

The device proposed for modification in this submission is the AtriCure Cryo Module System (ACM, Cryo1, and cryolCE) (K112072).

## Device Description

The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to an AtriCure cryo-ablation probe to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias. The AtriCure cryo-ablation probe (Cryo1 or crvolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or frigitronics CCS-200 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

### Materials

All materials used in the manufacture of the AtriCure Cryo Module System are safe and suitable for their intended use and suitable for their use with pressurized nitrous oxide. The ACM is not intended for patient contact. Testing has been previously conducted in accordance with ISO 10993-1 to ensure biocompatibility of all appropriate materials in the AtriCure crvo-ablation probes (Cryo1 and cryolCE).

## Testing

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K121507 P2/2

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Transit testing, design verification and validation, software validation, etc. were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications. The standards and FDA Guidance used to determine substantial equivalence include, but are not limited to:

- . UL 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety. (2006)
- EN 60601-1: Medical Electrical Equipment Part 1: General Requirements for . Safety (1998) +A1 +A2, 2nd Edition
- ◆ IEC 60601-1-2: Collateral Standard- Electromagnetic Compatibility - Req. & Tests (2007)
- . EN 55011: Industrial, scientific and medical (ISM) radio-frequency Equipment. Electromagnetic disturbance characteristics. Limits and methods of measurement. (2007)
- 1STA Procedure 3A: Packaged Product for Parcel Delivery System Shipment . 70kg (150 lb) or Less; (2008)
- ASTM F882-84: Standard Performance and Safety Specification for Cryosurgical . Medical Instrument's (2002)
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Issued May 11, 2005)

## Summary of Substantial Equivalence

The modified AtriCure Cryo Module System proposed in this submission is considered substantially equivalent to the AtriCure Cryo Module System cleared via K112072. The indications for use, basic overall function, and materials used are substantially equivalent.

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Atricure, Inc. c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 53313

JUN - 6 2012

Re: K121507

Trade Name: Atricure Cryo Module System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II (two) Product Codes: GEH Dated: May 18, 2012 Received: May 21, 2012

### Dear Mr. Job:

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 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 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

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Page 2 - Atricure, Inc., c/o Mr. Mark Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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):

Device Name: AtriCure Cryo Module System (ACM, Cryo1, and cryolCE)

Indications For Use:

The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable deviceused with the Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe a sterile, single use device.

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)

Concyrence of CDRH, Office of Device Evaluation (ODE)

signature

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K121507