ATRICURE CRYO MODULE SYSTEM

K140058 · AtriCure, Inc. · GEH · Jan 24, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140058
• Device Name: ATRICURE CRYO MODULE SYSTEM
• Applicant: AtriCure, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jan 24, 2014
• Decision: SESE
• Submission Type: Special
• 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 Cryo1 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; delivers Nitrous Oxide to sterile, single-use cryo-ablation probes (Cryo1 or cryoICE). System creates lines of ablation through cardiac tissue via cryonecrosis or inflammatory response to block electrical conduction pathways. Used in clinical settings by physicians; ACM unit is non-sterile and reusable; probes are sterile and single-use. Output is controlled delivery of cryogenic energy to target tissue. Benefits include effective treatment of cardiac arrhythmias by interrupting abnormal electrical pathways.

Clinical Evidence

No clinical data provided. Substantial equivalence established through bench testing, design verification, validation, and electrical safety testing (UL 60601-1, IEC 60601-1-2). Biocompatibility of probes confirmed per ISO 10993-1.

Technological Characteristics

Electro-mechanical and pneumatic cryosurgical system; utilizes Nitrous Oxide as energy source. Components: ACM unit (reusable, non-sterile) and cryo-ablation probes (single-use, sterile). Materials biocompatible per ISO 10993-1. Connectivity: Standalone. Safety standards: UL 60601-1, IEC 60601-1-2.

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 (K111042)
• AtriCure Cryo Module System (K112072)
• AtriCure Cryo Module System (K121507)

Reference Devices

• AtriCure ACC2 (Frigitronics CCS-200) Cardiac Cryosurgical System (K811390)

Submission Summary (Full Text)

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# ATRICURE Cryo Module System 510(k) SUMMARY

JAN 2 4 2014

| General Information | |
|---------------------|--|
|---------------------|--|

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| Date Compiled | December 6, 2013 |
|----------------|-------------------------------------------------------------------------------------------------------------|
| 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 | Karl Dahlquist<br>VP of Quality Systems, Regulatory Affairs, and Legal |

# 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 Cryo1 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) (K111042, K112072, and K121507).

# 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 cryolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or AtriCure ACC2 (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 Crvo 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 cryo-ablation probes (Cryo1 and cryoICE).

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# Testing

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Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Design verification and validation, software validation, and electrical safety testing 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 60601-1 186 Ed.: Medical Electrical Equipment, Part 1: General Requirements . for Safety. (2003)
- . EN
- IEC 60601-1-2: Collateral Standard- Electromagnetic Compatibility Reg. & Tests . (2007)
- FDA Guidance for the Content of Premarket Submissions for Software Contained . in Medical Devices (Issued May 11, 2005)

# Summary of Technological Characteristics

The modified AtriCure Cryo Module System has the following similarities to the technological characteristics of the previously cleared predicate AtriCure Cryo Module System (K111042, K112072, and K121507):

- Same intended use .
- Same operating principle .
- Same fundamental scientific technology .
- Same cryo-ablation probes .
- . Same materials used
- Same module design .
- Same electronic solenoid valves

# 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 K111042. K112072. and K121507. The indications for use, basic overall function, and materials used are substantially equivalent.

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

January 24, 2014

Atricure Inc. % Mr. Mark Job Third Party Reviewer Regulatory Technology Service LLC 1394 25th Street NW Buffalo, MN 55313

Re: K140058

> Trade/Device Name: Atricure Cryo Module System Regulation Number: 21 CFR 879.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: January 8, 2014 Received: January 10, 2014

# Dear Mr. Mark 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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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); medical device reporting (reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Owe

Paris-S

for

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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on lest page.

### 510(k) Number (if known)

K140058

#### Device Name

AtriCure Cryo Module System (ACM, Cryol, and cryolCE)

### Indications for Use (Describe)

The AttiCure Cryo Module System is in the cryosurgical treatment of cardias arthythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable device-used with the Cryol cryo-ablation probe-a sterile, single use device -and/or the cryolCE cryo-ablation probe-a sterile, single use device.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

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ダ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Owen
P. Faris-S
Date: 2014.01.24
14:34:14-05'00'

FORM FDA 3881 (9/13)

PSC Publishing Secrives (34 ) 24 J-4 748

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