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 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 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.

AI/ML Overview

The provided text describes the AtriCure Cryo Module System, a Class II medical device intended for the cryosurgical treatment of cardiac arrhythmias. However, the document focuses heavily on the regulatory approval process (510(k) submission) and substantial equivalence to a predicate device. It does not contain specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for a device that relies on such metrics, nor does it describe a study designed to validate such performance.

Instead, the "Testing" section refers to product testing for conformance to specifications, substantial equivalence, and international standards. This suggests that the device's acceptable performance is defined by its adherence to engineering and safety standards, rather than clinical performance metrics typically associated with AI-driven diagnostic or prognostic devices.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary, as it pertains to a physical cryosurgical device rather than an AI/ML-based system.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (from submission)
Conformance to Product Specification	"Appropriate product testing was conducted to evaluate conformance to product specification."
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."
International Standards Compliance	Demonstrated conformance to standards including: - UL 60601-1 (Medical Electrical Equipment Safety) - EN 60601-1 (Medical Electrical Equipment Safety) - IEC 60601-1-2 (Electromagnetic Compatibility) - EN 55011 (Electromagnetic Disturbance Characteristics) - ISTA Procedure 3A (Packaged Product for Parcel Delivery Shipment) - ASTM F882-84 (Cryosurgical Medical Instruments Performance and Safety) - FDA Guidance for Software Contained in Medical Devices (if applicable)
Biocompatibility	"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)." (Note: ACM is not intended for patient contact).
Software Validation	"Software validation, etc. were completed."
Transit Testing	"Transit testing... were completed."
Design Verification and Validation	"Design verification and validation... were completed."

Note on Acceptance Criteria: For this type of device (a cryosurgical system), acceptance criteria are primarily related to safety, electrical performance, material compatibility, and manufacturing quality, rather than diagnostic or predictive accuracy metrics. The 510(k) process primarily assesses "substantial equivalence" to a predicate device, meaning it performs similarly and is as safe and effective.

2. Sample size used for the test set and the data provenance

Not applicable. The document describes engineering and regulatory testing, not a clinical study involving a "test set" of patient data for performance evaluation in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of "ground truth" establishment by experts in the context of performance metrics for an AI/ML system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is not an AI/ML system requiring adjudication of results based on a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical surgical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of AI/ML performance. The "ground truth" for this device's approval relates to its adherence to engineering specifications, safety standards, and performance benchmarks established for the predicate device.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML system.

9. How the ground truth for the training set was established

Not applicable. This device does not use a training set or ground truth in the AI/ML context.

Summary regarding AI/ML context: This 510(k) submission describes a traditional Class II medical device (a cryosurgical system) and its regulatory path. It does not involve artificial intelligence or machine learning, and thus the acceptance criteria and study descriptions are focused on engineering, safety, and substantial equivalence rather than performance metrics typically associated with AI/ML systems.

Summary

{0}------------------------------------------------

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, Inc6217 Centre Park DriveWest Chester, OH 45069(513) 755-4100(513) 644-1354 (fax)
Contact	James L. LuckyVP 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

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

{1}------------------------------------------------

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.

{2}------------------------------------------------

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a bird-like figure with three upward-pointing lines and a curved base.

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

{3}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{4}------------------------------------------------

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

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
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.(b)
Classification. Class II.