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 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.

AI/ML Overview

This looks like a 510(k) summary for a medical device (AtriCure Cryo Module System), not a study demonstrating that a device meets acceptance criteria. A 510(k) submission generally aims to prove "substantial equivalence" to a predicate device, rather than meeting specific performance acceptance criteria through clinical or rigorous standalone studies as you might see for novel devices or AI/ML-based systems.

Here's a breakdown based on the provided text, indicating what information is not present because this is a substantial equivalence submission, not a study demonstrating performance against acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Applicable - This submission focuses on substantial equivalence to predicate devices rather than specific performance acceptance criteria for the modified device.	Not Applicable - No specific performance metrics or acceptance criteria are provided in the document.

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

Not applicable. This is a 510(k) for a modified cryosurgical system seeking substantial equivalence. The document describes product testing for conformance to product specifications, design verification and validation, software validation, and electrical safety testing. These are engineering and safety tests, not clinical or performance studies with a "test set" in the context of AI/ML or comparative clinical device performance.

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

Not applicable. Ground truth and expert consensus are relevant for studies evaluating device performance against a clinical "truth," often in diagnostic or prognostic AI/ML applications. This document concerns a physical cryosurgical system and its modifications.

4. Adjudication method for the test set

Not applicable. No test set or clinical performance adjudication is mentioned.

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. An MRMC study is relevant for evaluating diagnostic performance, particularly for AI-assisted image interpretation. This device is a cryosurgical system, not a diagnostic AI tool.

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

Not applicable. This is a physical cryosurgical device, not an algorithm. The testing mentioned (design verification, software validation, electrical safety) is for the device's functionality and safety, not for standalone algorithmic performance.

7. The type of ground truth used

Not applicable. No clinical ground truth (e.g., pathology, outcomes data) is mentioned as part of the submission for validating the modified device's performance. The "truth" here relates to compliance with engineering standards and existing predicate device characteristics.

8. The sample size for the training set

Not applicable. Training sets are relevant for AI/ML models. This document describes a physical medical device.

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

Not applicable. See point 8.

Summary based on the provided text:

The document describes a 510(k) premarket notification for the AtriCure Cryo Module System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K111042, K112072, and K121507) for the cryosurgical treatment of cardiac arrhythmias.

The "study" described is a series of product tests to evaluate conformance to product specifications and substantial equivalence, including:

Design verification and validation
Software validation
Electrical safety testing

These tests were performed to show that the modified device is substantially equivalent and conforms to international standards and device specifications. The standards referenced include:

UL 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety)
IEC 60601-1-2 (Electromagnetic Compatibility)
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)

The basis for substantial equivalence relies on similarities to predicate devices in:

Intended use
Operating principle
Fundamental scientific technology
Cryo-ablation probes used
Materials used
Module design
Electronic solenoid valves

The document does not contain information about clinical trials, performance studies with specific acceptance criteria, or the use of AI/ML algorithms that would necessitate ground truth establishment, expert adjudication, or MRMC studies. The focus is on demonstrating that the modified device maintains the safety and effectiveness characteristics of its predicates through engineering and safety testing.

Summary

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ATRICURE Cryo Module System 510(k) SUMMARY

JAN 2 4 2014

General Information
---------------------	--

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, Inc6217 Centre Park DriveWest Chester, OH 45069(513) 755-4100(513) 644-1354 (fax)
Contact	Karl DahlquistVP of Quality Systems, Regulatory Affairs, and Legal

Indications for Use

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

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

ﺔ ﺍﻟﺘﻲ

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

Page 8 of 210

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.