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 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 a cryosurgical handpiece to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias.

AI/ML Overview

Here's an analysis of the provided text regarding the AtriCure Cryo Module, focusing on the acceptance criteria and study details:

Analysis of Acceptance Criteria and Study Information for AtriCure Cryo Module (K111042)

Based on the provided 510(k) summary, the AtriCure Cryo Module is a Class II device intended for the cryosurgical treatment of cardiac arrhythmias. The submission primarily relies on demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence (Overall)	Device is substantially equivalent to predicate devices.	"The AtriCure Cryo Module is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products."
Conformance to Product Specifications	Device meets its defined product specifications.	"Appropriate product testing was conducted to evaluate conformance to product specification..."
Bench Comparison Testing	Performance comparable to predicate devices in bench tests.	"Bench comparison testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific metrics or thresholds for comparison are not provided in the summary.)
Transit Testing	Device withstands transportation stresses.	"Transit testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific tests or outcomes are not provided in the summary.)
Electromagnetic Compatibility (EMC)	Device meets EMC standards.	"Electromagnetic compatibility...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific standards or test results are not provided in the summary.)
Reliability	Device operates reliably over time.	"Reliability, reliability testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific reliability metrics, duration, or outcomes are not provided in the summary.)
Conformance to International Standards	Device adheres to relevant international standards.	"...in conformance international standards and device specifications." (Specific standards are not listed in the summary, but common ones for medical devices would include those related to electrical safety, quality management, etc.)
Materials Suitability	Materials are appropriate for intended use.	"All materials used in the manufacture of the AtriCure Cryo Module are suitable for their intended use and suitable for use with pressurized nitrous oxide." (This is a statement of suitability rather than a specific test outcome, implying internal material qualification presumably met prior established criteria.)
Safety (No Patient Contact)	Device has no direct patient contact.	"The AtriCure Cryo Module is not intended for patient contact." (This is a design characteristic that influences the level of safety testing required, rather than a test result. It implicitly means that acceptance criteria related to biocompatibility for direct patient contact were not applicable.)
Intended Use (Cryosurgical Treatment)	Device effectively performs cryosurgery.	"The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias." (The "substantially equivalent" assertion implies that its ability to perform cryosurgery is comparable to the predicate devices, which are already cleared for this purpose. No specific performance metrics for cryosurgery (e.g., lesion depth, temperature achieved) are provided in this summary.)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify a distinct "test set" sample size in the context of clinical data or patient samples. The testing described ("bench comparison testing, transit testing, electromagnetic compatibility, reliability") appears to refer to engineering and functional verification/validation, rather than a clinical study with a patient test set.
Data Provenance: Not applicable in the context of a clinical test set, as no clinical studies with patient data are described for the primary submission. The data provenance is from internal engineering and bench testing conducted by AtriCure, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This question is not applicable as the provided 510(k) summary does not describe a clinical study requiring expert-established ground truth for a test set (e.g., image interpretation, disease diagnosis). The testing performed is primarily focused on engineering and functional aspects of the device.

4. Adjudication Method for the Test Set:

This question is not applicable as no clinical test set requiring adjudication (e.g., for diagnostic accuracy or outcome assessment) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on engineering and bench testing, not clinical comparative effectiveness with human readers or AI assistance. No mention of AI is made in the document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The AtriCure Cryo Module is a physical medical device (cryosurgical system), not an algorithm or AI software. Therefore, "standalone" algorithm performance is not relevant to this submission.

7. The Type of Ground Truth Used:

For the engineering and bench testing described, the "ground truth" would be defined by engineering specifications, industry standards, and the performance characteristics of the predicate devices. For example:
- For EMC, the ground truth would be conformance to specific electromagnetic compatibility standards.
- For reliability, the ground truth would be predetermined failure rates or operational lifespan targets.
- For bench comparison, the ground truth would be the established performance parameters of the predicate devices.
- For material suitability, the ground truth would be material specifications and safety data for use with nitrous oxide.

8. The Sample Size for the Training Set:

This question is not applicable as there is no mention of an algorithm or AI model requiring a training set in this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set for an algorithm or AI model mentioned in this 510(k) submission.

Summary

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ATRICURE CRYO MODULE 510(k) SUMMARY

MAY 2 6 2011

General Information

Date Compiled	January 31, 2011
Classification	Class II
Product Code	GEH
Trade Name	AtriCure Cryo Module
Manufacturer	AtriCure, Inc6217 Centre Park DriveWest Chester, OH 45069
Contact	Rebecca Walters, RACRegulatory Affairs Manager(513) 755-4576

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 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.

Predicate Devices

The predicate devices for the AtriCure Cryo Module are the AtriCure frigitronics CCS-200 Cardiac Cryosurgical System (K811390) and the AtriCure Cryo1 cryo-ablation probe (K082074).

Device Description

Materials

All materials used in the manufacture of the AtriCure Cryo Module are suitable for their intended use and suitable for use with pressurized nitrous oxide. The AtriCure Cryo Module is not intended for patient contact.

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K111042²/₂

Testing

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. Bench comparison testing, transit testing, electromagnetic compatibility, reliability, reliability testing, etc. were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications.

Summary of Substantial Equivalence

The AtriCure Cryo Module is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products.

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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 Third Party Official Regulatory Technology Services LLC. 1394 25th Street NW Buffalo, MN 55313

MAY 2 6 2011

Re: K111042

Trade/Device Name: AtriCure Cryo Module System (ACM, CRYO1 and cryoICE) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II (two) Product Code: GEH Dated: April 14, 2011 Received: April 15, 2011

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.

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Page 2 -- Mr. Mark Job

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 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/CDRH/CDRHOffices/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/ReportalProblem/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,

D. Zadeh M.D.

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) K111042

Device Name: AtriCure Cryo Module

Indications for Use:

× Prescription Use (Part 21 CRF 801 Subpart D) AND/OR

Over-The-Counter Use (21 CRF 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K111042

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.