AtriCure Cryo Module Indication for Use Statement: The AtriCure Cryo Module is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation probes.

cryolCE™ Indication for Use Statement: AtriCure's cryoICE™ cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.

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 the AtriCure cryo-ablation probes. The AtriCure's cryo-ablation probe (CRYO2) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or ACC2 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The cryolCE™ probe can also be used to temporarily ablate peripheral nerves.

AI/ML Overview

The information provided in the document focuses on the substantial equivalence of the AtriCure Cryosurgical System to predicate devices, rather than establishing specific acceptance criteria and detailed study results for a new medical device's performance. The document describes the system and its indications for use, and then lists various non-clinical bench tests that were conducted. However, it does not provide the specific acceptance criteria for these tests, nor does it present detailed performance data that would allow for a direct comparison against such criteria. The "Results" column in the "Non-clinical Bench Testing" table simply states "Passed" for all tests, without quantitative or qualitative metrics.

Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and sample sizes for effectiveness studies (especially related to human-in-the-loop or standalone AI performance) cannot be extracted from the provided text. This document is a 510(k) summary, which typically focuses on demonstrating equivalence to legally marketed devices rather than presenting novel performance studies in the way a PMA application might.

Based on the provided text, here is what can be inferred and what is missing:

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

The document does not explicitly list quantitative acceptance criteria for the various tests. The 'Performance Data' section only lists the types of tests performed and states "Passed" as the result, without providing specific metrics or targets that define "Passed".

Acceptance Criteria (Inferred/Not Provided)	Reported Device Performance
Not explicitly stated in the document	"Passed" for all listed Non-clinical Bench Tests
CRYO2 Comparison testing (Bench testing)	Passed
CRYO2 Mechanical Reliability (Bench testing)	Passed
CRYO2 Performance testing (Bench testing)	Passed
CRYO2 Acute Animal Verification Lab (Bench testing)	Passed
CRYO2 ASTM Testing (Bench testing)	Passed
Evaluation Against Similar Product (Bench testing)	Passed
ACM Software Validation (Software testing)	Passed
ACM Display Board Verification (Bench testing)	Passed
ACM Controller Board Verification (Bench testing)	Passed
Handpiece Connector Board Verification (Bench testing)	Passed
ACM Power Board Verification (Bench testing)	Passed
ACM Reliability Testing (Bench testing)	Passed
ACM Simulated Use (Bench testing)	Passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for any of the non-clinical bench tests or studies. It also does not specify the provenance of any data (e.g., country of origin, retrospective/prospective nature). The "Acute Animal Verification Lab" test implies animal data, but no specifics are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Given that the studies are non-clinical bench tests and a single "Acute Animal Verification Lab" test, it's unlikely that 'experts for ground truth' in the context of clinical interpretation (like radiologists) would be relevant. The "ground truth" for these types of engineering tests would typically be established by established test methodologies and reference standards.

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

This information is not provided.

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

No such study is mentioned or implied. The device described, the AtriCure Cryosurgical System, is a cryo-ablation device, not an AI or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable. The device is not an algorithm or AI system.

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

The document does not explicitly state the type of "ground truth" used for any of the tests. For bench testing, the "ground truth" would typically be defined by engineering specifications, physical measurements, and adherence to validated test protocols. For the "Acute Animal Verification Lab," this would involve physiological measurements and potentially histological examination, but no specifics are provided.

8. The sample size for the training set

Not applicable. The device is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized human figure with three faces in profile, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.

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

AtriCure Inc., Jonathan McElwee Regulatory Engineer 6217 Centre Park Dr. West Chester, OH 45069

Re: K142203

Trade/Device Name: AtriCure Cryosurgical System - AtriCure Cryo Module (ACM) and AtriCure cryoICE cryo-ablation probes (CRY02) Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Regulatory Class: Class II Product Code: GXH, GEH Dated: October 30, 2014 Received: October 31, 2014

Dear Mr. Jonathan McElwee:

This letter corrects our substantially equivalent letter of November 25, 2014.

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.

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

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Page 2 - Mr. Jonathan McElwee:

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/1/Picture/7 description: The image shows the FDA logo. The logo is in light gray and consists of the letters "FDA" in a stylized font. The letters are connected and have a geometric design.

Bram D. Zuckerman -S

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) K142203

Device Name: AtriCure Cryosurqical System, comprising:

a) AtriCure Crvo Module (ACM)
b) AtriCure cryolCE™ cryo-ablation probes (CRYO2)

Indications for Use:

AtriCure Cryo Module Indication for Use Statement: The AtriCure Cryo Module is a nonsterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation probes.

× 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)

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Image /page/3/Picture/0 description: The image shows the logo for AtriCure. The logo is in two colors, blue and orange. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure."

510(k) Summary

I. Submitter
Manufacturer:	AtriCure, Inc.6217 Centre Park Dr.West Chester, OH 45069P: 513-755-4100F: 513-755-4108
Contact Person:	Jonathan McElwee, RACRegulatory Engineer
Alternate Contact:	Dennis Hong, JD, RACSenior Director, Regulatory Affairs
Date Prepared:	08/8/2014
II. Device
Name of Device:	AtriCure Cryosurgical System, comprising:a) AtriCure Cryo Module (ACM)b) AtriCure cryoICE™ cryo-ablation probes (CRYO2)
Common Name:	Cryosurgical probeCryo Surgical Unit and AccessoriesCryoanalgesia System
Classification Name:	Surgical, General and Plastic Surgery, 21 CFR 878.4350Cryogenic Surgical Device, 21 CFR 882.4250
Regulatory Class:	Class II
Product Code:	GEH and GXH

lll. Predicate Devices

AtriCure cryo-ablation probe K082074 AtriCure Cryo Module System K111042, K112072, K121507, and K140058 Cryomedical Instruments LTD. CryoStar™ System K031482

The predicate devices have not been subject to a design-related recall.

No reference devices were used in this submission.

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IV. Device Description

Model numbers:

AtriCure Cryo Module - ACM1 AtriCure cryoICE™ cryo-ablation probe - CRYO2

Materials:

All materials used in the manufacture of the AtriCure Cryosurgical 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 cryolCE™ cryoablation probe (CRYO2).

V. Indications For Use

AtriCure Cryo Module Indication for Use Statement: The AtriCure Cryo Module is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to the AtriCure cryoablation probes.

cryolCE™ Indication for Use Statement: AtriCure's cryolCE™ cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.

VI. Comparison Of Technological Characteristics With The Predicate Devices

When used for the intended use of "cryosurgical treatment of cardiac arrhythmias", the AtriCure Cryosurgical System has the following similarities to the technological characteristics of the previously cleared predicate AtriCure Cryo Module System (K082074, K111042, K112072, K121507, and K140058):

Same intended use ●
. Same operating principle
Same fundamental scientific technology ●
Same crvo-ablation probes ●
Same materials used ●
. Same module design
Same electronic solenoid valves ●
Same 3 year age shelf life of the cryo-ablation probes ●

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AtriCure®

When used for the intended use of "blocking pain by temporarily ablating the peripheral nerve", the AtriCure Cryosurgical System has the following similarities to the technological characteristics of the previously cleared predicate CryoStar™ System K031482:

	CryoStar™ Predicate	AtriCure Device
Manufacturer	Cryomedical Instruments LTD.(now Kryo Science LTD)	AtriCure
Market ProductName	CryoStar™ System(Cryostar™ console, 1 & 2mmcryoprobe, convenience procedure kitfor the probe placement)	AtriCure Cryosurgical System(ACM and cryolCE™ (CRYO2) cryo-ablation probe)
510(k) Number	K031482	Subject of this Submission
Intended Use	Cryoanalgesia device intended for usein blocking pain by temporarily ablatingthe peripheral nerves.	The AtriCure Cryosurgical System isintended for use in blocking pain bytemporarily ablating the peripheralnerves.
Target Population	Adults	Adults
Operating Principle	Joule-Thompson Effect	Joule-Thompson Effect
Technology	The system consists of a range ofcryoprobes that are used for freezingnerves to block pain by temporaryablation. A console is used to houseand control the supply of gas to thecryoprobe and to provide an electricalnerve location device.	The system consists of cryoprobesthat are used for freezing target tissueto treat cardiac arrhythmias and forfreezing nerves to block pain bytemporary ablation. A console is usedto control the supply of gas to thecryoprobe.
Energy Used	Nitrous Oxide	Nitrous Oxide
OperatingTemperature	-40C to -70C	-50°C to 70°C
Peripheral NerveStimulation	Included as part of the system	Not included in the system.
Human Factors	Hand-held device containing cryogenwith footswitch.	Hand-held device containing cryogenwith activation button on console orfootswitch.
Gas Purge System	Automatic	Automatic
Freeze Timer	Manual or automatic	Manual or automatic
Patient ContactingMaterials	Hemispherical and trocar-tip stainlesssteel 1mm & 2mm diameter cryoprobe	Closed-tip aluminum 4mm cryoprobe
Cryotip	Rigid	Malleable
Biocompatibility	Biocompatible patient contactingmaterials.	Biocompatible patient contactingmaterials.
Probe Packaging	Non-Sterile - Reusable device	Sterile - Single Use disposable device
Sterilization	Steam Autoclave; EtO; or Sterrad	Gamma Irradiation
Power Source	Mains Powered	Mains Powered

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Image /page/6/Picture/0 description: The image shows the AtriCure logo. The word "Atri" is in blue, while "Cure" is in orange. There is a blue dot in the middle of the "C".

VII. Performance Data

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 AtriCure Cryosurgical System is substantially equivalent and in conformance with international standards and device specifications.

Non-clinical Bench Testing

Name	Description	Results
CRYO2 Comparison testing to Predicate Device	Bench testing	Passed
CRYO2 Mechanical Reliability	Bench testing	Passed
CRYO2 Performance testing	Bench testing	Passed
CRYO2 Acute Animal Verification Lab	Bench testing	Passed
CRYO2 ASTM Testing	Bench testing	Passed
Evaluation Against Similar Product	Bench testing	Passed
ACM Software Validation	Software testing	Passed
ACM Display Board Verification	Bench testing	Passed
ACM Controller Board Verification	Bench testing	Passed
Handpiece Connector Board Verification	Bench testing	Passed
ACM Power Board Verification	Bench testing	Passed
ACM Reliability Testing	Bench testing	Passed
ACM Simulated Use	Bench testing	Passed

VIII. Conclusions

When used for the intended use of "cryosurgical treatment of cardiac arrhythmias", the proposed AtriCure Cryosurgical System is equivalent to the previously cleared AtriCure Cryo Module System, as the intended use, overall function, and materials used are the same.

When used for the intended use of "blocking pain by temporarily ablating the peripheral nerve", the proposed AtriCure Cryosurgical System is equivalent to the previously cleared CryoStar™ System, as the intended use, basic overall function, and materials used are substantially equivalent.

Regulation Number and Section

§ 882.4250 Cryogenic surgical device.

(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).