AtriCure's cryolCE™ cryo-ablation probe is a sterile, single use device intended for use in the cryosurgical treatment of cardiac arrhythmias. The PROBE freezes target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

Device Description

AtriCure's cryolCE cryo-ablation probe (CRYO3) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module [K111042, K112072, K121507, K140058] or ACC2 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The devices are disposable, single-use instruments including a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AtriCure CryoICE Cryo-Ablation Probe (CRYO3). This document aims to demonstrate substantial equivalence to a previously cleared predicate device rather than presenting a comprehensive study of the device's performance against specific acceptance criteria in the way a clinical trial would. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not explicitly detailed in the provided text, as this type of submission focuses on demonstrating equivalence through non-clinical testing and comparison.

Based on the provided text, here is an attempt to answer the questions:

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

The provided document does not contain a table explicitly listing acceptance criteria with numerical targets and the device's performance against them in a quantitative clinical sense. Instead, it focuses on demonstrating that modifications to the device do not affect its ability to successfully ablate cardiac tissue and that it conforms to design controls and product specifications.

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Functional/Performance	"modifications do not affect the ability to successfully ablate cardiac tissue."
Design Conformance	"conformed to design controls and product specifications."
Biocompatibility	Met ISO 10993-1 requirements for Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis.
Mechanical Reliability	Non-clinical bench testing for Mechanical Testing, Reliability Testing, Cryogen Performance Testing (details not specified).

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

Sample Size (Test Set): The document mentions "Validation Testing on an Animal Model" without specifying the number of animals or the sample size.
Data Provenance: The testing was done on an "animal model." The country of origin is not specified, but the submission is to the U.S. FDA. The testing was likely prospective for the purpose of this submission.

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)

The document does not mention the use of experts to establish a "ground truth" for the animal model testing. The assessment of successful ablation would likely be based on objective physiological or pathological findings as determined by the researchers performing the animal study.

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

Not applicable. The document describes animal model testing and non-clinical bench testing, not a human reader study with adjudication.

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 device is a cryo-ablation probe, not an image analysis or AI-driven diagnostic device. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant.

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

Not applicable. This is a physical medical device (cryo-ablation probe), not an algorithm.

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

For the "Validation Testing on an Animal Model," the ground truth for successful ablation would likely be based on pathology (histological examination of the ablated tissue) and potentially physiological outcomes/measurements within the animal model to determine the effectiveness of the ablation in blocking electrical conduction.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of three human profiles facing right, with flowing lines representing hair or fabric.

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

October 29, 2014

AtriCure, Inc. Jonathan McElwee Regulatory Engineer 6217 Center Park Drive West Chester, Ohio 45069

Re: K142441

Trade/Device Name: CryoICE Cryo-Ablation Probe Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: October 20, 2014 Received: October 21, 2014

Dear Jonathan McElwee,

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 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

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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" (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 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,

Melissa A. Torres -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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Indications for Use

K142441 510(k) Number (if known) _______

Device Name: AtriCure® cryolCE™ cryo-ablation probe (CRYO3)

Indications for Use:

AtriCure's cryolCE cryo-ablation probe is a sterile, single use device intended for use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

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 AtriCure logo. The logo is in blue and orange. The word "Atri" is in blue, and the word "Cure" is in orange. The dot on the "i" in "Atri" is blue, and the dot on the "i" in "Cure" is orange.

510(k) Summary

l. 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 RACSr. Director of Regulatory Affairs
Date Prepared:	08/29/2014
II. Device
Name of Device:	AtriCure® cryoICE™ cryo-ablation probe(CRYO3)
Common Name:	Cryosurgical probe
Classification Name:	Unit, Cryosurgical, AccessoriesSurgical, General and Plastic Surgery, 878.4350
Regulatory Class:	Class II
Product Code:	GEH

lll. Predicate Device

The device proposed for modification in this submission is the AtriCure Cryo1 cryo-ablation probe cleared via 510(k) K082074 on March 2, 2009.

The predicate device has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. Device Description

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Image /page/4/Picture/0 description: The image shows the AtriCure logo. 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". There is a registered trademark symbol next to the "e" in "Cure".

V. Indications For Use

VI. Comparison Of Technological Characteristics With The Predicate Device

. Same intended use and;
o Same operating principle
Same fundamental scientific technology ●
Used with the same crvo module units
The basic design of the proposed device and the previously cleared devices are the same. 0 The devices are disposable, single-use instruments including a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube.
o The modifications to the proposed cryolCE probe are designed to provide increased options for surgeons based on patient body habitus and surgeon preference. Major modifications compared to the predicate include a more malleable aluminum alloy cryotip and a different colored rigid shaft.

VII. Performance Data

The modified cryolCE cryo-ablation probe was tested on an animal model to confirm the modifications do not affect the ability to successfully ablate cardiac tissue. Additional testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified cryo-ablation probe's conformance to design controls and specification. Testing determined that the modified cryo-ablation probe conformed to design controls and product specifications.

Non-clinical Bench Testing

Mechanical Testing
. Reliability Testing
Cryogen Performance Testing ●
o Validation Testing on an Animal Model

Biocompatibility Testing

The biocompatibility evaluation for the cryolCE cryo-ablation probe was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:

. Cytotoxicity
. Sensitization
Irritation ●
Systemic Toxicity ●
. Hemolysis

The cryolCE cryo-ablation probe is considered an "External Communicating Device," contact for "Tissue/Bone" and contact duration for "under 24 hours."

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Image /page/5/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The first three letters, "Atri", are in blue, while the rest of the word, "Cure", is in orange. There is a blue dot above the "C" in "Cure", and a registered trademark symbol to the right of the word.

VIII. Conclusions

The modified cryolCE cryo-ablation probe is equivalent to the previously cleared Cryo1 cryoablation probe as there is no change to intended use, the operating principle, or the basic design of the cryo-ablation probe. The modifications to the cryo-ablation probe do not affect the ability of the probe to successfully ablate cardiac tissue.

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.