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.

Device Description

The cryosurgical handpieces, or cryo-ablation probes, utilized in the AtriCure Cryosurgical System are hand held, single use, cryosurgical instruments intended for the cryosurgical treatment of cardiac arrhythmias during cardiac surgery. The cryosurgical handpieces utilize a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpieces provide probe temperatures below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitrous oxide is supplied to the cryoprobes via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probes are malleable to allow access to varying anatomy and anatomical sites.

The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler or stainless-steel boiler and three internal inlet orifices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be used the cryotip into the desired form. The cryotip is attached to an insulated rigid shaft that allows the surgeon to adjust the length of the exposed cryotip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the shaft to display real time temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).

AI/ML Overview

The provided text is a 510(k) premarket notification from the FDA, describing a medical device called the AtriCure cryoICE cryo-ablation probe. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission. This submission is about a modified device and primarily relies on non-clinical bench testing to show that the modifications do not alter the device's performance, safety, or intended use compared to the predicates.

Here's a breakdown of what can be extracted and what information is missing/not applicable based on the provided document:

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

The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum temperature achieved, specific ablation zone size) or their corresponding reported performance values from a clinical study. Instead, it relies on demonstrating equivalence through non-clinical bench testing for specific attributes.

Acceptance Criteria Category (Implied)	Reported Device Performance (as stated in document)
Mechanical Reliability	"Demonstrated equivalency in performance"
Transit (Shipping/Handling)	"Demonstrated equivalency in performance"
Shelf-life	"Demonstrated equivalency in performance"
Cryogen Performance/Thermal Insulation	"Demonstrated equivalency in performance" (Specifically: "provide probe temperatures below -40°C")
Intended Use	"The devices have the same intended use"
Operating Principle	"No changes were made in operating principle"
Specifications of Performance	"No changes were made...in specifications of performance"
Patient-Contacting Materials	"Both the previously cleared and proposed CRYO3, and CRYOF probes use the same patient contacting materials"
Safety Issues	"Did not raise any new issues of safety"

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

Sample Size for Test Set: Not specified in terms of clinical cases or individual patient data. The "test set" here refers to the number of devices or components subjected to non-clinical bench testing. The document states "Non-clinical Bench Testing" was conducted but doesn't specify the sample size for these tests.
Data Provenance: Not explicitly stated as retrospective/prospective or country of origin for clinical data, because this submission is based on non-clinical bench testing of the device itself, not clinical data from patients.

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)

Not applicable. This submission does not involve human expert interpretation of clinical data to establish ground truth. The "ground truth" for this device's performance is based on direct physical measurements and engineering specifications verified through bench testing.

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

Not applicable. This relates to clinical data adjudication by multiple readers, which is not part of this 510(k) submission.

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 medical device (cryo-ablation probe), not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This refers to AI algorithm performance. This is a physical medical device.

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

The "ground truth" for this device's performance is based on engineering specifications, direct physical measurements (e.g., temperature, mechanical integrity), and functional testing to ensure it meets its design requirements and operates comparably to the predicate devices. It relies on the inherent physical properties and verified performance during non-clinical bench testing.

8. The sample size for the training set

Not applicable. This refers to AI model training data. This is a physical medical device.

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

Not applicable. This refers to AI model training data. This is a physical medical device.

Summary of the K180137 Submission's Approach:

This 510(k) submission (K180137) is a "Special 510(k)" because it deals with minor modifications to an already cleared device. The core argument for clearance is substantial equivalence to predicate devices. This is established by demonstrating that the modifications (non-patient contacting tube-sets, packaging) do not affect the device's fundamental operating principle, performance specifications, patient-contacting materials, or intended use.

The study that proves the device meets the (implied) acceptance criteria is Non-clinical Bench Testing. The document states that these tests:

"Demonstrated equivalency in performance" for Mechanical Reliability, Transit, Shelf-life, and Cryogen Performance/Thermal Insulation.
"Did not raise any new issues of safety."

This type of submission typically avoids extensive new clinical trials if the modifications are minor and substantial equivalence can be demonstrated through rigorous non-clinical testing.

Summary

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February 15, 2018

AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

Re: K180137

Trade/Device Name: AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CR YOF) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: January 15, 2018 Received: January 17, 2018

Dear Melissa Smallwood:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.G. Willemann

for 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) K180137 Subject of this Special 510(k) submission

Device Name AtriCure® cryoICE® cryo-ablation probe (CRYO3), and AtriCure® cryoICE® cryoFORM® cryo-ablation probe (CRYOF)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

l. Submitter

Manufacturer:	AtriCure, Inc.7555 Innovation WayMason, Ohio 45040P: 1 (513) 755-4100
Contact Person:	Melissa SmallwoodRegulatory Affairs Specialist
Alternate Contact:	Jonathan McElweeManager, Regulatory Affairs
Date Prepared:	01/12/2018
II.Device
Name of Device:	AtriCure® cryoICE® cryo-ablation probe (CRYO3)AtriCure® cryoICE® cryoFORM® cryo-ablation probe (CRYOF)
Common Name:	Cryosurgical Probe
Classification Name:	Unit, Cryosurgical, AccessoriesSurgical, General and Plastic Surgery
Regulatory Class:	Class II
Product Code:	GEH

lll. Predicate Device

The device proposed for modification in this submission is the AtriCure cryolCE cryo-ablation probe cleared via K142441 on October 29, 2014, and the AtriCure cryolCE cryoFORm cryo-ablation probe cleared via K152337 on March 22, 2016.

The following reference device was also used in this submission:

K142203 AtriCure cryoICE cryoablation probe

IV. Device Description

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V. Indications For Use

Comparison Of Technological Characteristics With The Predicate Device VI.

Minor modifications were made to the non-patient contacting tube-sets of the cryo-ablation probes. The packaging was modified to align with AtriCure's current product lines.

. The devices have the same intended use, and;
No changes were made in operating principle, or specifications of performance, and;
Both the previously cleared and proposed CRYO3, and CRYOF probes use the same patient contacting materials, and;
The results of the verification and validation testing:
- o Demonstrated equivalency in performance
- Did not raise any new issues of safety O

The modifications to the proposed AtriCure cryolCE cryo-ablation probe are intended to 1.) align components with the previously cleared cryolCE cryoFORM cryo-ablation probe, and 2.) align the device packaging with AtriCure's commercial product lines.

VII. Performance Data

Non-clinical Bench Testing

Mechanical Reliability .
Transit
Shelf-life
Cryogen Performance/Thermal Insulation ●

VIII. Conclusions

The modified AtriCure cryolCE cryo-ablation probe (CRYO3) and AtriCure cryolCE cryoFORM cryoablation probe are equivalent to the previously cleared CRYOF probes as there is no change to intended use, operating principals, or function of the devices.

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.