AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)

K180137 · AtriCure, Inc. · GEH · Feb 15, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180137
• Device Name: AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
• Applicant: AtriCure, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Feb 15, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Handheld, single-use cryo-ablation probes used during cardiac surgery; operated by surgeons. Probes utilize high-pressure nitrous oxide (N2O) supplied by AtriCure Cryo Module; rapid cooling achieved via Joule-Thompson effect. Probes reach temperatures below -40°C to induce cryonecrosis in target cardiac tissue. Malleable cryotip allows anatomical access; forming tool adjusts shape. Thermocouple on shaft provides real-time temperature feedback to console. Device blocks electrical conduction pathways to treat arrhythmias. Benefits include precise tissue ablation and anatomical flexibility.

Clinical Evidence

Bench testing only. Testing included mechanical reliability, transit testing, shelf-life, and cryogen performance/thermal insulation.

Technological Characteristics

Cryosurgical probe; aluminum or stainless-steel boiler cryotip; malleable 4-mm diameter tip (10-cm length); insulated rigid shaft; thermocouple for temperature monitoring. Energy source: high-pressure nitrous oxide (N2O). Principle: Joule-Thompson effect for cryo-ablation. Single-use, sterile. Connects to AtriCure Cryo Module.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring cryosurgical treatment of cardiac arrhythmias via tissue freezing to block electrical conduction pathways.

Regulatory Classification

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.

Predicate Devices

• AtriCure cryoICE cryo-ablation probe (K142441)
• AtriCure cryoICE cryoFORM cryo-ablation probe (K152337)

Reference Devices

• AtriCure cryoICE cryoablation probe (K142203)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

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Image /page/3/Picture/1 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" in "Cure". There is a registered trademark symbol to the right of the word "Cure".

# 510(k) Summary

#### l. Submitter

| Manufacturer: | AtriCure, Inc.<br>7555 Innovation Way<br>Mason, Ohio 45040<br>P: 1 [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------|
| Contact Person: | Melissa Smallwood<br>Regulatory Affairs Specialist |
| Alternate Contact: | Jonathan McElwee<br>Manager, Regulatory Affairs |
| Date Prepared: | 01/12/2018 |
| II.<br>Device | |
| Name of Device: | AtriCure® cryoICE® cryo-ablation probe (CRYO3)<br>AtriCure® cryoICE® cryoFORM® cryo-ablation probe (CRYOF) |
| Common Name: | Cryosurgical Probe |
| Classification Name: | Unit, Cryosurgical, Accessories<br>Surgical, 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

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.

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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).

### V. Indications For Use

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.

#### 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.