Atricure Cryo Module System; cryoICE cryoablation probe

K142203 · AtriCure, Inc. · GXH · Nov 25, 2014 · Neurology

Device Facts

• Record ID: K142203
• Device Name: Atricure Cryo Module System; cryoICE cryoablation probe
• Applicant: AtriCure, Inc.
• Product Code: GXH · Neurology
• Decision Date: Nov 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 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 Story

System comprises AtriCure Cryo Module (ACM) console and sterile, single-use cryoICE (CRYO2) probes; delivers nitrous oxide to probe tip; utilizes Joule-Thomson effect for cryo-ablation; freezes target tissue to create cryonecrosis; blocks electrical conduction pathways in cardiac tissue or temporarily ablates peripheral nerves for pain management; console controls gas supply and freeze parameters; operated by clinicians; provides therapeutic benefit through targeted tissue destruction; ACM is non-sterile, reusable electro-mechanical/pneumatic unit; CRYO2 probe is malleable, closed-tip aluminum; system includes manual/automatic freeze timer and automatic gas purge.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included CRYO2 mechanical reliability, performance testing, acute animal verification, ASTM testing, and ACM software/controller board validation. All tests passed.

Technological Characteristics

Electro-mechanical/pneumatic system; Nitrous Oxide energy source; Joule-Thomson effect; Malleable aluminum cryoprobe; Gamma irradiation sterilization; Mains powered; Automatic gas purge; Manual/automatic freeze timer; Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for adults requiring cryosurgical treatment of cardiac arrhythmias via cryonecrosis of electrical conduction pathways or temporary ablation of peripheral nerves for pain management.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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.

× 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.<br>6217 Centre Park Dr.<br>West Chester, OH 45069<br>P: 513-755-4100<br>F: 513-755-4108 |
| Contact Person: | Jonathan McElwee, RAC<br>Regulatory Engineer |
| Alternate Contact: | Dennis Hong, JD, RAC<br>Senior Director, Regulatory Affairs |
| Date Prepared: | 08/8/2014 |
| II. Device | |
| Name of Device: | AtriCure Cryosurgical System, comprising:<br>a) AtriCure Cryo Module (ACM)<br>b) AtriCure cryoICE™ cryo-ablation probes (CRYO2) |
| Common Name: | Cryosurgical probe<br>Cryo Surgical Unit and Accessories<br>Cryoanalgesia System |
| Classification Name: | Surgical, General and Plastic Surgery, 21 CFR 878.4350<br>Cryogenic 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

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.

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.<br>(now Kryo Science LTD) | AtriCure |
| Market Product<br>Name | CryoStar™ System<br>(Cryostar™ console, 1 & 2mm<br>cryoprobe, convenience procedure kit<br>for the probe placement) | AtriCure Cryosurgical System<br>(ACM and cryolCE™ (CRYO2) cryo-<br>ablation probe) |
| 510(k) Number | K031482 | Subject of this Submission |
| Intended Use | Cryoanalgesia device intended for use<br>in blocking pain by temporarily ablating<br>the peripheral nerves. | The AtriCure Cryosurgical System is<br>intended for use in blocking pain by<br>temporarily ablating the peripheral<br>nerves. |
| Target Population | Adults | Adults |
| Operating Principle | Joule-Thompson Effect | Joule-Thompson Effect |
| Technology | The system consists of a range of<br>cryoprobes that are used for freezing<br>nerves to block pain by temporary<br>ablation. A console is used to house<br>and control the supply of gas to the<br>cryoprobe and to provide an electrical<br>nerve location device. | The system consists of cryoprobes<br>that are used for freezing target tissue<br>to treat cardiac arrhythmias and for<br>freezing nerves to block pain by<br>temporary ablation. A console is used<br>to control the supply of gas to the<br>cryoprobe. |
| Energy Used | Nitrous Oxide | Nitrous Oxide |
| Operating<br>Temperature | -40C to -70C | -50°C to 70°C |
| Peripheral Nerve<br>Stimulation | Included as part of the system | Not included in the system. |
| Human Factors | Hand-held device containing cryogen<br>with footswitch. | Hand-held device containing cryogen<br>with activation button on console or<br>footswitch. |
| Gas Purge System | Automatic | Automatic |
| Freeze Timer | Manual or automatic | Manual or automatic |
| Patient Contacting<br>Materials | Hemispherical and trocar-tip stainless<br>steel 1mm & 2mm diameter cryoprobe | Closed-tip aluminum 4mm cryoprobe |
| Cryotip | Rigid | Malleable |
| Biocompatibility | Biocompatible patient contacting<br>materials. | Biocompatible patient contacting<br>materials. |
| 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.