Isolator Synergy EnCapture Ablation System (EMH)

K234151 · AtriCure, Inc. · OCL · Aug 27, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K234151
• Device Name: Isolator Synergy EnCapture Ablation System (EMH)
• Applicant: AtriCure, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Aug 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.

Device Story

The AtriCure Isolator Synergy EnCapture Clamp is a single-patient-use electrosurgical instrument used for cardiac tissue ablation during surgery. It operates by connecting to an AtriCure RF Generator, which delivers bipolar radiofrequency (RF) energy to linear electrodes located on the device's insulated jaws. The operator controls energy delivery via a footswitch. The device features an in-line handle with syringe-type actuation, a button release mechanism, and textured jaw surfaces to improve tissue engagement. It is compatible with an optional Glidepath Tape Instrument (GUIDE) to assist in positioning the clamp around target tissue. The device is used by surgeons in an operating room setting. By creating transmural lesions, the device enables the treatment of cardiac tissue, providing a surgical tool for cardiac electrophysiology procedures.

Clinical Evidence

A 7-day subacute GLP animal study was conducted using 12 pigs (6 subject, 6 predicate). The study evaluated the ability to create transmural lesions on cardiac structures. Results showed no procedure-related complications and confirmed the subject device creates transmural lesions in a manner substantially equivalent to the predicate. Biocompatibility testing per ISO 10993-1:2018 and electrical safety/EMC testing per IEC 60601-1 and IEC 60601-1-2 were also performed, meeting all acceptance criteria.

Technological Characteristics

Bipolar electrosurgical clamp; single-patient use. Features textured jaws, right-angled end effector, and syringe-type actuation. Materials are biocompatible per ISO 10993. Sterilization via Ethylene Oxide (SAL 10-6). System includes RF handpiece and RF generator (ASU2 or MAG). Complies with IEC 60601-1 and IEC 60601-1-2 standards.

Indications for Use

Indicated for the ablation of cardiac tissue during surgery in patients requiring such procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Isolator® Synergy™ Surgical Ablation System (EMR2/EML2) (K211311)

Reference Devices

• DeBakey Satinsky Atrauma Tangential Occlusion Clamp (K123077)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. The FDA logo is in blue.

August 27, 2024

AtriCure Inc. Dominique Neisz Manager, Regulatory Affairs 7555 Innovation Way Mason, Ohio 45040

Re: K234151

Trade/Device Name: AtriCure Isolator Synergy EnCapture Ablation System (EMH) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: August 7, 2024 Received: August 7, 2024

Dear Dominique Neisz:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality

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Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K234151

Device Name

AtriCure Isolator Synergy EnCapture Ablation System (EMH)

Indications for Use (Describe)

The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.

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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Image /page/4/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The first three letters, "Atri", are in blue, while the last four letters, "Cure", are in orange. The "C" in "Cure" is designed with a blue dot in the middle, and there is a small circled "R" symbol to the right of the word.

## 510(k) Summary

#### 1. Applicant Information

| Manufacturer: | AtriCure, Inc.<br>7555 Innovation Way<br>Mason, Ohio 45040<br>P: 513-498-5067<br>F: 513-895-9013 | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Dominique Neisz<br>Manager, Regulatory Affairs | |
| Alternate Contact: | Jim Taufen<br>Director, Regulatory Affairs | |
| Date Prepared: | December 29th, 2023 | |
| | Device Information | |
| Proprietary Name: | AtriCure Isolator Synergy EnCapture Ablation System (EMH) | |
| Common Name: | Cardiac Radio Frequency Ablation System Clamp | |
| Classification: | Electrosurgical cutting and coagulation device and accessories<br>Regulatory Class: Class II; per 21 CFR 878.4400<br>Product Code: OCL<br>Classification Panel: Cardiovascular | |
| Predicate Device: | Isolator® Synergy™ Surgical Ablation System (EMR2/EML2)<br>(K211311, OCL, May 28th, 2021) | |
| Reference Device: | DeBakey Satinsky Atrauma Tangential Occlusion Clamp<br>(K123077, DXC, May 14th, 2013) | |

#### III. Device Description

The AtriCure Isolator Synergy EnCapture Clamp (referred to hereafter as CLAMP) is a single patient use electrosurgical instrument designed for use with an AtriCure RF GENERATOR. The CLAMP is used for cardiac tissue ablation. When activated, the GENERATOR delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch. The CLAMP features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. The device outer and ablative faces of the distal jaw segments have textured surfaces to increase the engagement between the jaw face and the cardiac tissue. The CLAMP is compatible with the Gidepath Tape Instrument (hereafter known as GUIDE), that is designed to attach to the fixed jaw of the CLAMP with a half turn attachment end connection. The GUIDE is a single-patient, optional component designed to facilitate the guidance of the CLAMP around target tissue during general surgical procedures.

#### IV. Intended Use/ Indications for Use

The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.

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#### V. Comparison of Technological Characteristics

The science and fundamental technology of the Isolator Synergy EnCapture Ablation System (EMH) in comparison to the predicate Isolator Synergy Surgical Ablation System (EMR2/EML2), cleared per K211311, remain the same and include an angled jaw in comparison to the predicate to allow for surgeon preference and body habitus. A comparison of the Isolator Synergy EnCapture Ablation System (EMH) technological characteristics as compared to the predicate Isolator Synergy Surgical Ablation System (EMR2/EML2) are provided in Table 1 below:

| Feature | Predicate (K211311) Isolator<br>Synergy Surgical Ablation<br>System (EMR2/EML2) | Subject Isolator Synergy<br>EnCapture Ablation System<br>(EMH) | Equivalence<br>Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | ATRICURE Bipolar<br>(Transpolar) System | AtriCure Isolator Synergy<br>EnCapture Ablation System<br>(EMH) | Same |
| Model Numbers | EMR2 | EMH | N/a |
| Indications for Use | The ATRICURE Bipolar<br>(Transpolar) System is<br>intended to ablate cardiac<br>tissue during surgery. | The AtriCure Isolator Synergy<br>EnCapture Clamp is intended<br>to ablate cardiac tissue during<br>surgery. | Same |
| Clamp Design | Clamps featuring<br>clamping jaws with left and right<br>curvature, designed with<br>parallel closure throughout<br>clamping motion. | Clamp featuring textured<br>clamping jaws designed with<br>right angled end effector, and<br>hinge to parallel closure in<br>range of tissue clamping as<br>compared to predicate. | Similar, orientation,<br>jaw geometry and<br>texture modifications<br>provide additional<br>options based on<br>patient body habitus<br>and surgeon<br>preference. |
| Positioning / Guide | Supplied with Glidepath Tape<br>Instrument Guide (GPT100) | Supplied separately,<br>compatible with Glidepath<br>Tape Instrument Guide<br>(GPT200) | Similar, GPT200 guide<br>supports positioning of<br>the clamp if desired by<br>user using half-turn<br>connection as<br>compared to snap fit<br>feature. |
| Generator/RF<br>Energy | Bipolar radiofrequency energy<br>generated by ASU2 or MAG | Bipolar radiofrequency<br>energy generated by ASU2 or<br>MAG | Same |
| Biocompatibility | Biocompatible patient<br>contacting materials per ISO<br>10993 | Biocompatible patient<br>contacting materials per ISO<br>10993 | Same |
| Packaging | PETG blister with Tyvek® lid | PETG blister with Tyvek® lid | Same |
| Sterilization | Ethylene Oxide SAL 10-6 | Ethylene Oxide SAL 10-6 | Same |

| Table 1: Comparison of Technological Characteristics | |
|------------------------------------------------------|--|
| | |

Performance testing was conducted and confirmed that the difference in technological characteristics between the lsolator Synergy EnCapture Ablation System (EMH) and the predicate Isolator System (EMR2/EML2) does not introduce different questions of safety and effectiveness. Inclusion of a textured surface on the subject device was supported by a reference device with textured jaws commonly used in cardiovascular procedures (DeBakey Satinsky Vascular Clamp).

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## VI. Performance Data

The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate substantial equivalence of the Isolator Synergy EnCapture Ablation System (EMH) to the previously cleared Isolator Synergy Surgical Ablation System (EMR2/EML2).

## Non-clinical Performance Testing:

- Mechanical Testing
- . Ex vivo Ablation Comparison Testing
- Reliability Testing ●
- External Surface Temperature Testing ●
- In-vivo GLP Animal Study ●
- Biocompatibility Testing ●
- . Shelf-Life Testing
- . Electrical Safety Testing & Electromagnetic Compatibility (EMC)

## Mechanical Testing

- Jaw Aperture Testing ●
- Clamp Force Testing ●
- Handle Closure Force Testing .

## In Vivo GLP Animal Study

A 7-day subacute animal study was conducted. 12 pigs underwent median sternotomy and received ablations on targeting clinically relevant structures, 6 pigs were utilized for the use of the Isolator Syneray Surgical Ablation System (EMR2/EML2), while the remaining 6 pigs were ablated with the Isolator Synergy EnCapture Ablation System (EMH). There were no procedure related complications attributed to the control or subject device. The pigs were evaluated 7 days post-op for evidence of conduction block and evidence effects. In addition, macroscopic and microscopic analysis was performed to complete pathology endpoints of the study objective.

Results of the sub-acute animal study demonstrated the Isolator Synergy EnCapture Ablation System (EMH) can create transmural lesions on intended cardiac structures in a substantially equivalent manner as compared to the predicate Isolator Synergy Surgical Ablation System (EMR2/EML2).

## Biocompatibility Testing

The biocompatibility evaluation of the Isolator Synergy EnCapture Clamp was conducted in accordance with ISO 10993-1:2018, "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
- . Acute Systemic Toxicity
- Material Mediated Pyrogenicity .

The Isolator Synergy EnCapture Clamp is categorized as an externally communicating device with tissue and/or bone contact and limited duration (≤24 hours). Results demonstrated there were no new or increased biocompatibility risks and the Isolator Synergy EnCapture Clamp complies with ISO 10993-1:2018.

## Electrical Safety Testing & Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the Isolator Synergy EnCapture Ablation System (EMH), consisting of the RF Handbiece and RF Generator. The system complies with IEC 60601-1:2005+A1:2012+A2:2020 Ed. 3.2 "General requirements for basic safety and essential performance" and IEC 60601-1-2:2014+A1:2020 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance."

The Isolator Synergy EnCapture Clamp (EMH) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared Isolator System (EMR2/EML2). No new safety or performance issues were raised during testing.

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Image /page/7/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 in the middle of the "C", and a small "R" in a circle to the right of the word.

### VII. Conclusions

AtriCure has demonstrated that the Isolator Synergy EnCapture Ablation System (EMH) is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared Isolator Synergy Surgical Ablation System (EMR2/EML2) per K211311.