AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
Device Facts
| Record ID | K210477 |
|---|---|
| Device Name | AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE |
| Applicant | AtriCure, Inc. |
| Product Code | OCL · General, Plastic Surgery |
| Decision Date | Jul 26, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The AtriCure Isolator Synergy EnCompass Clamp and Guide system is intended to ablate cardiac tissue during surgery.
Device Story
The Isolator Synergy EnCompass Clamp and Guide system is a single-use electrosurgical instrument used by surgeons in cardiothoracic procedures to ablate cardiac tissue. The system consists of a vascular clamp (available in standard OSH or long OLH jaw configurations) and a malleable magnetic guide (GPM100). The clamp features an in-line handle with syringe-type actuation and button release. The guide facilitates instrument positioning through tissue via magnetic attachment to the clamp's metal jaw tips. The device operates by delivering bipolar radiofrequency (RF) energy from an AtriCure Ablation and Sensing Unit (ASU2) to linear electrodes on the clamp jaws. The surgeon controls energy delivery via a footswitch. By creating controlled lesions in cardiac tissue, the device assists in surgical ablation procedures, potentially benefiting patients by treating cardiac arrhythmias.
Clinical Evidence
No human clinical data provided. Substantial equivalence supported by non-clinical bench testing, including mechanical, ex vivo ablation comparison, reliability, external surface temperature, electrical safety, shelf life, and biocompatibility testing, alongside a GLP animal study.
Technological Characteristics
Bipolar RF electrosurgical clamp; single-use; PETG blister/Tyvek packaging; Ethylene Oxide sterilized (SAL 10^-6). Materials are biocompatible per ISO 10993. Features in-line handle, syringe-type actuation, and magnetic guide attachment. Operates with ASU2 generator.
Indications for Use
Indicated for ablation of cardiac tissue during surgery. No specific patient population, age, or gender restrictions are provided.
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 Dual Electrode Clamp (K110117)
Submission Summary (Full Text)
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July 26, 2021
AtriCure, Inc. Melissa Smallwood Manager, Regulatory Affairs 7555 Innovation Way Mason, Ohio 45040
Re: K210477
Trade/Device Name: Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: June 21, 2021 Received: June 21, 2021
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K210477
## Device Name
Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) system
Indications for Use (Describe)
The AtriCure Isolator Synergy EnCompass Clamp and Guide system 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/3/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 next to the "e".
## 510(k) Summary
### l. 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: | Melissa Smallwood, MHA<br>Manager, Regulatory Affairs |
| Alternate Contact: | Jonathan McElwee, RAC<br>Sr. Manager, Regulatory Affairs |
| Date Prepared: | 07/22/2021 |
| II.<br>Device Information | |
| Proprietary Name: | Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100)<br>System |
| Common Name: | Cardiac Radio Frequency Ablation System Clamps |
| 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 |
### lll. Device Description
The CLAMP is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms.
The GUIDE is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The GUIDE has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the CLAMP jaws inside the jaw magnet cups.
### IV. Intended Use/ Indications for Use
The AtriCure Isolator Synergy EnCompand Guide system 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 EnCompass Clamp (OLH, OSH) and Guide (GPM100) in comparison to the predicate Isolator Synergy Dual Electrode Clamp (EMR2/EML2), cleared per K110117, remain the same and include a longer jaw in comparison to the predicate to allow for surgeon preference and body habitus.. A comparison of the Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) technological characteristics as compared to the predicate Isolator Synergy Dual Electrode Clamp (EMR2/EML2) are provided in Table 1 below:
| Feature | Predicate (K110117) Isolator Synergy<br>Dual Electrode Clamp (EMR/ EML2) | Subject Isolator Synergy<br>EnCompass Clamp (OLH, OSH) and<br>Guide (GPM100) | Equivalence<br>Comparison |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary<br>Name | Isolator Synergy Dual Electrode Clamp | Isolator Synergy EnCompass Clamp<br>and Guide | N/a |
| Model<br>Numbers | EMR2, EML2 | OLH, OSH | N/a |
| Indications for<br>Use | The ATRICURE Bipolar (Transpolar)<br>System is intended to ablate cardiac<br>tissue during surgery. | The Isolator Synergy EnCompass<br>Clamp and Guide system is intended<br>to ablate cardiac tissue during<br>surgery. | Same |
| Device<br>Description in<br>Instructions for<br>Use | The AtriCure ISOLATOR Synergy<br>Surgical Ablation System is comprised<br>of the Ablation<br>and Sensing Unit (ASU), an AtriCure<br>ISOLATOR Synergy device, and a<br>footswitch. The<br>ISOLATOR is a single patient use<br>electrosurgical instrument designed for<br>use only with the<br>ASU. The ISOLATOR is used for<br>cardiac tissue ablation. When activated,<br>the ASU delivers<br>radiofrequency (RF) energy to the linear<br>electrodes on the insulated jaws of the<br>ISOLATOR.<br>The Operator controls the application of<br>this RF energy by pressing the<br>Footswitch.<br>All ISOLATOR Synergy devices are<br>configured as vascular clamps and<br>feature<br>clamping jaws of various lengths and<br>curvatures.<br>The AtriCure ISOLATOR Synergy<br>Clamps feature an in-line handle with<br>syringe-type actuation and button<br>release mechanisms. The Guide is<br>packaged with<br>ISOLATOR devices that have the<br>Attachment Tip.<br>The GLIDEPATH™ Tape Instrument<br>Guide is a single patient, surgical device<br>designed | The CLAMP is a single-use<br>electrosurgical instrument offered in<br>two configurations: standard length<br>jaws (OSH), and long length jaws<br>(OLH). All Isolator devices are<br>configured as vascular clamps and<br>feature clamping jaws of various<br>lengths and curvatures. The AtriCure<br>Isolator clamps feature an in-line<br>handle with syringe-type actuation<br>and button release mechanisms.<br>The GUIDE is a single-use surgical<br>accessory designed to facilitate the<br>guidance of surgical instruments<br>through tissue during cardiothoracic<br>surgical procedures. The GUIDE has<br>a flexible, malleable shaft, and<br>magnetic attachment ends that<br>connect to the metal tip of the<br>CLAMP jaws inside the jaw magnet<br>cups. | Similar,<br>added<br>reference to<br>OSH, OLH,<br>and<br>GPM100.<br>Removed<br>reference to<br>EMR2,<br>EML2.<br>The Isolator<br>Synergy<br>EnCompass<br>Clamp and<br>Guide have<br>the same<br>intended use<br>as the<br>predicate<br>Isolator<br>Synergy<br>Dual<br>Electrode<br>Clamp. |
| | to facilitate the guidance of surgical<br>instruments through soft tissue during<br>general<br>surgical procedures. | | |
| Clamp Design | Vascular clamps featuring<br>clamping jaws with left and right<br>curvature, designed with parallel closure<br>throughout clamping motion. | Vascular clamps featuring<br>clamping jaws of various lengths,<br>designed with lengthened end<br>effector, and hinge to parallel closure<br>in range of tissue clamping as<br>compared to predicate. | Similar,<br>orientation<br>and length<br>modifications<br>provide<br>additional<br>options<br>based on<br>patient body<br>habitus and<br>surgeon<br>preference. |
| Positioning /<br>Guide | Glidepath Tape (GPT100) | Glidepath Magnetic (GPM100) | Similar,<br>GPM100<br>guide<br>supports<br>positioning<br>of the clamp<br>using<br>magnetic<br>tips as<br>compared to<br>snap fit<br>feature. |
| Generator/RF<br>Energy | Bipolar radiofrequency energy<br>generated by ASU2 | Bipolar radiofrequency energy<br>generated by ASU2 | Same |
| Biocompatibility | Biocompatible patient contacting<br>materials per ISO 10993 | Biocompatible patient contacting<br>materials per ISO 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
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Image /page/5/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The first four letters, "Atri", are in blue, while the last four letters, "Cure", are in orange. The dot in the "i" is also orange, and there is a small circled "R" symbol next to the "e".
Performance testing as identified in Section VI, was conducted and confirmed that the difference in technological characteristics between the Isolator Synergy EnCompass Clamp and Guide and the predicate Isolator Synergy Dual Electrode do not affect safety and effectiveness of the device.
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### VI. Performance Data
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence of the Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) to the previously cleared lsolator Synergy Dual Electrode Clamp (EMR2/EML2). The Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared lsolator Synergy Dual Electrode Clamp (EMR2/EML2). No new safety or performance issues were raising during testing.
## Non-clinical Performance Testing:
- Mechanical Testing
- Ex vivo Ablation Comparison Testing
- . Reliability Testing
- . External Surface Temperature Testing
- . GLP Animal Study
- Biocompatibility Testing ●
- Shelf Life Testing ●
- . Electrical Safety Testing
### VII. Conclusions
AtriCure has demonstrated that the modifications made to the Isolator Synerqy EnCompass Clamp (OLH, OSH) and Guide (GPM100) are 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 Dual Electrode Clamp (EMR2/EML2/EMT) per K110117.
