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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AtriCure Isolator Synergy EnCapture Ablation System (EMH). It primarily focuses on demonstrating substantial equivalence to a predicate device (Isolator Synergy Surgical Ablation System, K211311) rather than presenting a study proving a device meets specific acceptance criteria based on human expert performance in image analysis or similar tasks.

Therefore, many of the requested details about acceptance criteria for AI/image analysis devices, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training sets are not applicable to this document. This document details the clearance of a surgical ablation system, which is a physical device used to ablate cardiac tissue during surgery, not a software or AI-driven diagnostic/image analysis tool.

However, I can extract and present the relevant performance data and "acceptance criteria" (in the context of substantial equivalence) as described in the provided text.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Context: The device in question is the "AtriCure Isolator Synergy EnCapture Ablation System (EMH)," an electrosurgical instrument for cardiac tissue ablation. The regulatory submission is a 510(k), which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute performance against a predefined clinical metric as one might for a novel AI diagnostic. The "acceptance criteria" here therefore relate to demonstrating this substantial equivalence through various performance tests.

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

The document doesn't provide a direct table of "acceptance criteria" with numerical performance targets in the way one would for an AI diagnostic (e.g., AUC > 0.9). Instead, it presents various non-clinical and animal studies conducted to demonstrate that the new device performs "substantially equivalent" to its predicate. The acceptance for these tests is implicitly that the device performs comparably to the predicate and raises no new safety or effectiveness concerns.

Test Category	Specific Tests Conducted	Reported Device Performance / Conclusion
Non-clinical Performance Testing	Mechanical Testing (Jaw Aperture, Clamp Force, Handle Closure Force Testing)	Not explicitly detailed, but implied to demonstrate comparable mechanical performance to the predicate.
	Ex vivo Ablation Comparison Testing	Not explicitly detailed, but implied to demonstrate comparable ablation characteristics ex vivo.
	Reliability Testing	Not explicitly detailed, but implied to meet reliability standards.
	External Surface Temperature Testing	Not explicitly detailed, but implied to meet safety standards.
	Shelf-Life Testing	Not explicitly detailed, but implied to demonstrate acceptable shelf-life.
	Electrical Safety Testing & Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1:2005+A1:2012+A2:2020 Ed. 3.2 and IEC 60601-1-2:2014+A1:2020. No new safety or performance issues raised.
Biocompatibility Testing	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity (all per ISO 10993-1:2018)	No new or increased biocompatibility risks; complies with ISO 10993-1:2018.
In Vivo GLP Animal Study	Measurement of conduction block and evidence of effects, macroscopic and microscopic pathology analysis.	Demonstrated the AtriCure 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).
Overall Conclusion	N/A	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.

2. Sample sized used for the test set and the data provenance:

In Vivo GLP Animal Study: 12 pigs were used.
- 6 pigs for the subject device (Isolator Synergy EnCapture Ablation System EMH).
- 6 pigs for the predicate device (Isolator Synergy Surgical Ablation System EMR2/EML2).
Data Provenance: The study was a GLP (Good Laboratory Practice) animal study. No information about country of origin, or retrospective/prospective human data is relevant as this is an animal study for a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical surgical device, not an AI/image analysis product requiring human expert interpretation for ground truth. The "ground truth" in the animal study would be the physiological and pathological outcomes measured directly from the animals (e.g., "conduction block" and "macroscopic and microscopic analysis").

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

Not Applicable. As per point 3.

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 not an AI-assisted diagnostic device. No MRMC study was performed because the device does not involve human readers interpreting cases/images.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the In Vivo GLP Animal Study: The ground truth was based on direct physiological outcomes (evidence of conduction block) and histopathology (macroscopic and microscopic analysis of tissue) post-ablation from the animal subjects. For the other tests (mechanical, biocompatibility, electrical safety), the "ground truth" is adherence to established engineering and safety standards.

8. The sample size for the training set:

Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in the context of this regulatory submission.

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

Not Applicable. As per point 8.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.7555 Innovation WayMason, Ohio 45040P: 513-498-5067F: 513-895-9013
Contact Person:	Dominique NeiszManager, Regulatory Affairs
Alternate Contact:	Jim TaufenDirector, 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 accessoriesRegulatory Class: Class II; per 21 CFR 878.4400Product Code: OCLClassification Panel: Cardiovascular
Predicate Device:	Isolator® Synergy™ Surgical Ablation System (EMR2/EML2)(K211311, OCL, May 28th, 2021)
Reference Device:	DeBakey Satinsky Atrauma Tangential Occlusion Clamp(K123077, DXC, May 14th, 2013)

III. Device Description

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) IsolatorSynergy Surgical AblationSystem (EMR2/EML2)	Subject Isolator SynergyEnCapture Ablation System(EMH)	EquivalenceComparison
Proprietary Name	ATRICURE Bipolar(Transpolar) System	AtriCure Isolator SynergyEnCapture Ablation System(EMH)	Same
Model Numbers	EMR2	EMH	N/a
Indications for Use	The ATRICURE Bipolar(Transpolar) System isintended to ablate cardiactissue during surgery.	The AtriCure Isolator SynergyEnCapture Clamp is intendedto ablate cardiac tissue duringsurgery.	Same
Clamp Design	Clamps featuringclamping jaws with left and rightcurvature, designed withparallel closure throughoutclamping motion.	Clamp featuring texturedclamping jaws designed withright angled end effector, andhinge to parallel closure inrange of tissue clamping ascompared to predicate.	Similar, orientation,jaw geometry andtexture modificationsprovide additionaloptions based onpatient body habitusand surgeonpreference.
Positioning / Guide	Supplied with Glidepath TapeInstrument Guide (GPT100)	Supplied separately,compatible with GlidepathTape Instrument Guide(GPT200)	Similar, GPT200 guidesupports positioning ofthe clamp if desired byuser using half-turnconnection ascompared to snap fitfeature.
Generator/RFEnergy	Bipolar radiofrequency energygenerated by ASU2 or MAG	Bipolar radiofrequencyenergy generated by ASU2 orMAG	Same
Biocompatibility	Biocompatible patientcontacting materials per ISO10993	Biocompatible patientcontacting materials per ISO10993	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.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.