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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as per your request:

Based on the provided FDA 510(k) summary for the AtriCure Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System (K210477), the device described is an electrosurgical cutting and coagulation device, not an AI/ML-based diagnostic device. Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sensitivity, specificity, human-in-the-loop performance, expert ground truth for image data, MRMC studies, effect size of AI assistance, training set details) are not applicable or not provided in this type of submission for this medical device.

This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here refer to the pre-established benchmarks for these engineering and performance tests, rather than clinical efficacy metrics for a diagnostic algorithm.

Here's a breakdown of the available information:

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

The document states: "The Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared Isolator Synergy Dual Electrode Clamp (EMR2/EML2)." However, the specific numerical acceptance criteria for each test and the precise reported device performance against those criteria are not detailed in this summary. The summary only lists the types of tests performed.

Acceptance Criteria Category (Implied)	Reported Device Performance
Mechanical Integrity & Functionality	Met predetermined criteria
Ablation Performance (Ex vivo)	Met predetermined criteria
Reliability	Met predetermined criteria
External Surface Temperature	Met predetermined criteria
Biocompatibility	Met predetermined criteria
Shelf Life	Met predetermined criteria
Electrical Safety	Met predetermined criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for any of the individual tests. This type of detail is typically found in the full test reports, not the 510(k) summary.
Data Provenance: The tests are "bench testing" and "Ex vivo Ablation Comparison Testing," and a "GLP Animal Study." This indicates laboratory and animal testing, not human patient data. Therefore, country of origin is not applicable in the same way as with clinical data. The studies are prospective in nature, as they involve testing the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is an electrosurgical clamp, not a diagnostic imaging device requiring expert interpretation for ground truth. Ground truth for these engineering tests would be established through physical measurements, chemical analyses, and biological observations (in the animal study/biocompatibility).

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the type of testing performed for this device.

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 device is a surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device is established through:

Engineering specifications and measurements (e.g., clamp force, electrical resistance, temperature).
Ex vivo and in vivo (animal study) observations of ablation lesion quality and tissue response.
Standardized biocompatibility tests to assess material interactions with biological systems.
Accelerated aging for shelf life.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA acronym and name are written in blue.

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.7555 Innovation WayMason, Ohio 45040P: 513-498-5067F: 513-895-9013
Contact Person:	Melissa Smallwood, MHAManager, Regulatory Affairs
Alternate Contact:	Jonathan McElwee, RACSr. Manager, Regulatory Affairs
Date Prepared:	07/22/2021
II.Device Information
Proprietary Name:	Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100)System
Common Name:	Cardiac Radio Frequency Ablation System Clamps
Classification:	Electrosurgical cutting and coagulation device and accessoriesRegulatory Class: Class II; per 21 CFR 878.4400Product Code: OCLClassification Panel: Cardiovascular

lll. Device Description

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 SynergyDual Electrode Clamp (EMR/ EML2)	Subject Isolator SynergyEnCompass Clamp (OLH, OSH) andGuide (GPM100)	EquivalenceComparison
ProprietaryName	Isolator Synergy Dual Electrode Clamp	Isolator Synergy EnCompass Clampand Guide	N/a
ModelNumbers	EMR2, EML2	OLH, OSH	N/a
Indications forUse	The ATRICURE Bipolar (Transpolar)System is intended to ablate cardiactissue during surgery.	The Isolator Synergy EnCompassClamp and Guide system is intendedto ablate cardiac tissue duringsurgery.	Same
DeviceDescription inInstructions forUse	The AtriCure ISOLATOR SynergySurgical Ablation System is comprisedof the Ablationand Sensing Unit (ASU), an AtriCureISOLATOR Synergy device, and afootswitch. TheISOLATOR is a single patient useelectrosurgical instrument designed foruse only with theASU. The ISOLATOR is used forcardiac tissue ablation. When activated,the ASU deliversradiofrequency (RF) energy to the linearelectrodes on the insulated jaws of theISOLATOR.The Operator controls the application ofthis RF energy by pressing theFootswitch.All ISOLATOR Synergy devices areconfigured as vascular clamps andfeatureclamping jaws of various lengths andcurvatures.The AtriCure ISOLATOR SynergyClamps feature an in-line handle withsyringe-type actuation and buttonrelease mechanisms. The Guide ispackaged withISOLATOR devices that have theAttachment Tip.The GLIDEPATH™ Tape InstrumentGuide is a single patient, surgical devicedesigned	The CLAMP is a single-useelectrosurgical instrument offered intwo configurations: standard lengthjaws (OSH), and long length jaws(OLH). All Isolator devices areconfigured as vascular clamps andfeature clamping jaws of variouslengths and curvatures. The AtriCureIsolator clamps feature an in-linehandle with syringe-type actuationand button release mechanisms.The GUIDE is a single-use surgicalaccessory designed to facilitate theguidance of surgical instrumentsthrough tissue during cardiothoracicsurgical procedures. The GUIDE hasa flexible, malleable shaft, andmagnetic attachment ends thatconnect to the metal tip of theCLAMP jaws inside the jaw magnetcups.	Similar,addedreference toOSH, OLH,andGPM100.Removedreference toEMR2,EML2.The IsolatorSynergyEnCompassClamp andGuide havethe sameintended useas thepredicateIsolatorSynergyDualElectrodeClamp.
	to facilitate the guidance of surgicalinstruments through soft tissue duringgeneralsurgical procedures.
Clamp Design	Vascular clamps featuringclamping jaws with left and rightcurvature, designed with parallel closurethroughout clamping motion.	Vascular clamps featuringclamping jaws of various lengths,designed with lengthened endeffector, and hinge to parallel closurein range of tissue clamping ascompared to predicate.	Similar,orientationand lengthmodificationsprovideadditionaloptionsbased onpatient bodyhabitus andsurgeonpreference.
Positioning /Guide	Glidepath Tape (GPT100)	Glidepath Magnetic (GPM100)	Similar,GPM100guidesupportspositioningof the clampusingmagnetictips ascompared tosnap fitfeature.
Generator/RFEnergy	Bipolar radiofrequency energygenerated by ASU2	Bipolar radiofrequency energygenerated by ASU2	Same
Biocompatibility	Biocompatible patient contactingmaterials per ISO 10993	Biocompatible patient contactingmaterials 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.

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.