The AtriCure Isolator Synergy Surgical Ablation System is comprised of the Ablation and Sensing Unit (ASU), AtriCure Switch Matrix (ASB), an AtriCure Isolator Synergy device, and a footswitch. The AtriCure Isolator Synergy device is a single-patient use, electrosurgical instrument designed for use only with the ASU.

The AtriCure Isolator Synergy clamp is used for cardiac tissue ablation. When activated, the ASU delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the AtriCure Isolator Synergy Clamp. The Operator controls the application of this RF energy by pressing the Footswitch.

All AtriCure Isolator Synerqy devices are configured as vascular clamps and feature clamping jaws of various lengths, curvatures and apertures; rounded jaw tips, and cables that plugs into the ASB switch matrix and ASU RF generator.

The AtriCure Isolator Synergy Clamps features two pairs of opposing dual electrodes, an in-line handle with syringetype grip handle/ actuation and button release mechanisms.

There is a Glidepath™ Tape Guide that is a single-patient use, detachable, surgical device the guidance of surgical instruments through soft tissue during general surgical procedures. The Guide is package with ISOLATOR devices that have the Attachment Tip.

The Glidepath Tape Instrument Guide is a single-patient use, surgical device designed to facilitate the guidance of surgical instruments through soft tissue during general surgical procedures.

AI/ML Overview

The provided document is a 510(k) summary for the AtriCure Isolator® Synergy™ Surgical Ablation System, which describes modifications to an existing device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria for a new device's performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study designs (like MRMC or standalone) are not explicitly present in the provided text as it pertains to showing the device meets new acceptance criteria. Instead, the document discusses how the modified device meets the same requirements for safety and efficacy as the predicate device.

Here's an attempt to answer the questions based on the information available:

Acceptance Criteria and Device Performance Study for AtriCure Isolator® Synergy™ Surgical Ablation System (K211311)

The submission K211311 describes modifications to the AtriCure Isolator Synergy Clamps, specifically an alternate end effector design change to an overmold configuration. The core claim is that the modified device remains substantially equivalent to the predicate device (cleared per K110117) and meets the same requirements for safety and efficacy. Therefore, the "acceptance criteria" can be inferred as maintaining the performance characteristics of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Item	Acceptance Criteria (Inferred from Predicate)	Reported Device Performance (Modified Device)
End Effector Design	Non-overmolded design with ABS resin MG37EP (Predicate)	Overmolded design with ABS resin MG37EPX (Proposed) - Found equivalent
Ablation Performance - Transmurality	Transmural lesions	Transmural lesions
Ablation Performance - Lesion Width	Lesions tightly confined to the region between the opposing insulated jaws	Lesions tightly confined to the region between the opposing insulated jaws
Sterilization Site	EO	EO
Packaging	PETG blister with Tyvek® lid	PETG blister with Tyvek® lid
Sterilization	Ethylene Oxide	Ethylene Oxide
Sterility Assurance Level	10-6 SAL	10-6 SAL
Biocompatibility	Meets requirements of ISO 10993	Meets requirements of ISO 10993 (supported by Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity testing)
Shelf Life	3 years	3 years
Pyrogen	Non-pyrogenic	Non-pyrogenic
Latex	Not made with natural rubber latex	Not made with natural rubber latex
Software	No software in the clamp	No software in the clamp

2. Sample Size and Data Provenance for Test Set:

The document states, "Performance testing confirmed that the Isolator Synergy Clamps meets the same requirements for safety and efficacy as the predicate Isolator Synergy Clamp." It also mentions, "the previously submitted bench and animal data remain valid for the AtriCure Isolator Synergy clamps."

Sample Size: Not explicitly stated for specific performance tests on the modified device. The testing conducted was to confirm the modified clamps meet the same requirements as the predicate device.
Data Provenance: Not specified, but likely proprietary internal testing data given the nature of a 510(k) submission for device modification. The reference to "previously submitted bench and animal data" suggests a combination of laboratory and animal studies, which would be prospective in nature. Country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This is a technical device modification submission, not a study involving expert human reader interpretation of images or data to establish ground truth. The ground truth for performance characteristics (e.g., transmurality, lesion width) would be established through direct physical measurements during bench and animal testing.

4. Adjudication Method for Test Set:

Not applicable. The "test set" performance is evaluated against engineering and biological criteria (e.g., lesion characteristics, biocompatibility), not through human reader adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human reader performance is a key metric. This submission concerns a surgical ablation system.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical electrosurgical instrument; it does not involve algorithms or AI that would have standalone performance in the context of this submission. The clamp itself has no software.

7. Type of Ground Truth Used:

The ground truth for the performance claims (e.g., transmurality, lesion width, biocompatibility) would be based on:

Direct Physical and Biological Measurements: During bench testing and animal studies. For instance, lesion transmurality would be confirmed through histological analysis in animal models.
Standardized Testing Protocols: Results from tests against ISO and IEC standards (e.g., ISO 10993 for biocompatibility) serve as the ground truth for those specific aspects.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The clinical application and underlying technology (RF ablation) are well-established.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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May 28, 2021

AtriCure, Inc. Jon McElwee Senior Manager, Regulatory Affairs 7555 Innovation Wav Mason, Ohio 45040

Re: K211311

Trade/Device Name: AtriCure Isolator® Synergy™ Surgical Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: April 27, 2021 Received: April 30, 2021

Dear Jon McElwee:

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

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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 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 (OS) 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 mediation-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) K211311

Device Name

AtriCure Isolator® Synergy™ Surgical Ablation System

Indications for Use (Describe)

The AtriCure Isolator Synergy Surgical Ablation 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 letters "A," "t," "r," and "i" are in blue, while the "C," "u," "r," and "e" are in orange. There is a blue dot above the "i" and inside the "C." There is a registered trademark 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:	Jonathan McElwee, RACSr. Manager, Regulatory Affairs
Alternate Contact:	Mary GaleanoSr Regulatory Affairs Specialist
Date Prepared:	04/29/2021
II.Device Information
Proprietary Name:	AtriCure Isolator® Synergy™ Surgical Ablation 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: Card ovascular

lll. Device Description

The AtriCure Isolator Synergy Clamps features two pairs of opposing dual electrodes, an in-line handle with syringetype grip handle/ actuation and button release mechanisms.

The Glidepath Tape Instrument Guide is a single-patient use, surgical device designed to facilitate the guidance of surgical instruments through soft tissue during general surgical procedures.

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NOTE: Please refer to the AtriCure ASU2 and ASB3 Instructions for information specific to the ASU2 and ASB3.

IV. Indications for Use

The AtriCure Isolator Synergy Surgical Ablation System is intended to ablate cardiac tissue during surgery.

V. Comparison of Technological Characteristics (Isolator Synergy Clamp -K110117)

This submission included modifications to allow for an alternate end effector design change to an overmold configuration. The science and fundamental technology of the Isolator Synergy Clamps (EMR2) in comparison to the predicate Isolator Synergy Clamp (EMR2, EML2), cleared per K110117, remain the same. Performance testing confirmed that the Isolator Synergy Clamps meets the same requirements for safety and efficacy as the predicate Isolator Synergy Clamp.

Table 1: Device Comparison

#	Category	Feature/Item	Current - IsolatorSynergy Clamps(EMR2, EML2)	Proposed IsolatorSynergy Clamps(EMR2, EML2)	EquivalenceComparison
1		Manufacturer	AtriCure, Inc.	AtriCure, Inc.	Same
2		Product Name	Isolator Synergy Clampwith Glidepath softguide	Isolator Synergy Clampwith Glidepath softguide	Same
3		510(k) and PastSubmissionReferences	K110117	K211311	N/A
4		DeviceClassification /Product Code	Class II,21 CFR § 878.4400OCL	Class II,21 CFR § 878.4400OCL	Same
5		Model Number	EMR2, EML2	EMR2, EML2	N/A
6	GeneralInformation	Indications for Use	The System isintended for theablation of cardiactissue during surgery.	The System isintended for theablation of cardiactissue during surgery.	Same
7		Contraindication	The Bipolar(Transpolar) System isnot indicated forcontraceptivecoagulation of thefallopian tubes.	The Bipolar(Transpolar) System isnot indicated forcontraceptivecoagulation of thefallopian tubes.	Same
8		Device Description	Electrosurgical BipolarRF Clamp and optionalaccessory (Class I)instrument guide	Electrosurgical BipolarRF Clamp and optionalaccessory (Class I)instrument guide	Same
9		GeneratorDescription/Energy Source	RF Generator –Ablation and SensingUnit and Source SwitchMatrix(ASU2, ASB3)	RF Generator –Ablation and SensingUnit and Source SwitchMatrix(ASU2, ASB3)	Same
10		Accessory/Positioning Guide	Product Name:Glidepath TapeMaterials: Santoprene8000 ThermoplasticRubber with Ultem pins	Product Name:Glidepath TapeMaterials: Santoprene8000 ThermoplasticRubber with Ultem pins	Same

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#	Category	Feature/Item	Current - IsolatorSynergy Clamps(EMR2, EML2)	Proposed IsolatorSynergy Clamps(EMR2, EML2)	EquivalenceComparison
		End EffectorDesign	Non-overmolded designwith ABS resinMG37EP	Overmolded designwith ABS resinMG37EPX	Equivalent
11	Performance	AblationPerformance -Transmurality	Transmural lesions	Transmural lesions	Same
12		AblationPerformance -Lesion Width	Lesions tightly confinedto the region betweenthe opposing insulatedjaws.	Lesions tightly confinedto the region betweenthe opposing insulatedjaws.	Same
13	Sterilizationand Other	Sterilization Site	EO	EO	Same
14		Packaging	PETG blister withTyvek® lid	PETG blister withTyvek® lid	Same
15		Sterilization	Ethylene Oxide	Ethylene Oxide	Same
16		Sterility AssuranceLevel	10-6 SAL	10-6 SAL	Same
17		Biocompatibility	Meets requirements ofISO 10993	Meets requirements ofISO 10993	Same
18		Shelf Life	3 year	3 year	Same
19		Pyrogen	Non-pyrogenic	Non-pyrogenic	Same
20		Latex	Not made with naturalrubber latex	Not made with naturalrubber latex	Same
21		Software	No software in theclamp	No software in theclamp	Same

VI. Performance Data

A review of the risk analysis concluded there is not overall change to the risk profile of the proposed AtriCure Isolator Synergy clamps versus the previously cleared AtriCure Isolator Synergy clamps as the modifications to the proposed AtriCure Isolator Synergy do not add or remove any features of the device or change the clinical application.

The proposed changes do not include any change to design or performance specifications of the AtriCure Isolator Synergy clamps. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriCure Isolator Synergy clamps.

The following consensus standards were leveraged in this submission:

ISO 10993-1
IEC 60601-2-2
. ASTM E1952-11
ISO 11607-2
AAMI TIR 28

Biocompatibility Testing

The biocompatibility evaluation is in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. Data collected from the following tests support this change:

Cytotoxicity
Sensitization ●
Irritation ●
. Acute Systemic Toxicity
. Material Mediated Pyrogenicity

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Image /page/6/Picture/0 description: The image shows the logo for AtriCure. 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". There is a registered trademark symbol next to the word "Cure".

VII. Conclusions

AtriCure has demonstrated that the modifications made to the Isolator Synergy Clamp (EMR2, EML2) are substantially equivalent in intended use/indication for use as the previously cleared Isolator Synergy Clamp (EMR2, EML2) 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.