The Isolator linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU/ASB or MAG in Ablation mode.

The Isolator linear pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Isolator Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The Isolator Transpolar Pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

Device Description

The Isolator Linear Pen (MLP1) utilizes radiofrequency (RF) energy from a RF generator to create lines of ablation on cardiac tissue. The MLP1 device is comprised of an end effector, shaft, handle, and cable. This end effector consists of one pair of ablation electrodes separated with insulating material, with the electrodes used for the pacing and sensing functions. When the Isolator linear pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Isolator Transpolar Pen (MAX1, MAX5) is a hand-held, single use bipolar surgical instrument intended for the ablation of cardiac tissue and for use by trained surgeons only. It is composed of a handpiece with a bipolar electrode configuration at its distal end with integral cable and is powered by a radiofrequency (RF) generator. When the Transpolar pen is connected to an external cardiac pacemaker or recording device, it may be used for temporary cardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias.

The Coolrail Linear Pen (MCR1) is a hand-held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by a radiofrequency (RF) generator. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar RF energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.

The Isolator Synergy Clamps (EMR2, EML2) are single-patient use, electrosurgical instruments designed for use with a radiofrequency (RF) generator and are indicated to ablate cardiac tissue. 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. The AtriCure Isolator Synergy Clamps feature two pairs of opposing dual electrodes, an in-line handle with syringe-type grip handle/ actuation and button release mechanisms.

The Isolator Synergy EnCompass Clamps (OLH, OSH) are a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms. The clamps utilize bipolar energy generated from a radiofrequency (RF) generator.

The Isolator Synergy Access Clamp (EMT1) is a handheld, single use, bipolar radiofrequency (RF) surgical instrument intended for the ablation of cardiac tissue. EMT1 is part of the AtriCure Bipolar (Transpolar) System which includes an accessory instrument guide (Glidepath Tape). The EMT1 clamp is connected via an integral cable to a radiofrequency (RF) generator.

The ASU/ASB Generator is the original RF energy source for the cleared handpieces listed above. The ASU/ASB Generator will continue to be available for use and is unchanged from the original clearances.

The Multifunctional Ablation Generator (MAG) is an alternate RF energy source to the currently cleared ASU/ASB generator for each handpiece system above. The MAG RF generator is a portable reusable device that produces and delivers monopolar and bipolar RF energy at 460 kHz. It provides a pass-thru to an external sense and pace system (feature relates to the Pen devices). The MAG consists of several circuit boards, power supplies, a power entry module, a footswitch interface, and an LCD display with an integrated touchscreen. Like the ASU/ASB generator, the main function of the MAG is to deliver and control of voltage and current output to the selected handpiece. Upon reaching a predetermined threshold (voltage and/or current relationship or a preset time), the RF generator will provide visual and audible indications to signal the end of the ablation cycle and decrease the energy level until RF is stopped or the time limit is reached. A footswitch and a Start-Stop button on the touchscreen are included in the system to start and stop RF ablation. The output of the MAG generator is designed to be equivalent to the ASU/ASB generator when connected to each handpiece listed above.

AI/ML Overview

This looks like a 510(k) summary for a medical device called the AtriCure RF Pen and Clamp Handpieces, which are electrosurgical devices intended to ablate cardiac tissue. The summary is primarily aimed at demonstrating substantial equivalence to previously cleared predicate devices, with the main change being the addition of an alternative radiofrequency (RF) generator, the Multifunctional Ablation Generator (MAG).

Here's an analysis of the provided information concerning acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets for performance metrics. Instead, the entire submission hinges on demonstrating equivalence to predicate devices. The "reported device performance" is the finding that the system with the MAG generator is "equivalent" to the system with the predicate ASU/ASB generator.

The tables (Table 2 to Table 7) list various technological characteristics for each specific device (Isolator Synergy Clamps EMR2 & EML2, Isolator Synergy Access System EMT1, EnCompass OLH/OSH, Isolator Transpolar Pen MAX1/5, and Multifunctional Linear Pen MLP1, Coolrail Linear Pen MCR1). For almost all features, the comparison is "Same," meaning the proposed device/system feature is identical to the current/predicate device.

The key "acceptance criteria" here implicitly are:

Identical Intended Use: The proposed device must have the same intended use as the predicate device (verified in row 3 of each table, with minor language adjustments noted as "Equivalent - Adjusted language to align with AtriCure's other RF devices" but indicating no change in core intent).
Equivalent RF Generator Performance: The MAG generator must demonstrate equivalent RF energy output, algorithms, frequency, and duration to the ASU/ASB generator (verified in rows 13-15 or 14-17 of each table, marked as "Equivalent" for the generator itself, and "Same" for algorithm, frequency, and duration).
No Change in Handpiece Design: The single-use handpieces themselves must be unchanged from the predicate systems.
Conformance to Standards: The device must meet recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
Packaging, Sterilization, Biocompatibility: These aspects must remain the same and meet relevant standards (ISO 10993 for biocompatibility, 10-6 SAL for sterility assurance).
System Performance Equivalence: Bench testing and ex-vivo lesion equivalency testing must confirm that system performance with the MAG generator is equivalent to performance with the ASU/ASB generator.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for "test sets" in the traditional sense of clinical or statistically powered performance studies. The testing described is primarily bench testing and ex-vivo lesion equivalency testing.

Sample Size: Not explicitly stated as a number of devices or data points from a large population. It mentions "System testing with each handpiece" which implies a representative number of each device type was tested.
Data Provenance: The data provenance is from "Bench testing" and "ex-vivo lesion equivalency testing." This indicates the testing was done in a laboratory setting, likely on animal tissue or synthetic models, not human subjects. There is no mention of country of origin for the data, but given the company is US-based and seeking FDA clearance, the testing would generally align with US regulatory expectations and likely performed in the US or by a recognized international testing facility. The data is retrospective in the sense that it's performed to support a pre-market notification, not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications

This information is not provided in the document. For bench and ex-vivo testing, "ground truth" might be established by direct physical measurements or comparisons to established baselines, rather than expert interpretation of complex data like medical images. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not directly applicable here.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of bench and ex-vivo performance testing described. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving human interpretation or subjective assessments where multiple experts need to agree on a "ground truth" diagnosis or outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is critical for evaluating the impact of AI or new technologies on human reader performance, typically in diagnostic imaging. The device described is an electrosurgical device, and the focus of this submission is on the equivalence of a new power generator, not on changing human diagnostic performance.

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

The specific context of "standalone algorithm performance" as it relates to AI is not directly applicable here. The "algorithm" referenced (Algorithm G, B, C, L in the tables) refers to the proprietary algorithms within the RF generator controlling power output based on tissue impedance.

However, the bench testing and ex-vivo lesion equivalency testing essentially represent standalone performance of the device's ability to ablate tissue. These tests evaluate the device's technical capabilities (e.g., power output characteristics, lesion depth/quality) without human intervention beyond operating the device according to its instructions. The equivalence was demonstrated by comparing the MAG generator's performance in these standalone bench tests to the ASU/ASB generator's performance.

7. The Type of Ground Truth Used

For the bench and ex-vivo testing, the "ground truth" would be established through direct physical measurement and characterization of the ablations. This could involve:

Physical measurements: Lesion dimensions (depth, width), temperature profiles.
Histopathology: For ex-vivo tissue, microscopic examination to confirm lesion extent and cellular changes (though not explicitly stated, this is standard for lesion equivalency).
Electrical measurements: Characterizing RF power output, frequency, and current delivery under various load conditions.

8. The Sample Size for the Training Set

This information is not applicable as the document describes an electrosurgical device system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "proprietary algorithm which senses tissue impedance" within the generator would have been developed and refined through engineering processes and testing, not a machine learning training paradigm of external data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as point 8.

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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

December 30, 2022

AtriCure, Inc Jonathan McElwee Director, Regulatory Affairs 7555 Innovation Way Mason, Ohio 45040

Re: K221358

Trade/Device Name: Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: May 9, 2022 Received: May 11, 2022

Dear Jonathan 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.

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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 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 S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K221358

Device Name Isolator® Linear Pen (MLP1)

Indications for Use (Describe)

The Isolator linear pen is a sterile, single use electrosurgery device intended to ablate cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU/ASB or MAG in Ablation mode.

The Isolator linear pen may be used for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac or recording device.

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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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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

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510(k) Number (if known) K221358

Device Name Isolator® Transpolar™ Pen (MAX1, MAX5)

Indications for Use (Describe)

The Isolator Transpolar Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.

The Isolator Transpolar Pen may be used for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac or recording device.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

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510(k) Number (if known) K221358

Device Name Coolrail® Linear Pen (MCR1)

Indications for Use (Describe)

The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X 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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

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510(k) Number (if known) K221358

Device Name

Isolator® Synergy Surgical Ablation System (EMR2, EML2)

Indications for Use (Describe) The AtriCure Bipolar (Transpolar) 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)

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

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510(k) Number (if known) K221358

Device Name

Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide 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)

X 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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

{7}------------------------------------------------

510(k) Number (if known) K221358

Device Name Isolator® Synergy Access® Clamp (EMT1)

Indications for Use (Describe) The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☒ Registration (Both OFF-Highway & On-Highway)	☐ On-Site Consumption (OFF-Highway Only)
-----------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------

|× | 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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

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510(k) Summary

I. Applicant Information

Manufacturer:	AtriCure®, Inc.7555 Innovation WayMason, Ohio 45040P: 513-755-4100
Contact Person:	Jonathan McElweeDirector, Regulatory Affairs
Alternate Contact:	Dennis HongVice President, Regulatory Affairs
Date Prepared:	01 December 2022

II. Device Information

Proprietary Names:	Isolator® Linear Pen (MLP1)Isolator® Transpolar™ Pen (MAX1, MAX5)Coolrail® Linear Pen (MCR1)Isolator® Synergy Surgical Ablation System (EMR2, EML2)Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide SystemIsolator® Synergy Access® Clamp (EMT1)
Common Name:	Electrosurgical device
Classification:	Surgical device for cutting, coagulation, and/or ablation of tissue,including cardiac tissueRegulatory Class: Class II; per 21 CFR 878.4400Product Code: OCLClassification Panel: Cardiovascular
Predicate Devices:	• Isolator® Linear Pen (MLP1) cleared via K192125 on November 4, 2019• Isolator® Transpolar Pen (MAX1, MAX5) cleared via K192125 on November 4, 2019• Coolrail® Linear Pen (MCR1) cleared via K190587 on July 24, 2019• Isolator® Synergy Surgical Ablation System (EMR2, EML2) cleared via K211311 on May 28, 2021• Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System cleared via K210477 on July 26, 2021• Isolator® Synergy Access Clamp (EMT1) cleared via K110117 on April 8, 2011.

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III. Device Description

The Isolator Synergy Clamps (EMR2, EML2) are single-patient use, electrosurgical instruments designed for use with a radiofrequency (RF) generator and are indicated to ablate cardiac tissue. 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. The AtriCure Isolator Synergy Clamps feature two pairs of opposing dual electrodes, an in-line handle with syringetype grip handle/ actuation and button release mechanisms.

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Intended Use/ Indications for Use IV.

Isolator Linear Pen (MLP1)

Isolator Transpolar Pen (MAX1, MAX5)

Coolrail Linear Pen (MCR1)

The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.

Isolator Synergy Surgical Ablation System (EMR2/EML2)

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) System

The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

Isolator Synergv Access Clamp (EMT1)

The AtriCure Bipolar (Transpolar) System is intended to ablate cardiac tissue during surgery.

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V. Proposed Change

The proposed change is to add an alternative radiofrequency (RF) generator, the Multifunctional Ablation Generator (MAG), for use with each of AtriCure's RF Pen and Clamp Handpieces. The MAG generator is equivalent to the ASU/ASB generator and has the same RF energy output when connected to each handpiece listed above.

VI. Comparison of Technological Characteristics:

. The single-use handpieces are not modified compared to the predicate systems;
. The alternate MAG generator has equivalent RF energy output as the ASU/ASB generator cleared for the predicate systems;
. The devices have the same intended use;
No changes were made in operating principle, or performance specifications; ●
The contraindications, warnings, and precautions remain the same;
The results of the verification and validation testing: ●
- . demonstrated equivalence in performance
- . did not raise any safety concerns

VII. Performance Data

Verification and validation testing for the use of an alternative RF generator, MAG, were completed per AtriCure's Quality System to verify the device's conformance to appropriate design controls and specifications to demonstrate equivalence to the devices as previously cleared for use with the predicate ASU RF Generator.

Software verification and validation were completed for the MAG generator to assure that MAG features and functions operate correctly and are equivalent to the ASU/ASB generator.

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Electrical safety and electromagnetic compatibility (EMC) testing were conducted, and the results demonstrated that the MAG RF performance is in accordance with the following standards:

Standard	FDAConsensus #	Description
IEC 60601-1	19-4	Medical Electrical Equipment – Part 1: General requirements forbasic safety and essential performance
IEC 60601-1-2	19-8	Medical Electrical Equipment Part 1-2: General requirements forsafety – Collateral Standard: Electromagnetic Compatibility –Requirements and tests
IEC 60601-2-2	6-389	Medical electrical equipment – Part 2-2: Particular requirementsfor the basic safety and essential performance of high frequencysurgical equipment and high frequency surgical accessories

Table 1: Electrical Standards

Environmental and transportation testing were conducted to assure that packaging is acceptable and that the MAG generator can withstand expected environmental conditions of transportation and use.

Bench testing was conducted to characterize and confirm that MAG load curves are equivalent to ASU/ASB load curves for each handpiece listed above.

System testing with each handpiece was completed including ex-vivo lesion equivalency testing to confirm that system performance with the MAG generator is equivalent to performance with the ASU/ASB generator.

Substantial Equivalence

AtriCure has conducted performance testing for each of the clamps and pens listed above with the MAG generator to establish equivalent system performance compared with use of the ASU/ASB generator. There are no changes to the handpiece designs or specifications and the system performance with the MAG generator was equivalent to performance with the ASU/ASB generator.

The following tables summarizes the specifications for each of the clamps and pens included in this bundled submission.

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. Isolator Synergy Clamps EMR2 and EML2 Substantial Equivalence

Table 2: EMR2 and EML2 Technological Characteristics Comparison

#	Category	Feature/Item	Current - Isolator SynergyClamps (EMR2 & EML2)	Proposed Isolator SynergyClamps (EMR2 & EML2) withASU/ASB or MAG	EquivalenceComparison
1.	GeneralInformation	510(k) Reference	K211311	K221358	N/A
2.		Device Classification /Product Code	Class II,21 CFR § 878.4400OCL	Class II,21 CFR § 878.4400OCL	Same
3.		Intended Use	The AtriCure Bipolar(Transpolar) System is intendedto ablate cardiac tissue duringsurgery.	The AtriCure Bipolar(Transpolar) System is intendedto ablate cardiac tissue duringsurgery.	Same
4.		Accessory/Positioning Guide	Product Name: Glidepath Tape(GPT100, GPT200, GPT300)	Product Name: Glidepath Tape(GPT100, GPT200, GPT300)	Same
5.	DeviceConstruction	End-EffectorConfiguration	Opposing, curved, insulated jawswith two electrodes runningaxially and medially on the innersurface of each jaw	Opposing, curved, insulated jawswith two electrodes runningaxially and medially on the innersurface of each jaw	Same
6.		Jaw Tip	Rounded proximal jaw tip andreceptacle (attachment) tip ondistal jaw for use with or withoutthe Glidepath soft guide	Rounded proximal jaw tip andreceptacle (attachment) tip ondistal jaw for use with or withoutthe Glidepath soft guide	Same
7.		Number of Electrodesand location	Two (2) electrode pairs (totalfour (4) electrodes) consisting ofopposing linear electrodeslocated medially and axially oninsulated inner surface of eachopposing jaw.	Two (2) electrode pairs (totalfour (4) electrodes) consisting ofopposing linear electrodeslocated medially and axially oninsulated inner surface of eachopposing jaw.	Same
8.		Power Output	28.5 W MaxBased on proprietary algorithmwhich senses tissue impedance.	28.5 W MaxBased on proprietary algorithmwhich senses tissue impedance.	Same
9.		Packaging	PETG blister with Tyvek® lid	PETG blister with Tyvek® lid	Same
10.	Sterilizationand Other	Sterilization	Ethylene Oxide	Ethylene Oxide	Same
11.		Sterility AssuranceLevel	10-6 SAL	10-6 SAL	Same
12.		Biocompatibility	Meets requirements of ISO10993	Meets requirements of ISO10993	Same
13.		Generator	ASU / ASB	ASU / ASB OR MAG	Equivalent
14.	RF Generator	Algorithm	G	G	Same
15.		RF Frequency andduration	28.5 W for 40 sec.	28.5 W for 40 sec.	Same

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. Isolator Synergy Access System EMT1 Substantial Equivalence

#	Category	Feature	Current - Isolator SynergyAccess System (EMT1)	Proposed - Isolator SynergyAccess System (EMT1) withASU/ASB or MAG	EquivalenceComparison
1.		510K Reference	K110117	K221358	N/A
2.	GeneralInformation	Device Classification/Product Code	Class II,21 CFR § 878.4400OCL	Class II,21 CFR § 878.4400OCL	Same
3.		Intended Use	The AtriCure Bipolar(Transpolar) System isintended to ablate cardiactissue during surgery.	The AtriCure Bipolar(Transpolar) System isintended to ablate f cardiactissue during surgery.	Same
4.		Accessory/PositioningGuide	Product Name: Glidepath Tape(GPT100, GPT200, GPT300)	Product Name: Glidepath Tape(GPT100, GPT200, GPT300)	Same
5.	DeviceConstruction	End-EffectorConfiguration	Parallel, opposing, convexcurve left to right, insulatedjaws with two electrodesrunning axially and mediallyon the inner surface of eachjaw	Parallel, opposing, convexcurve left to right, insulatedjaws with two electrodesrunning axially and mediallyon the inner surface of eachjaw	Same
6.		Jaw Tip	Rounded proximal jaw tip andreceptacle (attachment) tip ondistal jaw for use with orwithout the Glidepath softguide	Rounded proximal jaw tip andreceptacle (attachment) tip ondistal jaw for use with orwithout the Glidepath softguide	Same
7.		Number of Electrodesand location	Four (4), two electrode pairsconsisting of opposing linearelectrodes located mediallyand axially on the insulatedinner surface of each opposingjaw.	Four (4), two electrode pairsconsisting of opposing linearelectrodes located mediallyand axially on the insulatedinner surface of each opposingjaw.	Same
8.		Power Output	28.5 W Max	28.5 W Max	Same
			Based on proprietaryalgorithm which senses tissueimpedance.	Based on proprietaryalgorithm which senses tissueimpedance.
9.	Sterilizationand Other	Packaging	PETG blister with Tyvek Lid	PETG blister with Tyvek Lid	Same
10.		Sterilization	Ethylene Oxide	Ethylene Oxide	Same
#	Category	Feature	Current - Isolator SynergyAccess System (EMT1)	Proposed - Isolator SynergyAccess System (EMT1) withASU/ASB or MAG	EquivalenceComparison
11.		Sterility AssuranceLevel	$10^{-6}$ SAL	$10^{-6}$ SAL	Same
12.		Biocompatibility	Meets requirements of ISO10993	Meets requirements of ISO10993	Same
13.	RF Generator	Generator	ASU/ASB	ASU/ASB OR MAG	Equivalent
14.		Algorithm	G	G	Same
15.		RF Frequency andduration	28.5 W for 40 sec.	28.5 W for 40 sec.	Same

Table 3: EMT1 Technological Characteristics Comparison

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. EnCompass OLH/OSH Substantial Equivalence

Table 4: OLH and OSH Technological Characteristics Comparison

#	Category	Feature	Current - Isolator SynergyEnCompass Clamp(OLH/OSH)	Proposed - Isolator SynergyEnCompass Clamp(OLH/OSH) with ASU/ASB orMAG	EquivalenceComparison
1.		510K Reference	K210477	K221358	N/A
2.		DeviceClassification/Product Code	Class II,21 CFR § 878.4400OCL	Class II,21 CFR § 878.4400OCL	Same
3.	GeneralInformation	Intended Use	The AtriCure Isolator SynergyEnCompass Clamp and GuideSystem is intended to ablatecardiac tissue during surgery.	The AtriCure Isolator SynergyEnCompass Clamp and GuideSystem is intended to ablatecardiac tissue during surgery.	Same
4.		Accessory/Positioning Guide	Product Name: GlidepathMagnetic Tape (GMP100)	Product Name: GlidepathMagnetic Tape (GMP100)	Same
5.	DeviceConstruction	End-EffectorConfiguration	Parallel 'Hex'-shaped jaws atclosed position and hingesprior to reaching parallelclosure. Two different lengthsof jaws to allow for differingpatient habitus.	Parallel 'Hex'-shaped jaws atclosed position and hinges priorto reaching parallel closure.Two different lengths of jaws toallow for differing patienthabitus.	Same

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#	Category	Feature	Current - Isolator SynergyEnCompass Clamp(OLH/OSH)	Proposed - Isolator SynergyEnCompass Clamp(OLH/OSH) with ASU/ASB orMAG	EquivalenceComparison
8.		Number ofElectrodes andlocation	Four (4), two electrode pairsconsisting of opposing linearelectrodes located mediallyand axially on the insulatedinner surface of each opposingjaw.	Four (4), two electrode pairsconsisting of opposing linearelectrodes located medially andaxially on the insulated innersurface of each opposing jaw.	Same
9.		Power Output	28.5 W MaxBased on proprietaryalgorithm which senses tissueimpedance.	28.5 W MaxBased on proprietary algorithmwhich senses tissue impedance.	Same
10.		Packaging	PETG blister with Tyvek Lid	PETG blister with Tyvek Lid	Same
11.		Sterilization	Ethylene Oxide	Ethylene Oxide	Same
12.	Sterilizationand Other	Sterility AssuranceLevel	10-6 SAL	10-6 SAL	Same
13.		Biocompatibility	Meets requirements of ISO10993	Meets requirements of ISO10993	Same
14.	RF Generator	Generator	ASU / ASB	ASU/ASB OR MAG	Equivalent
15.		Algorithm	G	G	Same
16.		RF Frequency andduration	28.5 W for 40 sec.	28.5 W for 40 sec.	Same

Isolator Transpolar Pen MAX1/5 Substantial Equivalence

Table 5: MAX1 and MAX5 Technological Characteristics Comparison

#	Category	Feature	Current - Isolator TranspolarPen (MAX1/5)	Proposed - Isolator TranspolarPen (MAX1/5) with ASU/ASB orMAG	EquivalenceComparison
1.	GeneralInformation	510K reference	K192125	K221358	N/A
2.	GeneralInformation	Device Classification/ Product Code	Class II,21 CFR § 878.4400OCL	Class II,21 CFR § 878.4400OCL	Same
3.	GeneralInformation	Intended Use	The Isolator Transpolar Pen is asterile, single use electrosurgery	The Isolator Transpolar Pen is asterile, single use electrosurgery	Equivalent -Adjusted
			device intended to ablate cardiactissue during cardiac surgeryusing radiofrequency (RF)energy when connected directlyto the ASU or to the ASU SourceSwitch in Ablation mode.When the Pen is connected tothe ASU Source Switch inAuxiliary mode, it may be usedfor temporary cardiac sensing,recording, stimulation, andtemporary pacing during theevaluation of cardiacarrhythmias.	device intended to ablate cardiactissue during cardiac surgeryusing radiofrequency (RF)energy.The Isolator Transpolar Pen maybe used for temporary cardiacpacing, sensing, recording, andstimulation during the evaluationof cardiac arrhythmias duringsurgery when connected to atemporary external cardiacpacemaker or recording device.	language toalign withAtriCure'sother RFdevices.
4.		Contraindication	The device is not intended forcontraceptive tubal coagulation(permanent femalesterilization).Do not ablate directly on cardiacvalves.	The device is not intended forcontraceptive tubal coagulation(permanent female sterilization).Do not ablate directly on cardiacvalves.	Same
5.	DeviceConstruction	Ablating ElementLength	8mm	8mm	Same
8.	DeviceConstruction	Electrode Number	2	2	Same
9.		Packaging	PETG blister with Tyvek Lid	PETG blister with Tyvek Lid	Same
10.		Sterilization	Ethylene Oxide	Ethylene Oxide	Same
11.	Sterilizationand Other	Sterility AssuranceLevel	10-6 SAL	10-6 SAL	Same
12.	Sterilizationand Other	Biocompatibility	Meets requirements of ISO10993	Meets requirements of ISO 10993	Same
13.	RF Generator	Generator	ASU/ASB	ASU/ASB OR MAG	Equivalent
14.	RF Generator	Algorithm	B	B	Same
15.	RF Generator	RF Frequency andduration	15W for 40s	15W for 40s	Same

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{19}------------------------------------------------

. Multifunctional Linear Pen MLP1 Substantial Equivalence

Table 6: MLP1 Technological Characteristics Comparison

#	Category	Feature	Current - Isolator Linear Pen(MLP1)	Proposed - Isolator Linear Pen(MLP1) with ASU/ASB or MAG	EquivalenceComparison
1.		510K reference	K192125	K221358	N/A
2.		DeviceClassification/Product Code	Class II,21 CFR § 878.4400OCL	Class II,21 CFR § 878.4400OCL	Same
3.	GeneralInformation	Intended Use	The Isolator linear pen is asterile, single use electrosurgerydevice intended to ablatecardiac tissue during cardiacsurgery using radiofrequency(RF) energy when connecteddirectly to the ASU or to the ASUSource Switch in Ablation mode.The Isolator linear pen may beused for temporary cardiacpacing, sensing, recording, andstimulation during theevaluation of cardiacarrhythmias during surgerywhen connected to a temporaryexternal cardiac pacemaker orrecording device.	The Isolator linear pen is a sterile,single use electrosurgery deviceintended to ablate cardiac tissueduring cardiac surgery usingradiofrequency (RF) energy to theASU/ASB or MAG in Ablationmode. The Isolator linear pen maybe used for temporary cardiacpacing, sensing, recording, andstimulation during the evaluationof cardiac arrhythmias duringsurgery when connected to atemporary external cardiacpacemaker or recording device.	Equivalent -Adjustedlanguage toalign withAtriCure'sother RFdevices.
4.		Contraindication	The device is not intended forcontraceptive tubal coagulation(permanent femalesterilization).Do not ablate directly on cardiacvalves.	The device is not intended forcontraceptive tubal coagulation(permanent female sterilization).Do not ablate directly on cardiacvalves.	Same
5.	DeviceConstruction	Ablating ElementLength	20 mm	20 mm	Same
6.		Electrode Number	4 total: 2 ablation and 2 forpacing / sensing	4 total: 2 ablation and 2 for pacing/ sensing	Same
10.		Packaging	Tyvek Pouch with HDPE insertcard	Tyvek Pouch with HDPE insertcard	Same
11.	Sterilizationand Other	Sterilization	Ethylene Oxide	Ethylene Oxide	Same
12.		Sterility AssuranceLevel	10-6 SAL	10-6 SAL	Same
13.		Biocompatibility	Meets requirements of ISO10993	Meets requirements of ISO 10993	Same
#	Category	Feature	Current - Isolator Linear Pen(MLP1)	Proposed - Isolator Linear Pen(MLP1) with ASU/ASB or MAG	EquivalenceComparison
15.	RF Generator	Generator	ASU/ASB	ASU/ASB OR MAG	Equivalent
16.		Algorithm	C	C	Same
17.		RF Frequency andduration	20W for 40s	20W for 40s	Same

{20}------------------------------------------------

Coolrail Linear Pen MCR1 Substantial Equivalence .

Table 7: MCR1 Technological Characteristics Comparison

#	Category	Feature	Current - Coolrail Linear Pen(MCR1)	Proposed - Coolrail Linear Pen(MCR1) with ASU/ASB or MAG	EquivalenceComparison
1.		510K reference	K190587	K221358	N/A
2.		DeviceClassification /Product Code	Class II,21 CFR § 878.4400OCL	Class II,21 CFR § 878.4400OCL	Same
3.	GeneralInformation	Intended Use	The Coolrail® Linear pen is asterile, single useelectrosurgery device intendedto ablate cardiac tissue duringcardiac surgery usingradiofrequency (RF) energy.	The Coolrail® linear pen is asterile, single use electrosurgerydevice intended to ablate cardiactissue during cardiac surgeryusing radiofrequency (RF) energy.	Same
4.		Contraindication	The device is not intended forcontraceptive tubal coagulation(permanent femalesterilization).	The device is not intended forcontraceptive tubal coagulation(permanent female sterilization).	Same
5.		Ablating ElementLength	30 mm	30 mm	Same
11.	DeviceConstruction	RF and Pump controlmodule	Circuit board controlled.	Circuit board controlled.	Same
21.		Packaging	PETG blister with Tyvek Lid	PETG blister with Tyvek Lid	Same
22.		Sterilization	Ethylene Oxide	Ethylene Oxide	Same
23.	Sterilizationand Other	Sterility AssuranceLevel	10-6 SAL	10-6 SAL	Same
24.		Biocompatibility	Meets requirements of ISO10993	Meets requirements of ISO 10993	Same
25.	RF Generator	Generator	ASU/ASB	ASU/ASB OR MAG	Equivalent
26.		Algorithm	L	L	Same
27.		RF Frequency andduration	30W for 40s	30W for 40s	Same

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VIII. Conclusions

AtriCure has demonstrated that each of AtriCure's RF Handpieces, when connected to the Multifunctional Ablation Generator (MAG) is substantially equivalent in performance, safety, and intended use to AtriCure's previously cleared RF Handpieces 510(k)s with the ASU/ASB Generator.

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.