← Product Code [OCL](/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL) · K221358 # 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) (K221358) _AtriCure, Inc. · OCL · Dec 30, 2022 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K221358 ## Device Facts - **Applicant:** AtriCure, Inc. - **Product Code:** [OCL](/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL.md) - **Decision Date:** Dec 30, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use 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 Story System consists of various hand-held, single-use bipolar RF electrosurgical instruments (pens and clamps) used with a radiofrequency generator (ASU/ASB or new MAG). Devices input RF energy to cardiac tissue to create ablation lines; pens also interface with external cardiac pacemakers/recorders for sensing/pacing. MAG generator provides 460 kHz RF energy, controlled by proprietary impedance-sensing algorithms; features touchscreen, footswitch, and visual/audible indicators for cycle completion. Used in cardiac surgery by trained surgeons. Output is thermal lesion creation; clinical benefit is treatment of cardiac arrhythmias. MAG generator is portable, reusable, and provides equivalent output to existing ASU/ASB generators. ## Clinical Evidence Bench testing only. No clinical data. Verification and validation included electrical safety (IEC 60601-1, 60601-1-2, 60601-2-2), environmental/transportation testing, and ex-vivo lesion equivalency testing to confirm MAG generator performance is equivalent to the predicate ASU/ASB generator. ## Technological Characteristics Bipolar RF electrosurgical instruments. Materials: PETG/Tyvek packaging, biocompatible per ISO 10993. Energy: 460 kHz RF. Connectivity: Wired connection to MAG or ASU/ASB generator. Sterilization: Ethylene Oxide (10^-6 SAL). Software: Proprietary impedance-sensing algorithms (labeled G, B, C, L). ## Regulatory Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## Predicate Devices - Isolator® Linear Pen (MLP1) ([K192125](/device/K192125.md)) - Isolator® Transpolar Pen (MAX1, MAX5) ([K192125](/device/K192125.md)) - Coolrail® Linear Pen (MCR1) ([K190587](/device/K190587.md)) - Isolator® Synergy Surgical Ablation System (EMR2, EML2) ([K211311](/device/K211311.md)) - Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System ([K210477](/device/K210477.md)) - Isolator® Synergy Access Clamp (EMT1) ([K110117](/device/K110117.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. 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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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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) | #### 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov {3}------------------------------------------------ 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.* 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 {4}------------------------------------------------ 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.* 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 {5}------------------------------------------------ 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.* 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 {6}------------------------------------------------ 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.* 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 {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.* 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 {8}------------------------------------------------ ## 510(k) Summary #### I. Applicant Information | Manufacturer: | AtriCure®, Inc.
7555 Innovation Way
Mason, Ohio 45040
P: 513-755-4100 | |--------------------|--------------------------------------------------------------------------------| | Contact Person: | Jonathan McElwee
Director, Regulatory Affairs | | Alternate Contact: | Dennis Hong
Vice 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 System
Isolator® Synergy Access® Clamp (EMT1) | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Electrosurgical device | | Classification: | Surgical device for cutting, coagulation, and/or ablation of tissue,
including cardiac tissue
Regulatory Class: Class II; per 21 CFR 878.4400
Product Code: OCL
Classification 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. | {9}------------------------------------------------ #### III. 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 syringetype grip handle/ actuation and button release mechanisms. {10}------------------------------------------------ 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. {11}------------------------------------------------ #### Intended Use/ Indications for Use IV. #### Isolator Linear Pen (MLP1) 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. #### Isolator Transpolar Pen (MAX1, MAX5) 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. #### 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. {12}------------------------------------------------ #### 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. {13}------------------------------------------------ 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 | FDA
Consensus # | Description | |---------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1 | 19-4 | Medical Electrical Equipment – Part 1: General requirements for
basic safety and essential performance | | IEC 60601-1-2 | 19-8 | Medical Electrical Equipment Part 1-2: General requirements for
safety – Collateral Standard: Electromagnetic Compatibility –
Requirements and tests | | IEC 60601-2-2 | 6-389 | Medical electrical equipment – Part 2-2: Particular requirements
for the basic safety and essential performance of high frequency
surgical 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. {14}------------------------------------------------ - . Isolator Synergy Clamps EMR2 and EML2 Substantial Equivalence ### Table 2: EMR2 and EML2 Technological Characteristics Comparison | # | Category | Feature/Item | Current - Isolator Synergy
Clamps (EMR2 & EML2) | Proposed Isolator Synergy
Clamps (EMR2 & EML2) with
ASU/ASB or MAG | Equivalence
Comparison | |-----|----------------------------|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | 1. | General
Information | 510(k) Reference | K211311 | K221358 | N/A | | 2. | | Device Classification /
Product Code | Class II,
21 CFR § 878.4400
OCL | Class II,
21 CFR § 878.4400
OCL | Same | | 3. | | Intended Use | The AtriCure Bipolar
(Transpolar) System is intended
to ablate cardiac tissue during
surgery. | The AtriCure Bipolar
(Transpolar) System is intended
to ablate cardiac tissue during
surgery. | Same | | 4. | | Accessory/
Positioning Guide | Product Name: Glidepath Tape
(GPT100, GPT200, GPT300) | Product Name: Glidepath Tape
(GPT100, GPT200, GPT300) | Same | | 5. | Device
Construction | End-Effector
Configuration | Opposing, curved, insulated jaws
with two electrodes running
axially and medially on the inner
surface of each jaw | Opposing, curved, insulated jaws
with two electrodes running
axially and medially on the inner
surface of each jaw | Same | | 6. | | Jaw Tip | Rounded proximal jaw tip and
receptacle (attachment) tip on
distal jaw for use with or without
the Glidepath soft guide | Rounded proximal jaw tip and
receptacle (attachment) tip on
distal jaw for use with or without
the Glidepath soft guide | Same | | 7. | | Number of Electrodes
and location | Two (2) electrode pairs (total
four (4) electrodes) consisting of
opposing linear electrodes
located medially and axially on
insulated inner surface of each
opposing jaw. | Two (2) electrode pairs (total
four (4) electrodes) consisting of
opposing linear electrodes
located medially and axially on
insulated inner surface of each
opposing jaw. | Same | | 8. | | Power Output | 28.5 W Max
Based on proprietary algorithm
which senses tissue impedance. | 28.5 W Max
Based on proprietary algorithm
which senses tissue impedance. | Same | | 9. | | Packaging | PETG blister with Tyvek® lid | PETG blister with Tyvek® lid | Same | | 10. | Sterilization
and Other | Sterilization | Ethylene Oxide | Ethylene Oxide | Same | | 11. | | Sterility Assurance
Level | 10-6 SAL | 10-6 SAL | Same | | 12. | | Biocompatibility | Meets requirements of ISO
10993 | Meets requirements of ISO
10993 | Same | | 13. | | Generator | ASU / ASB | ASU / ASB OR MAG | Equivalent | | 14. | RF Generator | Algorithm | G | G | Same | | 15. | | RF Frequency and
duration | 28.5 W for 40 sec. | 28.5 W for 40 sec. | Same | {15}------------------------------------------------ - . Isolator Synergy Access System EMT1 Substantial Equivalence | # | Category | Feature | Current - Isolator Synergy
Access System (EMT1) | Proposed - Isolator Synergy
Access System (EMT1) with
ASU/ASB or MAG | Equivalence
Comparison | |-----|----------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | 1. | | 510K Reference | K110117 | K221358 | N/A | | 2. | General
Information | Device Classification/
Product Code | Class II,
21 CFR § 878.4400
OCL | Class II,
21 CFR § 878.4400
OCL | Same | | 3. | | Intended Use | The AtriCure Bipolar
(Transpolar) System is
intended to ablate cardiac
tissue during surgery. | The AtriCure Bipolar
(Transpolar) System is
intended to ablate f cardiac
tissue during surgery. | Same | | 4. | | Accessory/Positioning
Guide | Product Name: Glidepath Tape
(GPT100, GPT200, GPT300) | Product Name: Glidepath Tape
(GPT100, GPT200, GPT300) | Same | | 5. | Device
Construction | End-Effector
Configuration | Parallel, opposing, convex
curve left to right, insulated
jaws with two electrodes
running axially and medially
on the inner surface of each
jaw | Parallel, opposing, convex
curve left to right, insulated
jaws with two electrodes
running axially and medially
on the inner surface of each
jaw | Same | | 6. | | Jaw Tip | Rounded proximal jaw tip and
receptacle (attachment) tip on
distal jaw for use with or
without the Glidepath soft
guide | Rounded proximal jaw tip and
receptacle (attachment) tip on
distal jaw for use with or
without the Glidepath soft
guide | Same | | 7. | | Number of Electrodes
and location | Four (4), two electrode pairs
consisting of opposing linear
electrodes located medially
and axially on the insulated
inner surface of each opposing
jaw. | Four (4), two electrode pairs
consisting of opposing linear
electrodes located medially
and axially on the insulated
inner surface of each opposing
jaw. | Same | | 8. | | Power Output | 28.5 W Max | 28.5 W Max | Same | | | | | Based on proprietary
algorithm which senses tissue
impedance. | Based on proprietary
algorithm which senses tissue
impedance. | | | 9. | Sterilization
and Other | Packaging | PETG blister with Tyvek Lid | PETG blister with Tyvek Lid | Same | | 10. | | Sterilization | Ethylene Oxide | Ethylene Oxide | Same | | # | Category | Feature | Current - Isolator Synergy
Access System (EMT1) | Proposed - Isolator Synergy
Access System (EMT1) with
ASU/ASB or MAG | Equivalence
Comparison | | 11. | | Sterility Assurance
Level | $10^{-6}$ SAL | $10^{-6}$ SAL | Same | | 12. | | Biocompatibility | Meets requirements of ISO
10993 | Meets requirements of ISO
10993 | Same | | 13. | RF Generator | Generator | ASU/ASB | ASU/ASB OR MAG | Equivalent | | 14. | | Algorithm | G | G | Same | | 15. | | RF Frequency and
duration | 28.5 W for 40 sec. | 28.5 W for 40 sec. | Same | ### Table 3: EMT1 Technological Characteristics Comparison {16}------------------------------------------------ - . EnCompass OLH/OSH Substantial Equivalence ### Table 4: OLH and OSH Technological Characteristics Comparison | # | Category | Feature | Current - Isolator Synergy
EnCompass Clamp
(OLH/OSH) | Proposed - Isolator Synergy
EnCompass Clamp
(OLH/OSH) with ASU/ASB or
MAG | Equivalence
Comparison | |----|------------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | 1. | | 510K Reference | K210477 | K221358 | N/A | | 2. | | Device
Classification/
Product Code | Class II,
21 CFR § 878.4400
OCL | Class II,
21 CFR § 878.4400
OCL | Same | | 3. | General
Information | Intended Use | The AtriCure Isolator Synergy
EnCompass Clamp and Guide
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. | Same | | 4. | | Accessory/
Positioning Guide | Product Name: Glidepath
Magnetic Tape (GMP100) | Product Name: Glidepath
Magnetic Tape (GMP100) | Same | | 5. | Device
Construction | End-Effector
Configuration | Parallel 'Hex'-shaped jaws at
closed position and hinges
prior to reaching parallel
closure. Two different lengths
of jaws to allow for differing
patient habitus. | Parallel 'Hex'-shaped jaws at
closed position and hinges prior
to reaching parallel closure.
Two different lengths of jaws to
allow for differing patient
habitus. | Same | {17}------------------------------------------------ | # | Category | Feature | Current - Isolator Synergy
EnCompass Clamp
(OLH/OSH) | Proposed - Isolator Synergy
EnCompass Clamp
(OLH/OSH) with ASU/ASB or
MAG | Equivalence
Comparison | |-----|----------------------------|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | 8. | | Number of
Electrodes and
location | Four (4), two electrode pairs
consisting of opposing linear
electrodes located medially
and axially on the insulated
inner surface of each opposing
jaw. | Four (4), two electrode pairs
consisting of opposing linear
electrodes located medially and
axially on the insulated inner
surface of each opposing jaw. | Same | | 9. | | Power Output | 28.5 W Max
Based on proprietary
algorithm which senses tissue
impedance. | 28.5 W Max
Based on proprietary algorithm
which 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. | Sterilization
and Other | Sterility Assurance
Level | 10-6 SAL | 10-6 SAL | Same | | 13. | | Biocompatibility | Meets requirements of ISO
10993 | Meets requirements of ISO
10993 | Same | | 14. | RF Generator | Generator | ASU / ASB | ASU/ASB OR MAG | Equivalent | | 15. | | Algorithm | G | G | Same | | 16. | | RF Frequency and
duration | 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 Transpolar
Pen (MAX1/5) | Proposed - Isolator Transpolar
Pen (MAX1/5) with ASU/ASB or
MAG | Equivalence
Comparison | |-----|----------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | 1. | General
Information | 510K reference | K192125 | K221358 | N/A | | 2. | General
Information | Device Classification
/ Product Code | Class II,
21 CFR § 878.4400
OCL | Class II,
21 CFR § 878.4400
OCL | Same | | 3. | General
Information | Intended Use | The Isolator Transpolar Pen is a
sterile, single use electrosurgery | The Isolator Transpolar Pen is a
sterile, single use electrosurgery | Equivalent -
Adjusted | | | | | device intended to ablate cardiac
tissue during cardiac surgery
using radiofrequency (RF)
energy when connected directly
to the ASU or to the ASU Source
Switch in Ablation mode.
When the Pen is connected to
the ASU Source Switch in
Auxiliary mode, it may be used
for temporary cardiac sensing,
recording, stimulation, and
temporary pacing during the
evaluation of cardiac
arrhythmias. | 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. | language to
align with
AtriCure's
other RF
devices. | | 4. | | Contraindication | The device is not intended for
contraceptive tubal coagulation
(permanent female
sterilization).
Do not ablate directly on cardiac
valves. | The device is not intended for
contraceptive tubal coagulation
(permanent female sterilization).
Do not ablate directly on cardiac
valves. | Same | | 5. | Device
Construction | Ablating Element
Length | 8mm | 8mm | Same | | 8. | Device
Construction | 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. | Sterilization
and Other | Sterility Assurance
Level | 10-6 SAL | 10-6 SAL | Same | | 12. | Sterilization
and Other | Biocompatibility | Meets requirements of ISO
10993 | 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 and
duration | 15W for 40s | 15W for 40s | Same | {18}------------------------------------------------ {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 | Equivalence
Comparison | |-----|----------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | 1. | | 510K reference | K192125 | K221358 | N/A | | 2. | | Device
Classification/
Product Code | Class II,
21 CFR § 878.4400
OCL | Class II,
21 CFR § 878.4400
OCL | Same | | 3. | General
Information | Intended Use | 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 or to the ASU
Source Switch 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 linear pen is a sterile,
single use electrosurgery device
intended to ablate cardiac tissue
during cardiac surgery using
radiofrequency (RF) energy 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. | Equivalent -
Adjusted
language to
align with
AtriCure's
other RF
devices. | | 4. | | Contraindication | The device is not intended for
contraceptive tubal coagulation
(permanent female
sterilization).
Do not ablate directly on cardiac
valves. | The device is not intended for
contraceptive tubal coagulation
(permanent female sterilization).
Do not ablate directly on cardiac
valves. | Same | | 5. | Device
Construction | Ablating Element
Length | 20 mm | 20 mm | Same | | 6. | | Electrode Number | 4 total: 2 ablation and 2 for
pacing / sensing | 4 total: 2 ablation and 2 for pacing
/ sensing | Same | | 10. | | Packaging | Tyvek Pouch with HDPE insert
card | Tyvek Pouch with HDPE insert
card… --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K221358](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K221358) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com