(242 days)
EMR2, EML2
No
The device description and performance studies focus on mechanical, electrical, and biological aspects of a surgical clamp, with no mention of AI or ML algorithms, data processing, or related performance metrics.
Yes
The device is described as an electrosurgical instrument intended to ablate cardiac tissue during surgery, which is a therapeutic action.
No
The device description and intended use state that it is an electrosurgical instrument used to ablate cardiac tissue during surgery, which is a therapeutic function, not diagnostic.
No
The device description clearly details a physical electrosurgical instrument (clamp) that delivers RF energy for tissue ablation. The performance studies also focus on hardware-related testing (mechanical, electrical safety, biocompatibility, animal studies). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ablate cardiac tissue during surgery." This is a surgical procedure performed on a living patient, not a test performed on a sample taken from a patient (which is the definition of an in vitro diagnostic).
- Device Description: The device is an electrosurgical instrument used to deliver RF energy to tissue. This is consistent with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for therapeutic use during surgery, not for diagnostic testing outside of the body.
N/A
Intended Use / Indications for Use
The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.
Product codes
OCL
Device Description
The AtriCure Isolator Synergy EnCapture Clamp (referred to hereafter as CLAMP) is a single patient use electrosurgical instrument designed for use with an AtriCure RF GENERATOR. The CLAMP is used for cardiac tissue ablation. When activated, the GENERATOR delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch. The CLAMP features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. The device outer and ablative faces of the distal jaw segments have textured surfaces to increase the engagement between the jaw face and the cardiac tissue. The CLAMP is compatible with the Gidepath Tape Instrument (hereafter known as GUIDE), that is designed to attach to the fixed jaw of the CLAMP with a half turn attachment end connection. The GUIDE is a single-patient, optional component designed to facilitate the guidance of the CLAMP around target tissue during general surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical Performance Testing:
- Mechanical Testing
- Ex vivo Ablation Comparison Testing
- Reliability Testing
- External Surface Temperature Testing
- In-Vivo GLP Animal Study
- Biocompatibility Testing
- Shelf-Life Testing
- Electrical Safety Testing & Electromagnetic Compatibility (EMC)
Mechanical Testing:
- Jaw Aperture Testing
- Clamp Force Testing
- Handle Closure Force Testing
In Vivo GLP Animal Study:
Study type: 7-day subacute animal study
Sample size: 12 pigs (6 for predicate device, 6 for subject device)
Key results: There were no procedure related complications attributed to the control or subject device. The pigs were evaluated 7 days post-op for evidence of conduction block and evidence effects. Macroscopic and microscopic analysis was performed to complete pathology endpoints. Results demonstrated the Isolator Synergy EnCapture Ablation System (EMH) can create transmural lesions on intended cardiac structures in a substantially equivalent manner as compared to the predicate Isolator Synergy Surgical Ablation System (EMR2/EML2).
Biocompatibility Testing:
Study type: Biocompatibility evaluation in accordance with ISO 10993-1:2018
Key results: No new or increased biocompatibility risks; complies with ISO 10993-1:2018.
Electrical Safety Testing & Electromagnetic Compatibility (EMC):
Key results: The system complies with IEC 60601-1:2005+A1:2012+A2:2020 Ed. 3.2 and IEC 60601-1-2:2014+A1:2020. The Isolator Synergy EnCapture Clamp (EMH) met predetermined acceptance criteria; no new safety or performance issues were raised.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. The FDA logo is in blue.
August 27, 2024
AtriCure Inc. Dominique Neisz Manager, Regulatory Affairs 7555 Innovation Way Mason, Ohio 45040
Re: K234151
Trade/Device Name: AtriCure Isolator Synergy EnCapture Ablation System (EMH) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: August 7, 2024 Received: August 7, 2024
Dear Dominique Neisz:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality
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Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
AtriCure Isolator Synergy EnCapture Ablation System (EMH)
Indications for Use (Describe)
The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The first three letters, "Atri", are in blue, while the last four letters, "Cure", are in orange. The "C" in "Cure" is designed with a blue dot in the middle, and there is a small circled "R" symbol to the right of the word.
510(k) Summary
1. Applicant Information
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason, Ohio 45040
P: 513-498-5067
F: 513-895-9013 | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Dominique Neisz
Manager, Regulatory Affairs | |
| Alternate Contact: | Jim Taufen
Director, Regulatory Affairs | |
| Date Prepared: | December 29th, 2023 | |
| | Device Information | |
| Proprietary Name: | AtriCure Isolator Synergy EnCapture Ablation System (EMH) | |
| Common Name: | Cardiac Radio Frequency Ablation System Clamp | |
| Classification: | Electrosurgical cutting and coagulation device and accessories
Regulatory Class: Class II; per 21 CFR 878.4400
Product Code: OCL
Classification Panel: Cardiovascular | |
| Predicate Device: | Isolator® Synergy™ Surgical Ablation System (EMR2/EML2)
(K211311, OCL, May 28th, 2021) | |
| Reference Device: | DeBakey Satinsky Atrauma Tangential Occlusion Clamp
(K123077, DXC, May 14th, 2013) | |
III. Device Description
The AtriCure Isolator Synergy EnCapture Clamp (referred to hereafter as CLAMP) is a single patient use electrosurgical instrument designed for use with an AtriCure RF GENERATOR. The CLAMP is used for cardiac tissue ablation. When activated, the GENERATOR delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch. The CLAMP features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. The device outer and ablative faces of the distal jaw segments have textured surfaces to increase the engagement between the jaw face and the cardiac tissue. The CLAMP is compatible with the Gidepath Tape Instrument (hereafter known as GUIDE), that is designed to attach to the fixed jaw of the CLAMP with a half turn attachment end connection. The GUIDE is a single-patient, optional component designed to facilitate the guidance of the CLAMP around target tissue during general surgical procedures.
IV. Intended Use/ Indications for Use
The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.
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V. Comparison of Technological Characteristics
The science and fundamental technology of the Isolator Synergy EnCapture Ablation System (EMH) in comparison to the predicate Isolator Synergy Surgical Ablation System (EMR2/EML2), cleared per K211311, remain the same and include an angled jaw in comparison to the predicate to allow for surgeon preference and body habitus. A comparison of the Isolator Synergy EnCapture Ablation System (EMH) technological characteristics as compared to the predicate Isolator Synergy Surgical Ablation System (EMR2/EML2) are provided in Table 1 below:
| Feature | Predicate (K211311) Isolator
Synergy Surgical Ablation
System (EMR2/EML2) | Subject Isolator Synergy
EnCapture Ablation System
(EMH) | Equivalence
Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | ATRICURE Bipolar
(Transpolar) System | AtriCure Isolator Synergy
EnCapture Ablation System
(EMH) | Same |
| Model Numbers | EMR2 | EMH | N/a |
| Indications for Use | The ATRICURE Bipolar
(Transpolar) System is
intended to ablate cardiac
tissue during surgery. | The AtriCure Isolator Synergy
EnCapture Clamp is intended
to ablate cardiac tissue during
surgery. | Same |
| Clamp Design | Clamps featuring
clamping jaws with left and right
curvature, designed with
parallel closure throughout
clamping motion. | Clamp featuring textured
clamping jaws designed with
right angled end effector, and
hinge to parallel closure in
range of tissue clamping as
compared to predicate. | Similar, orientation,
jaw geometry and
texture modifications
provide additional
options based on
patient body habitus
and surgeon
preference. |
| Positioning / Guide | Supplied with Glidepath Tape
Instrument Guide (GPT100) | Supplied separately,
compatible with Glidepath
Tape Instrument Guide
(GPT200) | Similar, GPT200 guide
supports positioning of
the clamp if desired by
user using half-turn
connection as
compared to snap fit
feature. |
| Generator/RF
Energy | Bipolar radiofrequency energy
generated by ASU2 or MAG | Bipolar radiofrequency
energy generated by ASU2 or
MAG | Same |
| Biocompatibility | Biocompatible patient
contacting materials per ISO
10993 | Biocompatible patient
contacting materials per ISO
10993 | Same |
| Packaging | PETG blister with Tyvek® lid | PETG blister with Tyvek® lid | Same |
| Sterilization | Ethylene Oxide SAL 10-6 | Ethylene Oxide SAL 10-6 | Same |
| Table 1: Comparison of Technological Characteristics | |
|---|---|
Performance testing was conducted and confirmed that the difference in technological characteristics between the lsolator Synergy EnCapture Ablation System (EMH) and the predicate Isolator System (EMR2/EML2) does not introduce different questions of safety and effectiveness. Inclusion of a textured surface on the subject device was supported by a reference device with textured jaws commonly used in cardiovascular procedures (DeBakey Satinsky Vascular Clamp).
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VI. Performance Data
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate substantial equivalence of the Isolator Synergy EnCapture Ablation System (EMH) to the previously cleared Isolator Synergy Surgical Ablation System (EMR2/EML2).
Non-clinical Performance Testing:
- Mechanical Testing
- . Ex vivo Ablation Comparison Testing
- Reliability Testing ●
- External Surface Temperature Testing ●
- In-vivo GLP Animal Study ●
- Biocompatibility Testing ●
- . Shelf-Life Testing
- . Electrical Safety Testing & Electromagnetic Compatibility (EMC)
Mechanical Testing
- Jaw Aperture Testing ●
- Clamp Force Testing ●
- Handle Closure Force Testing .
In Vivo GLP Animal Study
A 7-day subacute animal study was conducted. 12 pigs underwent median sternotomy and received ablations on targeting clinically relevant structures, 6 pigs were utilized for the use of the Isolator Syneray Surgical Ablation System (EMR2/EML2), while the remaining 6 pigs were ablated with the Isolator Synergy EnCapture Ablation System (EMH). There were no procedure related complications attributed to the control or subject device. The pigs were evaluated 7 days post-op for evidence of conduction block and evidence effects. In addition, macroscopic and microscopic analysis was performed to complete pathology endpoints of the study objective.
Results of the sub-acute animal study demonstrated the Isolator Synergy EnCapture Ablation System (EMH) can create transmural lesions on intended cardiac structures in a substantially equivalent manner as compared to the predicate Isolator Synergy Surgical Ablation System (EMR2/EML2).
Biocompatibility Testing
The biocompatibility evaluation of the Isolator Synergy EnCapture Clamp was conducted in accordance with ISO 10993-1:2018, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- . Irritation
- . Acute Systemic Toxicity
- Material Mediated Pyrogenicity .
The Isolator Synergy EnCapture Clamp is categorized as an externally communicating device with tissue and/or bone contact and limited duration (≤24 hours). Results demonstrated there were no new or increased biocompatibility risks and the Isolator Synergy EnCapture Clamp complies with ISO 10993-1:2018.
Electrical Safety Testing & Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the Isolator Synergy EnCapture Ablation System (EMH), consisting of the RF Handbiece and RF Generator. The system complies with IEC 60601-1:2005+A1:2012+A2:2020 Ed. 3.2 "General requirements for basic safety and essential performance" and IEC 60601-1-2:2014+A1:2020 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance."
The Isolator Synergy EnCapture Clamp (EMH) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared Isolator System (EMR2/EML2). No new safety or performance issues were raised during testing.
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Image /page/7/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The first three letters, "Atri", are in blue, while the rest of the word, "Cure", is in orange. There is a blue dot in the middle of the "C", and a small "R" in a circle to the right of the word.
VII. Conclusions
AtriCure has demonstrated that the Isolator Synergy EnCapture Ablation System (EMH) is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use / indication for use as the previously cleared Isolator Synergy Surgical Ablation System (EMR2/EML2) per K211311.