(28 days)
Not Found
No
The device description and performance studies focus on electrosurgical ablation and mechanical components, with no mention of AI or ML.
Yes
The device is intended to ablate cardiac tissue during surgery, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is described as an ablation system intended to ablate cardiac tissue during surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including an Ablation and Sensing Unit (ASU), AtriCure Switch Matrix (ASB), the AtriCure Isolator Synergy device (a physical electrosurgical instrument/clamp), and a footswitch. It also mentions a Glidepath Tape Guide, which is a physical surgical device. This is not a software-only device.
Based on the provided information, the AtriCure Isolator® Synergy™ Surgical Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "ablate cardiac tissue during surgery." This is a direct surgical intervention on living tissue within the body.
- Device Description: The device is described as an "electrosurgical instrument" that delivers radiofrequency energy to ablate tissue. This is a therapeutic device used for treatment, not for analyzing samples outside the body.
- Anatomical Site: The device is used on "cardiac tissue," which is part of the living organism.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
In summary, the AtriCure Isolator Synergy Surgical Ablation System is a surgical device used for therapeutic purposes within the body, which is the defining characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The AtriCure Isolator® Synergy™ Surgical Ablation System is intended to ablate cardiac tissue during surgery.
Product codes
OCL
Device Description
The AtriCure Isolator Synergy Surgical Ablation System is comprised of the Ablation and Sensing Unit (ASU), AtriCure Switch Matrix (ASB), an AtriCure Isolator Synergy device, and a footswitch. The AtriCure Isolator Synergy device is a single-patient use, electrosurgical instrument designed for use only with the ASU.
The AtriCure Isolator Synergy clamp is used for cardiac tissue ablation. When activated, the ASU delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the AtriCure Isolator Synergy Clamp. The Operator controls the application of this RF energy by pressing the Footswitch.
All AtriCure Isolator Synerqy devices are configured as vascular clamps and feature clamping jaws of various lengths, curvatures and apertures; rounded jaw tips, and cables that plugs into the ASB switch matrix and ASU RF generator.
The AtriCure Isolator Synergy Clamps features two pairs of opposing dual electrodes, an in-line handle with syringetype grip handle/ actuation and button release mechanisms.
There is a Glidepath™ Tape Guide that is a single-patient use, detachable, surgical device the guidance of surgical instruments through soft tissue during general surgical procedures. The Guide is package with ISOLATOR devices that have the Attachment Tip.
The Glidepath Tape Instrument Guide is a single-patient use, surgical device designed to facilitate the guidance of surgical instruments through soft tissue during general surgical procedures.
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
surgery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing confirmed that the Isolator Synergy Clamps meets the same requirements for safety and efficacy as the predicate Isolator Synergy Clamp.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 28, 2021
AtriCure, Inc. Jon McElwee Senior Manager, Regulatory Affairs 7555 Innovation Wav Mason, Ohio 45040
Re: K211311
Trade/Device Name: AtriCure Isolator® Synergy™ Surgical Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: April 27, 2021 Received: April 30, 2021
Dear Jon McElwee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211311
Device Name
AtriCure Isolator® Synergy™ Surgical Ablation System
Indications for Use (Describe)
The AtriCure Isolator Synergy Surgical Ablation System is intended to ablate cardiac tissue during surgery.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The letters "A," "t," "r," and "i" are in blue, while the "C," "u," "r," and "e" are in orange. There is a blue dot above the "i" and inside the "C." There is a registered trademark symbol next to the "e".
510(k) Summary
l. Applicant Information
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason, Ohio 45040
P: 513-498-5067
F: 513-895-9013 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jonathan McElwee, RAC
Sr. Manager, Regulatory Affairs |
| Alternate Contact: | Mary Galeano
Sr Regulatory Affairs Specialist |
| Date Prepared: | 04/29/2021 |
| II.
Device Information | |
| Proprietary Name: | AtriCure Isolator® Synergy™ Surgical Ablation System |
| Common Name: | Cardiac Radio Frequency Ablation System Clamps |
| Classification: | Electrosurgical cutting and coagulation device and accessories
Regulatory Class: Class II; per 21 CFR 878.4400
Product Code: OCL
Classification Panel: Card ovascular |
lll. Device Description
The AtriCure Isolator Synergy Surgical Ablation System is comprised of the Ablation and Sensing Unit (ASU), AtriCure Switch Matrix (ASB), an AtriCure Isolator Synergy device, and a footswitch. The AtriCure Isolator Synergy device is a single-patient use, electrosurgical instrument designed for use only with the ASU.
The AtriCure Isolator Synergy clamp is used for cardiac tissue ablation. When activated, the ASU delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the AtriCure Isolator Synergy Clamp. The Operator controls the application of this RF energy by pressing the Footswitch.
All AtriCure Isolator Synerqy devices are configured as vascular clamps and feature clamping jaws of various lengths, curvatures and apertures; rounded jaw tips, and cables that plugs into the ASB switch matrix and ASU RF generator.
The AtriCure Isolator Synergy Clamps features two pairs of opposing dual electrodes, an in-line handle with syringetype grip handle/ actuation and button release mechanisms.
There is a Glidepath™ Tape Guide that is a single-patient use, detachable, surgical device the guidance of surgical instruments through soft tissue during general surgical procedures. The Guide is package with ISOLATOR devices that have the Attachment Tip.
The Glidepath Tape Instrument Guide is a single-patient use, surgical device designed to facilitate the guidance of surgical instruments through soft tissue during general surgical procedures.
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NOTE: Please refer to the AtriCure ASU2 and ASB3 Instructions for information specific to the ASU2 and ASB3.
IV. Indications for Use
The AtriCure Isolator Synergy Surgical Ablation System is intended to ablate cardiac tissue during surgery.
V. Comparison of Technological Characteristics (Isolator Synergy Clamp -K110117)
This submission included modifications to allow for an alternate end effector design change to an overmold configuration. The science and fundamental technology of the Isolator Synergy Clamps (EMR2) in comparison to the predicate Isolator Synergy Clamp (EMR2, EML2), cleared per K110117, remain the same. Performance testing confirmed that the Isolator Synergy Clamps meets the same requirements for safety and efficacy as the predicate Isolator Synergy Clamp.
Table 1: Device Comparison
| # | Category | Feature/Item | Current - Isolator
Synergy Clamps
(EMR2, EML2) | Proposed Isolator
Synergy Clamps
(EMR2, EML2) | Equivalence
Comparison |
|----|------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------|
| 1 | | Manufacturer | AtriCure, Inc. | AtriCure, Inc. | Same |
| 2 | | Product Name | Isolator Synergy Clamp
with Glidepath soft
guide | Isolator Synergy Clamp
with Glidepath soft
guide | Same |
| 3 | | 510(k) and Past
Submission
References | K110117 | K211311 | N/A |
| 4 | | Device
Classification /
Product Code | Class II,
21 CFR § 878.4400
OCL | Class II,
21 CFR § 878.4400
OCL | Same |
| 5 | | Model Number | EMR2, EML2 | EMR2, EML2 | N/A |
| 6 | General
Information | Indications for Use | The System is
intended for the
ablation of cardiac
tissue during surgery. | The System is
intended for the
ablation of cardiac
tissue during surgery. | Same |
| 7 | | Contraindication | The Bipolar
(Transpolar) System is
not indicated for
contraceptive
coagulation of the
fallopian tubes. | The Bipolar
(Transpolar) System is
not indicated for
contraceptive
coagulation of the
fallopian tubes. | Same |
| 8 | | Device Description | Electrosurgical Bipolar
RF Clamp and optional
accessory (Class I)
instrument guide | Electrosurgical Bipolar
RF Clamp and optional
accessory (Class I)
instrument guide | Same |
| 9 | | Generator
Description/
Energy Source | RF Generator –
Ablation and Sensing
Unit and Source Switch
Matrix
(ASU2, ASB3) | RF Generator –
Ablation and Sensing
Unit and Source Switch
Matrix
(ASU2, ASB3) | Same |
| 10 | | Accessory/
Positioning Guide | Product Name:
Glidepath Tape
Materials: Santoprene
8000 Thermoplastic
Rubber with Ultem pins | Product Name:
Glidepath Tape
Materials: Santoprene
8000 Thermoplastic
Rubber with Ultem pins | Same |
5
| # | Category | Feature/Item | Current - Isolator
Synergy Clamps
(EMR2, EML2) | Proposed Isolator
Synergy Clamps
(EMR2, EML2) | Equivalence
Comparison |
|----|----------------------------|--------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------|
| | | End Effector
Design | Non-overmolded design
with ABS resin
MG37EP | Overmolded design
with ABS resin
MG37EPX | Equivalent |
| 11 | Performance | Ablation
Performance -
Transmurality | Transmural lesions | Transmural lesions | Same |
| 12 | | Ablation
Performance -
Lesion Width | Lesions tightly confined
to the region between
the opposing insulated
jaws. | Lesions tightly confined
to the region between
the opposing insulated
jaws. | Same |
| 13 | Sterilization
and Other | Sterilization Site | EO | EO | Same |
| 14 | | Packaging | PETG blister with
Tyvek® lid | PETG blister with
Tyvek® lid | Same |
| 15 | | Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| 16 | | Sterility Assurance
Level | 10-6 SAL | 10-6 SAL | Same |
| 17 | | Biocompatibility | Meets requirements of
ISO 10993 | Meets requirements of
ISO 10993 | Same |
| 18 | | Shelf Life | 3 year | 3 year | Same |
| 19 | | Pyrogen | Non-pyrogenic | Non-pyrogenic | Same |
| 20 | | Latex | Not made with natural
rubber latex | Not made with natural
rubber latex | Same |
| 21 | | Software | No software in the
clamp | No software in the
clamp | Same |
VI. Performance Data
A review of the risk analysis concluded there is not overall change to the risk profile of the proposed AtriCure Isolator Synergy clamps versus the previously cleared AtriCure Isolator Synergy clamps as the modifications to the proposed AtriCure Isolator Synergy do not add or remove any features of the device or change the clinical application.
The proposed changes do not include any change to design or performance specifications of the AtriCure Isolator Synergy clamps. Additionally, the proposed changes did not modify the intended use, therefore the previously submitted bench and animal data remain valid for the AtriCure Isolator Synergy clamps.
The following consensus standards were leveraged in this submission:
- ISO 10993-1
- IEC 60601-2-2
- . ASTM E1952-11
- ISO 11607-2
- AAMI TIR 28
Biocompatibility Testing
The biocompatibility evaluation is in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. Data collected from the following tests support this change:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- . Acute Systemic Toxicity
- . Material Mediated Pyrogenicity
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Image /page/6/Picture/0 description: The image shows the logo for AtriCure. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot in the middle of the "C" in "Cure". There is a registered trademark symbol next to the word "Cure".
VII. Conclusions
AtriCure has demonstrated that the modifications made to the Isolator Synergy Clamp (EMR2, EML2) are substantially equivalent in intended use/indication for use as the previously cleared Isolator Synergy Clamp (EMR2, EML2) per K110117.