(157 days)
Not Found
No
The summary describes a mechanical and electrosurgical clamp and guide system with no mention of AI or ML capabilities.
Yes
The device is intended to ablate cardiac tissue during surgery, which is a therapeutic intervention.
No.
Explanation: The device is described as an electrosurgical instrument intended to ablate cardiac tissue during surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical hardware components (clamp, guide, handle, jaws, shaft, magnetic attachment ends) and the performance studies include bench testing of these physical attributes (mechanical, electrical safety, biocompatibility, etc.). There is no mention of software as the primary or sole component.
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 therapeutic procedure performed directly on the patient's tissue, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device is described as an "electrosurgical instrument" and a "surgical accessory" used to facilitate surgical procedures. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AtriCure Isolator Synergy EnCompand Guide system is intended to ablate cardiac tissue during surgery.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
The CLAMP is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms.
The GUIDE is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The GUIDE has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the CLAMP jaws inside the jaw magnet cups.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing as identified in Section VI, was conducted and confirmed that the difference in technological characteristics between the Isolator Synergy EnCompass Clamp and Guide and the predicate Isolator Synergy Dual Electrode do not affect safety and effectiveness of the device.
Non-clinical Performance Testing:
- Mechanical Testing
- Ex vivo Ablation Comparison Testing
- . Reliability Testing
- . External Surface Temperature Testing
- . GLP Animal Study
- Biocompatibility Testing
- Shelf Life Testing
- . Electrical Safety Testing
The Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared Isolator Synergy Dual Electrode Clamp (EMR2/EML2). No new safety or performance issues were raising during testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA acronym and name are written in blue.
July 26, 2021
AtriCure, Inc. Melissa Smallwood Manager, Regulatory Affairs 7555 Innovation Way Mason, Ohio 45040
Re: K210477
Trade/Device Name: Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: June 21, 2021 Received: June 21, 2021
Dear Melissa Smallwood:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 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
2
Indications for Use
510(k) Number (if known) K210477
Device Name
Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) 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)
× 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 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 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: | Melissa Smallwood, MHA
Manager, Regulatory Affairs |
| Alternate Contact: | Jonathan McElwee, RAC
Sr. Manager, Regulatory Affairs |
| Date Prepared: | 07/22/2021 |
| II.
Device Information | |
| Proprietary Name: | Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100)
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: Cardiovascular |
lll. Device Description
The CLAMP is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The AtriCure Isolator clamps feature an in-line handle with syringe-type actuation and button release mechanisms.
The GUIDE is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The GUIDE has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the CLAMP jaws inside the jaw magnet cups.
IV. Intended Use/ Indications for Use
The AtriCure Isolator Synergy EnCompand Guide system is intended to ablate cardiac tissue during surgery.
4
V. Comparison of Technological Characteristics
The science and fundamental technology of the Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) in comparison to the predicate Isolator Synergy Dual Electrode Clamp (EMR2/EML2), cleared per K110117, remain the same and include a longer jaw in comparison to the predicate to allow for surgeon preference and body habitus.. A comparison of the Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) technological characteristics as compared to the predicate Isolator Synergy Dual Electrode Clamp (EMR2/EML2) are provided in Table 1 below:
| Feature | Predicate (K110117) Isolator Synergy
Dual Electrode Clamp (EMR/ EML2) | Subject Isolator Synergy
EnCompass Clamp (OLH, OSH) and
Guide (GPM100) | Equivalence
Comparison |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary
Name | Isolator Synergy Dual Electrode Clamp | Isolator Synergy EnCompass Clamp
and Guide | N/a |
| Model
Numbers | EMR2, EML2 | OLH, OSH | N/a |
| Indications for
Use | The ATRICURE Bipolar (Transpolar)
System is intended to ablate cardiac
tissue during surgery. | The Isolator Synergy EnCompass
Clamp and Guide system is intended
to ablate cardiac tissue during
surgery. | Same |
| Device
Description in
Instructions for
Use | The AtriCure ISOLATOR Synergy
Surgical Ablation System is comprised
of the Ablation
and Sensing Unit (ASU), an AtriCure
ISOLATOR Synergy device, and a
footswitch. The
ISOLATOR is a single patient use
electrosurgical instrument designed for
use only with the
ASU. The ISOLATOR is used for
cardiac tissue ablation. When activated,
the ASU delivers
radiofrequency (RF) energy to the linear
electrodes on the insulated jaws of the
ISOLATOR.
The Operator controls the application of
this RF energy by pressing the
Footswitch.
All ISOLATOR Synergy devices are
configured as vascular clamps and
feature
clamping jaws of various lengths and
curvatures.
The AtriCure ISOLATOR Synergy
Clamps feature an in-line handle with
syringe-type actuation and button
release mechanisms. The Guide is
packaged with
ISOLATOR devices that have the
Attachment Tip.
The GLIDEPATH™ Tape Instrument
Guide is a single patient, surgical device
designed | The CLAMP is a single-use
electrosurgical instrument offered in
two configurations: standard length
jaws (OSH), and long length jaws
(OLH). All Isolator devices are
configured as vascular clamps and
feature clamping jaws of various
lengths and curvatures. The AtriCure
Isolator clamps feature an in-line
handle with syringe-type actuation
and button release mechanisms.
The GUIDE is a single-use surgical
accessory designed to facilitate the
guidance of surgical instruments
through tissue during cardiothoracic
surgical procedures. The GUIDE has
a flexible, malleable shaft, and
magnetic attachment ends that
connect to the metal tip of the
CLAMP jaws inside the jaw magnet
cups. | Similar,
added
reference to
OSH, OLH,
and
GPM100.
Removed
reference to
EMR2,
EML2.
The Isolator
Synergy
EnCompass
Clamp and
Guide have
the same
intended use
as the
predicate
Isolator
Synergy
Dual
Electrode
Clamp. |
| | to facilitate the guidance of surgical
instruments through soft tissue during
general
surgical procedures. | | |
| Clamp Design | Vascular clamps featuring
clamping jaws with left and right
curvature, designed with parallel closure
throughout clamping motion. | Vascular clamps featuring
clamping jaws of various lengths,
designed with lengthened end
effector, and hinge to parallel closure
in range of tissue clamping as
compared to predicate. | Similar,
orientation
and length
modifications
provide
additional
options
based on
patient body
habitus and
surgeon
preference. |
| Positioning /
Guide | Glidepath Tape (GPT100) | Glidepath Magnetic (GPM100) | Similar,
GPM100
guide
supports
positioning
of the clamp
using
magnetic
tips as
compared to
snap fit
feature. |
| Generator/RF
Energy | Bipolar radiofrequency energy
generated by ASU2 | Bipolar radiofrequency energy
generated by ASU2 | 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
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Image /page/5/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The first four letters, "Atri", are in blue, while the last four letters, "Cure", are in orange. The dot in the "i" is also orange, and there is a small circled "R" symbol next to the "e".
Performance testing as identified in Section VI, was conducted and confirmed that the difference in technological characteristics between the Isolator Synergy EnCompass Clamp and Guide and the predicate Isolator Synergy Dual Electrode do not affect safety and effectiveness of the device.
6
VI. Performance Data
The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence of the Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) to the previously cleared lsolator Synergy Dual Electrode Clamp (EMR2/EML2). The Isolator Synergy EnCompass Clamp (OLH, OSH) and Guide (GPM100) met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared lsolator Synergy Dual Electrode Clamp (EMR2/EML2). No new safety or performance issues were raising during testing.
Non-clinical Performance Testing:
- Mechanical Testing
- Ex vivo Ablation Comparison Testing
- . Reliability Testing
- . External Surface Temperature Testing
- . GLP Animal Study
- Biocompatibility Testing ●
- Shelf Life Testing ●
- . Electrical Safety Testing
VII. Conclusions
AtriCure has demonstrated that the modifications made to the Isolator Synerqy EnCompass Clamp (OLH, OSH) and Guide (GPM100) are 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 Dual Electrode Clamp (EMR2/EML2/EMT) per K110117.