The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, and laparoscopic surgical techniques.

The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.

Device Description

The EPi-Sense Guided Coagulation System flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical RF Generator (nonsterile, re-useable) connected through an Instrument Cable (sterile). The device is designed to produce local tissue heating which results in coagulation of cardiac tissue. A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile).

The Subtle Cannula is a sterile, single-use access tool used to introduce the EPi-Sense probe into the chest cavity. The cannula is a 30 cm or 40 cm long device with a large central lumen to accommodate both the EPi-Sense probe and a commercially available laparoscope for visualization. The cannula is comprised of a distal tip, a shaft with a textured grip at the proximal end, a vacuum line and an integrated quidewire.

The Sensing Cable is a reusable, non-sterile cable that provides connection for the sensing electrodes of the EPi-Sense probe to a commercially available external electrogram recording system.

The Subtle Cannula and Sensing Cable are accessories to the EPi-Sense Guided Coagulation System.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EPi-Sense Guided Coagulation System with VisiTrax:

Summary of Device and Changes:

The device in question is the EPi-Sense Guided Coagulation System with VisiTrax. The submission (K193162) is for modifications to two accessories: the Sensing Cable and the Subtle Cannula. The core EPi-Sense system itself (and its intended use) remains unchanged from its previously cleared version (K142084).

Acceptance Criteria and Device Performance (Based on the provided text):

The document states that the modified devices met "the new and existing predetermined acceptance criteria." However, it does not explicitly list the specific acceptance criteria or the reported device performance metrics in a quantitative manner. Instead, it refers to general categories of testing and compliance.

Since specific criteria and metrics are not provided in the text, a table can only indicate the categories of testing performed and the general outcome.

Acceptance Criteria Category	Reported Device Performance (General Statement)
Mechanical Performance	Demonstrated equivalency to predicate device.
System Compatibility	Demonstrated equivalency to predicate device.
Compliance to IEC 60601-2-2	Was met.
Safety and Effectiveness	No new issues raised.
Conformance to Design Controls and Specifications	Verified.

Detailed Study Information:

Based on the provided text, the study conducted was a design verification and validation testing for modifications made to existing accessories (Sensing Cable and Subtle Cannula) of a previously cleared device. It was not a standalone performance study of the entire system or a multi-reader, multi-case comparative effectiveness study.

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Mechanical design verification testing" but does not quantify the number of units or tests performed.
- Data Provenance: The study was internal, conducted "per AtriCure's Quality System." There is no mention of country of origin for data or whether it was retrospective or prospective in the sense of patient data. This appears to be engineering verification testing rather than clinical study data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a technical design verification study, not a clinical study involving expert interpretation of data or images. Ground truth, in this context, would be engineering specifications and standards, not clinical consensus.
Adjudication method for the test set:
- Not applicable for this type of technical verification testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states, "No changes were made in operating principle, or specifications of performance" for the core device. The testing focused on demonstrating that the modifications to the accessories did not negatively impact mechanical performance or system compatibility, and that the device still complied with a relevant electrical safety standard (IEC 60601-2-2). There is no mention of AI, human readers, or clinical effectiveness studies in this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the sense that the testing was focused on the components themselves, independent of direct clinical human-in-the-loop interaction for performance evaluation. However, it's not an "algorithm-only" study as the device is a physical electrosurgical system, not a software algorithm in the typical sense of AI/ML. The "standalone" here refers to the device being tested against specifications.
The type of ground truth used:
- Engineering specifications, design controls, and recognized standards (e.g., IEC 60601-2-2). The goal was to demonstrate conformance to these predefined technical requirements and equivalency to the previously cleared predicate device's mechanical and system compatibility characteristics.
The sample size for the training set:
- Not applicable. This was design verification for hardware modifications, not an AI/ML model for which a "training set" would typically be used.
How the ground truth for the training set was established:
- Not applicable, as there was no training set in the context of an AI/ML algorithm.

Summary

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December 16, 2019

AtriCure, Inc. Caitlin Wunderlin Regulatory Affairs Specialist 7555 Innovation Wav Mason, Ohio 45040

Re: K193162

Trade/Device Name: EPi-Sense Guided Coagulation System with VisiTrax Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OCL Dated: November 14, 2019 Received: November 15, 2019

Dear Caitlin Wunderlin:

This letter corrects our substantially equivalent letter sent on December 13, 2019.

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 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

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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 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,

Nicole M. Gillette -S

Nicole Gillette Acting Assistant Director 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) K193162

Device Name

EPi-Sense Guided Coagulation System with VisiTrax

Indications for Use (Describe)

The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, and laparoscopic surgical techniques.

The EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the AtriCure logo. The logo is in two colors, blue and orange. The word "Atri" is in blue, while 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 to the right of the word "Cure".

510(k) Summary

l. Applicant Information

Manufacturer:	AtriCure®, Inc.7555 Innovation WayMason, Ohio 45040P: 513-755-4100
Contact Person:	Caitlin WunderlinRegulatory Affairs Specialist
Alternate Contact:	Jonathan McElweeSr. Manager, Regulatory Affairs
Date Prepared:	14 November 2019

II. Device Information

Proprietary Name:	EPi-Sense Guided Coagulation System with VisiTrax®
Common Name:	Guided Coagulation System
Classification:	Surgical device for cutting, coagulation, and/or ablation of tissue,including cardiac tissueRegulatory Class: Class II; per 21 CFR 878.4400Product Code: OCLClassification Panel: Cardiovascular
Predicate Device:	EPi-Sense Guided Coagulation System with VisiTrax(K142084, 28 October 2014)

lll. Device Description

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Atril.

The Sensing Cable is a reusable, non-sterile cable that provides connection for the sensing electrodes of the EPi-Sense probe to a commercially available external electrogram recording system.

The Subtle Cannula and Sensing Cable are accessories to the EPi-Sense Guided Coagulation System.

IV. Indications for Use

The EPi-Sense Guided Coaqulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, and laparoscopic surgical techniques.

The EPi-Sense Guided Coaqulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.

V. A. Device Changes From Predicate

The changes for the CSK-2030 Sensing Cable include:

Overmolded strain reliefs
o Overmolded yoke
In-line receptacle ●
In-line receptacle strain relief .

The changes for the Subtle Cannula include:

Shortened shaft and internal spring ●
Lengthened molded tip ●
Added lumens and NiTi wires ●
. Shortened stainless steel wires

B. Comparison of Technological Characteristics

. The devices include the same intended use, and;
No changes were made in operating principle, or specifications of performance, and; .
The biocompatibility remains unchanged, and;
The results of the verification and validation testing: ●
- Demonstrated equivalency in mechanical performance and system compatibility o
- Compliance to IEC 60601-2-2 was met o
- Did not raise any new issues of safety or effectiveness ೧

VI. Performance Data

Mechanical design verification testing was completed per AtriCure's Quality System to verify the device's conformance to appropriate design controls and specifications to demonstrate equivalence to the previously cleared Sensing Cable and Subtle Cannula devices. The modified devices met the new and existing predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K142084 cannula device. No new safety or performance issues were raising during testing.

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AtriCure®

VII. Conclusions

AtriCure demonstrated that the EPi-Sense Guided Coagulation System with modified Sensing Cable and Subtle Cannula is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principle, and intended use/ indication for use as the previously cleared EPi-Sense Guided Coagulation System via K142084 on 28 October 2014.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.