(28 days)
No
The document describes a radiofrequency ablation system and accessories, focusing on mechanical and electrical function for tissue coagulation and signal sensing. There is no mention of AI, ML, or any related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy, which is a therapeutic intervention aimed at treating a medical condition (e.g., cardiac arrhythmias).
No
The primary intended use of the device is for the coagulation of cardiac tissue. While it can also be used for "temporary cardiac signal sensing and recording during surgery when connected to an external recording device," this function appears to be an ancillary feature for surgical guidance rather than a standalone diagnostic purpose for disease detection or characterization. Its primary role is therapeutic (coagulation), with sensing as a supportive function during the therapeutic procedure.
No
The device description clearly outlines hardware components such as a flexible, cooled electrode device, an Electrosurgical RF Generator, instrument cables, and a cannula. It is a system that includes both hardware and potentially software for control or sensing, but it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the coagulation of cardiac tissue using RF energy and temporary cardiac signal sensing. This is a therapeutic and monitoring function performed directly on the patient's body.
- Device Description: The device is a surgical tool that delivers RF energy to tissue and can sense electrical signals from the heart. It is used during surgery.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis on specimens.
The device is clearly intended for use in vivo (within the living body) for surgical and monitoring purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
OCL
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.
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)
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.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
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 Way
Mason, Ohio 45040
P: 513-755-4100 |
|--------------------|--------------------------------------------------------------------------------|
| Contact Person: | Caitlin Wunderlin
Regulatory Affairs Specialist |
| Alternate Contact: | Jonathan McElwee
Sr. 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 tissue | |
| Regulatory Class: Class II; per 21 CFR 878.4400 | |
| Product Code: OCL | |
| Classification Panel: Cardiovascular | |
| Predicate Device: | EPi-Sense Guided Coagulation System with VisiTrax |
| (K142084, 28 October 2014) |
lll. 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.
4
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.