The EPi-Sense Guided Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, 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 with VisiTrax - generation 4 product) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). An optional 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).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the nContact Surgical, Inc. EPi-Sense Guided Coagulation System with VisiTrax. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and performance against them.

Therefore, the study described is primarily focused on demonstrating equivalence to existing predicate devices, not on proving that the device meets novel, independently established acceptance criteria through a clinical trial with a defined ground truth and expert consensus. The acceptance criteria in this context are implicitly met by demonstrating this equivalence through non-clinical testing.

Here's an analysis based on the information provided, highlighting why it doesn't fit the typical "acceptance criteria and study proving performance" structure you're looking for, but rather focuses on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria (e.g., sensitivity, specificity thresholds) for device performance in a clinical context, nor does it report specific performance metrics for such criteria. Instead, the "acceptance criteria" are implied by demonstrating equivalence to a predicate device, and the "performance" is judged by successful completion of non-clinical tests.

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (as demonstrated by non-clinical tests)
Biocompatibility as per ISO 10993	Successfully completed
Sterilization validation as per ISO 11137-2	Successfully completed
Reliability (shipping, accelerated aging)	Successfully completed
Tensile strength of critical bonds and joints	Successfully completed
Flexion fatigue	Successfully completed
Electrical integrity per IEC 60601-1-2	Successfully completed
Equivalent performance for coagulating cardiac tissue (in-vivo)	Successfully demonstrated
Equivalent performance for temporary cardiac signal sensing (in-vivo)	Successfully demonstrated
Tissue coagulation feature equivalence (in-vitro)	Successfully demonstrated
Device design features and specifications are equivalent to predicate devices	Verified through design controls and testing
No substantial changes or modifications affecting safety or efficacy compared to predicate devices	Verified through design controls and testing

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical testing (bench and in-vivo pre-clinical testing). There is no mention of human clinical trial data, and therefore no "test set" in the sense of patient data.

Sample Size for Test Set: Not applicable, as no human clinical test set data is described.
Data Provenance: Not applicable, as no human clinical test set data is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as no human clinical test set data or ground truth established by experts for such data is described. The "ground truth" for the non-clinical tests would be the established performance of the predicate device and the design specifications.

4. Adjudication Method for the Test Set:

Not applicable, as no human clinical test set data is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or described. The submission is for a medical device (surgical system) used for coagulation and sensing, not for an imaging or diagnostic AI device that would typically involve an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a surgical instrument where human interaction is integral to its function. Its "performance" is inherently tied to its use by a human surgeon or clinician. There is no isolated algorithm being evaluated for standalone performance.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by:

Predicate Device Performance: The primary ground truth is the established safety and effectiveness profile of the legally marketed predicate devices.
Design Specifications: The device's design specifications serve as a benchmark for bench testing.
ISO and IEC Standards: Compliance with relevant international standards (e.g., ISO 10993, ISO 11137-2, IEC 60601-1-2) defines successful performance in those areas.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware system, not an AI/ML model that requires a "training set" of data in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as above.

Summary

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· ·

nContact Surgical, Inc.
Coagulation System Device Modification
K120857 – EPi-Sense

510(k) Summary:

Application Date:	March 19, 2012
Date Summary Revised:	September 25, 2012
Sponsor:	nContact Surgical, Inc.1001 Aviation Parkway, Suite 400,Morrisville, NC 27560
Establishment RegistrationNumber:	3006142617
Correspondent:	Jane RicuperoVP of Regulatory & Quality1001 Aviation Parkway, Suite 400,Morrisville, NC 27560
Contact Numbers:	Phone: 919 655-1355Fax: 919 655-1690E-mail: jricupero@ncontactinc.com
Device Proprietary Name(s):	EPi-SenseTM Guided CoagulationSystem with VisiTrax®Model numbers: CDK-1411; CDK-1412; CDK-1413
Device Common Name:	Electrosurgical device andaccessories
Device Classification:	21 CFR 878.4400Class II
Product Code:	OCL
Classification Name:	Electrosurgical cutting andcoagulation device and accessories
Predicate Device #1(for coagulation function)	Numeris Guided Coagulation Systemwith VisiTrax, Model numbers: CSK-121, CSK-122, CSK-123, CSK-125
Predicate Device #2(for sensing function)	K090202 cleared Feb. 17, 2009Estech COBRA Adhere XL 2
	K113475 cleared Mar. 20, 2012

Section 5 - Summary Sept. 25, 2012 Page 5-1 of 5-3

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Device Description:

Indications for Use:

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, endoscopic, 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 a temporary external recording device.

Comparison to Predicate Device and Summary of Technological Characteristics:

The nContact EPi-Sense System has the identical intended use and technological characteristics as the predicate nContact Numeris System for the coagulation function. The sensing function is considered equivalent to the stated predicate #2 for temporary cardiac signal sensing and recording when connected to a temporary external recording device.

The nContact Coagulation System combines design features of marketed predicate devices. The design features of the subject device are the same as or fall within ranges specified by the predicate devices. The dimensional parameters, materials, generator specifications, and design specifications are covered within the ranges offered by predicate devices. Shared features include:

All devices (subject and predicate) rely on transmitting radiofrequency . energy through electrodes to achieve the intended coagulation use.
Electrode design is identical to predicate #1. ●
Perfusion feature is identical to predicate #1. .
Suction feature is identical to predicate #1. .
RF Generator energy levels, software revision and hardware are . identical to predicate #1.
. Temporary cardiac signal sensing feature is similar the function in predicate #2.

Section 5 - Summary Sept. 25, 2012 Page 5-2 of 5-3

Page 2 of 3

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Summary of Nonclinical Testing:

Performance bench tests were executed to ensure that the EPi-Sense Guided Coagulation System with VisiTrax (Generation 4 product) performed as intended and met design specifications.

The subject device incorporates design features and specifications equivalent to those specified by the predicate devices. In vitro and in vivo testing was conducted to verify that no safety or effectiveness issues arise when using the subject device to coagulate cardiac tissue or during use for the temporary cardiac signal sensing and recording function.

The following tests were successfully completed to evaluate equivalence.

1. Biocompatibility testing per ISO 10993 for device and accessory materials.
1. Sterilization validation per ISO 11137-2, Sterilization of Health Care Products - Radiation - Method VD Max.
1. Reliability testing such as shipping and accelerated aging of packaged units.
1. Tensile testing of critical bonds and joints.
1. Flexion fatique testing.
1. Electrical integrity testing for the subject device and accessories to pertinent sections of IEC 60601-1-2.
1. In-vivo pre-clinical testing to demonstrate equivalent performance for coagulating cardiac tissue and temporary cardiac signal sensing.
1. In-vitro bench testing to demonstrate tissue coagulation feature equivalence.

Substantial Equivalence Conclusion:

nContact concludes that the material and design modifications for the EPi-Sense Guided Coagulation System with VisiTrax may be considered substantially equivalent or identical to the legally marketed predicate devices based on the results of design verification and validation. The indications for use, principle of operation, technology, performance specifications (as reverified through design controls), labeling and sterilization parameters have no substantial changes or modifications that significantly affect the safety or efficacy of the devices. The Epi-Sense Guided Coagulation System with VisiTrax is substantially equivalent to the stated predicate devices.

Page 3 of 3

Section 5 - Summary Sept. 25, 2012 Page 5-3 of 5-3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and resemble a caduceus without the snake.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NOV 1 3 2012

nContact Surgical Inc. c/o Ms. Jane Ricupero 1001 Aviation Parkway, Suite 400 Morrisville, NC 27560

Re: K120857

Trade 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 (two) Product Code: OCL

Dated: September 25, 2012 Received: September 27, 2012

Dear Ms. Ricupero:

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. 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

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Page 2 - Ms. Jane Ricupero

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours, 7

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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nContact Surgical, Inc. Coagulation System Device Modification K120857 - EPi-Sense

K120857

Indications for Use

510(k) Number (if known): K120857

Device Name: EPi-Sense™ Guided Coagulation System with VisiTrax®

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K120857
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Page 1 of

Section 4 - Indications for Use Statement Sept. 25/2012 Page 4-1 of 4-1

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.