The nContact Guided Coagulation System (VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm 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). The functionality of this System is the same as the cleared predicate system.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Device must perform as intended (coagulation of cardiac tissue using RF energy).	"Performance bench tests were executed to ensure that the nContact Guided Coagulation System (VisiTrax) performed as intended and met design specifications."
Device must meet design specifications.	"met design specifications."
Device modifications (material and design) must not significantly affect safety or efficacy.	"The indications for use, principle of operation, technology, performance specifications (as reverified through design controls), labeling and sterilization parameters are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
Device must be substantially equivalent to the predicate device (K063012).	"This special 510(k) proposes that the material and design modifications for the nContact Guided Coagulation System (VisiTrax) may be considered substantially equivalent to the legally marketed unmodified nContact Coagulation System (previously cleared under K063012 on Dec. 1, 2006) based on the results of design verification and validation."

Explanation of "Acceptance Criteria":

It's important to note that this document is a Special 510(k) summary for a device modification. The concept of "acceptance criteria" here is implicitly tied to demonstrating substantial equivalence to the predicate device. Unlike a de novo submission where new performance metrics might be established, for a 510(k), the primary "acceptance criterion" is that the modified device is as safe and effective as the predicate, and that the modifications do not raise new questions of safety or effectiveness. The performance data presented is focused on demonstrating this substantial equivalence.

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

The document does not specify a sample size for a "test set" in the traditional sense of a clinical trial or algorithm validation. The "Performance Data" section states:

"Performance bench tests were executed to ensure that the nContact Guided Coagulation System (VisiTrax) performed as intended and met design specifications."

This indicates bench testing, which typically involves laboratory experiments, not patient data. Therefore, there's no information on data provenance (country of origin) or whether it was retrospective/prospective in a clinical context.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided in the document. The study described relies on bench tests and design verification/validation directly against specifications and the predicate device's performance, not on expert-adjudicated ground truth from a test set.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as there is no mention of a test set requiring adjudication in a clinical or image-based context.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or is not reported. The document describes bench testing and design verification, not studies involving human readers or clinical comparative effectiveness against an AI system.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not done or is not reported. This device is a physical electrosurgical system, not an AI or software algorithm. The "Performance Data" refers to the physical device's operation.

7. Type of Ground Truth Used

The "ground truth" for this special 510(k) is implicitly derived from design specifications and the performance characteristics of the legally marketed predicate device. The modified device's performance was compared to these established benchmarks through "performance bench tests" and "design verification and validation." There is no mention of pathology, outcomes data, or expert consensus in this context.

8. Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is not an AI or machine learning model, so there is no concept of a "training set."

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

This information is not applicable and not provided in the document, as there is no training set for this type of device.

Summary

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nContact Surgical, Inc. Coagulation System Device Modification
Special 510k Notification

KO71819

JUL 26 2007

Special 510(k) Summary:

Special 510(k) Summary:
Page 1 of 2
Application Date:	July 2, 2007
Sponsor:	nContact Surgical, Inc.new address:
	1001 Aviation Parkway, Suite 400,Morrisville, NC 27560
	formerly at:2880 Slater Road, Suite 103,Morrisville, NC 27560
Establishment RegistrationNumber:	3006142617
Correspondent:	Jane RicuperoDirector of Regulatory & Quality1001 Aviation Parkway, Suite 400,Morrisville, NC 27560
Contact Numbers:	Phone: 919 466-9810 x3013Fax: 919 466-9811E-mail: jane@ncontact.us
Device Proprietary Name:	nContact Guided Coagulation Systemor VisiTrax TM Guided CoagulationSystemModel numbers: CSK-212; CSK-515
Device Common Name:	Electrosurgical device andaccessories
Device Classification:	21 CFR 878.4400
Product Code:	GEI
Classification Name:	Electrosurgical cutting andcoagulation device and accessories
Accessory Classification: Cannula	21 CFR 878.4800 (Manual surgicalinstrument for general use)
Accessory Product Code: Cannula	GEA (Class I exempt)
Predicate Device	1. nContact Surgical Inc.,nContact Coagulation System(CSK) Model numbers: CSK-100;CSK-200; CSK-500
Legally marketed unmodifieddevice 510k number	K063012 cleared Dec. 1/06

Section 5 – Summary
Page 5-1 of 5-2

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page 2 of (2)

Device Description:

Indications for Use:

The nContact Guided Coagulation System (VisiTrax) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy. The indications for use of this System are the same as the cleared predicate system.

Technological Characteristics:

The modified nContact Coagulation Device has minor material changes and minor design modifications with the main technological characteristics of transmitting RF energy from an electrosurgical generator connected by an instrument cable to a coagulation electrode remaining identical to the predicate device.

Performance Data:

Performance bench tests were executed to ensure that the nContact Guided Coagulation System (VisiTrax) performed as intended and met design specifications.

Substantial Equivalence Conclusion:

This special 510(k) proposes that the material and design modifications for the nContact Guided Coagulation System (VisiTrax) may be considered substantially equivalent to the legally marketed unmodified nContact Coagulation System (previously cleared under K063012 on Dec. 1, 2006) 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 are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

We believe that the nContact Guided Coagulation System (VisiTrax) is substantially equivalent to the unmodified predicate device.

Section 5 - Summary Page 5-2 of 5-2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2008

nContact Surgical, Inc. c/o Ms. Jane Ricupero Director, Regulatory and Quality 1001 Aviation Parkway, Sutie 400 Morrisville, NC 27560

Re: K071819

Trade/Device Name: Contact Guided Coagulation System (VisiTrax™) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL Dated: July 2, 2007 Received: July 3, 2007

Dear Ms. Ricupero:

This letter corrects our substantially equivalent letter of July 26, 2007.

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 (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.

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.

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Page 2 - Ms. Jane Ricupero

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 801); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

elgmee

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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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Indications for Use

510(k) Number (if known): __ K_OZI 81 9

Device Name: nContact Guided Coagulation System (VisiTrax™)

Indications for Use: The nContact Coagulation System (VisiTrax™) is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy.

Mark M. Milken

(Division Sign.Off (Division of General, Restorative, and Neurological Devices

09/8/9 510(k) Number_

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Section 4 - Indications for Use Statement 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.