The Numeris™ Tethered Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery.

Device Description

The modified nContact system, "Numeris Tethered Coagulation System with VisiTrax", consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, 3cm, & 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, however two addition RF coil electrode lengths have been added to the product offering (1cm and 3cm).

AI/ML Overview

The provided documentation is a K082203 510(k) Special Notice for the nContact Surgical, Inc. Coagulation System Device Modification, specifically the Gen 3 tethered version. This submission focuses on demonstrating substantial equivalence to a predicate device for minor material and design changes, and the addition of new electrode lengths. As such, the information you're requesting regarding clinical studies, acceptance criteria for performance metrics, and detailed ground truth establishment is not present in this type of submission.

Special 510(k)s typically rely on bench testing and comparisons to the predicate device to establish that the modified device's performance is not adversely affected and remains substantially equivalent. They do not usually involve extensive clinical trials or human-in-the-loop studies unless the changes are considered significant enough to warrant them, which is not the case here.

Here's a breakdown of why many of your requested points cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance

Not present. The document states: "Performance bench tests were executed to ensure that the Numeris Tethered Coagulation System with VisiTrax performed as intended and met design specifications." However, no specific acceptance criteria (e.g., minimum RF energy delivered, maximum temperature, coagulation depth) or the actual results of these tests (e.g., "device achieved X coagulation depth, meeting the criterion of Y") are shared in the summary. This information would typically be in the detailed testing protocols and results submitted to the FDA, but not in the public summary provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not present. No clinical "test set" in the context of human subjects or complex data analysis is described. The "performance data" refers to bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not present. No ground truth established by experts is mentioned, as there are no clinical trials or image analysis involved.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not present. No clinical test set to adjudicate.

5. 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

Not applicable/Not present. This device is an electrosurgical tool, not an AI-powered diagnostic system. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not present. This device is not an algorithm; it's a medical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not present. The "ground truth" for this type of device modification would be its ability to perform its stated function (coagulating tissue) reliably and safely, as demonstrated through engineering and bench testing against design specifications, and its equivalence to the predicate device. These are established through physical measurements and comparisons, not expert clinical consensus or pathology from human trials in this context.

8. The sample size for the training set

Not applicable/Not present. This device does not use machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable/Not present. As there's no training set, this is not relevant.

Summary of what IS stated regarding performance:

Device Performance Claim: "Performance bench tests were executed to ensure that the Numeris Tethered Coaqulation System with VisiTrax performed as intended and met design specifications."
Basis for Substantial Equivalence: The submission claims substantial equivalence based on "the results of design verification and validation." The key characteristics that are maintained are the "indications for use, principle of operation, technology, performance specifications (as reverified through design controls), labeling and sterilization parameters."
Comparison to Predicate Device: The functionality of the system is stated to be the same as the cleared predicate system. The technological characteristics (transmitting RF energy from an electrosurgical generator to an electrode) remain "identical to the predicate device."

In conclusion, based solely on the provided text, a detailed table of acceptance criteria and proven device performance as requested cannot be constructed. The document emphasizes that the modifications are minor and that bench testing confirmed the device performed as intended and met design specifications, implying successful adherence to internal criteria, but these criteria themselves are not disclosed in this public summary.

Summary

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Kortzo3

nContact Surgical, Inc. Coagulation System Device Modification Special 510k Notification - Gen 3 tethered

DEC 3 0 2008

Special 510(k) Summary:
Application Date:	August 1, 2008
Sponsor:	nContact Surgical, Inc.1001 Aviation Parkway, Suite 400,Morrisville, NC 27560
Establishment RegistrationNumber:	3006142617
Correspondent:	Jane RicuperoDirector of Regulatory & Quality1001 Aviation Parkway, Suite 400,Morrisville, NC 27560
Contact Numbers:	Phone: 919 655-1355Fax: 919 655-1690E-mail:jricupero@ncontactsurgical.com
Device Proprietary Name(s):	NumerisTM Tethered CoagulationSystem with VisiTrax®Model numbers: CSK-021; CSK-022;CSK-023; CSK-025
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. nContact Surgical Inc.,nContact Coagulation System(CSK) Model numbers: CSK-100;CSK-200; CSK-500
Legally marketed unmodifieddevice 510k number	K063012 cleared Dec. 1/06K071819 cleared July 26/07 (will beused for packaging comparison only)

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Device Description:

The functionality of this System is the same as the cleared predicate system, however two addition RF coil electrode lengths have been added to the product offering (1cm and 3cm).

Indications for Use:

The Numeris Tethered Coagulation System with VisiTrax is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during openchest cardiac surgery.

The indications for use of this System are the same as the cleared predicate system.

Technological Characteristics:

The Numeris Tethered Coagulation System with VisiTrax 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 Numeris Tethered Coaqulation System with VisiTrax performed as intended and met design specifications.

Substantial Equivalence Conclusion:

This special 510(k) proposes that the material and design modifications for the Numeris Tethered Coagulation System with 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.

Section 5 – Summary Page 5-2 of 5-3

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We believe that the Numeris Tethered Coagulation System with VisiTrax is substantially equivalent to the unmodified predicate device.

Section 5 – Summary Page 5-3 of 5-3

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three parallel lines forming its body and a flowing ribbon-like tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2008

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

Re: K082203

Trade/Device Name: Numeris Coagulation System with Visitrax (Gen 3 with Tether) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: December 4, 2008 Received: December 5, 2008

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 includications for use stated in the enclosure) to legally marketed predicate devices marketed in intestate 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, insting of devices, good manufacturing practice, labeling, and prohibitions against misbandi, noand adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, TDA move 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 not the Act

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Page 2 - Ms. Jane A. 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); 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 begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally markcted 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Survcillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

M. L. Villeneuve

A 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 Special 510k Notification - Gen 3 tethered

Indications for Use

510(k) Number (if known): K082203

Device Name: Numeris™ Tethered Coagulation System with VisiTrax®

Indications for Use: The Numeris™ Tethered Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy during open-chest cardiac surgery.

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)

M. S. Kelleher

Section 4 - Indications for Use Statement Page 4-1 of 4-1

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510(k) Number K082203

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.