The nContact Coagulation System consists of a sterile, single-use, disposable coagulation electrode device (2cm & 5cm sizes provided) intended to be used to coagulate soft 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).

AI/ML Overview

The provided text describes a 510(k) summary for the nContact Coagulation System, an electrosurgical device intended for the coagulation of soft tissue using radiofrequency (RF) energy. However, the document does not contain specific acceptance criteria or a detailed study description with performance metrics.

The summary states that "Performance testing was completed to validate its intended use" and that "The nContact Coagulation System may be considered substantially equivalent to the predicate devices based on performance and comparative data, and does not raise new questions of safety and efficacy." This implies that the device likely met acceptance criteria, but the criteria themselves and the detailed results are not provided in this document.

Therefore, I cannot populate the requested table or answer most of the questions as the necessary information is not present in the provided text.

Based on the provided information, I can only state the following:

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

Information Not Available: The document only generally states that "Performance testing was completed to validate its intended use" and that the device is "substantially equivalent to the predicate devices based on performance and comparative data." It does not provide specific acceptance criteria (e.g., minimum coagulation depth, maximum thermal spread) or quantitative performance metrics (e.g., specific coagulation results, efficacy rates).

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

Information Not Available: The document mentions "Performance testing" but does not specify sample sizes, whether the data was from animal or human subjects, its country of origin, or if it was retrospective or prospective.

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)

Information Not Available: The document does not describe any study involving experts for ground truth establishment.

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

Information Not Available: The document does not describe any study that would require an adjudication method.

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

Information Not Applicable/Not Available: This involves a medical imaging device with AI assistance, which is not what the nContact Coagulation System is. No such study is mentioned or relevant to this device's description.

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

Information Not Applicable/Not Available: This involves an algorithm, which is not part of the nContact Coagulation System's description.

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

Information Not Available: The document does not describe the specific type of ground truth used for performance testing beyond "to validate its intended use."

8. The sample size for the training set

Information Not Applicable/Not Available: There is no mention of a training set, as this is not an AI/machine learning device.

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

Information Not Applicable/Not Available: As there's no training set, this question is not applicable.

Summary

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11062539 510(k) Summary:

Application Date:	August 25, 2006
Sponsor:	nContact Surgical, Inc.2880 Slater Road, Suite 103,Morrisville, NC 27560
Correspondent:	Jane RicuperoDirector of Regulatory & Quality2880 Slater Road, Suite 103,Morrisville, NC 27560
Contact Numbers:	Phone: 919 466-9810 x3013Fax: 919 466-9811
Device Proprietary Name:	nContact Coagulation SystemModel number: CSK
Device Common Name:	Electrosurgical device andaccessories
Device Classification:	21 CFR 878.4400
Product Code:	GEI
Classification Name:	Electrosurgical cutting andcoagulation device and accessories
Predicate Device(s):	Electrosurgical Cutting & CoagulationDevice
Predicate Device Classification:	21 CFR 878.4400
Predicate Device Descriptions:	1. Medtronic, Inc., Cardioblate BipolarRadiofrequency Ablation System(K031247)2. Arthrocare, CorporationElectrosurgery System (K992972)3. Arthrocare, CorporationElectrosurgery System (K971532)4. Boston Scientific, ElectrosurgicalSystem (K981981)

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Device Description:

Intended Use:

The nContact Coagulation System is intended for the coagulation of soft tissue using radiofrequency (RF) energy.

Non-clinical Performance:

The nContact Coagulation System has been compared to the listed predicate devices with respect to intended use, technological characteristics, and principle of operation. Performance testing was completed to validate its intended use. All of the features specified for the subject device are covered by those listed in at least one predicate device.

Substantial Equivalence:

The nContact Coagulation System may be considered substantially equivalent to the predicate devices based on performance and comparative data, and does not raise new questions of safety and efficacy.

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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, facing left. The eagle is composed of three thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2006

nContact Surgical, Inc. % Ms. Jane Ricupero Director, Regulatory and Ouality 2880 Slater Road, Suite 103 Morrisville, North Carolina 27560

Re: K062539

Trade/Device Name: nContact Coaguation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 22, 2006 Received: November 24, 2006

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.

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, 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 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.

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Page 2 - Ms. Jane Ricupero

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 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) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Mark N. Mellon

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _1062539

Device Name: nContact Coagulation System

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

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of General, Restorative,and Neurological Devices

Section 4 - Indications for Use StatementPage 4-1 of 4-1
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510(k) Number	L0625235
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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.