NCONTACT COAGULATION SYSTEM KIT, MODEL CSK

K063012 · Ncontact Surgical, Inc. · OCL · Dec 1, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063012
• Device Name: NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
• Applicant: Ncontact Surgical, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Dec 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The nContact Coagulation System is a sterile, single-use, disposable electrosurgical device used to coagulate cardiac tissue. It consists of a flexible, cooled electrode with a suction stabilizer feature. The device transmits radiofrequency (RF) energy from a non-sterile, reusable electrosurgical generator via a sterile instrument cable. It is intended for use by clinicians in a surgical setting. The device stabilizes tissue via suction to facilitate consistent RF energy delivery, which coagulates the target cardiac tissue. This process is intended to assist in cardiac surgical procedures.

Clinical Evidence

Bench testing only. Performance testing was completed to validate the intended use and demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Electrosurgical coagulation device; flexible, cooled electrode with suction stabilizer; radiofrequency (RF) energy source; sterile, single-use disposable electrode; non-sterile, reusable electrosurgical generator; instrument cable connectivity.

Indications for Use

Indicated for the coagulation of cardiac tissue using radiofrequency (RF) energy.

Regulatory Classification

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.

Predicate Devices

• Medtronic, Inc., Cardioblate Radiofrequency Ablation System (K013392)
• Endoscopic Technologies, Estech Cobra Adhere Surgical System (K041599, K053326)

Submission Summary (Full Text)

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DEC - I 2006

______________________________________________________________________________________________________________________________________________________________________________

nContact Surgical, Inc.
Coagulation System 510k Submission
Traditional Premarket Notification

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## 0 63012 510(k) Summary:

| Application Date: | September 29, 2006 |
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| Sponsor: | nContact Surgical, Inc.<br>2880 Slater Road, Suite 103,<br>Morrisville, NC 27560 |
| Correspondent: | Jane Ricupero<br>Director of Regulatory & Quality<br>2880 Slater Road, Suite 103,<br>Morrisville, NC 27560 |
| Contact Numbers: | Phone: [phone] x3013<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Proprietary Name: | nContact Coagulation System<br>Model number: CSK |
| Device Common Name: | Electrosurgical device and<br>accessories |
| Device Classification: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Classification Name: | Electrosurgical cutting and<br>coagulation device and accessories |
| Predicate Device(s): | Electrosurgical Cutting & Coagulation<br>Device |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Descriptions: | 1. Medtronic, Inc., Cardioblate<br>Radiofrequency Ablation System<br>(K013392)<br>2. Endoscopic Technologies, Estech<br>Cobra Adhere Surgical System<br>(K041599, K053326) |

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Page 2 of (2)

### Device Description:

The nContact Coagulation System 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).

63012

### Intended Use:

The nContact Coagulation System is intended for the coagulation of cardiac 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2008

nContact Surgical, Inc. c/o Ms. Jane Ricupero 2880 Slater Road, Suite 103 Morrisville, NC 27560

Re: K063012

Trade/Device Name: nContact Coagulation System 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 29, 2006 Received: October 2, 2006

Dear Ms. Ricupero:

This letter corrects our substantially equivalent letter of December 1, 2006.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

elgmee

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 (16 3012

per (UNKNOWN): 10301α

.

Device Name: nContact Coagulation System

Indications for Use: The nContact Coagulation System is intended for the coagulation of cardiac 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, Restorat

and Neurological Devices

| Section 4 - Indications for Use Statement Page 4-1 of 4-1 | 510(k) Number | k063012 |
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