NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125

K090202 · Ncontact Surgical, Inc. · OCL · Feb 17, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090202
• Device Name: NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
• Applicant: Ncontact Surgical, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Feb 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Numeris™ Guided Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.

Device Story

Numeris Guided Coagulation System with VisiTrax is a sterile, single-use, disposable electrosurgical device; includes flexible, cooled electrode with suction stabilizer. Device transmits RF energy from a non-sterile, reusable electrosurgical generator via a sterile instrument cable. Used by surgeons in thoracoscopic, endoscopic, and laparoscopic procedures to coagulate cardiac tissue. System provides controlled thermal energy delivery to target tissue; suction stabilizer assists in tissue contact. Output is thermal coagulation of cardiac tissue. Benefits include minimally invasive access to cardiac structures for ablation procedures.

Clinical Evidence

Bench testing only. Performance bench tests were executed to ensure the system performed as intended and met design specifications.

Technological Characteristics

Electrosurgical coagulation device; RF energy transmission; flexible, cooled electrode with suction stabilizer; sterile, single-use disposable electrode; non-sterile, reusable electrosurgical generator; instrument cable; 1cm, 2cm, 3cm, and 5cm electrode sizes.

Indications for Use

Indicated for coagulation of cardiac tissue in patients undergoing thoracoscopic, endoscopic, or laparoscopic surgical procedures.

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

• nContact Guided Coagulation System (VisiTrax) (K071819)
• Numeris Tethered Coagulation System with VisiTrax (K082203)

Submission Summary (Full Text)

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# Special 510(k) Summary:

| Application Date: | January 23, 2009 |
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| Sponsor: | nContact Surgical, Inc.<br>1001 Aviation Parkway, Suite 400,<br>Morrisville, NC 27560 |
| Establishment Registration<br>Number: | 3006142617 |
| Correspondent: | Jane Ricupero<br>Director of Regulatory & Quality<br>1001 Aviation Parkway, Suite 400,<br>Morrisville, NC 27560 |
| Contact Numbers: | Phone: [phone]<br>Fax: [phone]<br>E-mail:<br>[e-mail] |
| Device Proprietary Name(s): | Numeris™ Guided Coagulation<br>System with VisiTrax®<br>Model numbers: CSK-121; CSK-122;<br>CSK-123; CSK-125 |
| Device Common Name: | Electrosurgical device and<br>accessories |
| Device Classification: | 21 CFR 878.4400<br>Class II |
| Product Code: | OCL |
| Classification Name: | Electrosurgical cutting and<br>coagulation device and accessories |
| Predicate Device | 1. nContact Surgical Inc.,<br>nContact Guided Coagulation System<br>(VisiTrax)<br>(CSK) Model numbers: CSK-212;<br>CSK-515 (K071819)<br>2. Numeris Tethered Coagulation<br>System with VisiTrax, Model<br>numbers: CSK-021, CSK-022, CSK-<br>023, CSK-025 (K082203) |
| Legally marketed unmodified<br>device 510k number | K071819 cleared July 26/07<br>K082203 cleared Dec. 30/08 |

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Section 5 – Summary
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# Device Description:

The modified nContact Coagulation System (Numeris Guided Coaquiation System with VisiTrax) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 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).

K090202

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

# Indications for Use:

The Numeris 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 indications for use of this System are the same as the cleared predicate system for the coagulation of cardiac tissue.

### Technological Characteristics:

The modified 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 Numeris Guided Coagulation 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 Guided Coagulation System with VisiTrax may be considered substantially equivalent to the legally marketed unmodified nContact Guided Coagulation System (cleared under K071819 on July 26, 2007) and the Numeris Tethered Coagulation System with VisiTrax (cleared under K082203 on Dec. 30, 2008) based on the results of design verification and validation. The indications for use, principle of operation, technology, performance specifications (as re-verified through design controls), labeling and sterilization parameters have no substantial changes or modifications that significantly affect the safety or efficacy of the devices. We believe that the Numeris Guided Coagulation System with VisiTrax is substantially equivalent to the unmodified predicate device. V

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

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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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three stylized shapes. The symbol is black and the text is in a simple, sans-serif font.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2009

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

#### Re: K090202

Trade/Device Name: Numeris Guided Coagulation System with Visitrax Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: January 23, 2009 Received: January 27, 2009

#### 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 accordiance with the provisions of the the fleet . 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

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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 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 Center for Devices and Radiological Health's (CDRH's) Office of .Compliance at [phone]. 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 Surveillance 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

) 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 Guided

# Indications for Use

510(k) Number (if known): K090202

Device Name: Numeris™ Guided Coagulation System with VisiTrax®

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Indications for Use: The Numeris™ Guided Coagulation System with VisiTrax® is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
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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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)


| Division Sign-Off | |
|------------------------------------|---------|
| Date | 2/17/09 |
| Division of Cardiovascular Devices | |

Section 4 - Indications for Use Statement

Page 4-1 of 4-1

| 510(k) Number | K090202 |
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