EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

K120857 · Ncontact Surgical, Inc. · OCL · Nov 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120857
• Device Name: EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
• Applicant: Ncontact Surgical, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Nov 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The EPi-Sense™ 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 EPi-Sense™ Guided Coagulation System with VisiTrax® may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.

Device Story

EPi-Sense Guided Coagulation System (Gen 4) comprises sterile, single-use, flexible, cooled RF electrode (1cm, 2cm, 3cm) with suction stabilizer; non-sterile reusable RF generator; sterile instrument cable. Used in OR by surgeons (thoracoscopic, endoscopic, laparoscopic). Device transmits RF energy to cardiac tissue for coagulation; perfusion feature manages cooling; suction feature stabilizes contact. Optional sensing electrode connects to external electrogram recording system for temporary signal monitoring. Output allows surgeon to perform cardiac tissue ablation and monitor signals intraoperatively; facilitates surgical treatment of cardiac arrhythmias.

Clinical Evidence

No clinical data. Evidence consists of bench testing (biocompatibility per ISO 10993, sterilization per ISO 11137-2, tensile/flexion fatigue, electrical integrity per IEC 60601-1-2, shipping/aging) and in-vivo pre-clinical testing to demonstrate equivalent performance for cardiac tissue coagulation and temporary signal sensing.

Technological Characteristics

Flexible, cooled RF electrode; suction stabilizer; RF energy source. Materials biocompatible per ISO 10993. Sterilization via radiation (ISO 11137-2). Connectivity: standalone device with cable interface to external RF generator and external electrogram recording system. Dimensions: 1cm, 2cm, 3cm electrode sizes.

Indications for Use

Indicated for patients undergoing thoracoscopic, endoscopic, or laparoscopic surgery requiring cardiac tissue coagulation via RF energy and temporary cardiac signal sensing/recording.

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

• Numeris Guided Coagulation System with VisiTrax (K120857)
• Estech COBRA Adhere XL 2 (K090202, K113475)

Submission Summary (Full Text)

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nContact Surgical, Inc.
Coagulation System Device Modification
K120857 – EPi-Sense

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# 510(k) Summary:

| Application Date: | March 19, 2012 |
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| Date Summary Revised: | September 25, 2012 |
| Sponsor: | nContact Surgical, Inc.<br>1001 Aviation Parkway, Suite 400,<br>Morrisville, NC 27560 |
| Establishment Registration<br>Number: | 3006142617 |
| Correspondent: | Jane Ricupero<br>VP of Regulatory & Quality<br>1001 Aviation Parkway, Suite 400,<br>Morrisville, NC 27560 |
| Contact Numbers: | Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Proprietary Name(s): | EPi-SenseTM Guided Coagulation<br>System with VisiTrax®<br>Model numbers: CDK-1411; CDK-<br>1412; CDK-1413 |
| 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<br>(for coagulation function) | Numeris Guided Coagulation System<br>with VisiTrax, Model numbers: CSK-<br>121, CSK-122, CSK-123, CSK-125 |
| Predicate Device #2<br>(for sensing function) | K090202 cleared Feb. 17, 2009<br>Estech COBRA Adhere XL 2 |
| | K113475 cleared Mar. 20, 2012 |

Section 5 - Summary Sept. 25, 2012 Page 5-1 of 5-3

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# Device Description:

The EPi-Sense Guided Coagulation System with VisiTrax - generation 4 product) consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, & 3cm 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). An optional temporary sensing electrode feature may be used with . an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile).

## Indications for Use:

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

The EPi-Sense™ Guided Coagulation System with VisiTrax® may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.

# Comparison to Predicate Device and Summary of Technological Characteristics:

The nContact EPi-Sense System has the identical intended use and technological characteristics as the predicate nContact Numeris System for the coagulation function. The sensing function is considered equivalent to the stated predicate #2 for temporary cardiac signal sensing and recording when connected to a temporary external recording device.

The nContact Coagulation System combines design features of marketed predicate devices. The design features of the subject device are the same as or fall within ranges specified by the predicate devices. The dimensional parameters, materials, generator specifications, and design specifications are covered within the ranges offered by predicate devices. Shared features include:

- All devices (subject and predicate) rely on transmitting radiofrequency . energy through electrodes to achieve the intended coagulation use.
- Electrode design is identical to predicate #1. ●
- Perfusion feature is identical to predicate #1. .
- Suction feature is identical to predicate #1. .
- RF Generator energy levels, software revision and hardware are . identical to predicate #1.
- . Temporary cardiac signal sensing feature is similar the function in predicate #2.

Section 5 - Summary Sept. 25, 2012 Page 5-2 of 5-3

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# Summary of Nonclinical Testing:

Performance bench tests were executed to ensure that the EPi-Sense Guided Coagulation System with VisiTrax (Generation 4 product) performed as intended and met design specifications.

The subject device incorporates design features and specifications equivalent to those specified by the predicate devices. In vitro and in vivo testing was conducted to verify that no safety or effectiveness issues arise when using the subject device to coagulate cardiac tissue or during use for the temporary cardiac signal sensing and recording function.

The following tests were successfully completed to evaluate equivalence.

- 1. Biocompatibility testing per ISO 10993 for device and accessory materials.
- 2. Sterilization validation per ISO 11137-2, Sterilization of Health Care Products - Radiation - Method VD Max.
- 3. Reliability testing such as shipping and accelerated aging of packaged units.
- 4. Tensile testing of critical bonds and joints.
- 5. Flexion fatique testing.
- 6. Electrical integrity testing for the subject device and accessories to pertinent sections of IEC 60601-1-2.
- 7. In-vivo pre-clinical testing to demonstrate equivalent performance for coagulating cardiac tissue and temporary cardiac signal sensing.
- 8. In-vitro bench testing to demonstrate tissue coagulation feature equivalence.

## Substantial Equivalence Conclusion:

nContact concludes that the material and design modifications for the EPi-Sense Guided Coagulation System with VisiTrax may be considered substantially equivalent or identical to the legally marketed predicate devices 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 have no substantial changes or modifications that significantly affect the safety or efficacy of the devices. The Epi-Sense Guided Coagulation System with VisiTrax is substantially equivalent to the stated predicate devices.

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Section 5 - Summary Sept. 25, 2012 Page 5-3 of 5-3

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and resemble a caduceus without the snake.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NOV 1 3 2012

nContact Surgical Inc. c/o Ms. Jane Ricupero 1001 Aviation Parkway, Suite 400 Morrisville, NC 27560

Re: K120857

Trade Name: EPi-sense Guided Coagulation System with VisiTrax 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 25, 2012 Received: September 27, 2012

# 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

> Sincerely yours, 7

> > 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 K120857 - EPi-Sense

K120857

# Indications for Use

# 510(k) Number (if known): K120857

Device Name: EPi-Sense™ Guided Coagulation System with VisiTrax®

The EPi-Sense 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 EPi-Sense Guided Coagulation System with VisiTrax may be used for temporary cardiac signal sensing and recording during surgery when connected to an external recording device.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K120857 |
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