EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

K142084 · Ncontact Surgical, Inc. · OCL · Oct 28, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142084
• Device Name: EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
• Applicant: Ncontact Surgical, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Oct 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 an external recording device.

Device Story

System uses RF energy to coagulate cardiac tissue; features suction stabilizer for tissue contact; includes temporary sensing electrodes for electrogram recording. Used in thoracoscopic, endoscopic, or laparoscopic procedures; operated by surgeons. Device consists of sterile, single-use coagulation electrode and accessory cannula; connects to non-sterile, reusable RF generator and external recording system. Cannula facilitates access and visualization. Output is thermal coagulation of tissue and electrical cardiac signals for monitoring. Benefits include minimally invasive surgical access for cardiac tissue ablation.

Clinical Evidence

Bench testing only. Testing included ISO 10993 biocompatibility, ISO 11137-2 sterilization validation, shipping/aging reliability, tensile testing, flexion fatigue, and IEC 60601-1-2 electrical integrity.

Technological Characteristics

System includes RF coagulation electrode (1cm, 2cm, 3cm) and accessory cannula. Materials meet ISO 10993 biocompatibility standards. Energy source: RF generator. Connectivity: wired to external generator and recording system. Sterilization: radiation per ISO 11137-2. Features suction stabilization and temporary sensing electrodes.

Indications for Use

Indicated for coagulation of cardiac tissue via thoracoscopic, endoscopic, or laparoscopic surgical techniques; also indicated for temporary cardiac signal sensing and recording during surgery.

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

• EPi-Sense Guided Coagulation System with VisiTrax (K120857)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

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

October 28, 2014

nContact Surgical, Inc. % Jane Ricupero VP of Regulatory and Quality 1001 Aviation Parkway, Suite 400 Morrisville, North Carolina 27560

Re: K142084

> Trade/Device Name: Epi-Sense Guided Coagulation Device 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: September 4, 2014 Received: September 8, 2014

Dear Jane 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known): K

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)

{3}------------------------------------------------

## 510(k) Summary:

| Application Date: | July 30, 2014 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| 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-Sense® 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 | EPi-Sense Guided Coagulation<br>System with VisiTrax, Model<br>numbers: CDK-1411; CDK-1412;<br>CDK-1413 |
| Legally Marketed unmodified<br>device 510k number | K120857 cleared Nov. 13, 2012 |

{4}------------------------------------------------

#### Device Description:

The EPi-Sense Guided Coagulation System with VisiTrax 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). A 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). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The Cannula accessory changes are the subject of this submission.

#### Indications for Use:

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.

#### Description of Change for this Submission:

The following changes are being made to the Cannula Accessory for the EPi-Sense Guided Coaqulation System with VisiTrax.

- Manufacturing process change for the cannula tip from an extrusion ● process to a molded process
- Material/part vendor changes ●
- Vacuum tubing wall thickness increase
- Addition of blue lumen marker ●
- Sterile barrier pouch sealing operation change of location .
- Addition of two Cannula models

#### Comparison to Predicate Device and Summary of Technological Characteristics:

The nContact EPi-Sense System described in this submission is identical to the predicate nContact EPi-Sense System described in K120857 and has the identical intended use and technological characteristics.

- · Coagulation Device functions, such as perfusion, suction, the RF electrode, and sensing electrodes are identical, with use of the same RF Generator and connecting cables.

{5}------------------------------------------------

- The Cannula accessory used with the EPi-Sense device has minor ● changes as described above with design features that are the same or slightly modified from the previous Cannula design.
### Summary of Nonclinical Testing for Accessory Cannula:

Performance bench tests were executed to ensure that the Cannula accessory performed as intended and met design specifications in conjunction with the EPi-Sense Guided Coagulation System with VisiTrax.

The EPi-Sense device incorporates design features and specifications identical to those specified by the predicate device, there were no changes made to the coagulation device. The Cannula accessory with minor changes has completed testing to verify that no safety or effectiveness issues arise when using the coagulation device in conjunction with the Cannula.

The following tests were successfully completed to evaluate equivalence.

- 1. Biocompatibility testing per ISO 10993 for cannula accessory materials.
- 2. Sterilization validation per ISO 11137-2, Sterilization of Health Care Products - Radiation - Method VD Max for cannula accessory.
- 3. Reliability testing such as shipping and accelerated aging of packaged units.
- 4. Tensile testing of critical bonds and joints.
- 5. Flexion fatigue testing.
- 6. Electrical integrity testing for the cannula accessory used with the coagulation device to pertinent sections of IEC 60601-1-2.

#### Substantial Equivalence Conclusion:

nContact concludes that the modifications for the Cannula Accessory used with 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 re-verified through design controls), and 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 with Accessory Cannula is substantially equivalent to the stated predicate device.