ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM

K113475 · Endoscopic Technologies, Inc. D/B/A Estech · OCL · Mar 20, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113475
• Device Name: ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
• Applicant: Endoscopic Technologies, Inc. D/B/A Estech
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Mar 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ESTECH COBRA Adhere XL 2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU). The ESTECH COBRA Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

Device Story

Estech COBRA Adhere XL 2 is a sterile, single-use surgical ablation probe. Device uses vacuum stabilizer to maintain contact between ablation electrodes and target cardiac tissue; internal ribcage provides structural integrity and shape conformability. RF energy delivered via electrodes when connected to COBRA Electrosurgical Unit (ESU). Device includes integrated indifferent electrode; surgeon-selectable modes allow energy return via integrated electrode or external patient-placed electrode. When disconnected from ESU and connected to auxiliary external pacemaker/recording device, probe provides temporary cardiac pacing, sensing, recording, and stimulation. Used in OR by surgeons during cardiac procedures. Output allows surgeon to ablate tissue or evaluate arrhythmias; benefits include controlled tissue ablation and intraoperative diagnostic capability.

Clinical Evidence

No clinical data. Substantial equivalence supported by in-vitro and in-vivo bench testing demonstrating device ability to pace, sense, stimulate, and ablate cardiac tissue equivalent to predicates. Biocompatibility tested per ISO 10993; electrical safety tested per IEC 60601-1-2 and IEC 60601-2-2.

Technological Characteristics

RF ablation probe with vacuum-assisted tissue contact. Features: internal ribcage for conformability, multiple active RF electrodes, two thermocouples per electrode, integrated indifferent electrode. Connectivity: ESU for ablation; auxiliary cable for external pacemaker/recording device. Biocompatibility: ISO 10993 compliant. Electrical safety: IEC 60601-1-2, IEC 60601-2-2.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring cardiac tissue ablation or temporary cardiac pacing, sensing, recording, and stimulation for arrhythmia evaluation.

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

• Estech COBRA Adhere XL (K051749)
• Estech COBRA Bipolar Recording Electrode (K051749)
• Multifunctional Linear Pen (K100501)

Submission Summary (Full Text)

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# KIT3445

## SECTION 5: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 2 0 2012

#### Device Information:

| Category | Comments |
|--------------------------|--------------------------------------------------------------------------------------------|
| Sponsor: | ESTECH, Inc.<br>2603 Camino Ramon<br>Suite 100<br>San Ramon, CA 94583<br>Tel: [phone] |
| Correspondent: | Tamer Ibrahim<br>Vice President<br>ESTECH, Inc |
| Contact Information: | Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Surgical Device, For Ablation of Cardiac<br>Tissue |
| Device Proprietary Name: | Estech COBRA Adhere XL 2 |
| Device Classification: | Class II, OCL (21 CFR 878.4400) |

#### Predicate Device Information:

| Predicate Devices: | Estech COBRA Adhere XL (K051749)<br>Estech COBRA Bipolar Recording Electrode<br>(K051749) |
|-----------------------------------------|-------------------------------------------------------------------------------------------|
| Predicate Device Manufacturers: | Endoscopic Technologies, Inc (dba Estech) |
| Predicate Device Common Name: | Surgical Device, For Ablation of Cardiac<br>Tissue |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification Number: | Class II, OCL |

#### Predicate Device Information:

| Predicate Devices: | Multifunctional Linear Pen (K100501) |
|-----------------------------------------|----------------------------------------------------|
| Predicate Device Manufacturers: | AtriCure, Inc. |
| Predicate Device Common Name: | Surgical Device, For Ablation of Cardiac<br>Tissue |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification Number: | Class II, OCL |

### b. Date Summary Prepared

21 November 2011 (Updated 22Feb2012)

#### c. Description of Device

The Estech COBRA Adhere XL 2 is a sterile, single use device intended for the ablation of The Esteon CODIA Cranel to deliver RF energy to the target tissue via electrodes in the device when connected to the COBRA Electrosurgical Unit (ESU).

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When the COBRA Adhere XL 2 is connected to an auxiliary temporary external pacemaker or recording device it can be used to provide temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery. The COBRA Adhere XL 2 must be disconnected from the ESU and connected to a temporary external pacemaker or recording device using the accessory cable provided.

#### d. Intended Use

The ESTECH COBRA Adhere XL 2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).

The ESTECH COBRA Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

#### e. Comparison to Predicate Device and Summary of Technological Characteristics

The ESTECH COBRA Adhere XL2 has the identical intended use and the same technological characteristics as the predicate devices. There have been no significant changes in technological characteristics with respect to the predicate device including materials, design, energy sources, or other features from the predicate device.

The COBRA Adhere XL 2 and predicate COBRA Adhere XL both comprise a vacuum stabilizer to maintain contact between the ablation probe and target tissue to be ablated. These vacuum te hilizers are flexible. The COBRA Adhere XL 2 further comprises an internal ribeage which gives the device the ability to conform into various shapes while providing the flexible suction stabilizer with structural integrity. The predicate COBRA Adhere XL has a vacuum stabilizer with a centrally located series of electrodes. The COBRA Adhere XL 2 has a vacuum stabilizer with a laterally located series of electrodes. As the vacuum stabilizers form a seal with the tissue, while is drawn into the device creating contact between tissue to be ablated and the electrodes.

Both the COBRA Adhere XL2 and predicate COBRA Adhere XL include temperature controlled Doar are of endicate and application devices each have multiple active RF electrodes that are individually selectable and controlled by the ESU (generator). Predicate and application devices each have two (2) thermocouples attached to each active RF electrode. The COBRA Adhere XL2 also comprises an integrated indifferent electrode. With the COBRA Adhere XL 2, RF energy is directed from the active electrode to the integrated indifferent electrode or to the indifferent electrode placed on the patient's back, depending on the mode the device is in, as selected by the surgeon. The surgeon depresses the button on the device handle and the switch in serveted by the bargeon. I am enables or disables the integrated indifferent electrode.

The COBRA Adhere XL 2 also provides transient pacing/sensing capability when connected to an auxiliary temporary external pacemaker or recording device like the predicate devices.

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#### f. Summary of Nonclincal Testing

Appropriate testing, included in this application, has been performed to ensure that the ESTECH COBRA Adhere XL 2 meets its product specifications. The data demonstrates substantial equivalence to the predicate devices. In-vitro and in-vivo testing demonstrate that the COBRA Adhere XL2 is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the predicate devices.

The patient contacting materials of the ESTECH COBRA Adhere XL 2 have been tested in accordance with ISO 10993: Biological Evaluation of Medical Device to ensure biocompatibility. The safety of the electrical design has been tested per and is in conformance with the pertinent sections of IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests and IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.

#### g. Summary of Substantial Equivalence

Estech concludes that the COBRA Adhere XL 2 is substantially equivalent to the predicate devices. The indications for use, basic overall function, materials, packaging, and sterilization methods are identical or substantially equivalent.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

#### Public Health Service

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

MAR 2 0 2012

Endoscopic Technologies, Inc. C/O Mr. Tamer Ibrahim 2603 Camino Ramon, Suite 100 San Ramon, CA 94583

Re: K113475

Trade/Device Name: ESTECH Cobra Adhere XL 2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OCL Dated: February 21, 2012 Received: February 22, 2012

Dear Mr. Ibrahim:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premailer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regally manatiment date of the Medical Device Amendments, or to commence prior to May 20, 1970, the enaounter with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allu Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The You may, therefore, market me device, basjever to assements for annual registration, listing of general controls provisions of the fielding, and prohibitions against misbranding and devices, good manufacturing practice, tabeling, and information related to contract liability adulteration. Please note: CDNT docs not overance increases and misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) finitials affecting your device can be may be subject to additional controls. "Internal Regulations, "In addition, FDA may lound in the Code of I each. Regarders
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 Please be advised that FDA s issualled of a bays of a be requirements of the Act
that FDA has made a determination that your device complies with on any must that FDA has made a decernmanch and Joan Seeel by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not issuesting of m comply with all the Act 3 requirements, incruaing, our access of the subsiting of medical

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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 1100 for 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ronn D. Zuckerman, M.D.

Bram D. Zackerman, 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): K113475

Device Name: ESTECH Cobra Adhere XL 2

Indications For Use:

The ESTECH Cobra Adhere XL2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical Unit (ESU).

The ESTECH Cobra Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external pacemaker or recording device.

Prescription Use __ × (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 | A13475 |
| | Page 1 |

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