ONCOBIONIC SYSTEM

K060054 · Oncobionics, Inc. · OAB · Nov 21, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060054
• Device Name: ONCOBIONIC SYSTEM
• Applicant: Oncobionics, Inc.
• Product Code: OAB · General, Plastic Surgery
• Decision Date: Nov 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oncobionic System is indicated for surgical ablation of soft tissue, including cardiac and smooth muscle.

Device Story

Oncobionic System is a tissue ablation device used in surgical settings. It consists of a low energy direct current (LEDC) generator and two electrodes. The system functions by applying an LEDC pulse or series of pulses between the two electrodes to ablate target soft tissue. It is designed for use on cardiac and smooth muscle. The device is operated by clinicians during surgical procedures to create lesions in target tissue. Performance is verified through in-vitro and in-vivo animal studies comparing lesion formation against microwave ablation systems. The device provides a therapeutic alternative for tissue ablation using direct current rather than radiofrequency or microwave energy.

Clinical Evidence

No human clinical data provided. Evidence consists of in-vitro proof-of-concept testing and in-vivo animal studies (pig liver and cardiac tissue). Animal studies compared the Oncobionic System to the Guidant Microwave System using recommended treatment parameters to determine minimum voltage for target lesion size and confirm safety and effectiveness.

Technological Characteristics

System comprises a low energy direct current (LEDC) generator and two stainless steel electrodes. Operates as a bipolar device. Energy source is direct current. Form factor includes needle-tip electrodes for energy delivery to target tissue.

Indications for Use

Indicated for surgical ablation of soft tissue, including cardiac and smooth muscle, in patients requiring such 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

• Guidant Microwave Ablation System (K041340)
• Medtronic Cardioblate Bipolar Radiofrequency Ablation (K031247)

Submission Summary (Full Text)

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K060054

510(k) Summary

Page 1 of 2

Device Name

Oncobionic System

Common or Usual Name

Tissue Ablation System

NOT 2 1 2006

510(k) Owner's Name, Address, Phone and Fax Numbers, and Contact Person

Oncobionics, Inc. 30211 Avenida de las Banderas, Suite 200 Rancho Santa Margarita, CA 92688 Phone Number: [phone] Fax Number: [phone]

Contact Person: Paul Mikus, Regulatory Manager

Predicate Device:

The Guidant Microwave Ablation System (K041340) and Medtronic Cardioblate Bipolar Radiofrequency Ablation (K031247).

Date Prepared:

October 30, 2006

Indications For Use:

The Oncobionic System is indicated for surgical ablation of soft tissue, including cardiac and smooth muscle.

Device Description/Technological Characteristics:

The Oncobionic System comprises a low energy direct current (LEDC) Generator and two Electrodes. The Oncobionic System applies a LEDC pulse or series of pulses between two electrodes to ablate tissue.

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Page 2 of 2

## Performance Data:

The submission included data from in-vitro testing to confirm the proof of concept and in-vivo animal tissue testing regarding the use of different voltages of electric current to determine the minimum voltage needed to achieve the target lesion size. In addition, Oncobionics conducted in vivo testing comparing the Oncobionic System to the Guidance Microwave System in ablating pig liver and cardiac tissue using the treatment parameters recommended in the labeling for each device. These studies show that the Oncobionic System is at least as safe and effective as the predicate devices.

## Substantial Equivalence

The Oncobionic System has the same indication for use of ablating soft tissue as the Medtronic's Cardioblate and the Guidant Microwave Ablation System and the same indications for use of ablating cardiac tissue and smooth muscle as the Guidant Microwave Ablation System. The Oncobionic System, like Medtronic's Cardioblate and the Guidant Microwave Ablation System, is made of stainless steel. All of these devices use one or more electrodes or probes with a needle tip to deliver the energy to the target tissue. The Oncobionic System has some technological differences compared to the predicate devices; namely, that it delivers low energy direct current to ablate tissue, while the Medtronic's Cardioblate delivers radiofrequency electric energy and the Guidant Device delivers microwave energy to ablate. However, the Oncobionic System and the Medtronic Device are bipolar devices, although the Medtronic's Cardioblate is also a monopolar device. Moreover, performance data demonstrates that the Oncobionic System is as safe and effective as the Guidant Device in ablating soft tissue and cardiac tissue. Thus, the Oncobionic System is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FF3 2 1 2008

Oncobionic Incorporated c/o Ms. Laurie A. Clark King & Spalding 1700 Pennsylvania Avenue Washington, DC 20006

Re: K060054

Trade/Device Name: Oncobionic System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL, OAB Dated: November 1, 2006 Received: November 1, 2006

Dear Ms. Clark:

This letter corrects our substantially equivalent letter of November 21, 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. Laurie A. Clark

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,

Eemal.

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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K060054

## Indications for Use

510(k) Number:

Device Name: Oncobionic System

Indications for Use: The Oncobionic System is indicated for surgical ablation of soft tissue, including cardiac and smooth muscle.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Polo R

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number 1060054

WDC_IMANAGE-567820 v1-12695.189001

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