ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT

K080202 · Oncobionics, Inc. · OAB · May 8, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080202
• Device Name: ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
• Applicant: Oncobionics, Inc.
• Product Code: OAB · General, Plastic Surgery
• Decision Date: May 8, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oncobionic System with 6 probe output is indicated for use for surgical ablation of soft tissue.

Device Story

Oncobionic System with 6 probe output is an electrosurgical tissue ablation system. Device functions by delivering energy to electrodes for soft tissue ablation. Subject device modifies predicate Oncobionic System (K060054) by adding 4 output ports, increasing capacity to 6 electrodes. This allows simultaneous connection of multiple probe pairs, eliminating need for manual disconnection/reconnection during multi-site treatment. Operated by physicians in surgical settings. Output is controlled energy delivery for tissue destruction. Benefits include increased procedural convenience and efficiency for surgeons treating multiple sites.

Clinical Evidence

Bench testing only. Testing confirmed that the generator output with the additional ports conforms to the output specifications of the predicate device.

Technological Characteristics

Electrosurgical cutting and coagulation device. Features 6 output ports for electrode connection. Energy source is electrical. Design is identical to predicate K060054 except for port count.

Indications for Use

Indicated for surgical ablation of soft tissue in patients requiring such procedures. Prescription use only.

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

• Oncobionic System (K060054)

Submission Summary (Full Text)

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80202

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## 510k Summary Statement

MAY - 8 2008

This 510(k) Summary Statement is submitted in accordance with 21 CFR §807.92 as amended in the Final Rule published in the Federal Register Vol. 59, No. 239, 12-14-94, p. 64295.

Company Information

| Name | Oncobionic Incorporated |
|------------------|-----------------------------------------|
| Address | 30211 Avenida de las Banderas Suite 200 |
| | Rancho Santa Margarita, CA 92688 |
| Telephone Number | 949.888.6658 |
| Contact Person | Paul Mikus |
| Date Submitted: | March 7th 2008 |

Device Information:

| Name of Device | Oncobionic System with 6 probe output |
|----------------|---------------------------------------|
| Common Name: | Tissue Ablation System |

Classification: Electrosurgical Cutting and Coagulation Device

Predicate Device Information:

Oncobionic System K060054

1

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Kogo202

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## 510k Summary Statement

Device Description:

The Oncobionic System with 6 probe output is identical in design specification to the Oncobionic System cleared under K060054. The only change to the Oncobionic System with 6 probe output is the addition of 4 output ports to allow for the connection of up to six electrodes to the Generator. This design addition has been added for convenience to the use. The user can connect multiple pairs of probes thus to removing the need to connect and disconnect pairs of electrodes when treating multiple treatment sites.

Indications for Use:

2

The Oncobionic System with 6 probe output is indicated for use for surgical ablation of soft tissue.

Comparison to Predicate Device:

The Oncobionic System with 6 probe output was tested to confirm conformance with the output specifications of the Oncobionic System in Attachment 3, Bench Top Test of Generator Output. The test results demonstrate the output of each pair of ports performs within the output specifications of the Oncobionic System, thus no changes were made to the output of the Generator when using any of the additional output ports.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2008

Oncobionic, Inc. % Mr. Paul Mikus Regulatory Manager 30211 Avenida de las Banderas Suite 200 Rancho Santa Margarita, California 92679

Re: K080202

Trade/Device Name: Oncobionic System with 6 probe output Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: OAB Dated: April 29, 2008 Received: May 1, 2008

Dear Mr. Mikus:

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.

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 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

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Page 2 - Mr. Paul Mikus

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 Biometric's (OSB's) Division of Prestmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark M Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

0202

## INDICATIONS FOR USE

510(k) Application: Special 510K Application

Oncobionic System with 6 probe output Device Name:

Indications for Use: The Oncobionic System with 6 probe output is indicated for use for surgical ablation of soft tissue.

Prescription Use --------X OR

Over-the-Counter Use

(Per 21 CFR 801.109)

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 General, Restorative
and Neurological Devices

510(k) Number K080202