ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT by ONCOBIONICS, INC.

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided documents do not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. This 510(k) submission is for a modification to an existing device, specifically adding more output ports for convenience. The primary "study" mentioned is a benchtop test to confirm the new configuration still meets the output specifications of the original device, not a performance study in a clinical setting.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Acceptance Criteria and Device Performance

Acceptance Criterion	Reported Device Performance
Conformance with output specifications of the Oncobionic System (predicate device K060054).	"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."

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in terms of units or cases. The study was a "Bench Top Test of Generator Output," implying measurement of the device itself rather than patient data.
Data Provenance: Benchtop testing, not clinical data from a specific country or population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This was a technical benchtop test, not a clinical study requiring expert ground truth.

4. Adjudication method for the test set:

Not applicable. No clinical test set or human interpretation was involved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC or human-in-the-loop study was done. This device is an electrosurgical ablation system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the device's technical output, which was confirmed through bench testing.

7. The type of ground truth used:

The "ground truth" for this technical assessment was the established output specifications of the predicate Oncobionic System (K060054).

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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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.

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

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

510k Summary Statement

Device Description:

Indications for Use:

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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.