The Oncobionic System includes additional treatment parameters. These additional treatment parameters allow for the application of the Oncobionic System to target and ablate additional volumes of soft tissue. The Oncobionic System with additional treatment parameters applies a I .EDC pulse or series of pulses between two clectrodes to cause an ablation clicel to occur. The fundamental application and design of the device has not changed, but new treatment parameters have been tested and added to the device to cause additional volumes of soft tissue ablation

AI/ML Overview

The provided 510(k) summary for the Oncobionic System (K080376) primarily focuses on demonstrating substantial equivalence to predicate devices through in-vivo testing related to tissue ablation efficacy and safety.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
At least as safe as predicate devices (K060054, K070101)	In-vivo test data (Attachment 1) shows the Oncobionic System to be at least as safe as the predicate devices.
At least as effective as predicate devices (K060054, K070101) in creating tissue ablation volumes	In-vivo test data (Attachment 1) shows the Oncobionic System to be at least as effective as the predicate devices. Specifically, it creates equivalent tissue ablation to the Rita Medical UniBlate Device (K070101).
Functional requirements of controlling software met	"The testing demonstrated that the functional requirements were met, and system specifications over a fulfilled."
System specifications of controlling software fulfilled	"The testing demonstrated that the functional requirements were met, and system specifications over a fulfilled."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample size used for the in-vivo test set. It only mentions "in-vivo test data, Attachment 1."
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "in-vivo test data."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study described is an in-vivo test, likely involving direct measurement of ablation zones or assessment of safety parameters, rather than expert interpretation of images or other data requiring a "ground truth" established by human experts in the way an AI diagnostic device might.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the study described is an in-vivo performance test rather than an expert-adjudicated study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a tissue ablation system, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of this device. The Oncobionic System is a physical device used for surgical ablation, not an algorithm, and thus standalone performance in this sense is not relevant. The software validation mentioned refers to the controlling software for the device's functional operation, not a diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the in-vivo performance study would be direct physiological measurements or observations of the effects of tissue ablation within the test subjects. This could include:

Physical dimensions (volume, diameter, depth) of the ablated tissue.
Histopathological assessment of the ablated and surrounding tissue to confirm the extent of ablation and any non-target tissue damage (safety).
Physiological parameters confirming the "safety" aspect mentioned.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided, as the Oncobionic System and its evaluation as described do not involve machine learning or a "training set" in the typical sense. The software validation refers to functional testing of the controlling software, not training of an AI model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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K080376

Attachment 2

510k Summary

APR - 2 200'

This 510(k) Summary 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 200Rancho Santa Margarita, CA 92688
Telephone Number	949.888.6658
Contact Person	Paul Mikus
Date Submitted:	February 8, 2008

510k Summary

Device Description:

Intended Use:

The Oncobionic System is indicated for surgical ablation of soft tissue

Comparison to Predicate Device:

The Oncobionic System creates equivalent tissue ablation to the Rita Medical UniBlate Device (K070101). The Oncobionic System is as safe and effective as the Oncobionic System K060054. We have compared the efficacy of our device to the prodicate devices and found them to be equivalent.

Porformance Data:

We have included in-vivo test data, Attachment 1, which shows the Oncobionic System to be at least as safe and offective as the prodicate devices. This test shows that the Oncobionic System is substantially equivalent to the predicate devices for creating ablation zones in soft tissuc.

Sterilization Validation:

The Sterilization method used for the single use Oncobionic System electrode is Ethylene Oxide Sterilization.

Software Validation:

The Company certifies that it used an adequate test plan to validate the Oncobionic System controlling software. The testing demonstrated that the functional requirements were mot, and system specifications over a fulfilled.

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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 consists of a stylized eagle with three bars representing its wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oncobionic Incorporated % Mr. Paul Mikus Regulatory Manager 30211 Avenida de las Banderas Suite 200 Rancho Santa Margarita, California 92688

APR - 2 2008

Re: K080376

Trade/Device Name: Oncobionic System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: OAB Dated: February 8, 2008 Received: February 12, 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 Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Survey arverse arverse 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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Attachment 1

Indications for Use

510(k) Number: K080376

Device Name: Oncobionic System

Indications for Use: The Oncobionic System is indicated for surgical ahlation of soft tissuc

Prescription Use ਮ (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 Tvaluation (ODE)

Mik Rrdyk for mxn
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K080576

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.