(319 days)
The Oncobionic System is indicated for surgical ablation of soft tissue, including cardiac and smooth muscle.
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.
Here's a breakdown of the acceptance criteria and the study that proves the Oncobionic System meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative "acceptance criteria" for performance metrics like lesion size, or specific safety thresholds. Instead, the primary acceptance criterion is establishing "substantial equivalence" to predicate devices in terms of safety and effectiveness.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (overall) | "The Oncobionic System is at least as safe and effective as the predicate devices." |
| Ablation of pig liver tissue | "as safe and effective as the Guidant Device in ablating soft tissue" |
| Ablation of pig cardiac tissue | "as safe and effective as the Guidant Device in ablating cardiac tissue" |
| Achieve target lesion size (minimum voltage) | In-vivo animal tissue testing performed "to determine the minimum voltage needed to achieve the target lesion size." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text does not provide specific numerical sample sizes for the "in-vivo animal tissue testing" or the comparative studies. It mentions "pig liver and cardiac tissue" but not the number of animals or tissue samples.
- Data Provenance: The studies were prospective animal studies conducted by Oncobionics. No country of origin is specified beyond the company's address in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or diagnostic performance. The ground truth for ablation effectiveness (e.g., lesion size, tissue damage) would likely have been determined directly through anatomical and histological examination of the ablated animal tissues by veterinarians, pathologists, or other relevant scientific personnel. However, the document does not specify the number or qualifications of these individuals.
4. Adjudication Method for the Test Set
Not applicable. The reported studies are focused on direct physical effects of ablation on tissue, not on subjective interpretations or diagnoses that would require adjudication among multiple readers or experts.
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
Not applicable. This device is an ablation system, not an AI-powered diagnostic or decision-support tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not entirely applicable in the context of an ablation device. The device itself is "standalone" in that it performs the ablation based on operator-selected parameters. However, there isn't a "standalone algorithm performance" in the way one might evaluate an AI diagnostic tool. The performance evaluated was the direct effect of the device on tissue.
7. The Type of Ground Truth Used
The ground truth used in the studies described was likely:
- Physiological/Anatomical Data: Direct measurement and observation of the ablated tissue, including lesion size, in-vivo.
- Histopathological Data: Microscopic examination of tissue samples to confirm the extent and nature of tissue damage caused by ablation (though not explicitly stated, this is standard practice for such studies).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product developed with a training set. The "in-vitro testing to confirm the proof of concept" and "in-vivo animal tissue testing regarding the use of different voltages" served as developmental and optimization studies, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The "ground truth" for optimizing the device's parameters (like minimum voltage for target lesion size) would have been established through direct experimental observation and measurement in the in-vivo animal studies.
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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: (949) 888-6658 Fax Number: (949) 888-6659
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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Kobvoszl
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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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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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§ 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.