(101 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware changes for convenience, not algorithmic capabilities.
Yes
The device is indicated for "surgical ablation of soft tissue," which is a therapeutic intervention.
No
The device is indicated for surgical ablation of soft tissue, which is a treatment (therapeutic) function, not a diagnostic one.
No
The device description explicitly mentions a "Generator" and "electrodes," which are hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for surgical ablation of soft tissue." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from a patient.
- Device Description: The device is a "System with 6 probe output" used to connect electrodes for treatment. This aligns with a surgical or therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information. The focus is on delivering energy for ablation.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is therapeutic (ablation), not diagnostic.
N/A
Intended Use / Indications for Use
The Oncobionic System with 6 probe output is indicated for use for surgical ablation of soft tissue.
Product codes
OAB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
80202
Page 1 of 2
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
1
Kogo202
Page 2 of 2
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.
2
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
3
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
4
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