(50 days)
No
The summary describes a device that uses electrical pulses for ablation and mentions adding new treatment parameters, but there is no mention of AI, ML, image processing, or any data-driven decision-making process.
Yes
The device is indicated for surgical ablation of soft tissue, which is a therapeutic intervention.
No
The device is described as being for "surgical ablation of soft tissue" and applies "a pulse or series of pulses... to cause an ablation effect." This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states the system applies a "LEDC pulse or series of pulses between two electrodes," indicating the presence of hardware components (electrodes and a pulse generator) beyond just software.
Based on the provided information, the Oncobionic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "surgical ablation of soft tissue." This describes a procedure performed directly on a patient's body, not a test performed on samples outside the body.
- Device Description: The description details the application of energy (LEDC pulse) between electrodes to cause ablation in soft tissue. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Oncobionic System's function is to physically alter tissue through ablation, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The Oncobionic System is indicated for surgical ablation of soft tissue
Product codes
OAB
Device Description
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
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
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.
Key Metrics
Not Found
Predicate Device(s)
Oncobionic System K060054, Rita Medical UniBlate Device (K070101)
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
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.
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: | February 8, 2008 |
February 8, 2008
Device Information:
Name of Device Oncobionic System
Common Name:
Tissue Ablation Device
Classification: Electrosurgical Cutting and Coagulation Device
Predicate Device Information:
Oncobionic System K060054
Rita Medical UniBlate Device (K070101)
1
1
510k Summary
Device Description:
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
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.
2
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
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 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
4
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)
1
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