(150 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on the physical electrodes and energy delivery.
Yes
The device is intended for surgical ablation of soft tissue, which is a therapeutic intervention.
No
The device is intended for surgical ablation of soft tissue, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Bipolar Electrode" which is a physical hardware component used for surgical ablation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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 a sample taken from the body.
- Device Description: The device delivers energy to cause an "ablation effect." This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is therapeutic (ablation), not diagnostic.
N/A
Intended Use / Indications for Use
The Oncobionic Bipolar Electrode is intended to be used only with the Oncobionic System and is intended for surgical ablation of soft tissue.
Product codes
GEI
Device Description
The Oncobionic Bipolar Electrode combines two electrodes into one device. The combined electrodes operate to deliver energy from the previously cleared Oncobionic System (K060054). The Oncobionic Bipolar electrode applies a LEDC pulse or series of pulses between two electrodes to cause an ablation effect to occur.
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
in-vivo test data, Attachment 1, which shows the Oncobionic Bipolar Electrode to be at least as safe and effective as the predicate devices. This test shows that the Oncobionic Bipolar Electrode is substantially equivalent to the predicate devices for creating ablation zones in soft tissue.
Key Metrics
Not Found
Predicate Device(s)
Oncobionic System, K060054, Rita Medical UniBlate Electrosurgical 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
pg 1 of 2
510k Summary
JUL - 3 2008
This 510K 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:
-
AngioDynamics, Inc. Name: 603 Queensbury Avenue Address:
Queensbury, New York 12804 -
518-798-1215 Telephone Number:
-
Teri Juckett Contact Person:
-
February 1, 2008 Date Submitted:
Device information:
| Name of Device: | Bipolar Electrode |
|---|---|
| Common Name: | Tissue Ablation Accessory |
| Classification: | Electrosurgical Cutting and Coagulation Device |
Predicate Device information:
Oncobionic System, K060054
Rita Medical UniBlate Electrosurgical Device, K070101
Device Description:
The Oncobionic Bipolar Electrode combines two electrodes into one device. The combined electrodes operate to deliver energy from the previously cleared Oncobionic System (K060054). The Oncobionic Bipolar electrode applies a LEDC pulse or series of pulses between two electrodes to cause an ablation effect to occur.
1
K080287 pg2c
510k Summary Continued
Intended Use:
The Oncobionic Bipolar Electrode is intended to be used only with the Oncobionic System and is intended for surgical ablation of soft tissue.
Comparison to Predicate Device:
The Oncobionic Bipolar Electrode created equivalent tissue ablation to the Rita Medical UniBlate Electrosurgical Device. The Oncobionic System is as safe and effective as the Oncobionic Electrode K060054. We have compared the efficacy of our device to the predicate devices and found them equivalent.
Performance Data:
We have included in-vivo test data, Attachment 1, which shows the Oncobionic Bipolar Electrode to be at least as safe and effective as the predicate devices. This test shows that the Oncobionic Bipolar Electrode is substantially equivalent to the predicate devices for creating ablation zones in soft tissue.
Sterilization Validation:
The Sterilization method used for the single use Oncobionic Bipolar Electrode is Ethylene Oxide Sterilization.
Software Validation:
The Oncobionic Bipolar Electrode does not use software.
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 forming three curved lines. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2008
AngioDynamics, Inc. % Mr. Teri Juckett 602 Qucensbury Avenue Queensbury, New York 12804
Re: K080287
Trade/Device Name: Oncobionic Bipolar Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 30, 2008 Received: June 30, 2008
Dear Mr. Juckett:
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 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.
3
Page 2 - Mr. Teri Juckett
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 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. Millison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
P9
Indications for Use
510(k) Number:
Device Name: Oncobionic Bipolar Electrode
Indications for Use: The Oncobionic Bipolar Electrode is intended to be used only with the Oncobionic System and is indicated for surgical ablation of soft tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
រូបក្រូវប្រជុំដូចជួយដោយ ប្រកួតប្រទេស ប
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number /C080287