(135 days)
Not Found
No
The summary describes a standard RF ablation device and its components, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is intended for "coagulation and ablation of tissue" and "palliation of pain," which are therapeutic actions aimed at treating medical conditions.
No
The device is described as an electrosurgical device intended for "coagulation and ablation of tissue," which are treatment procedures, not diagnostic ones. It also mentions "temperature feedback to the generator," but this feedback is used to guide the ablation process, not to diagnose a condition.
No
The device description explicitly states it is a monopolar radiofrequency (RF) device consisting of a physical electrode, electrical cable, and infusion tubing set. It connects to a generator and pump, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a device that delivers radiofrequency energy and infuses saline for tissue ablation. This is a surgical tool, not a device used to examine specimens from the body.
- 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 from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
The AngioDynamics Uniblate System is intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures, such ar martial or complete ablation of non-resectable liver lesions, osteoid osteoma, and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
Product codes
GEI
Device Description
The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode that provides an adjustable ablation zone of 1 cm-3 cm. The device has an attached electrical cable and infusion tubing set which connects the it directly to the RTA Medical 1500X RF generator and the IntelliFlow peristaltic pump. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal salive through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue, liver lesions, osteoid osteoma, bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
percutaneous, laparoscopic, and intraoperative surgical procedures
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
Not Found
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
KO80451
JUL - 3 2008
510(k) Summary
Date: February 15, 2008
Sponsor of the 510(k)
AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12801 Establishment Registration number 1319211 Contact: Brian Kunst, Vice President, Regulatory Affairs and Quality Assurance 518-798-1215, x1123
Device Identification:
Proprietary Name: Common Name: Classification Name:
Classification Number: Classification Panel: Product Code: Regulatory Class:
Uniblate Electrosurgical Device Radiofrequency probe Electrosurgical cutting and coagulation device and accessories 21 CFR §878.4400 General and Plastic Surgery GEI II
Legally marketed device to which equivalence is claimed:
Angiodynamics Uniblate Electrosurgical Device, 510(k) K070101 Angiodynamics (formerly RITA Medical Systems) Starburst Electrosurgical Device 510(k) K030967 Valleylab Cool-Tip Electrosurgical probe, 510(k) K052796
Intended Use / Indications
The AngioDynamics Uniblate System is intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures, such ar martial or complete ablation of non-resectable liver lesions, osteoid osteoma, and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
Page 1 of 2
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K08045
Device Description
The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode that provides an adjustable ablation zone of 1 cm-3 cm. The device has an attached electrical cable and infusion tubing set which connects the it directly to the RTA Medical 1500X RF generator and the IntelliFlow peristaltic pump. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal salive through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.
Technological Differences:
The AngioDynamics UniBlate, AngioDynamics Starburst Electrosurgical device (K030967), and Valleylab Cool-Tip (K052796) are monopolar electrodes used to deliver RF energy during open, laparoscopic or percutaneous procedures to ablate and coagulate soft tissue. The UniBlate is designed to provide a scaleable coagulation zone. The UniBlate electrode has a single active electrode that can be exposed from 1 cm to 2.5 cm by retracting an insulating sheath. The Cool-Tip has a fixed length active electrode, but is available in different sizes of 1cm, 2cm, and 3cm. The UniBlate allows for local fluid delivery as well as temperature monitoring. The Starburst SDE is a mulit-tined probe that provides an adjustable ablation zone up to 2cm.
Intended Use
The AngioDynamics Uniblate Electrosurgical Device is intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgious procedures, such as partial or complete ablation of non-resectable liver sugars, osteoid osteoma, and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy
The Angiodynamics Starburst electrosurgical device is indicated for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgional procedures, such as partial or complete ablation of non-resectable liver lessions and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy
The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of several curved lines. The symbol is positioned in the center of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AngioDynamis, Inc. % Mr. Brian Kunst 603 Queensbury Avenue Qucensbury, New York 12804
JUL - 3 2008
Re: K080451
Trade/Device Name: Uniblate Electrosurgical Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 24, 2008 Received: May 29, 2008
Dear Mr. Kunst:
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. Brian Kunst
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence 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 Prostmarket, 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 vours.
Mark N Millham
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K080451
Device Name: Uniblate Electrosurgical Device
Indications for Use:
The AngioDynamics Uniblate Electrosurgical Device is intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures such as partial or complete ablation of non-resectable liver lesions, osteoid osteoma, and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807
Subpart C)
(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