(90 days)
The Nourotherm Radiofrequency Lesion cannula is indicated for use in neurosurgical lesioning procedures. Examples of these procedures include, but are not limited to, lessioning of nerve fibers for the reatment of pain and lesioning of the brain, spinal cord as in thalamotomies, pallidotomies, cordotomics and hypophysectossiones.
This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA
I am sorry, but based on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and a study proving device performance. The document is a 510(k) submission summary for a "Neurotherm Radiofrequency Lesion Cannula" from Rocket Medical plc. The text focuses on:
- Substantial Equivalence: It states that the device is substantially equivalent to existing devices and has been tested for safety and effectiveness for over 9 years without incident in the UK and other countries.
- Regulatory Information: It includes the notification of intent to market, regulatory class, product code, and the FDA's response regarding the substantial equivalence determination.
- Indications for Use: It specifies the neurosurgical lesioning procedures for which the cannula is intended.
The document does not contain:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- Details about a specific study designed to meet those acceptance criteria.
- Information on sample sizes (test set, training set).
- Data provenance, expert qualifications, or adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
Therefore, I cannot populate the table or answer the specific questions based on the provided input. This document serves as a regulatory clearance notice, not a detailed technical study report.
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Summary of Safety and Effectiveness
This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA
The device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness in this format for over 9 years, without incident in the UK and other countries around the world.
Rocket Medical plc., continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
Date: 17th December 1999
262M
Signed by Leslie Todd Quality Assurance and Regulatory Affairs Manager Rocket Medical plc Wear Industrial Estate, Washington Tyne & Wear, England. NE37 1NE
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Public Health Service
MAR 2 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Leslie Todd Quality Assurance and Regulatory Affairs Manager Rocket Medical plc Factories 3 & 4 Wear Industrial Estate, Washington Tyne & Wear, England NE37 INE
K994344 Re:
Trade Name: Neurotherm Radiofrequency Lesion Cannula Regulatory Class: II Product Code: GXI Dated: December 17, 1999 Received: December 22, 1999
Dear Mr. Todd:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Leslie Todd
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fa
Celia M. Witten, Ph.D., M.D. Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K994344 Kocket Medical plc - 510(k) Notification Radiofrequency Lesson Cannula
Indications for Use
The Nourotherm Radiofrequency Lesion cannula is indicated for use in neurosurgical lesioning procedures. Examples of these procedures include, but are not limited to, lessioning of nerve fibers for the reatment of pain and lesioning of the brain, spinal cord as in thalamotomies, pallidotomies, cordotomics and hypophysectossiones.
Z. Zill
Signed L.Todd QA and Regulatory Affairs Manager
Rocket Medical Plc 17th March 2000.
Stypt Ruvder
(Division Sign Off) Division of General Restorative Devices |<99 YJY 4 510(k) Number
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§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).