(465 days)
No
The device description and performance studies focus on the physical components, temperature sensing, and compatibility with existing RF lesion generators, with no mention of AI or ML algorithms for data analysis, decision-making, or control.
Yes
The device is used to create radiofrequency lesions in peripheral nerve tissue for therapeutic purposes, as indicated in the "Intended Use / Indications for Use" and "Device Description" sections.
No
Explanation: The device is described as an electrode used to deliver radiofrequency energy to create lesions in peripheral nerve tissue and to measure the temperature at the tip during this process. Its primary function is therapeutic (lesioning), not diagnostic. While it measures temperature, this measurement appears to be for monitoring the therapeutic process rather than for diagnosing a condition.
No
The device description explicitly details physical components (stainless steel shaft, PET hub, silicone rubber insulated electrical lead, plug connector) and describes it as a temperature sensor (thermocouple) used to deliver RF energy and measure temperature, 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 is "lesioning of peripheral nerve tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a temperature sensor and energy delivery tool used in conjunction with other devices to create lesions in nerve tissue. This is an interventional device used for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are used to diagnose, monitor, or screen for diseases or conditions using samples like blood, urine, or tissue.
This device falls under the category of therapeutic or interventional medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Minta Ryan RF Thermocouple Electrodes are indicated for use in the lesioning of peripheral nerve tissue.
Product codes (comma separated list FDA assigned to the subject device)
GXI
Device Description
The Minta Ryan RF Thermocouple Electrodes have been in use in this format for over fifteen years in the UK and other countries around the world including the U.S.A. previously labelled as Neurotherm (K011387). The Minta Ryan RF Thermocouple Electrodes are used in conjunction with the commercially available Neurotherm (K011387), RF Lesion Generators and Pajunk RF disposable cannula (K060397) to create radiofrequency (RF) lesioning of peripheral nerve tissue.
The Minta Ryan RF Thermocouple Electrode is a temperature sensor (thermocouple) which is used to deliver RF energy to the tissue. The RF energy is then transferred from the electrode which heats the surrounding tissue to create a lesion. The thermocouple also measures the temperature at the tip of the electrode. The Minta Ryan RF Thermocouple Electrodes are provided as non-sterile re-usable devices (re-processed single use). The Minta Ryan RF Thermocouple Electrode will be available in a variety of lengths and gauges. The Minta Ryan RF Thermocouple Electrode consists of a stainless steel shaft, a PET (polyethylene terephthalate) hub; a non-latex silicone rubber insulated electrical lead and a plug connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to validate the functional performance of the Minta Ryan RF Thermocouple Electrode. In particular, specific performance and compatibility testing was performed with the Neurotherm RF Lesion Generators to show that the performance was met.
Additional steam sterilisation validation studies were carried out in February 2010 to validate each of the recommended sterilisation processes.
The Minta Ryan RF Thermocouple Electrodes are safe and effective for the application for which they are intended and have been tested to che the safety and effectiveness in this formation and have been tested to confirm their safety and effectiveness in this format for over 15 years, without incident in their UK and other countries, plus the USA since 2001 , without incident in the UK and other countries, plus the USA since 2001.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Page 1 of 3
:
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 (c).
| Owners information: | Minta Medical Limited
Caddick Road
Knowsley Business Park
Knowsley
Prescot
Merseyside
United Kingdom
L34 9HP |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Andrew Edwards |
| Position: | Managing Director |
| Telephone:
E-Mail: | +44(0)151 548 6818
andy.edwards@mintamedical.co.uk |
| Date prepared: | 8th July 2009 |
| Trade Name: | Minta Ryan RF Thermocouple Electrode |
| Common Name: | Radiofrequency Lesion Probe |
| Classification: | Radiofrequency Lesion Probe
CFR882. 4725
Product Code: GXI
Class 2 Neurology Devices |
| Predicate Devices: | (SAME DEVICE) Neurotherm RF Lesioning System Probes
(K011387) |
| Description: | The Minta Ryan RF Thermocouple Electrodes have
been in use in this format for over fifteen years in the UK
and other countries around the world including the
U.S.A. previously labelled as Neurotherm (K011387).
(Minta Medical Registration No. 3004617090,
owner/operator Number 9064097).
The Minta Ryan RF Thermocouple Electrodes are used in
conjunction with the commercially available Neurotherm
(K011387), RF Lesion Generators and Pajunk RF
disposable cannula (K060397) to create radiofrequency
(RF) lesioning of peripheral nerve tissue. |
1
The Minta Ryan RF Thermocouple Electrode is a temperature sensor (thermocouple) which is used to deliver RF energy to the tissue.
The RF energy is then transferred from the electrode which heats the surrounding tissue to create a lesion. The thermocouple also measures the temperature at the tip of the electrode.
The Minta Ryan RF Thermocouple Electrodes are provided as non-sterile re-usable devices (re-processed single use).
The Minta Ryan RF Thermocouple Electrode will be available in a variety of lengths and gauges.
The Minta Ryan RF Thermocouple Electrode consists of a stainless steel shaft, a PET (polyethylene terephthalate) hub; a non-latex silicone rubber insulated electrical lead and a plug connector.
INTENDED USE
The Minta Ryan RF Thermocouple Electrodes are indicated for use in the lesioning of peripheral nerve tissue.
TECHNOLOGICAL CHARACTERISTICS
The Minta Ryan RF Thermocouple Electrodes have the same technological characteristics and intended use as the original device which was cleared for marketing in the U.S in 2001 under K011387.
They are the same device (name change only).
COMPARISON TO PREDICATE
The Minta RYAN RF Thermocouple Electrode is the same device that was cleared for marketing under K011387.
NON-CLINICAL DATA
All non-clinical data for the Minta Ryan RF Thermocouple Electrode was submitted under K011387 to confirm the performance characteristics.
A risk analysis identifying potential hazards and documentary mitigations of the hazards was developed and applied for K011387.
Testing was performed to validate the functional performance of the Minta Ryan RF Thermocouple Electrode. In particular, specific performance and compatibility testing was performed with the Neurotherm RF Lesion Generators to show that the performance was met.
2
Page 3 of 3
STERILISATION
Additional steam sterilisation validation studies were carried out in February 2010 to validate each of the recommended sterilisation processes.
CONCLUSION
The Minta Ryan RF Thermocouple Electrodes are safe and effective for the application for which they are intended and have been tested to che the
safety and effectiveness in this formation and have been tested to confirm their safety and effectiveness in this format for over 15 years, without incident in their
UK and other countries, plus the USA since 2001 , without incident in the UK and other countries, plus the USA since 2001.
The fundamental scientific technology of the Minta Ryan RF Thermocouple
Electrode was submitted under K011207 Electrode was submitted under K011387.
SIGNED:
:
ANDREW EDWARDS
MANAGING DIRECTOR
DATED: 7th May 2010
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, body, and legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUN 1 4 2010
Minta Medical Limited c/o Mr. Andrew Edwards Managing Director Caddick Road Knowsley Business Park Knowsley Prescot Merseyside United Kingdom L34 9HP
Re: K090608
Trade/Device Name: Minta Ryan RF Therocouple Electrode . Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: June 4, 2010 Received: June 7, 2010
Dear Mr. Edwards:
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 for are 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be may of saysor de a decessed Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcestoYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/4/Picture/7 description: The image contains a handwritten word "for" in cursive. The letter "f" has a descending loop that extends below the baseline, and the "o" and "r" are connected with a smooth curve. The writing appears to be done with a pen or marker, and the stroke thickness varies slightly, giving it a natural, handwritten look.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4
Sheet 1 of 1
Indications for Use
510(K) Number (if known): K090608
Device Name: Minta Ryan Radiofrequency Thermocouple Electrode
Indications for Use: The Minta Radiofrequency Thermocouple Electrodes are indicated for use in the lesioning of peripheral nerve tissue.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dani Kaufman
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
090608 510(k) Number.