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.

AI/ML Overview

The provided document is a 510(k) summary for the Minta Ryan RF Thermocouple Electrode. It states that this device is the same device that was previously cleared under K011387, with only a name change. Therefore, the acceptance criteria and the study that proves the device meets them refer to the original submission, K011387, and not to a new study conducted for K090608.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a table format with specific quantitative targets. Instead, it refers to the performance established with the predicate device (K011387). The core claim is that the device is the predicate device.

Acceptance Criteria (Implied from predicate device)	Reported Device Performance (as the same device)
Functional performance characteristics of a Radiofrequency Lesion Probe for lesioning peripheral nerve tissue.	"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."
Compatibility with predicate RF Lesion Generators (Neurotherm K011387) and disposable cannulas (Pajunk K060397).	"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." Also, "specific performance and compatibility testing was performed with the Neurotherm RF Lesion Generators to show that the performance was met."
Safety and effectiveness for its intended application.	"The Minta Ryan RF Thermocouple Electrodes are safe and effective for the application for which they are intended 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."
Re-processability for steam sterilization.	"Additional steam sterilisation validation studies were carried out in February 2010 to validate each of the recommended sterilisation processes."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states that "All non-clinical data for the Minta Ryan RF Thermocouple Electrode was submitted under K011387 to confirm the performance characteristics." It also mentions "functional performance testing" and "compatibility testing" but does not specify the sample size or data provenance beyond asserting the device's long-standing use in the UK, other countries, and the USA since 2001. No specific test set sample size is provided for K090608, as the justification relies on the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not describe a study involving expert review for establishing ground truth, as it is a submission for a non-clinical device based on equivalence to a predicate. The testing mentioned is for functional performance and compatibility, not diagnostic accuracy requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described, as the evaluation is based on non-clinical performance and compatibility testing, not diagnostic accuracy.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done, as this device is a physical electrode, not a diagnostic AI or imaging system. Therefore, there's no mention of human reader improvement or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation was implicitly done, as the document refers to "functional performance" and "compatibility testing" of the device itself. However, this is for a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device would be its demonstrated functional performance in generating radiofrequency lesions and its compatibility with specified RF generators and cannulas, established through engineering and performance testing. There's no mention of expert consensus, pathology, or outcomes data as "ground truth" for this type of device submission.

8. The sample size for the training set

This is not applicable. The device is a physical electrode, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set mentioned for this device.

Summary

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K090608

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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 LimitedCaddick RoadKnowsley Business ParkKnowsleyPrescotMerseysideUnited KingdomL34 9HP
Contact Name:	Andrew Edwards
Position:	Managing Director
Telephone:E-Mail:	+44(0)151 548 6818andy.edwards@mintamedical.co.uk
Date prepared:	8th July 2009
Trade Name:	Minta Ryan RF Thermocouple Electrode
Common Name:	Radiofrequency Lesion Probe
Classification:	Radiofrequency Lesion ProbeCFR882. 4725Product Code: GXIClass 2 Neurology Devices
Predicate Devices:	(SAME DEVICE) Neurotherm RF Lesioning System Probes(K011387)
Description:	The Minta Ryan RF Thermocouple Electrodes havebeen in use in this format for over fifteen years in the UKand other countries around the world including theU.S.A. previously labelled as Neurotherm (K011387).(Minta Medical Registration No. 3004617090,owner/operator Number 9064097).The Minta Ryan RF Thermocouple Electrodes are used inconjunction with the commercially available Neurotherm(K011387), RF Lesion Generators and Pajunk RFdisposable cannula (K060397) to create radiofrequency(RF) lesioning of peripheral nerve tissue.

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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.

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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

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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.

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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.

Regulation Number and Section

§ 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).