Pajunk RFTL Radiofrequency needles are electrically insulated and may be used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.

Device Description

Pajunk RFTL Radiofrequency needles are intended for coagulation of soft tissues, such as in long term pain treatment via neurosurgical lesioning procedures, as determined by professional neurosurgeon/ anesthetist and the instructions for use. These RF-cannulas are single use, sterile, non-pyrogenic and latex free medical devices. The RF-cannulas have bevel tips with an active area of 2 - 10 mm.

The needle puncture depth depends on the path chosen by the surgeon to reach and to eliminate the nerve bundle site. This required needle length is the patient contact part of the thermolesion needle. The nerve causing constant pain will be disrupted by utilizing the thermolesion heat radiating from the needle tip. Heat is generated by radio frequency and radiates only from the non-insulated needle tip. This limited heat radiation is used for focussed heat treatment depending on the surgeon's method of operation.

AI/ML Overview

This document is a Premarket Notification Submission (510k) for the Pajunk Thermolesion Cannula "RFTL Radiofrequency Needle". A 510k submission primarily demonstrates substantial equivalence to a predicate device, rather than conducting a de novo study with acceptance criteria and performance reporting as might be expected for a novel device. Therefore, the information provided below will reflect the nature of a 510k submission.

Here is an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. The performance is then judged on how well it matches or is considered equivalent to the predicate.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Summary of Equivalence)
Intended Use: Similar indications for use.	Pajunk RFTL Radiofrequency needles are intended for coagulation of soft tissues, such as in long term pain treatment via neurosurgical lesioning procedures. (Page 2) Also, the Pajunk RFTL Radiofrequency needles are electrically insulated and may be used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. (Page 4)
Technological Characteristics: Similar design, materials, and operating principles.	The indications for use as well as the basic technological characteristics of Pajunk's RFTL cannulas are identical to Radionics thermo lesion needles K021942 manufactured by TOP. Coating, overall cannula length of deinsulated tip are substantially equivalent and as safe and effective as the predicate device's. (Page 2) Pajunk's RFTL cannulas have the same technological characteristics as the predicate device identified above. (Page 2) The NanoLine coating technique Pajunks cannulas are coated with is cleared for market in Pajunks NanoLine PMN K053283. (Page 2)
Safety and Effectiveness: Demonstrate device is as safe and effective as the predicate.	Pajunk's single use anesthesia conduction needles for thermo lesion and neuro-stimulation are substantially equivalent in technique, specification, intended use, safety and effectiveness to the marketed predicate device listed above. (Page 2) The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices. (Page 2)
Sterilization: Equivalent sterilization methods.	The contract sterilizer and the sterilizing process... is the same as that used for Unipolar cannulas cleared for market by FDA under 510(k) number K000722 and Kit Products Pajunks Stimulong Set K043130, K033018 and Pajunks Plexolong Set K042979, K023218, K013041. (Page 2)
Packaging: Equivalent packaging materials and procedures.	The packaging materials and procedures of Pajunk's RFTL cannulas are the same as those used for Unipolar cannulas cleared for market by FDA under 510(k) number K000722 and Kit Products Pajunks Stimulong Set K043130, K033018 and Pajunks Plexolong Set K042979, K023218, K013041. (Page 2)

2. Sample Size Used for the Test Set and Data Provenance

This is a 510(k) submission focused on demonstrating substantial equivalence to predicate devices, not on a clinical study that would involve a "test set" in the traditional sense with patient data. Therefore, details regarding a specific sample size for a test set or data provenance (country of origin, retrospective/prospective) are not applicable to this document as no such study is described. The demonstration of equivalence relies on comparing technical characteristics and intended use, not on new clinical performance data from a dedicated test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As explained above, no separate "test set" with ground truth established by experts is discussed in this 510(k) submission. Therefore, this information is not applicable. The "ground truth", in a broader sense for a 510(k), is the established safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set

Again, no "test set" or clinical study requiring an adjudication method is described in this 510(k) submission. This information is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned or implied in this 510(k) submission. This information is not applicable. The submission focuses on device characteristics and equivalence, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device (a radiofrequency needle) is a physical medical instrument, not an algorithm or AI system. Therefore, the concept of a "standalone algorithm performance" is not applicable. Its use invariably involves a human neurosurgeon/anesthetist.

7. The Type of Ground Truth Used

For a 510(k) submission, the "ground truth" is typically the established safety and effectiveness of the legally marketed predicate devices. The new device aims to be substantially equivalent to this established standard. In this case, the predicate devices are "Radionics thermo lesion needles K021942" and "Stryker's RF cannulas K032406". The comparison also references other Pajunk devices previously cleared by FDA for sterilization and packaging equivalence (K000722, K043130, K033018, K042979, K023218, K013041, K053283).

8. The Sample Size for the Training Set

No "training set" in the context of an algorithm or AI development is mentioned in this document. This information is not applicable.

9. How the Ground Truth for the Training Set Was Established

As no "training set" or AI/algorithm development is described, the method for establishing its "ground truth" is not applicable.

Summary

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Thermolesion Premarket Notification Submission

KO 60397

510(k) Premarket Notification Submission:

Summary of Safety and Effectiveness

Date of Preparation: July 10th, 2006

Page 1 of 2

AUG 3 1 2006

MEDIZINTECHNOLOGIE

Submitter Information/ production site:

Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-00 Fax: +49(0)7704-9291-605

Sterilizer: SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Mörfelden Germany Tel +49 6105 23091 or +49 (0) 6105 93470 Fax +49 6105 24760

Contact:

Christian Quass, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com

Establishment Registration Number:

9611612

Device Information:

Trade Names:	Pajunk RFTL Radiofrequency needle
Common Name:	Disposable cannula for RF Thermolesion
Classification Name:	Neurological Devices: Radiofrequency lesion probe
Classification Reference:	21 CFR 882.4725, April 1. 2005
Proposed Classification:	Regulatory Class II
Proposed Product Code:	GXI
Predicate Devices:	1. Radionics thermo lesion needles K0219422. Stryker's RF cannulas K032406

2006-06-27 007

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Device Description:

MEDIZINTECHNOLOGIE

Page 2 of 2

Predicate Devices

Pajunk's single use anesthesia conduction needles for thermo lesion and neuro-stimulation are substantially equivalent in technique, specification, intended use, safety and effectiveness to the marketed predicate device listed above.

Sterilization

The contract sterilizer and the sterilizing process other than a company name change (was IBA Griffith Micro Science, and now is Sterigenics) is the same as that used for Unipolar cannulas cleared for market by FDA under 510(k) number K000722 and Kit Products Pajunks Stimulong Set K043130, K033018 and Pajunks Plexolong Set K042979, K023218, K013041.

Packaging

The packaging materials and procedures of Pajunk's RFTL cannulas are the same as those used for Unipolar cannulas cleared for market by FDA under 510(k) number K000722 and Kit Products Pajunks Stimulong Set K043130, K033018 and Pajunks Plexolong Set K042979, K023218, K013041.

Technology Characteristics

The indications for use as well as the basic technological characteristics of Pajunk's RFTL cannulas are identical to Radionics thermo lesion needles K021942 manufactured by TOP. Coating, overall cannula lenght of deinsulated tip are substantially equivalent and as safe and effective as the predicate device's.

Pajunk's RFTL cannulas have the same technological characteristics as the predicate device identified above.

The NanoLine coating technique Pajunks cannulas are coated with is cleared for market in Pajunks NanoLine PMN K053283.

Conclusion:

The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2006

Pajunk GmbH Medizintechnologie % Mr. Christian Quass Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen, Germany

Re: K060397

Trade/Device Name: Pajunk Thermolesion Cannula ,,RFTL Radiofrequency Needle" Regulatory Number: 21 CFR 882.4725 Regulatory Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: July 31, 2006 Received: August 3, 2006

Dear Mr. Quass:

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.

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Page 2 - Mr. Christian Quass

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marv Sacturers, 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 you

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/1 description: This document is a Thermolesion Premarket Notification Submission from Pajunk. The 510(k) Number is K060397, and the device name is Pajunk Thermolesion Cannula "RFTL Radiofrequency Needle". The indications for use are that the Pajunk RFTL Radiofrequency needles are electrically insulated and may be used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The document indicates prescription use and is page 1 of 1.

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).