RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED

K060397 · PAJUNK GmbH Medizintechnologie · GXI · Aug 31, 2006 · Neurology

Device Facts

• Record ID: K060397
• Device Name: RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: GXI · Neurology
• Decision Date: Aug 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Pajunk RFTL Radiofrequency needle is a single-use, sterile, non-pyrogenic, latex-free cannula; used for percutaneous nerve blocks or radiofrequency (RF) lesioning of soft tissues. Device features bevel tips with 2-10 mm active (non-insulated) areas. Operated by neurosurgeons or anesthetists in clinical settings. Principle of operation: needle is inserted to reach a target nerve bundle; RF energy is applied to the non-insulated tip to generate heat; heat radiates from the tip to disrupt the nerve causing chronic pain. Output is focused thermal energy for tissue coagulation. Device allows for precise, localized heat treatment based on surgeon's operational method.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, design, and intended use comparisons to predicate devices.

Technological Characteristics

Single-use RF cannula; bevel tip with 2-10 mm active (non-insulated) area; NanoLine coating; electrically insulated shaft. Energy source: external RF generator (not provided). Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for patients requiring percutaneous nerve blocks with local anesthetic or radiofrequency lesioning for long-term pain treatment, as determined by a neurosurgeon or anesthetist.

Regulatory Classification

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.

Predicate Devices

• Radionics thermo lesion needles (K021942)
• Stryker's RF cannulas (K032406)

Reference Devices

• Unipolar cannulas (K000722)
• Pajunks Stimulong Set (K043130)
• Pajunks Stimulong Set (K033018)
• Pajunks Plexolong Set (K042979)
• Pajunks Plexolong Set (K023218)
• Pajunks Plexolong Set (K013041)
• Pajunks NanoLine (K053283)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

## Sterilizer: SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Mörfelden Germany Tel [phone] or [phone] Fax [phone]

### Contact:

Christian Quass, Regulatory Affairs Fon: [phone] Fax: [phone] E-Mail: [e-mail]

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 K021942<br>2. Stryker's RF cannulas K032406 |

2006-06-27 007

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#### Device Description:

MEDIZINTECHNOLOGIE

Page 2 of 2

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.

#### 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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

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 [phone]. 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 [phone] or [phone] 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.