SMK, CX, CXE, RCN

K042375 · Technomed Europe · GXI · Oct 26, 2004 · Neurology

Device Facts

• Record ID: K042375
• Device Name: SMK, CX, CXE, RCN
• Applicant: Technomed Europe
• Product Code: GXI · Neurology
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A RF Injection Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radio frequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radio frequency lesion may be made.

Device Story

RF Injection Needles (SMK, CXE, CX, RCN models) are disposable cannulae used for percutaneous nerve blocks and radiofrequency (RF) lesioning. Input signals include electrical stimulation for nerve localization; input media include local anesthetics or contrast agents for radiographic guidance. The device functions as a conduit for anesthetic delivery or as an electrode for RF energy transfer to heat tissue and create lesions. Used in clinical settings by physicians; the needle connects to external RF generators or stimulus generators. The provider uses the needle to localize nerves, then delivers therapy (anesthetic or RF heat) to manage pain. Benefits include precise nerve targeting and minimally invasive pain relief.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Disposable hypodermic tubing cannulae with Luer hubs. Features include insulated shafts with uninsulated tips for RF energy delivery. Models vary by tip exposure (e.g., 1mm, 5mm) and electrical connectivity. Materials include hypodermic tubing and PVC tubing. Connectivity via electrical lead to external RF/stimulus generators. Sterilization method not specified.

Indications for Use

Indicated for percutaneous nerve blocks with local anesthetic or radiofrequency lesioning for pain relief. Used for nerve localization via electrical stimulation or radiographic contrast injection.

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 Pole Needles (K021942)
• Radionics disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) (K980430)
• RSM-C, Sluijter-Mehta Cannula (K963577)
• SMK Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible Needles (K870028)

Submission Summary (Full Text)

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OCT 2 6 2004

Attachment D:

K042375

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## 510(k) Summary

| Manufacturer: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands | | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by: | Technomed Europe<br>Amerikalaan 71<br>6199 AE Maastricht Airport<br>The Netherlands | | |
| Contact person: | René Roncken<br>Manager Quality Assurance<br>Tel.: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | | |
| Date: | August 18, 2004 | | |
| Proprietary Name: | RF Injections Needles | | |
| Common/usual Name: | Disposable cannula for radio frequency electrode | | |
| Classification Name: | Radiofrequency lesion probe (21 CFR section 882.4725) | | |
| Substantial Equivalence: | K021942:<br>K980430:<br>K963577:<br>K870028: | Radionics Pole Needles<br>Radionics disposable RF Cannulae (SC-C, RFK-<br>DB, RFK-DS)<br>RSM-C, Sluijter-Mehta Cannula<br>SMK Sluijter-Mehta Cannulae, RF Pole, Pole and<br>Flexible Needles | |
| Device description: | There are four types of needles: SMK, CXE, CX and RCN<br><br>SMK is used in radiofrequency (RF) lesion procedures for the<br>relief of pain. The device allows an injection of local anesthetic<br>to relieve the pain of RF. A SMK-TC electrode is then place<br>into the cannulae to create the lesion. The length of the cannula<br>is insulated except for a section of the tip. The RF energy is<br>then transferred from the electrode through this uninsulated<br>portion which heats the surrounding tissue to create a lesion.<br><br>CXE is used for percutaneous facet denervations. The device<br>consists of a shaft of hypodermic tubing, which is insulated<br>except for 5mm at the tip. Plastic tubing and an electrical lead<br>are unitized in a single flexible leader portion, which connects<br>to the shaft. The lead is insulated and feed through the plastic<br>tube. A Luer hub on the tubing allows injection of local<br>anesthetic. The needle can be connected to a Radionics<br>generator for stimulation and lesioning. The RF pole does not<br>allow for temperature monitoring. | | |

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K042375

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CX is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.

RCN is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hvoodermic tubing attached PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needle field.

A RF Injection Needle is an injection needle, which may be Intended Use: used either for percutaneous nerve blocks with local anesthetic solution or for radio frequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radio frequency lesion may be made.

Technological characteristics:

The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2004

Mr. René Roncken Manager Quality Assurance Technomed Europe Amerikalaan 71 6199 AE Maastricht Airport The Netherlands

Re: K042375

Trade/Device Name: RF Injection Needle Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: October 7, 2004 Received: October 12, 2004

Dear Mr. Roncken:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosuly to trgans actment date of the Medical Device Amendments, or to commerce proc to may 20, 1978, are excordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Costiere rece (1 tor) that be device, subject to the general controls provisions of the Act. The r ou may, morelore, maneve of the Act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is elaboried (tional controls. Existing major regulations affecting your device can may be subject to such address a legulations, 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 I loast of advised that I Drivieran that your device complies with other requirements of the Act that I DA has made a coulations administered by other Federal agencies. You must of any it catal statuted and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (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. René Roncken

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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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- Statement Indications for Use 2.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: RF Injection Needle

August 17, 2004

Indications for Use:

A RF Injection Needle is an injection needle, which may be used either for A KF Injection Needle is an injection froction froction or for radiofrequency
percutaneous nerve blocks with local anesthetic solution at stigulation through perculaneous netve blocks with lood antines electrical stimulation through the lessoning. The nerve is localized entiler of assist the needle and using radiography
needle or by injection contrast medium through the needle and using their or a needle of by injection contrast medialin the ough by injecting local anesthetic or a radiofrequency lesion may be made.

Prescription Use X (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 OMN ANOTHER PAGE IF NEEDED)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K142375