STRYKER RF ELECTRODES AND CANNULAE

K032406 · Stryker Instruments · GXI · Apr 1, 2004 · Neurology

Device Facts

• Record ID: K032406
• Device Name: STRYKER RF ELECTRODES AND CANNULAE
• Applicant: Stryker Instruments
• Product Code: GXI · Neurology
• Decision Date: Apr 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications. They are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the spinal cord, peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

Device Story

Stryker RF Electrodes and Cannulae function as accessories to Stryker RF Generator; deliver radiofrequency energy to target tissue. Used in orthopedic, arthroscopic, spinal, and neurosurgical procedures. Operated by physicians in clinical settings. Device facilitates coagulation of soft tissue and selective denervation/destruction of nerves for pain management. Output is thermal energy causing tissue lesioning. Benefits include minimally invasive pain relief for conditions like neuralgia and facet joint pain.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to existing predicate devices.

Technological Characteristics

Radiofrequency lesion probe and cannula system. Designed for use with RF generator. Class II device (21 CFR 882.4725).

Indications for Use

Indicated for patients requiring soft tissue coagulation or selective nerve denervation/destruction for pain relief in orthopedic, arthroscopic, spinal, and neurosurgical procedures. Applicable to lumbar, thoracic, and cervical spinal regions, peripheral nerves, and nerve roots. Conditions include Facette Denervation, Percutaneous Chordotomy/DREZ Lesion, Trigeminus Neuralgia, Peripheral Neuralgia, and Rhizotomy.

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.

Submission Summary (Full Text)

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APR - 1 2004

4100 Easl Milham Avenue Kalamazoo. Mi 49001 Phone [phone] [phone]

## Device Name:

| Trade Name: | Stryker RF Electrodes and Cannulae |
|----------------------|---------------------------------------------------|
| Common Name: | Electrosurgical electrode and cannulae |
| Classification Name: | Probe, Radiofrequency Lesion: 21 CFR 882.4725, GX |

## Device Sponsor:

| Manufacturer: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>Registration No.: 1811755 |
|---------------|--------------------------------------------------------------------------------------------------|
|---------------|--------------------------------------------------------------------------------------------------|

Class II Requiatory Class:

## Summary of Safety and Effectiveness:

The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for The Stryker RF Electrodes and Calindiae, in confidited with and neurosurgical applications.
coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical

They are also used for selective denervation and tissue destruction procedures which may be performed They are also used for selective denervation and insue a manner, and neves, and neves, and neves and neves and neves and neve on the lumbar, thoracle, and cervical regions of the bond portal of entralianeous
relief of pain. Examples include, but are not limited to, Facette Denervation, Percultanera relief of pain. Examples include, but are not limited to, Pacette Benervance, Preripheral Neuralgia, and Rhizotomy.

The Stryker RF Electrodes and Cannulae are equivalent in intended use, safety, and effectiveness to a The Stryker NF EloonSubleted by Stryker Instruments.

The Stryker RF Electrodes and Cannulae do not raise and efficacy concerns when
The Stryker RF and connect of and and annotated - Therefore, the Stryker RF Flectrodes and The Stryker RF Electrodes and Calinual and riotics any now of the Stryker RF Electrodes and compared to similar devious an outly roget of these existing devices.

By: Nicole Ruddy

Nicole Petty Nicole Folly
Associate Manager, Regulatory Affairs

Dated: 1-20-04

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APR = 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nicole Petty, RAC Associate Manager, Regulatory Affairs Stryker Instruments 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K032406

Trade/Device Name: Stryker RF Electrodes and Cannulae Regulation Number: 21 CFR 882.4725, 882.4400 Regulation Name: Radiofrequency lesion probe; Radiofrequency lesion generator Regulatory Class: II Product Code: GXI, GXD Dated: January 20, 2004 Received: January 21, 2004

Dear Ms. Petty:

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 - Ms. Nicole Petty, RAC

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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Page 1 of

510(k) Number:

KO32406

Device Name:

Indications For Use:

Stryker RF Electrodes and Cannulae

The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications.

They are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the spinal cord, peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The- Counter Use

(Per 21 CFR 801.109)

Muriam C. Priest (Optional Format 1-2-96)

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

510(k) Number_ Ko32406