STRYKER INTERVENTIONAL PAIN RF GENERATOR

K032601 · Valley Forge Scientific Corp. · GXD · Apr 1, 2004 · Neurology

Device Facts

• Record ID: K032601
• Device Name: STRYKER INTERVENTIONAL PAIN RF GENERATOR
• Applicant: Valley Forge Scientific Corp.
• Product Code: GXD · Neurology
• Decision Date: Apr 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications. 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 Interventional Pain RF Generator functions as an electrosurgical energy source for soft tissue coagulation. Used in orthopedic, arthroscopic, spinal, and neurosurgical procedures; operated by clinicians. Device delivers radiofrequency energy through compatible Stryker RF electrodes and cannulae to create lesions for pain management (e.g., denervation, rhizotomy). Output allows precise tissue coagulation; assists surgeons in achieving therapeutic outcomes for chronic pain conditions.

Clinical Evidence

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

Technological Characteristics

Radiofrequency (RF) lesion generator; 21 CFR 882.4400 (Product Code GXD). Designed for use with compatible RF electrodes and cannulae for soft tissue coagulation.

Indications for Use

Indicated for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications, including Facette Denervation, Percutaneous Chordotomy/DREZ Lesion, Trigeminus Neuralgia, Peripheral Neuralgia, and Rhizotomy.

Regulatory Classification

Identification

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Reference Devices

• Oratec
• Radionics
• Baylis
• NeuroTherm
• Arthrocare

Submission Summary (Full Text)

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K032601 1/1

APR = 1 2004

### Device Name:

| Trade Name: | Stryker Interventional Pain RF Generator |
|----------------------|----------------------------------------------|
| Common Name: | Electrosurgical generator |
| Classification Name: | Generator, Lesion, RF : 21 CFR 882.4400, GXD |

#### Device Sponsor:

Manufacturer:

Valley Forge Scientific 136 Green Tree Rd. P.O. Box 1179 Oaks, PA 2521567

Requiatory Class: Class II

#### Summary of Safety and Effectiveness:

The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coaqulation of soft tissues in orthroscopic, spinal, and neurosurgical applications. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, and Rhizotomy.

The Stryker Interventional Pain RF Generator is equivalent in intended use, safety, and effectiveness to existing devices being marketed by Oratec, Radionics, Baylis, NeuroTherm, and Arthrocare.

The Stryker interventional Pain RF Generator does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Interventional Pain RF Generator is substantially equivalent to these existing devices.

By: Jerry Malls President, CE

Dated: 3.31.04

Simply the finest energy source available for surgerym

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 1 2004

Mr. Jerry Malis President Valley Forge Scientific Corp. 136 Green Tree Road. Suite 100 Oaks, Pennsylvania 19456

Re: K032601

Trade/Device Name: Stryker Interventional Pain RF Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD Dated: January 30, 2004 Received: February 3, 2004

Dear Mr. Malis:

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. Jerry Malis

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.

Muriam 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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# Indications for Use

| 510(k) Number: | K032601 |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| Device Name: | Stryker Interventional Pain RF Generator |
| Indications For Use: | The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, |

arthroscopic, spinal, and neurosurgical applications. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral

is intended for coagulation of soft tissues in orthopedic,

| Prescription Use | <div style="text-align:center;">X</div> |
|------------------|-----------------------------------------|
|------------------|-----------------------------------------|

AND/OR

Neuralgia, and Rhizotomy.

Over-The- Counter Use

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thurman C. Provost
District Clerk

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

**510(k) Number** K632601

Simply the finest energy source available for surgery

Page 1 nf 136 Green Tree Road Suite 100 P.O. Sox 1179 Oaks, PA 19456 PHONE [phone] FAX [phone]