STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE

K061660 · Stryker Instruments · GEI · Oct 10, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061660
• Device Name: STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
• Applicant: Stryker Instruments
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker RF Parallel Bipolar Adaptor Cable is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications in combination with the separately cleared Stryker RF Generator, Electrodes and Cannulae. 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 Parallel BiPolar Adaptor Cable functions as accessory to Stryker RF Generator, electrodes, and cannulae; enables delivery of temperature-controlled radiofrequency energy to nerve tissue. Used in orthopedic, arthroscopic, spinal, and neurosurgical procedures; operated by clinicians. Cable facilitates bipolar configuration for tissue coagulation; assists in lesion creation for pain management. Output is thermal energy for tissue coagulation; clinical benefit includes targeted nerve lesioning for conditions like trigeminus neuralgia and rhizotomy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electrosurgical connecting cable; facilitates bipolar RF energy delivery. Passive accessory component; no internal software or active sensing circuitry. Designed for use with cleared RF generator systems.

Indications for Use

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

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Stryker RF Coaxial Bipolar Electrodes and Cannulae (K043442)
• Baylis Pain Management Generator (K020354)
• Baylis Pain Management Cooled Probe (K053082)
• Baylis Transdiscal System (K031951)
• NeuroTherm NT 1000 RF Lesioning System (K052878)

Submission Summary (Full Text)

{0}------------------------------------------------

OC1 1 0 2006

Kob/660

4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 800 965 6505
www.stryker.com

**stryker**®

**Interventional Pain**

| 510(k) Summary | | page 1 of 2 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Sponsor: | Stryker Interventional Pain<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 | |
| Registration No.: | 3005182723 | |
| Trade Name: | Stryker RF Parallel BiPolar Adaptor Cable | |
| Common Name: | Electrosurgical Connecting Cable | |
| Classification Name: | Probe, Radiofrequency Lesion (GXI) | |
| Equivalent to: | K043442 Stryker RF Coaxial Bipolar Electrodes and Cannulae<br>K020354 Baylis Pain Management Generator<br>K053082 Baylis Pain Management Cooled Probe<br>K031951 Baylis Transdiscal System<br>K052878 NeuroTherm NT 1000 RF Lesioning System | |
| Device Description: | The Stryker RF Parallel BiPolar Adaptor Cable will be used in conjunction<br>with the Stryker RF Generator, Electrodes and Cannulae to create<br>radiofrequency lesions in nerve tissue. The generator applies temperature-<br>controlled, radiofrequency (RF) energy into targeted nerve tissue via a pair<br>of electrode probes. | |
| Indications for Use: | The Stryker RF Parallel Bipolar Adaptor Cable is intended for coagulation of<br>soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical<br>applications in combination with the separately cleared Stryker RF<br>Generator, Electrodes and Cannulae.<br>Examples include, but are not limited to, Facette Denervation, Percutaneous<br>Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia,<br>Peripheral Neuralgia, and Rhizotomy | |
| Substantial Equivalence<br>(SE) Rational: | The Stryker RF Parallel BiPolar Adaptor Cable has the same intended use<br>as all of the predicate devices. This device and the predicate devices have<br>the same technological characteristics, the same operating principles and<br>have similar performance characteristics. | |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker RF<br>Parallel BiPolar Adaptor Cable is substantially equivalent to a legally<br>marketed device. | |

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Ko61/660

Page 2 of 2

Submitted by:

Jean Sheppard

Regulatory Analyst

Signature

September 26, 2006

Date submitted:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 0 2006

Stryker Instruments % Ms. Jean Sheppard Regulatory Analyst 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K061660

Trade/Device Name: Stryker RF Parallel BiPolar Adaptor Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GXI Dated: September 26, 2006 Received: September 27, 2006

Dear Ms. Sheppard:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave ro rowed your 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 for use stated in the encreases) to the enactment date of the Medical Device Amendments, or to eominer of the to they acoasified in accordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Cosmeter For (110) has the device, subject to the general controls provisions of the Act. The r ou may, increrere, mains of the Act include requirements for annual registration, listing of general control proctice, 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 or ury 1 vith 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 Errth 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. Jean Sheppard

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to oegin manteang your are a level valence of your device to a legally premarked notheation. The PDF Imaling of easification 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 If you desire specific acries is. Jour as 10. Job 276-0115. Also, please note the regulation entitled, Colliact the Office of Computible to the (21CFR Part 807.97). You may obtain Mission of Creation on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Corisa http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Poe S

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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K061660 510(K) Number (if known):

Device Name: Stryker RF Parallet BiPolar Adaptor Cable

127

## Indications for Use

Indications for Use
The Stryker RF Parallel Bipolar Adaptor Cable is intended for coagulation of soft tissues in The Surfact Ad Tataller Dipinal, and neurosurgical applications in combination with the separately cleared Stryker RF Generator, Electrodes and Cannulae.

Examples of procedures include, but are not limited to, Facette Denervation, Percutaneous Ehanpies of prossal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, and Rhizotomy

Prescription Use _____________________________________________________________________________________________________________________________________________________________

and/or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

Division of General, Restorative and Neurological Devices

510(k) Number k061660