(119 days)
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 of procedures include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia, and Rhizotomy
The Stryker RF Parallel BiPolar Adaptor Cable will be used in conjunction with the Stryker RF Generator, Electrodes and Cannulae to create radiofrequency lesions in nerve tissue. The generator applies temperature-controlled, radiofrequency (RF) energy into targeted nerve tissue via a pair of electrode probes.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a "Stryker RF Parallel BiPolar Adaptor Cable," outlining its intended use, device description, and substantial equivalence to predicate devices. It focuses on regulatory approval rather than performance study results.
Therefore, I cannot fulfill your request for the following information based on the provided input:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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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 Pain4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(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 CannulaeK020354 Baylis Pain Management GeneratorK053082 Baylis Pain Management Cooled ProbeK031951 Baylis Transdiscal SystemK052878 NeuroTherm NT 1000 RF Lesioning System | |
| Device Description: | The Stryker RF Parallel BiPolar Adaptor Cable will be used in conjunctionwith the Stryker RF Generator, Electrodes and Cannulae to createradiofrequency lesions in nerve tissue. The generator applies temperature-controlled, radiofrequency (RF) energy into targeted nerve tissue via a pairof electrode probes. | |
| Indications for Use: | The Stryker RF Parallel Bipolar Adaptor Cable is intended for coagulation ofsoft tissues in orthopedic, arthroscopic, spinal, and neurosurgicalapplications in combination with the separately cleared Stryker RFGenerator, Electrodes and Cannulae.Examples include, but are not limited to, Facette Denervation, PercutaneousChordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia,Peripheral Neuralgia, and Rhizotomy | |
| Substantial Equivalence(SE) Rational: | The Stryker RF Parallel BiPolar Adaptor Cable has the same intended useas all of the predicate devices. This device and the predicate devices havethe same technological characteristics, the same operating principles andhave similar performance characteristics. | |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker RFParallel BiPolar Adaptor Cable is substantially equivalent to a legallymarketed 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 (800) 638-2041 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K061660
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.