(241 days)
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.
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.
The provided text is a 510(k) premarket notification for the Stryker RF Electrodes and Cannulae. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device and therefore does not typically include detailed studies proving performance against acceptance criteria in the same way a novel device might.
Instead, the core of a 510(k) is to demonstrate that the new device is as safe and effective as an already approved device. The document explicitly states:
"The Stryker RF Electrodes and Cannulae are equivalent in intended use, safety, and effectiveness to a legally marketed predicate device submited by Stryker Instruments. The Stryker RF Electrodes and Cannulae do not raise and efficacy concerns when compared to similar devious an outly roget of these existing devices." (There appears to be a typo/parsing error in the original document, but the intent is clear.)
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance is not present in this 510(k) summary. These details are typically part of a Pre-Market Approval (PMA) application or a more extensive clinical validation for novel devices.
Here's a breakdown of why this information is absent:
- Acceptance criteria and reported device performance: Not applicable in a 510(k) in the way you're asking. The "performance" is implicitly deemed acceptable because it's equivalent to an already approved predicate.
- Sample size, data provenance: Not relevant for a substantial equivalence claim.
- Number/qualifications of experts, adjudication: Not relevant. The "ground truth" here is the established safety and efficacy of the predicate device.
- MRMC comparative effectiveness study: Not typically part of a 510(k) for devices like electrodes and cannulae.
- Standalone performance: Not explicitly proven as a new device.
- Type of ground truth: The "ground truth" is the performance of the legally marketed predicate device.
- Sample size for training set: Not applicable, as this is not an AI/algorithm-driven device requiring a training set.
- How ground truth for training set was established: Not applicable.
In summary: The provided document demonstrates "substantial equivalence" to a predicate device, which is a different regulatory pathway than proving novel performance against acceptance criteria through independent studies.
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APR - 1 2004
4100 Easl Milham Avenue Kalamazoo. Mi 49001 Phone (269) 323-7700 (800) 253-3210
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 Instruments4100 E. Milham AvenueKalamazoo, MI 49001Registration 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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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
§ 882.4725 Radiofrequency lesion probe.
(a)
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.(b)
Classification. Class II (performance standards).