(168 days)
The Stryker RF Coaxial Bipolar Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, 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 Coaxial Bipolar Electrodes and Cannulae will be used in conjunction with the Stryker RF Generator and Connector Cable to create radiofrequency lesions in nerve tissue. The generator applies temperature-controlled, radio frequency (RF) energy into targeted nerve tissue via an electrode probe. This energy destroys the nerve tissue's ability to conduct electrical signals. Pain relief is achieved by creating defined lesions on pain-conducting nerve fibers or tissue.
The two poles of the bipolar circuit will be referred to as RF1 and RF2. RF1 will define the sending pole while RF2 will define the return pole. Cannulae have both RF1 and RF2 Electrode connections. A secondary conductive surface (RF2) is offset axially to RF1 providing the return path for the RF energy. Thus the RF energy travels from the RF1 pole to the RF2 pole on the same probe. A lesion will be created between RF1 and RF2 on the singular probe.
This document is a 510(k) summary for the Stryker RF Coaxial Bipolar Electrodes and Cannulae. It states that the device is substantially equivalent to existing predicate devices. Therefore, the information typically found in a study demonstrating the device meets acceptance criteria (like specific performance metrics, sample sizes, expert qualifications, and study designs) is not present in this document.
The core argument for acceptance is substantial equivalence rather than direct performance testing against new acceptance criteria.
Here's how the requested information would apply to this document:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance because the device's acceptance is based on substantial equivalence to predicate devices, not on meeting new, specific performance metrics. The implicit "acceptance criteria" is that the device is as safe and effective as the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new safety concerns compared to predicate devices | The document states: "The Stryker RF Coaxial Bipolar Electrodes and Cannulae do not raise any new safety and efficacy concerns when compared to similar devices already legally marketed." |
| Equivalent effectiveness to predicate devices | The document states: "The Stryker RF Coaxial Bipolar Electrodes and Cannulae are equivalent in intended use, safety, and effectiveness to existing devices being marketed by Stryker, Smith and Nephew and Baylis." |
2. Sample size used for the test set and the data provenance
Not applicable. No new test set data is presented for this 510(k) submission. The substantial equivalence argument relies on the established safety and effectiveness of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set data where experts would establish ground truth is presented.
4. Adjudication method for the test set
Not applicable. No new test set data is presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electrosurgical electrode and cannulae, not an AI-assisted diagnostic or therapeutic tool with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, but a physical medical device.
7. The type of ground truth used
Not applicable in the context of new performance data. The "ground truth" for the substantial equivalence argument is the existing regulatory approval and demonstrated safety/effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned as this device is not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable.
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4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505 www.stryker.com
stryker®
MAY 3 ] 2005
K04342
Page 1 of ②
Summary of Safety and Effectiveness
Stryker Instruments Device Sponsor: 4100 E. Milham Avenue Kalamazoo, MI 49001 269-323-7700
Registration No.: 1811755
Trade Name: Stryker RF Coaxial Bipolar Electrodes and Cannulae Device Name: Common Name: Electrosurgical electrode and cannulae Classification Name: Probe, Radiofrequency Lesion: 21CFR882.4725
Product Code: GXI
Predicate Devices: Stryker RF Electrodes and Cannulae - K032406 Stryker Interventional Pain RF Generator - K032601 Stryker Instruments Neuro N50 - K896450 Bayliss Pain Management Probe - K002389 Smith and Nephew Saphyre Bipolar Ablation Probes – K031371
Description: The Stryker RF Coaxial Bipolar Electrodes and Cannulae will be used in conjunction with the Stryker RF Generator and Connector Cable to create radiofrequency lesions in nerve tissue. The generator applies temperature-controlled, radio frequency (RF) energy into targeted nerve tissue via an electrode probe. This energy destroys the nerve tissue's ability to conduct electrical signals. Pain relief is achieved by creating defined lesions on pain-conducting nerve fibers or tissue.
The two poles of the bipolar circuit will be referred to as RF1 and RF2. RF1 will define the sending pole while RF2 will define the return pole. Cannulae have both RF1 and RF2 Electrode connections. A secondary conductive surface (RF2) is offset axially to RF1 providing the return path for the RF energy. Thus the RF energy travels from the RF1 pole to the RF2 pole on the same probe. A lesion will be created between RF1 and RF2 on the singular probe.
Intended Use: The Stryker RF coaxial Bipolar Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications.
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Page 2 of (2)
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.
Substantial Equivalence (SE) Rational: The Stryker RF Coaxial Bipolar Electrodes and Cannulae are equivalent in intended use, safety, and effectiveness to existing devices being marketed by Stryker, Smith and Nephew and Baylis.
Safety and Effectiveness: The Stryker RF Coaxial Bipolar Electrodes and Cannulae do not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker RF Coaxial Bipolar Electrodes and Cannulae are substantially equivalent to these existing devices. They will be designed and manufactured in accordance with Stryker Instruments Quality Management System covered by QSR 21CFR 820.
Signed: Jean W. Sheppard Regulatory Affairs Analyst
Dated: Dated:
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 J 2005
Stryker Instruments C/o Mr. Ned Devine Sr. Staff Engineer Entela Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K043442
Trade/Device Name: Stryker RF Coaxial Bipolar Electrodes and Cannulae Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXI Dated: May 13, 2005 Received: May 16, 2005
Dear Mr. Devine:
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. Ned Devine
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 (240) 276-0115 . 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/industry/support/index.html.
Sincerely vours,
Stypt. Clwde
Miriam C. Provost, Ph.D. Acting 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 1
Indications for Use Statement
510(k) Numbr r: Stryker RF Coaxial Bipolar Electrodes and Cannulae Device Name: Indications For Use: The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coaqulation of soft tissues in orthopedic, 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.
Prescription Use × AND/OR Over-The-Counter Use (Per 21 CFR 801Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CQRH, Office of Device Evaluation (ODE)
Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).