(187 days)
The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath™ & Acutherm™ catheters.
The Stryker Intradiscal RF Generator when used with the separately cleared Stryker RF Intradiscal Adapter and the separately cleared Smith & Nephew SPINECATH™ Intradiscal Catheter (K993967) ACUTHERM ™ Decompression Catheter is is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
The provided documentation, K063489, is a 510(k) Summary for the Stryker Intradiscal RF Generator, submitted in 2007. It establishes substantial equivalence to a predicate device, the Smith & Nephew ElectroThermal 20S Spine Generator (K033981), rather than presenting a study with specific acceptance criteria and performance data for the Stryker device itself.
Therefore, many of the requested details regarding a study proving acceptance criteria are not directly available in this document. The submission asserts equivalence based on intended use, technological characteristics, operating principles, and similar performance characteristics.
Here’s an analysis based on the provided text, indicating what is not present in the document due to its nature as a 510(k) summary relying on predicate equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in this 510(k) for the Stryker device, as the submission relies on substantial equivalence to a predicate device. | Not specified directly in this 510(k) for the Stryker device. The document states "This device and the predicate device have the same technological characteristics, the same operating principles and have similar performance characteristics," implying the Stryker device is expected to perform comparably to the predicate without explicitly detailing the performance metrics or acceptance criteria it met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This 510(k) submission does not describe a new clinical or performance study with a test set for the Stryker Intradiscal RF Generator. It relies on the substantial equivalence to a previously cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No test set or ground truth establishment by experts is described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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. The device is a radiofrequency generator, not an AI-based diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not present in this document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. The device is a physical medical instrument (RF generator), not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics, and its safety relies on its design and manufacturing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As no specific performance study for this device is detailed, no ground truth data type is mentioned. The submission relies on the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.
9. How the ground truth for the training set was established:
- Not Applicable. As above, this is not an AI/machine learning device.
Summary of the K063489 Submission:
The K063489 submission for the Stryker Intradiscal RF Generator establishes substantial equivalence to the Smith & Nephew ElectroThermal 20S Spine Generator (K033981). This means that instead of conducting new performance studies, the applicant demonstrated that their device shares the same intended use, technological characteristics, operating principles, and similar performance characteristics as a device already legally marketed. Therefore, the detailed information typically found in a clinical or performance study (such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not provided in this 510(k) summary for the Stryker device itself. The FDA cleared the device based on this comparative assessment.
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MAY 2 3 2007
| 510(k) Summary for K063489 | |
|---|---|
| Device Sponsor: | Synergetics, Inc. |
| 3845 Corporate Centre Drive | |
| O'Fallon, MO 63368 | |
| (p)(636) 794-5013 | |
| (f) (636) 794-5120 | |
| Registration No.: | 1932402 |
| Trade Name: | Stryker Intradiscal RF Generator |
| Common Name: | Radiofrequency Lesion Generator |
| Classification Name: | Generator, Radiofrequency Lesion (GXD) |
| Equivalent to: | K033981 Smith & Nephew ElectroThermal 20S Spine Generator |
| Device Description: | The Stryker Intradiscal RF Generator when used with the separately cleared Stryker RF Intradiscal Adapter and the separately cleared Smith & Nephew SPINECATH™ Intradiscal Catheter (K993967) ACUTHERM ™ Decompression Catheter is is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. |
| Indications for Use: | The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath™ & Acutherm™ catheters. |
| Contraindications | The contraindications for the Stryker Intradiscal RF Generator would be the same as those for the catheter to which it is attached. The contraindications included in the instructions for use for the Smith & Nephew SPINECATH™ Intradiscal Catheter and ACUTHERM ™ Decompression Catheter. |
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Use of the SPINECATH™ Intradiscal Catheter is not appropriate for treating patients who present pain that is suspected to originate from structures other than contained herniated discs, or when free fragments or severe bony stenosis are present. In addition, patients presenting severely degenerative or disrupted discs should be excluded.
Use of the Decompression Catheter is not appropriate for treating patients who present pain that is suspected to originate from origins other than herniated discs, or when free fragments or severe spinal stenosis are present. In addition, patients presenting with severely degenerative or disrupted discs should be excluded.
Use of the Smith & Nephew SPINECATH™ Intradiscal Catheter and ACUTHERM TM Decompression Catheter is appropriate for treating patients with herniations of intervertebral discs who would typically undergo automated or laser percutaneous lumbar discectomy.
Use of the Smith & Nephew SPINECATH™ Intradiscal Catheter and ACUTHERM ™ Decompression Catheter is appropriate for treating patients with herniations of intervertebral discs who would typically undergo automated or laser percutaneous lumbar discectomy.
Precautions: Patients taking steroids and patients with pacemakers, lupus, gout, uncontrolled diabetes, Ehlers-Danlos syndrome, prior open capsular procedures, autoimmune disease, or etiologies where their immune systems are compromised require special consideration.
Substantial Equivalence
The Stryker Intradiscal RF Generator has the same intended (SE) Rational: use as the Smith & Nephew ElectroThermal 20S Spine Generator (K033981). This device and the predicate device have the same technological characteristics, the same
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operating principles and have similar performance characteristics.
Safety and Effectiveness: Based upon the comparison to the predicate devices, the Stryker Intradiscal RF Generator is substantially equivalent to a legally marketed device.
Submitted by:
: --
Dan Regan
QA/RA Director
Date submitted:
:
12 March 2007
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synergetics, Inc. % Mr. Dan Regan QA/RA Director 3845 Corporate Centre Drive O'Fallon, Missouri 63368
MAY 2 3 2007
Re: K063489
Trade/Device Name: Stryker Intradiscal RF Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD Dated: May 14, 2007 Received: May 15, 2007
Dear Mr. Regan:
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. Dan Regan
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
P-th
Mark N. Melkerson
Director
05/01/2022
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 (if known):
Device Name:
Stryker Intradiscal RF Generator
Indications for Use:
The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath™ & Acutherm™ catheters.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division of General, Restorative, vision of General, Devices
id Neurological Devices
Page | of
§ 882.4400 Radiofrequency lesion generator.
(a)
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.(b)
Classification. Class II (performance standards).