(187 days)
No
The 510(k) summary describes a radiofrequency generator for disc decompression and coagulation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The device description focuses on the physical generator and its intended use with specific catheters.
Yes
The device is intended for the "coagulation and decompression of disc material to treat symptomatic patients," which falls under the definition of a therapeutic intervention.
No
Explanation: The device is described as a radiofrequency generator used for coagulation and decompression of disc material, which is a therapeutic treatment. There is no indication that it is used to diagnose a medical condition.
No
The device is described as a "RF Generator," which is a hardware component that produces radiofrequency energy. It is used in conjunction with other hardware components (adapter and catheters) for a physical medical procedure.
Based on the provided information, the Stryker Intradiscal RF Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the "coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs." This is a therapeutic procedure performed directly on a patient's tissue (intradiscal), not a test performed on a sample taken from the body (in vitro).
- Device Description: The description reinforces its use in a surgical/interventional setting with catheters inserted into the disc.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), diagnostic testing, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Stryker Intradiscal RF Generator is a therapeutic device used to treat a condition directly within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GXD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc material, intervertebral discs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
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
5
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
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