(204 days)
Not Found
No
The summary describes a radio frequency generator for tissue coagulation and does not mention any AI or ML capabilities.
Yes
The device is intended for therapeutic interventions such as coagulation of soft tissues, Facette Denervation, Percutaneous Chordotomy, and decompression of disc material to treat symptomatic patients, all of which are designed to treat or alleviate a medical condition.
No
The device is described as a generator and system for coagulation and ablation of soft tissues, intended for treatment (therapy), not for identifying or diagnosing a condition.
No
The device description explicitly lists multiple hardware components including a generator, footswitch, hand controller, electrodes, cannulae, cables, and adapters.
Based on the provided information, the Stryker RF Multi-Lesion Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The intended use and device description clearly state that this device is used for the coagulation and ablation of soft tissues within the body (in orthopedic, spinal, and neurosurgical applications). It directly interacts with and treats tissues inside the patient.
- The device description focuses on delivering energy to tissue. The mechanism of action involves applying radio frequency energy to create lesions or coagulate tissue, not analyzing biological samples.
- The intended use is for therapeutic procedures. The examples provided (Facette Denervation, Percutaneous Chordotomy, etc.) are all surgical or interventional procedures performed on a patient.
IVD devices are typically used in laboratories or point-of-care settings to analyze blood, urine, tissue samples, etc., to diagnose diseases or monitor health conditions. This device is a surgical/interventional tool used for treatment.
N/A
Intended Use / Indications for Use
The Stryker RF Multi-lesion Generator, in combination with the Stryker RF Electrodes and Cannulae are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. 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 Multi-Lesion Generator in combination with a Smith & Nephew SPINECATH™ & Acutherm™ catheters are intended for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
Product codes (comma separated list FDA assigned to the subject device)
GXD, GEI
Device Description
The Stryker RF Multi Lesion Generator will be used in conjunction with Stryker RF Electrodes and Cannula for ablation and coagulation of soft tissue. The generator applies temperature controlled radio frequency RF energy into targeted tissue via an electrode probe, resulting in cellular necrosis. In the case of interventional pain applications, pain relief is achieved by creating defined lesions on pain-conducting nerve fibers or tissue. In addition, the Stryker RF Multi-Lesion Generator allows multiple areas to be targeted and treated concurrently. By treating multiple areas concurrently, overall procedure time can be reduced while maintaining thermal treatments each equivalent to an individual treatment.
The Stryker RF Multi-lesion System is a bipolar and monopolar, high frequency electrosurgical system. The System consists of the following components: a RF generator, footswitch hand controller, monopolar and bipolar electrodes, cannulae, neutral electrodes, coaxial bipolar electrodes and cannula, parallel bipolar adapter, connecting cables, and intradiscal cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
disc material
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.
Not Found
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
Page 1 of 2
| 510(k) Summary | ||
|---|---|---|
| Device Sponsor: | Synergetics, Inc. | |
| 3845 Corporate Centre Drive | ||
| O'Fallon, MO 63368 | ||
| (p) 636.794.5013 | ||
| (f) 636.794.5120 | ||
| Registration No.: | 1932402 | DEC 2 0 2007 |
| Trade Name: | Stryker RF Multi-lesion Generator | |
| Common Name: | Radiofrequency Lesion Generator | |
| Classification Name: | Generator, Radiofrequency Lesion (GXD) | |
| Equivalent to: | K032601 Stryker Interventional Pain RF Generator | |
| K052878 Neurotherm NT 1000 RF Lesioning System | ||
| Device Description: | Stryker RF Multi-lesion Generator | |
| The Stryker RF Multi Lesion Generator will be used in conjunction with | ||
| Stryker RF Electrodes and Cannula for ablation and coagulation of soft tissue. | ||
| The generator applies temperature controlled radio frequency RF energy into | ||
| targeted tissue via an electrode probe, resulting in cellular necrosis. In the case | ||
| of interventional pain applications, pain relief is achieved by creating defined | ||
| lesions on pain-conducting nerve fibers or tissue. In addition, the Stryker RF | ||
| Multi-Lesion Generator allows multiple areas to be targeted and treated | ||
| concurrently. By treating multiple areas concurrently, overall procedure time | ||
| can be reduced while maintaining thermal treatments each equivalent to an | ||
| individual treatment | ||
| The Stryker RF Multi-lesion System is a bipolar and monopolar, high | ||
| frequency electrosurgical system. The System consists of the following | ||
| components: a RF generator, footswitch hand controller, monopolar and | ||
| bipolar electrodes, cannulae, neutral electrodes, coaxial bipolar electrodes and | ||
| cannula, parallel bipolar adapter, connecting cables, and intradiscal cable, | ||
| Indications for Use: | Stryker RF Multi-lesion Generator | |
| The Stryker RF Multi-lesion Generator, in combination with the Stryker RF | ||
| Electrodes and Cannulae are intended for coagulation of soft tissues in | ||
| orthopedic, spinal, and neurosurgical applications. 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 Multi-Lesion Generator in combination with a Smith & | ||
| Nephew SPINECATH™ & Acutherm™ catheters are intended for coagulation | ||
| and decompression of disc material to treat symptomatic patients with annular | ||
| disruption of contained herniated discs. |
.
510(k) Summary
1
Page 2 of (2)
Substantial Equivalence (SE) Rational:
The Stryker RF Multi-lesion Generator is equivalent in intended use, safety. and effectiveness to existing devices being marketed by Stryker and Neurotherm.
Safety and Effectiveness:
Based upon the comparison to the predicate devices, the Stryker RF Multilesion Generator is substantially equivalent to a legally marketed device.
Submitted by:
Name: Dan Regan Title: QA/RA Director
Dan Ge
Signature
Date submitted:
5-29-07
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2007
Synergetics, Inc % Mr. Dan Regan QA/RA Director 3845 Corporate Centre Drive O'Fallon, Missouri 63368
Re: K071482
Trade/Device Name: Stryker Multi-lesion Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: Class II Product Code: GXD, GEI Dated: November 29, 2007 Received: November 30, 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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 071482 510(k) Number (if known):
Device Name:
Indications for Use:
Stryker Multi-lesion Generator
The Stryker RF Multi-Lesion Generator, in combination with the Stryker RF Electrodes and Cannulae are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. 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 Multi-Lesion Generator in combination with a Smith & Nephew SPINECATH™ & Acutherm™ catheters are intended for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
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 Enduluation(Office)20-Off
Division of General, Restorative, I Noventogical Devices
Page of
510(k) Number
8 of 563
1071482