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.

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,

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria or quantitative performance metrics for the Stryker RF Multi-lesion Generator. The basis for clearance is a demonstration of "substantial equivalence" to predicate devices.

Acceptance Criteria	Reported Device Performance
Not specified	Substantially equivalent to predicate devices (K032601 Stryker Interventional Pain RF Generator and K052878 Neurotherm NT 1000 RF Lesioning System) in terms of intended use, safety, and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not mention a test set, sample size for testing, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on a comparison to predicate devices rather than a new clinical study with a specific test cohort.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as a specific test set requiring expert-established ground truth is not described in the document.

4. Adjudication Method for the Test Set:

Not applicable, as a specific test set requiring adjudication is not described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention an MRMC comparative effectiveness study. The clearance is based on substantial equivalence, not on demonstrating an improvement in human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This is not applicable as the device is a radiofrequency lesion generator, a hardware device, not an algorithm or AI.

7. Type of Ground Truth Used:

Not applicable, as a specific test set requiring ground truth is not described in the document. The basis for clearance is "comparison to the predicate devices" for safety and effectiveness.

8. Sample Size for the Training Set:

This is not applicable as the device is a hardware product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reason as above – the device is not an AI/ML algorithm.

Summary

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K071482

Page 1 of 2

510(k) Summary
Device Sponsor:	Synergetics, Inc.3845 Corporate Centre DriveO'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 GeneratorK052878 Neurotherm NT 1000 RF Lesioning System
Device Description:	Stryker RF Multi-lesion Generator
	The Stryker RF Multi Lesion Generator will be used in conjunction withStryker RF Electrodes and Cannula for ablation and coagulation of soft tissue.The generator applies temperature controlled radio frequency RF energy intotargeted tissue via an electrode probe, resulting in cellular necrosis. In the caseof interventional pain applications, pain relief is achieved by creating definedlesions on pain-conducting nerve fibers or tissue. In addition, the Stryker RFMulti-Lesion Generator allows multiple areas to be targeted and treatedconcurrently. By treating multiple areas concurrently, overall procedure timecan be reduced while maintaining thermal treatments each equivalent to anindividual treatment
	The Stryker RF Multi-lesion System is a bipolar and monopolar, highfrequency electrosurgical system. The System consists of the followingcomponents: a RF generator, footswitch hand controller, monopolar andbipolar electrodes, cannulae, neutral electrodes, coaxial bipolar electrodes andcannula, 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 RFElectrodes and Cannulae are intended for coagulation of soft tissues inorthopedic, spinal, and neurosurgical applications. Examples include, but arenot limited to: Facette Denervation, Percutaneous Chordotomy/Dorsal RootEntry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia andRhizotomy.
	The Stryker RF Multi-Lesion Generator in combination with a Smith &Nephew SPINECATH™ & Acutherm™ catheters are intended for coagulationand decompression of disc material to treat symptomatic patients with annulardisruption of contained herniated discs.

510(k) Summary

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K071482

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

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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.

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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 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

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Indications for Use 071482 510(k) Number (if known):

Device Name:

Indications for Use:

Stryker Multi-lesion Generator

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

Regulation Number and Section

§ 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).