Who is the manufacturer of MultiGen 2 RF Generator System?

Stryker Corporation filed the 510(k) submission for MultiGen 2 RF Generator System (K170242).

What is the FDA product code for MultiGen 2 RF Generator System?

GXD. It is classified under 21 CFR 882.4400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for MultiGen 2 RF Generator System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MultiGen 2 RF Generator System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MultiGen 2 RF Generator System

Q: What are the predicate devices for MultiGen 2 RF Generator System?

Stryker RF Multi-lesion Generator (K071482); Stryker RF Electrodes and Cannulae (K032406); Stryker Venom Electrodes and Cannulae (K123178).

K170242 · Stryker Corporation · GXD · May 25, 2017 · Neurology

Device Facts

Record ID	K170242
Device Name	MultiGen 2 RF Generator System
Applicant	Stryker Corporation
Product Code	GXD · Neurology
Decision Date	May 25, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Stryker MultiGen™ 2 RF Generator, in combination with the Stryker MultiGen 2 Electrodes and RF Cannulae, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

Device Story

MultiGen™ 2 RF Generator is a bipolar/monopolar high-frequency electrosurgical system. It uses RF energy to create thermal lesions in targeted nerve tissue. System components include the generator, MultiGen 2 Splitter Cable, MultiGen 2 Electrodes, and RF Cannulae. The generator applies temperature-controlled RF energy via an active electrode inserted into an insulated cannula with an uninsulated tip. Used in clinical settings (orthopedic, spinal, neurosurgical) by physicians. The device features a touch screen GUI for manual/automatic control of stimulation (sensory/motor) and lesioning (pulsed/continuous). It provides real-time temperature monitoring via K-type thermocouples in the electrode tip. Output energy is 0-100 watts. The system supports multi-channel RF treatment with sequential energy delivery. The device assists clinicians in performing selective denervation and tissue destruction to provide pain relief for patients.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-2), electromagnetic compatibility (IEC 60601-1-2), and software verification/validation. Bench testing verified radiofrequency ablation equivalence, multi-lesion functionality, splitter cable life, NOVRAM specifications, and current limitation.

Technological Characteristics

High-frequency electrosurgical system; 500kHz sinusoid waveform. Materials: Nitinol, PEEK, silicone rubber, stainless steel, polycarbonate. Sensing: K-type thermocouple in electrode tip. Energy: RF, 0-100W, 37-95°C range. Connectivity: Touch screen GUI, 4-channel electrode connections. Sterilization: Steam or Vaporized Hydrogen Peroxide (electrodes); EtO (cannulae).

Indications for Use

Indicated for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications, including facet denervation, trigeminus neuralgia, peripheral neuralgia, and rhizotomy. Used for selective denervation and tissue destruction on lumbar, thoracic, and cervical peripheral nerves and nerve roots for pain relief.

Regulatory Classification

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.

Predicate Devices

Stryker RF Multi-lesion Generator (K071482)
Stryker RF Electrodes and Cannulae (K032406)
Stryker Venom Electrodes and Cannulae (K123178)

Reference Devices

Stryker Interventional Pain RF Generator (K032601)

Related Devices

K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 · Synergetics, Inc. · Dec 20, 2007
K220122 — APEX 6 · Rf Innovations, Inc. · Mar 15, 2023
K232632 — Racz Neurostat RF Generator · Epimed International · May 24, 2024
K181864 — Polaris RF Ablation System · Baylis Medical Company, Inc. · Jan 2, 2019
K201610 — IonicRF Generator · ABBOTT MEDICAL · Oct 21, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, resembling a stylized bird. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 25, 2017 Stryker Corporation David Colao Senior Manager Regulatory Affairs 4100 E. Milham Ave Kalamazoo, Michigan 49001 Re: K170242 Trade/Device Name: MultiGen™ 2 RF Generator System Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD, GXI Dated: April 25, 2017 Received: April 26, 2017 Dear Mr. Colao: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device {1}------------------------------------------------ related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Michael J. Hoffmann -S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K170242 Device Name Stryker MultiGen™ 2 RF Generator System #### Indications for Use (Describe) Stryker MultiGen™ 2 RF Generator The Stryker MultiGen™ 2 RF Generator, in combination with the Stryker MultiGen 2 Electrodes and RF Cannulae, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facet Denervation. Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. #### Venom MultiGen 2 Electrodes The Stryker Venom MultiGen 2 Electrodes, in combination with the Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia and Rhizotomy, #### Standard MultiGen 2 Standard Electrodes The Stryker MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGenI™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia and Rhizotomy. #### Venom and Standard Cannulae (RF Cannulae) The Stryker RF Cannulae, in combination with Stryker Electrodes and the Stryker RF Generator, Stryker MultiGen, or Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. They are also used for selective denervation and destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. #### Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # SECTION 510(k) Summary {5}------------------------------------------------ # Table of Contents | 510(k) Summary | 3 | |-----------------------------------------------------------------------|----| | Submitter | 3 | | Device | 3 | | Predicate Devices | 3 | | Device Description | 3 | | Indications for Use | 4 | | Comparison of Technological Characteristics with the Predicate Device | 5 | | Performance Data | 14 | | Conclusions | 15 | # List of Figures and Tables | Table 1: Generator Comparison Table | 8 | |-------------------------------------------------|----| | Table 2: Electrode and Cannula Comparison Table | 13 | {6}------------------------------------------------ # 510(k) Summary ## Submitter Stryker Instruments 4100 E Milham Ave Kalamazoo, MI 49001 (269) 389-4285 Contact Person: David Colao Date Prepared: May 23, 2017 ### Device Name of Device: MultiGen 2 RF Generator system Common or Usual Name: RF Generator Classification Regulation: 882.4400 / 882.4725 Panel: Neurology Product Code: GXD / GXI # Predicate Devices The following devices are predicates for the system: Stryker RF Multi-lesion Generator (K071482) Stryker RF Electrodes and Cannulae (K032406) Stryker Venom Electrodes and Cannulae (K123178) The following reference device was used in this submission: Stryker Interventional Pain RF Generator (K032601) # Device Description The MultiGen™ 2 RF Generator system is a bipolar and monopolar, high frequency electrosurgical system. The MultiGen 2 RF Generator will be used in conjunction with the MultiGen 2 Splitter Cable, MultiGen 2 Electrodes, RF Cannulae, and other accessories to produce lesions by the direct application of radiofrequency currents. The generator applies temperature-controlled, radiofrequency (RF) energy into the electrode. During lesion creation, targeted nerve tissue is exposed to RF energy using an active electrode inserted into an insulated cannula with an uninsulated tip. {7}------------------------------------------------ The application of RF energy causes a thermal reaction at the targeted nerve tissue site to create a lesion. ## Indications for Use ### Stryker MultiGen™ 2 RF Generator The Stryker MultiGen™ 2 RF Generator, in combination with the Stryker MultiGen 2 Electrodes and RF Cannulae, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. ### Venom MultiGen 2 Electrodes The Stryker Venom MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. ### Standard MultiGen 2 Standard Electrodes The Stryker MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. ### Venom and Standard Cannulae (RF Cannulae) The Stryker RF Cannulae, in combination with Stryker Electrodes and the Stryker RF Generator, Stryker MultiGen, or Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. They are also used for selective denervation and destruction {8}------------------------------------------------ procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. # Comparison of Technological Characteristics with the Predicate Device The predicate device is a previous generation of Stryker radiofrequency generator, the Stryker RF Multi-Lesion Generator (MultiGen). The intended uses of the subject and predicate devices are similar. The systems are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications using radiofrequency energy. Minor modifications were made to the indication for use statement to provide clarification and consistency, but do not change the meaning of the indication for use statement. The technological characteristics of the subject and predicate devices are equivalent. Both the subject device and the primary predicate device use same modes of operation, types of control, energy delivery and type of energy output. None of the changes alter the operating principle, modes of operation, temperature range. Both systems use the same type of accessories (a RF generator, connecting cables, electrodes, cannulae, and neutral electrode). The user interaction with the devices are similar. As demonstrated by the performance testing, the subject device has similar performance specifications as the predicate device. Based on the comparison of intended use and technological characteristics, the device is similar to the predicate device. The hardware and software verification and validation testing demonstrate that the subject device meets its performance specifications and will perform as intended in the specified use conditions and that any differences between the subject device and predicate device do not raise new questions of safety and effectiveness. Therefore, the subject device can be found substantially equivalent to the predicate device. {9}------------------------------------------------ | FEATURE | MultiGen™ 2 RF Generator SUBJECT DEVICE | Stryker RF Multi-Lesion Generator PREDICATE DEVICE | Equivalency | |-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Generator | | | | | 510(k) Clearance | Subject Device of Current Submission | K071482 | N/A. | | Indication for Use | The Stryker MultiGen™ 2 RF Generator, in combination with the Stryker MultiGen 2 Electrodes and Cannulae are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. | The Stryker Interventional Pain RF MultiGen, 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 Interventional Pain RF MultiGen 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. | Equivalent. Indications within scope of predicate indications. | | Modes of Operation | Sensory and Motor Stimulation. Pulsed and Continuous Lesioning | Sensory and Motor Stimulation. Pulsed and Continuous Lesioning | Identical. | | Type of Control | Manual and Automatic | Manual and Automatic | Identical. | | Temperature measurement technology | K-type thermocouple in electrode Thermocouple interface electronics in RF Generators | K-type thermocouple in electrode Thermocouple interface electronics in RF Generators | Identical. | | Temperature measurement location | Distal Tip of the Nitinol Electrode | Distal Tip of the Nitinol Electrode | Identical. | | Temperature Range | 37 °C - 95 °C | 37 °C - 97 °C | Equivalent. Within range of predicate. | | Temperature Accuracy | 37 °C - 95 °C +-2°C | 37 °C - 95 °C +-2°C | Identical | | Lesion Time | 0-999 seconds | 0-999 seconds | Identical. | | FEATURE | MultiGen™ 2 RF Generator | Stryker RF Multi-Lesion Generator | Equivalency | | | SUBJECT DEVICE | PREDICATE DEVICE | | | Stimulation Frequency | Sensory = 50 Hz Motor = 2 Hz | Sensory: 10, 20, 30, 50, 75, 100, 150, 200 (Hz) Motor: 1, 2, 3, 4, 5, 7, 10, 20 (Hz) | Equivalent. Reduce complexity. Within range of predicate. | | Stimulation Pulse Width | 1 ms | .1,.2,.5,.75,1,2,3,5 (ms) | Similar. Reduce complexity. Within range of predicate. | | Stimulation Amplitude Voltage Regulation Mode | 0-10 V peak; accuracy + 10%, current limited to 25 mA | 0-10 V peak; accuracy + 10%, current limited to 40 mA | Equivalent. Reduction in voltage. | | Impedance Range | 0-2000 ohms | 0-2000 ohms | Identical. | | Type of User Interface | Touch screen graphical user interface | Touch screen graphical user interface | Identical. | | Type of Probe Recognition | Automatic | Automatic | Identical. | | Number of Amp | 4 | 1 | Equivalent. Simplifies control of energy. | | Energy delivery during multi- channel RF treatment | Sequential non simultaneous energy delivery | Sequential non simultaneous energy delivery | Identical. | | Output Energy | 0-100 watts | 0-50 watts | Equivalent. The maximum current the patient is exposed to remains the same (700 mA). | | Output Waveform(s) | 500kHz sinusoid | Malis Dual/Wave Waveform | Equivalent. Sinusoid waveform requires lower voltage to achieve equivalent energy transfer. | | Monopolar/ Bipolar | Monopolar and Bipolar | Monopolar and Bipolar | Identical. | | Ability to perform multiple lesions simultaneously | Yes | Yes | Identical. | | FEATURE | MultiGen™ 2 RF Generator | | Equivalency | | | SUBJECT DEVICE | PREDICATE DEVICE | | | Number of electrode connections | 4 | 4 | Identical. | | Printer Output | No | Yes | Equivalent. Feature is not frequently used. | | Accessories | • Splitter Box • 3M Neutral Electrode (Ground Pad) • (Neutral Electrode) Ground Pad Cable • Stryker MultiGen 2 (Standard) Electrodes • Stryker RF (Standard) Cannulae • Venom MultiGen 2 Electrodes • Venom Cannulae | • MultiGen Cable • Connector Cable • Hand Controller • 3M Neutral Electrode (Ground Pad) • (Neutral Electrode) Ground Pad Cable • Stryker RF (Standard) Electrodes • Stryker RF (Standard) Cannulae • Venom Electrodes • Venom Cannulae | Similar. The Splitter Cable replaces the need for two MultiGen Cables or other connecting cables. | {10}------------------------------------------------ {11}------------------------------------------------ TABLE 1: GENERATOR COMPARISON TABLE {12}------------------------------------------------ | FEATURE | Standard and Venom MultiGen 2 Electrodes | Standard Electrodes | Venom Electrodes | Equivalency | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | | | | | Intended Use | | | | | | Electrodes | | | | 510(k) Clearance | Subject Device | K032406 | K123178 | N/A. | | Indication for Use (Electrodes) | Standard MultiGen 2 Electrodes The Stryker MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. Venom MultiGen 2 Electrodes The Stryker Venom MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and | The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, arthroscopic, 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 electrodes and cannulae, in combination with the Stryker RF Generator/Multigen, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facette Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. | Equivalent. Indications within scope of predicate indications. | | FEATURE | Standard and Venom MultiGen 2 Electrodes | Standard Electrodes | Venom Electrodes | Equivalency | | | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | | | | cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. | | | | | | | RF Cannulae | | | | Indication for Use (Cannulae) | Standard RF Cannulae / Venom RF Cannulae The Stryker RF Cannulae, in combination with Stryker Electrodes and the Stryker RF Generator, Stryker MultiGen, or Stryker MultiGen 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. They are also used for selective denervation and destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. | The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, arthroscopic, 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, Facet Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. | The Stryker RF electrodes and cannulae, in combination with the Stryker RF Generator/Multigen, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. | Equivalent. Indications within scope of predicate indications. | | FEATURE | Standard and Venom MultiGen 2 Electrodes…