MultiGen™ 2 RF Generator System

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

Indications for 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)

Submission Summary (Full Text)

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Public Health Service

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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### 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.

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# SECTION

510(k) Summary

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# 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 |

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# 510(k) Summary

## Submitter

Stryker Instruments 4100 E Milham Ave Kalamazoo, MI 49001 [phone]

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.

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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

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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.

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| FEATURE | MultiGen™ 2 RF Generator<br>SUBJECT DEVICE | Stryker RF Multi-Lesion Generator<br>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<br>Thermocouple interface<br>electronics in RF Generators | K-type thermocouple in electrode<br>Thermocouple interface<br>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<br>Frequency | Sensory = 50 Hz<br>Motor = 2 Hz | Sensory: 10, 20, 30, 50, 75, 100,<br>150, 200 (Hz)<br>Motor: 1, 2, 3, 4, 5, 7, 10, 20 (Hz) | Equivalent.<br>Reduce complexity.<br>Within range of<br>predicate. |
| Stimulation<br>Pulse Width | 1 ms | .1,.2,.5,.75,1,2,3,5 (ms) | Similar.<br>Reduce complexity.<br>Within range of<br>predicate. |
| Stimulation<br>Amplitude<br>Voltage<br>Regulation<br>Mode | 0-10 V peak; accuracy + 10%,<br>current limited to 25 mA | 0-10 V peak; accuracy + 10%,<br>current limited to 40 mA | Equivalent. Reduction<br>in voltage. |
| Impedance<br>Range | 0-2000 ohms | 0-2000 ohms | Identical. |
| Type of User<br>Interface | Touch screen graphical user<br>interface | Touch screen graphical user<br>interface | Identical. |
| Type of Probe<br>Recognition | Automatic | Automatic | Identical. |
| Number of Amp | 4 | 1 | Equivalent. Simplifies<br>control of energy. |
| Energy delivery<br>during multi-<br>channel RF<br>treatment | Sequential non simultaneous<br>energy delivery | Sequential non simultaneous<br>energy delivery | Identical. |
| Output Energy | 0-100 watts | 0-50 watts | Equivalent.<br>The maximum current<br>the patient is exposed<br>to remains the same<br>(700 mA). |
| Output<br>Waveform(s) | 500kHz sinusoid | Malis Dual/Wave Waveform | Equivalent.<br>Sinusoid waveform<br>requires lower voltage<br>to achieve equivalent<br>energy transfer. |
| Monopolar/<br>Bipolar | Monopolar and Bipolar | Monopolar and Bipolar | Identical. |
| Ability to<br>perform<br>multiple lesions<br>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.<br>Feature is not<br>frequently used. |
| Accessories | • Splitter Box<br>• 3M Neutral Electrode (Ground Pad)<br>• (Neutral Electrode) Ground Pad Cable<br>• Stryker MultiGen 2 (Standard) Electrodes<br>• Stryker RF (Standard) Cannulae<br>• Venom MultiGen 2 Electrodes<br>• Venom Cannulae | • MultiGen Cable<br>• Connector Cable<br>• Hand Controller<br>• 3M Neutral Electrode (Ground Pad)<br>• (Neutral Electrode) Ground Pad Cable<br>• Stryker RF (Standard) Electrodes<br>• Stryker RF (Standard) Cannulae<br>• Venom Electrodes<br>• Venom Cannulae | Similar.<br>The Splitter Cable<br>replaces the need for<br>two MultiGen Cables<br>or other connecting<br>cables. |

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TABLE 1: GENERATOR COMPARISON TABLE

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| FEATURE | Standard and Venom MultiGen 2<br>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<br>Use (Electrodes) | Standard MultiGen 2 Electrodes<br>The Stryker MultiGen 2 Electrodes, in<br>combination with the Stryker RF<br>Cannulae and Stryker MultiGen 2 RF<br>Generator, are intended for coagulation<br>of soft tissue in orthopedic, spinal, and<br>neurosurgical applications. These<br>products are also used for selective<br>denervation and tissue destruction<br>procedures which may be performed on<br>the lumbar, thoracic, and cervical regions<br>of the peripheral nerve, and nerve roots<br>for the relief of pain.<br>Examples include, but are not limited to:<br>Facet Denervation, Trigeminus Neuralgia,<br>Peripheral Neuralgia and Rhizotomy.<br>Venom MultiGen 2 Electrodes<br>The Stryker Venom MultiGen 2<br>Electrodes, in combination with the<br>Stryker RF Cannulae and Stryker<br>MultiGen 2 RF Generator, are intended<br>for coagulation of soft tissue in<br>orthopedic, spinal, and neurosurgical<br>applications. These products are also<br>used for selective denervation and tissue<br>destruction procedures which may be<br>performed on the lumbar, thoracic, and | The Stryker RF Electrodes and Cannulae, in<br>combination with the Stryker RF Generator,<br>are intended for coagulation of soft tissues<br>in orthopedic, arthroscopic, spinal, and<br>neurosurgical applications. They are also<br>used for selective denervation and tissue<br>destruction procedures which may be<br>performed on the lumbar, thoracic, and<br>cervical regions of the spinal cord, peripheral<br>nerves, and nerve roots for the relief of pain.<br>Examples include, but are not limited to,<br>Facette Denervation, Percutaneous<br>Chordotomy/Dorsal Root Entry Zone (DREZ)<br>Lesion, Trigeminus Neuralgia, Peripheral<br>Neuralgia and Rhizotomy. | The Stryker RF electrodes and<br>cannulae, in combination with the<br>Stryker RF Generator/Multigen,<br>are intended for coagulation of<br>soft tissues in orthopedic, spinal,<br>and neurosurgical applications.<br>These products are also used for<br>selective denervation and tissue<br>destruction procedures which may<br>be performed on the lumbar,<br>thoracic, and cervical regions of<br>the peripheral nerves, and nerve<br>roots for the relief of pain.<br>Examples include, but are not<br>limited to, Facette Denervation,<br>Trigeminus Neuralgia, Peripheral<br>Neuralgia and Rhizotomy. | Equivalent.<br>Indications within<br>scope of predicate<br>indications. |
| FEATURE | Standard and Venom MultiGen 2<br>Electrodes | Standard Electrodes | Venom Electrodes | Equivalency |
| | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | |
| | cervical regions of the peripheral nerve,<br>and nerve roots for the relief of pain.<br>Examples include, but are not limited to:<br>Facet Denervation, Trigeminus Neuralgia,<br>Peripheral Neuralgia and Rhizotomy. | | | |
| | | RF Cannulae | | |
| Indication for<br>Use (Cannulae) | Standard RF Cannulae / Venom RF<br>Cannulae<br>The Stryker RF Cannulae, in combination<br>with Stryker Electrodes and the Stryker<br>RF Generator, Stryker MultiGen, or<br>Stryker MultiGen 2 RF Generator, are<br>intended for coagulation of soft tissue in<br>orthopedic, spinal, and neurosurgical<br>applications. They are also used for<br>selective denervation and destruction<br>procedures which may be performed on<br>the lumbar, thoracic, and cervical regions<br>of the peripheral nerve, and nerve roots<br>for the relief of pain.<br>Examples include, but are not limited to:<br>Facet Denervation, Trigeminus Neuralgia,<br>Peripheral Neuralgia and Rhizotomy. | The Stryker RF Electrodes and Cannulae, in<br>combination with the Stryker RF Generator,<br>are intended for coagulation of soft tissues<br>in orthopedic, arthroscopic, spinal, and<br>neurosurgical applications. They are also<br>used for selective denervation and tissue<br>destruction procedures which may be<br>performed on the lumbar, thoracic, and<br>cervical regions of the spinal cord, peripheral<br>nerves, and nerve roots for the relief of pain.<br>Examples include, but are not limited to,<br>Facet Denervation, Percutaneous<br>Chordotomy/Dorsal Root Entry Zone (DREZ)<br>Lesion, Trigeminus Neuralgia, Peripheral<br>Neuralgia and Rhizotomy. | The Stryker RF electrodes and<br>cannulae, in combination with the<br>Stryker RF Generator/Multigen,<br>are intended for coagulation of<br>soft tissues in orthopedic, spinal,<br>and neurosurgical applications.<br>These products are also used for<br>selective denervation and tissue<br>destruction procedures which may<br>be performed on the lumbar,<br>thoracic, and cervical regions of<br>the peripheral nerves, and nerve<br>roots for the relief of pain.<br>Examples include, but are not<br>limited to, Facet Denervation,<br>Trigeminus Neuralgia, Peripheral<br>Neuralgia and Rhizotomy. | Equivalent.<br>Indications within<br>scope of predicate<br>indications. |
| FEATURE | Standard and Venom MultiGen 2<br>Electrodes…