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.

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.

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 and Rhizotomy.

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.

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. The application of RF energy causes a thermal reaction at the targeted nerve tissue site to create a lesion.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device, specifically the Stryker MultiGen™ 2 RF Generator System. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials for novel devices.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through a combination of comparisons to predicate devices, and various types of performance testing (electrical safety, EMC, software V&V, and bench testing). There are no clinical studies or human reader performance studies mentioned for this device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, meaning the new device should have similar or equivalent technical characteristics and performance to the previously cleared device. The "performance" refers to the results of various verification tests showing the device operates within its specifications and performs similarly to the predicate.

Feature	Predicate Device (Stryker RF Multi-Lesion Generator)	Subject Device (MultiGen™ 2 RF Generator)	Acceptance Criterion (Implicit)	Reported Performance / Equivalence
Generator
Indication for Use	Coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. (Includes: Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. Also for disc material coagulation/decompression.)	Coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. (Includes: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.)	Indications should be within the scope of predicate indications, not raising new questions of safety/effectiveness.	Equivalent. Indications within scope of predicate indications. Minor modifications for clarification and consistency, but do not change meaning.
Modes of Operation	Sensory and Motor Stimulation. Pulsed and Continuous Lesioning.	Sensory and Motor Stimulation. Pulsed and Continuous Lesioning.	Identical or equivalent.	Identical.
Type of Control	Manual and Automatic.	Manual and Automatic.	Identical or equivalent.	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 or equivalent.	Identical.
Temperature Measurement Location	Distal Tip of the Nitinol Electrode.	Distal Tip of the Nitinol Electrode.	Identical or equivalent.	Identical.
Temperature Range	37 °C - 97 °C.	37 °C - 95 °C.	Within range of predicate.	Equivalent. Within range of predicate.
Temperature Accuracy	37 °C - 95 °C ±2°C.	37 °C - 95 °C ±2°C.	Identical.	Identical.
Lesion Time	0-999 seconds.	0-999 seconds.	Identical.	Identical.
Stimulation Frequency	Sensory: 10, 20, 30, 50, 75, 100, 150, 200 (Hz); Motor: 1, 2, 3, 4, 5, 7, 10, 20 (Hz).	Sensory = 50 Hz; Motor = 2 Hz.	Equivalent, ideally reducing complexity while maintaining functionality.	Equivalent. Reduce complexity. Within range of predicate.
Stimulation Pulse Width	.1,.2,.5,.75,1,2,3,5 (ms).	1 ms.	Similar, ideally reducing complexity while maintaining functionality.	Similar. Reduce complexity. Within range of predicate.
Stimulation Amplitude Voltage Regulation Mode	0-10 V peak; accuracy + 10%, current limited to 40 mA.	0-10 V peak; accuracy + 10%, current limited to 25 mA.	Equivalent, ensuring safe and effective operation.	Equivalent. Reduction in voltage.
Impedance Range	0-2000 ohms.	0-2000 ohms.	Identical.	Identical.
Type of User Interface	Touch screen graphical user interface.	Touch screen graphical user interface.	Identical.	Identical.
Type of Probe Recognition	Automatic.	Automatic.	Identical.	Identical.
Number of Amps	1.	4.	Equivalent, potentially simplifying control.	Equivalent. Simplifies control of energy.
Energy Delivery during multi-channel RF treatment	Sequential non simultaneous energy delivery.	Sequential non simultaneous energy delivery.	Identical.	Identical.
Output Energy	0-50 watts.	0-100 watts.	Equivalent, demonstrating safe energy delivery.	Equivalent. The maximum current the patient is exposed to remains the same (700 mA).
Output Waveform(s)	Malis Dual/Wave Waveform.	500kHz sinusoid.	Equivalent, demonstrating safe and effective energy transfer.	Equivalent. Sinusoid waveform requires lower voltage to achieve equivalent energy transfer.
Monopolar/Bipolar	Monopolar and Bipolar.	Monopolar and Bipolar.	Identical.	Identical.
Ability to perform multiple lesions simultaneously	Yes.	Yes.	Identical.	Identical.
Number of electrode connections	4.	4.	Identical.	Identical.
Printer Output	Yes.	No.	Equivalent, if the feature is not essential for safety/effectiveness.	Equivalent. Feature is not frequently used.
Accessories	MultiGen Cable, Connector Cable, Hand Controller, 3M Neutral Electrode (Ground Pad), Ground Pad Cable, Stryker RF (Standard) Electrodes, Stryker RF (Standard) Cannulae, Venom Electrodes, Venom Cannulae.	Splitter Box, 3M Neutral Electrode (Ground Pad), Ground Pad Cable, Stryker MultiGen 2 (Standard) Electrodes, Stryker RF (Standard) Cannulae, Venom MultiGen 2 Electrodes, Venom Cannulae.	Similar, demonstrating compatibility and functionality.	Similar. The Splitter Cable replaces the need for two MultiGen Cables or other connecting cables.
Electrodes & Cannulae
Indication for Use (Electrodes)Standard & Venom	Standard: For coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications. Also for selective denervation and tissue destruction procedures for pain relief. Venom: Same, but more specific on peripheral nerves.	Standard & Venom MultiGen 2: For coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Also for selective denervation and tissue destruction procedures for pain relief.	Indications should be within the scope of predicate indications, not raising new questions of safety/effectiveness.	Equivalent. Indications within scope of predicate indications.
Indication for Use (Cannulae)Standard & Venom	Same as Electrodes for Standard. Venom: Same as Electrodes for Venom.	Same as Electrodes for Standard & Venom.	Indications should be within the scope of predicate indications, not raising new questions of safety/effectiveness.	Equivalent. Indications within scope of predicate indications.
Electrode Lengths	Standard: 50mm, 100mm, 150mm. Venom: 100mm, 150mm.	Standard: 50mm, 100mm, 150mm, 200mm. Venom: 100mm, 150mm.	Equivalent, potentially including additional compatible lengths.	Equivalent. Additional length (200mm for Standard).
Nitinol Electrode Radial Dimensions	Standard: ID 0.25mm, OD 0.40mm. Venom: ID 0.25mm, OD 0.50mm.	Standard: ID 0.25mm, OD 0.40mm. Venom: ID 0.25mm, OD 0.50mm.	Identical.	Identical.
Design	Standard: 27 gauge (0.4mm OD) Nitinol electrode, PEEK hub, 4 conductor silicone cable (approx 4 ft), K-type thermocouple, ODU connector (13.9mm D, 47.5mm L). Venom: 25 gauge (0.5mm OD) Nitinol electrode, PEEK hub, 4 conductor silicone cable (approx 4 ft), K-type thermocouple (13.9mm D, 47.5mm L).	Standard: 27 gauge (0.4mm OD) Nitinol electrode, PEEK hub, 4 conductor silicone cable (approx 5 ft), K-type thermocouple, ODU connector (8.9mm D, 34.9mm L). Venom: 25 gauge (0.5mm OD) Nitinol electrode, PEEK hub, 4 conductor silicone cable (approx 5 ft), K-type thermocouple (8.9mm D, 34.9mm L).	Equivalent, demonstrating similar form and function.	Equivalent. Differences in cable length and ODU connector size, but functionally equivalent.
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.	Identical.
Temperature Measurement Location	Distal Tip of the Electrode.	Distal Tip of the Electrode.	Identical.	Identical.
Sterility	Steam.	Steam or Vaporized Hydrogen Peroxide.	Equivalent, ensuring effective sterilization.	Equivalent.
Materials	Nitinol, Silicone Rubber, PEEK, Stainless Steel.	Nitinol, Silicone Rubber, PEEK, Stainless Steel.	Identical.	Identical.
Cannulae Sizes	Standard: Lengths 50, 100, 150mm; Diameters 20G, 22G; Active Tip 2.5, 4.0, 5.0, 7.5, 10.0, 15.0mm. Venom: Lengths 100, 150mm; Diameters 18G, 20G; Active Tip 10mm.	Standard: Lengths 50, 100, 150, 200mm; Diameters 18G, 20G, 22G; Active Tip 5.0, 7.5, 10.0, 15.0mm. Venom: Lengths 100, 150mm; Diameters 18G, 20G; Active Tip [Not explicitly listed, but implied from standard cannulae].	Equivalent, with potential new sizes falling within a clinically safe range.	Equivalent. Longer Length (200mm for Standard). Gages and Active Tips within cleared range.
Cannulae Design	Standard: 20 or 22G stainless steel tubing, bevel tip, siliconised polyester insulation, liquid silicone, polycarbonate hub. Venom: 18 or 20G stainless steel tubing, bevel tip and side port, siliconised polyester insulation, polycarbonate hub.	Standard: 18, 20 or 22G stainless steel tubing, bevel tip, siliconised polyester insulation, polycarbonate hub. Venom: 18 or 20G stainless steel tubing, bevel tip and side port, siliconised polyester insulation, polycarbonate hub.	Equivalent, maintaining similar functional properties.	Equivalent. Minor difference in Standard Design (absence of liquid silicone in subject device, but still functionally equivalent regarding insulation).
Cannulae Sterility	EtO.	EtO.	Identical.	Identical.
Cannulae Materials	Stainless Steel, Siliconised Polyester, Liquid Silicone (Standard only), Polycarbonate Plastic, Inert black ink, Polyethylene.	Stainless Steel, Siliconised Polyester, Polycarbonate plastic, Inert black ink, Polyethylene.	Equivalent, ensuring biocompatibility and functionality.	Equivalent. The absence of liquid silicone in the subject device's Standard Cannulae is noted but considered equivalent based on overall performance.

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

Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical data. This submission relies on a comparison to a predicate device and various engineering tests. For the engineering tests:
- "Substantial equivalence testing verifying the radiofrequency ablations created by the subject device are equivalent to the radiofrequency ablations created by the predicate device." - The number of tests/data points is not specified.
- "Multi-Lesion testing verifying that the MultiGen 2 RF Generator system functions properly with all possible set ups and procedural variations." - The number of test cases/scenarios is not specified.
- "MultiGen 2 Splitter Cable (Splitter Cable) life testing." - The number of cables tested and duration is not specified.
- "MultiGen 2 Electrode NOVRAM testing showing that the NOVRAM meets specifications." - The number of electrodes tested is not specified.
- "MultiGen 2 RF Generator current limitation testing." - The number of tests is not specified.
Data Provenance: Not specified. This submission is about the device's technical specifications and engineering testing, not typically patient-derived data. The tests are bench tests conducted by the manufacturer.

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

Not applicable. This submission relies on engineering and performance testing against specifications and comparison to the predicate device's established characteristics. There is no concept of "ground truth" derived from expert interpretation (e.g., of medical images) in this context.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for this type of submission (engineering and performance testing).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document explicitly states: "No clinical studies were performed to support substantial equivalence." The device is not an AI-assisted diagnostic tool; it is a radiofrequency generator used for soft tissue coagulation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (RF Generator), not an algorithm or AI system. Its performance is evaluated through engineering and bench testing, as well as comparison to its predicate device. This is analogous to "standalone performance" in the sense that the device's functional integrity is tested on its own and with its accessories.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, design requirements, and the performance characteristics of its legally marketed predicate device. For example, the accuracy of temperature measurement or the output power range are compared against the established parameters of the predicate and internal design specifications, not against clinical outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set."

Summary

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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 (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

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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)

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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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 (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

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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

Venom MultiGen 2 Electrodes

Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

Standard MultiGen 2 Standard Electrodes

Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

Venom and Standard Cannulae (RF Cannulae)

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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 GeneratorSUBJECT DEVICE	Stryker RF Multi-Lesion GeneratorPREDICATE 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 electrodeThermocouple interfaceelectronics in RF Generators	K-type thermocouple in electrodeThermocouple interfaceelectronics 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
StimulationFrequency	Sensory = 50 HzMotor = 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 ofpredicate.
StimulationPulse Width	1 ms	.1,.2,.5,.75,1,2,3,5 (ms)	Similar.Reduce complexity.Within range ofpredicate.
StimulationAmplitudeVoltageRegulationMode	0-10 V peak; accuracy + 10%,current limited to 25 mA	0-10 V peak; accuracy + 10%,current limited to 40 mA	Equivalent. Reductionin voltage.
ImpedanceRange	0-2000 ohms	0-2000 ohms	Identical.
Type of UserInterface	Touch screen graphical userinterface	Touch screen graphical userinterface	Identical.
Type of ProbeRecognition	Automatic	Automatic	Identical.
Number of Amp	4	1	Equivalent. Simplifiescontrol of energy.
Energy deliveryduring multi-channel RFtreatment	Sequential non simultaneousenergy delivery	Sequential non simultaneousenergy delivery	Identical.
Output Energy	0-100 watts	0-50 watts	Equivalent.The maximum currentthe patient is exposedto remains the same(700 mA).
OutputWaveform(s)	500kHz sinusoid	Malis Dual/Wave Waveform	Equivalent.Sinusoid waveformrequires lower voltageto achieve equivalentenergy transfer.
Monopolar/Bipolar	Monopolar and Bipolar	Monopolar and Bipolar	Identical.
Ability toperformmultiple lesionssimultaneously	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 notfrequently 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 Cablereplaces the need fortwo MultiGen Cablesor other connectingcables.

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TABLE 1: GENERATOR COMPARISON TABLE

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FEATURE	Standard and Venom MultiGen 2Electrodes	Standard Electrodes	Venom Electrodes	Equivalency
	SUBJECT DEVICE	PREDICATE DEVICE	PREDICATE DEVICE
		Intended Use
		Electrodes
510(k) Clearance	Subject Device	K032406	K123178	N/A.
Indication forUse (Electrodes)	Standard MultiGen 2 ElectrodesThe Stryker MultiGen 2 Electrodes, incombination with the Stryker RFCannulae and Stryker MultiGen 2 RFGenerator, are intended for coagulationof soft tissue in orthopedic, spinal, andneurosurgical applications. Theseproducts are also used for selectivedenervation and tissue destructionprocedures which may be performed onthe lumbar, thoracic, and cervical regionsof the peripheral nerve, and nerve rootsfor the relief of pain.Examples include, but are not limited to:Facet Denervation, Trigeminus Neuralgia,Peripheral Neuralgia and Rhizotomy.Venom MultiGen 2 ElectrodesThe Stryker Venom MultiGen 2Electrodes, in combination with theStryker RF Cannulae and StrykerMultiGen 2 RF Generator, are intendedfor coagulation of soft tissue inorthopedic, spinal, and neurosurgicalapplications. These products are alsoused for selective denervation and tissuedestruction procedures which may beperformed on the lumbar, thoracic, and	The Stryker RF Electrodes and Cannulae, incombination with the Stryker RF Generator,are intended for coagulation of soft tissuesin orthopedic, arthroscopic, spinal, andneurosurgical applications. They are alsoused for selective denervation and tissuedestruction procedures which may beperformed on the lumbar, thoracic, andcervical regions of the spinal cord, peripheralnerves, and nerve roots for the relief of pain.Examples include, but are not limited to,Facette Denervation, PercutaneousChordotomy/Dorsal Root Entry Zone (DREZ)Lesion, Trigeminus Neuralgia, PeripheralNeuralgia and Rhizotomy.	The Stryker RF electrodes andcannulae, in combination with theStryker RF Generator/Multigen,are intended for coagulation ofsoft tissues in orthopedic, spinal,and neurosurgical applications.These products are also used forselective denervation and tissuedestruction procedures which maybe performed on the lumbar,thoracic, and cervical regions ofthe peripheral nerves, and nerveroots for the relief of pain.Examples include, but are notlimited to, Facette Denervation,Trigeminus Neuralgia, PeripheralNeuralgia and Rhizotomy.	Equivalent.Indications withinscope of predicateindications.
FEATURE	Standard and Venom MultiGen 2Electrodes	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 forUse (Cannulae)	Standard RF Cannulae / Venom RFCannulaeThe Stryker RF Cannulae, in combinationwith Stryker Electrodes and the StrykerRF Generator, Stryker MultiGen, orStryker MultiGen 2 RF Generator, areintended for coagulation of soft tissue inorthopedic, spinal, and neurosurgicalapplications. They are also used forselective denervation and destructionprocedures which may be performed onthe lumbar, thoracic, and cervical regionsof the peripheral nerve, and nerve rootsfor 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, incombination with the Stryker RF Generator,are intended for coagulation of soft tissuesin orthopedic, arthroscopic, spinal, andneurosurgical applications. They are alsoused for selective denervation and tissuedestruction procedures which may beperformed on the lumbar, thoracic, andcervical regions of the spinal cord, peripheralnerves, and nerve roots for the relief of pain.Examples include, but are not limited to,Facet Denervation, PercutaneousChordotomy/Dorsal Root Entry Zone (DREZ)Lesion, Trigeminus Neuralgia, PeripheralNeuralgia and Rhizotomy.	The Stryker RF electrodes andcannulae, in combination with theStryker RF Generator/Multigen,are intended for coagulation ofsoft tissues in orthopedic, spinal,and neurosurgical applications.These products are also used forselective denervation and tissuedestruction procedures which maybe performed on the lumbar,thoracic, and cervical regions ofthe peripheral nerves, and nerveroots for the relief of pain.Examples include, but are notlimited to, Facet Denervation,Trigeminus Neuralgia, PeripheralNeuralgia and Rhizotomy.	Equivalent.Indications withinscope of predicateindications.
FEATURE	Standard and Venom MultiGen 2Electrodes	Standard Electrodes	Venom Electrodes	Equivalency
	SUBJECT DEVICE	PREDICATE DEVICE	PREDICATE DEVICE
		Technological Indications
	Electrodes
ElectrodeLengths	Standard50mm, 100mm, 150mm, 200mmVenom100mm, 150mm	50mm, 100mm, 150mm,	100mm, 150mm	Equivalent.Additional length.
Nitinol ElectrodeRadialDimensions	StandardInside Diameter: 0.25mmOutside Diameter: 0.40mmVenomInside Diameter: 0.25mmOutside Diameter: 0.50mm	Inside Diameter: 0.25mmOutside Diameter: 0.40mm	Inside Diameter: 0.25mmOutside Diameter: 0.50mm	Identical.
Design	Standard27 gauge (0.4mm OD) Nitinol electrodePEEK electrode hub4 conductor silicone cable(approximately 5 feet long)K-type thermocoupleODU cable connector assembly(diameter: 8.9mm, length 34.9 mm)Venom25 gauge (0.5mm OD) Nitinol electrodePEEK electrode hub4 conductor silicone cable(approximately 5 feet long)K-type thermocoupleODU cable connector assembly(diameter: 8.9mm, length 34.9 mm)	27 gauge (0.4mm OD) Nitinol electrodePEEK electrode hub4 conductor silicone cable (approximately 4feet long)K-type thermocoupleODU cable connector assembly (diameter:13.9mm, length 47.5 mm)	25 gauge (0.5mm OD) NitinolelectrodePEEK electrode hub4 conductor silicone cable(approximately 4 feet long)K-type thermocouple(diameter: 13.9mm, length 47.5mm)	Equivalent.
FEATURE	Standard and Venom MultiGen 2Electrodes	Standard Electrodes	Venom Electrodes	Equivalency
	SUBJECT DEVICE	PREDICATE DEVICE	PREDICATE DEVICE
TemperatureMeasurementTechnology	K-type thermocouple in electrodeThermocouple interface electronics inRF Generators	K-type thermocouple in electrodeThermocouple interface electronics in RFGenerators	K-type thermocouple in electrodeThermocouple interfaceelectronics in RF Generators	Identical.
TemperatureMeasurementLocation	Distal Tip of the Electrode	Distal Tip of the Electrode	Distal Tip of the Electrode	Identical.
Sterility	Steam or Vaporized Hydrogen Peroxide	Steam	Steam	Equivalent.
Materials	NitinolSilicone RubberPEEK(Polyether ether ketone)Stainless Steel	NitinolSilicone RubberPEEK(Polyether ether ketone)Stainless Steel	NitinolSilicone RubberPEEK(Polyether ether ketone)Stainless Steel	Identical.
	Cannulae
Sizes	LengthsStandard50mm, 100mm, 150mm, 200mmVenom100mm, 150mmDiametersStandard18G, 20G, 22GVenom18G, 20G,Active TipStandard5.0mm, 7.5mm, 10.0mm, 15.0mmVenom	Lengths50mm, 100mm, 150mmDiameters20G, 22GActive Tip2.5mm, 4.0mm, 5.0mm, 7.5mm, 10.0mm,15.0mm	Lengths100mm, 150mmDiameters18G, 20GActive Tip10mm	Equivalent.Longer Length.Gages and ActiveTips within clearedrange.
FEATURE	Standard and Venom MultiGen 2Electrodes	Standard Electrodes	Venom Electrodes	Equivalency
	SUBJECT DEVICE	PREDICATE DEVICE	PREDICATE DEVICE
Design	StandardThe Standard RF Cannula consists of 18,20 or 22 gauge stainless steel tubing cutto length. A bevel tip is created via anelectro-chemical grinding process. Thecannula is insulated with siliconisedpolyester. A polycarbonate cannulahub with inert black ink marking isattached to the proximal end.VenomThe Venom™ Cannula consists of 18 or20 gauge stainless steel tubing cut tolength. A bevel tip and a side port arecreated at the distal end via an electro-chemical grinding process. The cannulais insulated with siliconised polyester. Apolycarbonate cannula hub with inertblack ink marking is attached to theproximal end.	The Standard RF Cannula consists of 20 or22 gauge stainless steel tubing cut tolength. A bevel tip is created via an electro-chemical grinding process. The cannula isinsulated with siliconised polyester.Additionally the cannulae include a smallamount of liquid silicone. A polycarbonatecannula hub with inert black ink marking isattached to the proximal end.	The Venom™ Cannula consists of18 or 20 gauge stainless steeltubing cut to length. A bevel tipand a side port are created at thedistal end via an electro-chemicalgrinding process. The cannula isinsulated with siliconisedpolyester. A polycarbonatecannula hub with inert black inkmarking is attached to theproximal end.	Equivalent.
Sterility	EtO	EtO	EtO	Identical.
Materials	Stainless SteelSiliconised PolyesterPolycarbonate plasticInert black inkPolyethylene	Stainless SteelSiliconised PolyesterLiquid SiliconePolycarbonate plasticInert black inkPolyethylene	Stainless SteelSiliconised PolyesterPolycarbonate plasticInert black inkPolyethylene	Equivalent.

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TABLE 2: ELECTRODE AND CANNULA COMPARISON TABLE

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Performance Data

The following performance data were provided in support of the substantial equivalence decision:

Electrical Safety and Electromagnetic Compatibility (EMC) Testing

Electrical safety and EMC testing were conducted on the subject device in accordance with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012 (IEC 60601-1:2005, mod).
IEC 60601-2-2 Edition 5.0 2009-02 [including: technical corrigendum 1 (2014)]
IEC 60601-1-2 Edition 3: 2007-03 and
IEC 60601-1-2 Edition 4.0 2014-02

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Performance Testing - Bench

The following design verification activities have been performed to ensure the correct functionality of the system as it has been specified:

· Substantial equivalence testing verifying the radiofrequency ablations created by the subject device are equivalent to the radiofrequency ablations created by the predicate device.
· Multi-Lesion testing verifying that the MultiGen 2 RF Generator system functions properly with all possible set ups and procedural variations.
· MultiGen 2 Splitter Cable (Splitter Cable) life testing.
MultiGen 2 Electrode NOVRAM testing showing that the NOVRAM meets specifications.
· MultiGen 2 RF Generator current limitation testing.

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Animal Study

No animal studies were performed to support substantial equivalence.

Clinical Studies

No clinical studies were performed to support substantial equivalence.

Conclusions

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).

Michael J. Hoffmann -S

Indications for Use

Indications for Use (Describe)

Venom MultiGen 2 Electrodes

Standard MultiGen 2 Standard Electrodes

Venom and Standard Cannulae (RF Cannulae)

Type of Use (Select one or both, as applicable)

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SECTION

Table of Contents

List of Figures and Tables

510(k) Summary

Submitter

Device

Predicate Devices

Device Description

Indications for Use

Stryker MultiGen™ 2 RF Generator

Venom MultiGen 2 Electrodes

Standard MultiGen 2 Standard Electrodes

Venom and Standard Cannulae (RF Cannulae)

Comparison of Technological Characteristics with the Predicate Device

Performance Data

Electrical Safety and Electromagnetic Compatibility (EMC) Testing

Software Verification and Validation Testing

Performance Testing - Bench

Animal Study

Clinical Studies

Conclusions

§ 882.4400 Radiofrequency lesion generator.