(119 days)
No
The description focuses on the electrosurgical system's function of applying temperature-controlled RF energy for tissue coagulation and lesion creation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended for the coagulation of soft tissues, selective denervation, and tissue destruction procedures for pain relief, which are direct therapeutic interventions.
No
The device is described as an electrosurgical system intended for coagulation, denervation, and tissue destruction to relieve pain, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is a "high frequency electrosurgical system" and a "generator" that is used in conjunction with physical components like electrodes and cannulae to produce lesions. This indicates it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, the Stryker MultiGen™ 2 RF Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications" and "selective denervation and tissue destruction procedures." These are therapeutic procedures performed directly on a patient's body.
- Device Description: The device description explains that it's an "electrosurgical system" that applies "radiofrequency energy" to create lesions in targeted nerve tissue. This is a method of treatment, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The Stryker MultiGen™ 2 RF Generator is a therapeutic device used for surgical procedures.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GXD, GXI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues in orthopedic, spinal, and neurosurgical applications; lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Animal Study
No animal studies were performed to support substantial equivalence.
Clinical Studies
No clinical studies were performed to support substantial equivalence.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).
0
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
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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 | Standard Electrodes | Venom Electrodes | Equivalency |
| | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | |
| | | Technological Indications | | |
| | Electrodes | | | |
| Electrode
Lengths | Standard
50mm, 100mm, 150mm, 200mm
Venom
100mm, 150mm | 50mm, 100mm, 150mm, | 100mm, 150mm | Equivalent.
Additional length. |
| Nitinol Electrode
Radial
Dimensions | Standard
Inside Diameter: 0.25mm
Outside Diameter: 0.40mm
Venom
Inside Diameter: 0.25mm
Outside Diameter: 0.50mm | Inside Diameter: 0.25mm
Outside Diameter: 0.40mm | Inside Diameter: 0.25mm
Outside Diameter: 0.50mm | Identical. |
| Design | Standard
27 gauge (0.4mm OD) Nitinol electrode
PEEK electrode hub
4 conductor silicone cable
(approximately 5 feet long)
K-type thermocouple
ODU cable connector assembly
(diameter: 8.9mm, length 34.9 mm)
Venom
25 gauge (0.5mm OD) Nitinol electrode
PEEK electrode hub
4 conductor silicone cable
(approximately 5 feet long)
K-type thermocouple
ODU cable connector assembly
(diameter: 8.9mm, length 34.9 mm) | 27 gauge (0.4mm OD) Nitinol electrode
PEEK electrode hub
4 conductor silicone cable (approximately 4
feet long)
K-type thermocouple
ODU cable connector assembly (diameter:
13.9mm, length 47.5 mm) | 25 gauge (0.5mm OD) Nitinol
electrode
PEEK electrode hub
4 conductor silicone cable
(approximately 4 feet long)
K-type thermocouple
(diameter: 13.9mm, length 47.5
mm) | Equivalent. |
| FEATURE | Standard and Venom MultiGen 2
Electrodes | Standard Electrodes | Venom Electrodes | Equivalency |
| | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | |
| 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 | K-type thermocouple in electrode
Thermocouple interface
electronics in RF Generators | Identical. |
| Temperature
Measurement
Location | 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 | Nitinol
Silicone Rubber
PEEK(Polyether ether ketone)
Stainless Steel | Nitinol
Silicone Rubber
PEEK(Polyether ether ketone)
Stainless Steel | Nitinol
Silicone Rubber
PEEK(Polyether ether ketone)
Stainless Steel | Identical. |
| | Cannulae | | | |
| Sizes | Lengths
Standard
50mm, 100mm, 150mm, 200mm
Venom
100mm, 150mm
Diameters
Standard
18G, 20G, 22G
Venom
18G, 20G,
Active Tip
Standard
5.0mm, 7.5mm, 10.0mm, 15.0mm
Venom | Lengths
50mm, 100mm, 150mm
Diameters
20G, 22G
Active Tip
2.5mm, 4.0mm, 5.0mm, 7.5mm, 10.0mm,
15.0mm | Lengths
100mm, 150mm
Diameters
18G, 20G
Active Tip
10mm | Equivalent.
Longer Length.
Gages and Active
Tips within cleared
range. |
| FEATURE | Standard and Venom MultiGen 2
Electrodes | Standard Electrodes | Venom Electrodes | Equivalency |
| | SUBJECT DEVICE | PREDICATE DEVICE | PREDICATE DEVICE | |
| Design | Standard
The Standard RF Cannula consists of 18,
20 or 22 gauge stainless steel tubing cut
to length. A bevel tip is created via an
electro-chemical grinding process. The
cannula is insulated with siliconised
polyester. A polycarbonate cannula
hub with inert black ink marking is
attached to the proximal end.
Venom
The Venom™ Cannula consists of 18 or
20 gauge stainless steel tubing cut to
length. A bevel tip and a side port are
created at the distal end via an electro-
chemical grinding process. The cannula
is insulated with siliconised polyester. A
polycarbonate cannula hub with inert
black ink marking is attached to the
proximal end. | The Standard RF Cannula consists of 20 or
22 gauge stainless steel tubing cut to
length. A bevel tip is created via an electro-
chemical grinding process. The cannula is
insulated with siliconised polyester.
Additionally the cannulae include a small
amount of liquid silicone. A polycarbonate
cannula hub with inert black ink marking is
attached to the proximal end. | The Venom™ Cannula consists of
18 or 20 gauge stainless steel
tubing cut to length. A bevel tip
and a side port are created at the
distal end via an electro-chemical
grinding process. The cannula is
insulated with siliconised
polyester. A polycarbonate
cannula hub with inert black ink
marking is attached to the
proximal end. | Equivalent. |
| Sterility | EtO | EtO | EtO | Identical. |
| Materials | Stainless Steel
Siliconised Polyester
Polycarbonate plastic
Inert black ink
Polyethylene | Stainless Steel
Siliconised Polyester
Liquid Silicone
Polycarbonate plastic
Inert black ink
Polyethylene | Stainless Steel
Siliconised Polyester
Polycarbonate plastic
Inert black ink
Polyethylene | Equivalent. |
13
14
15
16
TABLE 2: ELECTRODE AND CANNULA COMPARISON TABLE
17
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.
18
Animal Study
No animal studies were performed to support substantial equivalence.
Clinical Studies
No clinical studies were performed to support substantial equivalence.
Conclusions
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.