Who is the manufacturer of STRYKER VENOM ELECTRODES AND CANNULAE?

Stryker Instruments, Instruments Div. filed the 510(k) submission for STRYKER VENOM ELECTRODES AND CANNULAE (K123178).

What is the FDA product code for STRYKER VENOM ELECTRODES AND CANNULAE?

GXI. It is classified under 21 CFR 882.4725 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for STRYKER VENOM ELECTRODES AND CANNULAE?

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

What are the predicate devices for STRYKER VENOM ELECTRODES AND CANNULAE?

Stryker Monopolar Electrodes and Cannulae (K032406); Cosman RF Cannula (K060799).

Who can help prepare an FDA 510(k) submission like STRYKER VENOM ELECTRODES AND CANNULAE?

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

STRYKER VENOM ELECTRODES AND CANNULAE

K123178 · Stryker Instruments, Instruments Div. · GXI · Mar 28, 2013 · Neurology

Device Facts

Record ID	K123178
Device Name	STRYKER VENOM ELECTRODES AND CANNULAE
Applicant	Stryker Instruments, Instruments Div.
Product Code	GXI · Neurology
Decision Date	Mar 28, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4725
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Stryker Venom Electrodes and Cannulae function as part of an RF system (with generator/cables) to create thermal lesions in nerve tissue; destroys nerve conduction ability to provide pain relief. Device consists of nitinol electrode and stainless steel cannula with distal side port; side port allows anesthesia diffusion and facilitates lesion creation comparable to larger-gauge devices. Used in clinical settings by physicians for orthopedic, spinal, and neurosurgical procedures. System delivers temperature-controlled RF energy to target tissue; provider monitors procedure via generator interface. Benefits include targeted pain relief through minimally invasive tissue destruction.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench testing comparing lesion sizes of the 18G Venom cannula against the 16G Cosman RF cannula, and biocompatibility testing per ISO 10993.

Technological Characteristics

Nitinol electrode; stainless steel cannula (18 or 20 gauge). Features distal bevel tip and side port. Energy source: RF generator. Connectivity: cable-based connection to RF generator. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients requiring soft tissue coagulation, selective denervation, or tissue destruction in orthopedic, spinal, and neurosurgical procedures, including lumbar, thoracic, and cervical peripheral nerves and nerve roots for pain relief (e.g., Facette Denervation, Trigeminus Neuralgia, Peripheral Neuralgia, Rhizotomy).

Regulatory Classification

Identification

A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

Predicate Devices

Stryker Monopolar Electrodes and Cannulae (K032406)
Cosman RF Cannula (K060799)

Related Devices

K043442 — STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE · Stryker Instruments · May 31, 2005
K032406 — STRYKER RF ELECTRODES AND CANNULAE · Stryker Instruments · Apr 1, 2004
K053415 — LESIONPOINT RF CANNULA · Cosman Medical, Inc. · Apr 25, 2006
K152642 — LCCS Disposable RF Electrode, LCCS Reusable RF Electrode · Lccs Products Limited · Aug 26, 2016
K041021 — RF INTRODUCTION CANNULA · Epimed International, Inc. · Sep 16, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ 11 123178 MAR 2 8 2013 Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 . t: 269 323 7700 f: 269 389 5412 www.stryker.com Image /page/0/Picture/3 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black, and the background is white. There is a trademark symbol to the right of the word. 510(k) Summary # 1. Contact Details Applicant Name: Stryker Instruments Stryker Instruments 4100 E. Milham Avenue Kalamazoo. MI 49001 (p) 269-389-4086 (f) 269-389-5412 Christina McKee Christina.McKee@Stryker.com Date Prepared: November 8, 2012 ### 2. Device Name Trade Name: Stryker ® Venom™ Electrodes and Cannulae Common Name: RF Electrodes and Cannulae Classification Name: probe, radiofrequency lesion; GXI ## 3. Legally Marketed Predicate Device(s) | 510(k) Number | Product Code | Trade Name | Manufacturer | |---------------|--------------|-----------------------------------------------|----------------------| | K032406 | GXI | Stryker® Monopolar Electrodes and Cannulae | Stryker Instruments | | K060799 | GXI | Cosman RF Cannula | Cosman Medical, Inc. | ## 4. Device Description The Stryker Cannulae will be used in conjunction with the Stryker RF Generator/MultiGen, cables and electrodes to create radiofrequency lesions in nerve tissue. The generator applies {1}------------------------------------------------ temperature-controlled, radio frequency (RF) energy into targeted nerve tissue via an electrode probe. This energy destroys the nerve tissue's ability to conduct electrical signals. Pain relief is achieved by creating defined lesions on pain-conducting nerve fibers or tissue. ## 5. Intended Use/Indications for use 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. ### 6. Substantial Equivalence Comparison | Stryker® Venom™ | Stryker® Monopolar | Cosman RF | Comparison | |------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Electrodes and | Electrodes and | Electrodes (K082012) | | | Cannulae | Cannulae (K032406) | and Cannulae (K060799) | | | Electrodes: Nitinol | Electrodes: Nitinol | Electrodes: Nitinol | The Stryker Venom™ Electrodes and Cannulae are manufactured from the same materials as the predicate. There are no changes to the material content. | | Cannulae: Stainless Steel | Cannulae: Stainless Steel | Cannula: Stainless Steel | 25 gauge (0.5mm OD) Nitinol electrode | | 27 gauge (0.4mm OD) Nitinol electrode | 27 gauge (0.4mm OD) Nitinol electrode | Stryker Venom™ electrode is constructed with a larger diameter nitinol electrode than the predicate Stryker Monopolar electrode and the Cosman electrode. The Venom™ electrode will not be used with a 22 gauge cannula; therefore the gauge of the Venom™ electrode can be slightly larger. The | | {2}------------------------------------------------ | | | | difference is size does not change the intended use of the device and does not introduce any new issues of safety and effectiveness. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The VenomTM 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 Monopolar 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 Cosman RF Cannula consists of a 16 gauge stainless steel tube with an insulated shaft and an exposed tip. | The Stryker VenomTM Cannula has an additional side port at the distal end. The side port allows for diffusion of anesthesia closer to the lesion site and, in conjunction with the electrode, helps to create a lesion size comparable to more invasive, larger gauge cannula and electrodes. The side port does not change the intended use of the device and does not introduce any new issues of safety and | #### 7. Non-clinical Testing The Stryker® Venom™ Electrodes and Cannulae meet the specification and performance characteristics as identified in Stryker's internal design control procedures and are substantially equivalent to the predicate devices. The testing which was conducted included simulated use, mechanical durability and cleaning. Biocompatibility testing of the Stryker® Venom™ confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing and are biocompatible. Bench testing was performed to compare lesion sizes of the 18G Venom™ Cannula using standard electrode deployment and Venom electrode deployment, and the Cosman 16G RF Cannula used with the 27 gauge electrode and Cosman generator. It was determined that the lesion sizes created were smallest for the 18 gauge Venom™ cannula standard deployment {3}------------------------------------------------ followed by the Venom™ cannula using the Venom deployment. The largest lesion was created by the 16 gauge Cosman cannula and electrode. # 8. Clinical Testing No clinical testing was performed. #### 9. Conclusions Based on device comparison information and non-clinical bench testing, the Stryker® Venom™ Electrodes and Cannulae are substantially equivalent to legally marketed predicate devices and do not raise any new concerns of safety and effectiveness. {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble a person embracing another person. March 28,2013 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Christina McKee Regulatory Affairs Associate Analyst 4100 East Milham Ave. Kalamazoo, MI 49001 Re: K123178 Trade/Device Name: Stryker Venom Electrodes and Cannulae Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: II Product Code: GXI Dated: February 25, 2013 Received: February 26, 2013 Dear Christina McKee: 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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Victor Krauthamer -S Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(K) Number (if knownK123178 · Device Name: #### Indications for Use 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. Prescription Use _____________________________________________________________________________________________________________________________________________________________ and/or Over-The-Counter Use (Part 21 CFR 801 Subpart D) . (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation (ODE) | Victor Krauthamer | S | |----------------------------------------------------------------|---------| | | FDA | | 2013.03.28 16:32:13 | -04'00' | | (Division Sign Off) | | | Division of Neurological and Physical Medicine Devices (DNPMD) | | | 510(k) Number: | K123178 |