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 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 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.

AI/ML Overview

This document describes the Stryker® Venom™ Electrodes and Cannulae, a medical device used for radiofrequency (RF) lesion creation in nerve tissue for pain relief.

The acceptance criteria for this device are primarily established through substantial equivalence to predicate devices and non-clinical bench testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (as per non-clinical testing)
Substantial Equivalence	Device materials: Same as predicate devices for electrodes (Nitinol) and cannulae (Stainless Steel).	Met: Stryker Venom™ Electrodes and Cannulae are manufactured from the same materials as the predicate devices (Stryker® Monopolar Electrodes and Cannulae, K032406, and Cosman RF Cannula, K060799). The document explicitly states: "There are no changes to the material content."
Functional Equivalence	Intended Use: Coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications; selective denervation and tissue destruction for pain relief (lumbar, thoracic, cervical peripheral nerves/nerve roots).	Met: The Intended Use/Indications for use for Stryker® Venom™ Electrodes and Cannulae are identical to the predicate devices. The document states the device "will be used in conjunction with the Stryker RF Generator/MultiGen, cables and electrodes to create radiofrequency lesions in nerve tissue" and for specific pain relief procedures, which aligns with the predicates.
	Lesion Size: Should not introduce new issues of safety and effectiveness, implying comparable or acceptable lesion characteristics relative to the intended use and predicate devices, despite a different electrode gauge.	Met (with nuance): Bench testing was performed to compare lesion sizes. It was determined that "the lesion sizes created were smallest for the 18 gauge Venom™ cannula standard deployment followed by the Venom™ cannula using the Venom deployment. The largest lesion was created by the 16 gauge Cosman cannula and electrode." The document concludes that the "difference is size does not change the intended use of the device and does not introduce any new issues of safety and effectiveness." (This implies the created lesions are within an acceptable range for the intended clinical effect).
Safety and Effectiveness	Mechanical Durability: Device must withstand simulated use conditions.	Met: "Testing which was conducted included simulated use, mechanical durability and cleaning." No specific performance metrics or thresholds are provided, but the statement indicates testing was performed and the device meets "specification and performance characteristics as identified in Stryker's internal design control procedures."
	Cleaning: Device must be cleanable.	Met: "Testing which was conducted included simulated use, mechanical durability and cleaning." (Same as above)
	Biocompatibility: Device materials must be biocompatible according to FDA guidelines (ISO-10993 Biological Evaluation of Medical Devices Part -1).	Met: "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."
Design Feature Impact	Side Port Impact: The additional side port on the Venom™ Cannula should not change the intended use or introduce new issues of safety and effectiveness, but aid in diffusion of anesthesia and create comparable lesion size to larger gauge cannulas/electrodes.	Met: The document states the side port "does not change the intended use of the device and does not introduce any new issues of safety and effectiveness. It 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."
Overall Conclusion	The device must be substantially equivalent to legally marketed predicate devices and "not raise any new concerns of safety and effectiveness."	Met: "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."

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not explicitly stated as numerical values for the "bench testing" of lesion sizes. The description mentions testing "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." This suggests a comparative test across different configurations, but the number of actual tests or samples per configuration is not provided.
Data provenance: Prospective, as it was specifically conducted bench testing for this submission. The origin is Stryker Instruments (Kalamazoo, MI, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Experts: Not applicable. The ground truth for bench testing (e.g., lesion size measurement, mechanical durability, biocompatibility) is typically established through objective measurements and validated laboratory protocols, not expert consensus in the clinical sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication method: Not applicable. The "test set" here refers to non-clinical bench testing, which doesn't involve subjective interpretations that would require adjudication.

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:

MRMC Study: No. This is a medical device (electrodes and cannulae) for surgical procedures, not an AI-assisted diagnostic or therapeutic system involving human readers interpreting data.

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

Standalone Study: Not applicable. This device is an instrument used during a surgical procedure by a human operator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Ground Truth Type: For the non-clinical testing, the "ground truth" was based on objective physical and biological measurements (e.g., lesion dimensions as measured in a bench setting, adherence to material specifications, biological response to materials, mechanical properties).

8. The sample size for the training set:

Training set sample size: Not applicable. This device does not use machine learning or AI models that require a "training set."

9. How the ground truth for the training set was established:

Training set ground truth establishment: Not applicable, as there is no training set for this type of device.

Summary

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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

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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® MonopolarElectrodes 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

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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

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

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			difference is size doesnot change the intendeduse of the device anddoes not introduce anynew issues of safety andeffectiveness.
The VenomTMCannula consists of 18or 20 gauge stainlesssteel tubing cut tolength. A bevel tipand a side port arecreated at the distalend via an electro-chemical grindingprocess.	The MonopolarCannula consists of 18,20 or 22 gaugestainless steel tubingcut to length. A beveltip is created via anelectro-chemicalgrinding process.	The Cosman RFCannula consists of a16 gauge stainlesssteel tube with aninsulated shaft and anexposed tip.	The Stryker VenomTMCannula has anadditional side port atthe distal end. The sideport allows for diffusionof anesthesia closer tothe lesion site and, inconjunction with theelectrode, helps to createa lesion size comparableto more invasive, largergauge cannula andelectrodes. The sideport does not change theintended use of thedevice and does notintroduce any newissues 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

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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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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

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510(K) Number (if knownK123178 ·

Device Name:

Indications for Use

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

Regulation Number and Section

§ 882.4725 Radiofrequency lesion probe.

(a)
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.(b)
Classification. Class II (performance standards).