(170 days)
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.
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.
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.
§ 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).