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The Stryker OptaBlate BVN Intraosseous Nerve Ablation System is intended for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The subject device Stryker Optablate® BVN Intraosseous Nerve Ablation System is a bipolar, high frequency electrosurgical system comprising the BVN probe, Microinfuser, syringe, introducer handpiece, introducer conduit, 10 G access cannula with diamond tip stylet, and 10 G bevel tip stylet. The subject device is intended to be used in conjunction with the existing Optablate radiofrequency (RF) generator (K221074), MultiGen2 Splitter Cable (K170242), and Optablate Microinfuser (K221074) to produce lesions by the direct application of radiofrequency currents for the relief of chronic low back pain. The subject generator applies temperature-controlled, radiofrequency (RF) energy into the probe. During lesion creation, targeted tissue is exposed to RF energy using an active probe inserted into a conduit that is within an access cannula. The application of RF energy causes a thermal reaction at the targeted tissue site to ablate the basivertebral nerve. It is indicated for the L3 through S1 vertebrae. When used, the subject OptaBlate BVN probes are connected to the splitter cable, which is connected to the generator, to deliver RF energy to the target tissue. The Optablate Microinfuser is connected to the probe to deliver a small amount of saline to the ablation site. The saline exits the probe between the emitters and helps ensure there is good electrical connection between the emitters and the tissue. The quality of the connection is measured in units called impedance. Impedance goes up if the connection is poor. If the impedance goes to high, the generator will trigger an error and stop the ablation. The Microinfuser slowly introduces saline to prevent impedance rises.

The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of sterile, singleuse components: The Intracept Access Instruments include cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. The Intracept RF Probe conducts RF energy to the target location. To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant Radiofrequency Generator (RFG). The Relievant RFG is a universal AC powered, microcontroller controlled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. Currently, the Relievant RF Generator (reference device (K171143)) is the only compatible RF generator for use with the Intracept System. The Intracept System uses RF energy to ablate the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel and controlled RF energy is delivered to ablate the basivertebral nerve. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The Intracept Intraosseous Nerve Ablation System is comprised of sterile, singleuse components: - The Intracept Access Instruments include introducers, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. - The Intracept RF Probe conducts RF energy to the target location. To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant Radiofrequency Generator (RFG). The Intracept System uses RF ablation of the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel at the terminus of the basivertebral foramen and controlled RF energy is delivered to ablate the basivertebral nerve (BVN). This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed ostecarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block. The COOLIEF® SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADV ANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVAN CED) to create RF lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.

The COOLIEF* Cooled Radiofrequency Kit Advanced is a modification to the predicate COOLIEF* Cooled Radiofrequency Kit cleared under K163461. The subject device consists of the following: - COOLIEF* Cooled Radiofrequency Probe Advanced - COOLIEF* Cooled Radiofrequency Fluid Tubing Kit ● - COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer ● The modifications to the subject device are specific to the probe and fluid tubing kit. The subject probe and fluid tubing kit are also included in the COOLIEF*SINERGY* Cooled Radiofrequency Kit Advanced. The subject device has several configurations based on the anatomic region of use, length of the introducer and probe, and the length of the active electrode. The COOLIEF* Cooled Radiofrequency Kit Advanced is composed of fluid delivery introducers, probes, and fluid tubing kit. The kit is sterile, non-pyrogenic, and single-use. The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVANCED) to create RF lesions in nervous tissue. This device includes the same components as the COOLIEF* Cooled RF Kit Advanced, but also includes an Epsilon The Epsilon Ruler is a circular stainless-steel ruler that may be used during the COOLIEF Ruler. SINERGY* procedure to assist the user in providing a 'template' around the foramen, which is specific to performing procedure around the sacroiliac (SI) nerve.

The Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.

The Vesta RF Cannula consists of an insulated cannula with an active tip for use in radiofrequency heat lesion procedures for the relief of pain. It is designed to be used with compatible pain management generators and probes that have a maximum voltage rating less than or equal to 280 V. The Vesta RF Cannula is sterilized and intended for single use only.

The LCCS VC-S RF Cannula is intended for use in RF heat lesion procedures for the relief of pain.

The LCCS VC-S RF Cannula is used in conjunction with the RF electrode for the use in RF heat lesion procedures. The LCCS VC-S RF Cannulas are offered in a variety of lengths, gauges to accommodate various anatomical locations and differences in patients' anatomy. The LCCS VC-S RF Cannula is a stainless steel cannula with an insulated shaft having one exposed tip and one side port located at the end of the cannula to diffuse the anesthesia closer to the lesion site and deliver the RF energy to the tissue. When RF Electrode was inserted into LCCS VC-S RF Cannula and came out from the side port, both active tip and RF Electrode section stuck out of side port can deliver Radio Frequency energy. This RF cannula is provided as a sterile, single use, disposable device. This RF Cannula is offered in a variety of length and Needle outside Dimension to accommodate various anatomical locations and differences in patient anatomy. The LCCS VC-S RF Cannula is consisted of: Protection Sleeve, Needle Tube, Insulating layer, Needle hub, Stylet, Stylet Hub.

The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of sterile, single-use components: - . The Intracept Access Instruments include introducers, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. - The Intracept RF Probe conducts RF energy to the target location. To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant RFG. The Intracept System technique uses RF ablation of the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel at the terminus of the basivertebral foramen and controlled RF energy is delivered to ablate the basivertebral nerve. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.

The Nitinol Thermocouple (TCN) Electrode is a reusable nitinol Radio Frequency (RF) electrode that has a Thermocouple (TC) sensor at the tip and is used in conjunction with a Ground Pad and a Generator to deliver therapeutic RF power to treat the peripheral nerve tissue. The electrode shaft is composed of Nitinol to allow for flexibility. The TCN electrode has a hub that connects to the Active Output Jack on the Generator. The TCN - 3M Electrode configurations are provided with a 3-meter cable.