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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 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 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 either Type 1 or Type 2 Modic changes on an MRI.

The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of two 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 RF Generator (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 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 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

The Relievant RFG is a universal AC powered, microcontrolled, 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. RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System are used with the Relievant RFG.

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 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

The INTRACEPT® Intraosseous Nerve Ablation System is comprised of two sterile, single use components: - The INTRACEPT Access Instruments include trocars, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. This submission describes modifications to the Access Instruments to improve ease of use compared to the predicate. Easy Access Instrument Set. - The INTRACEPT Flexible Bi-Polar RF Probe conducts RF energy to the target location. There have been no changes to this component; therefore, there is no impact on RF ablation. Additionally, a commercially available, legally marketed, RF Generator that has been confirmed by Relievant to be compatible, provides RF energy to the RF Probe. An Interconnect Cable connects the RF Probe to the RF Generator. 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 is placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. An RF Probe is then placed into this channel at the terminus of the basivertebral foramen, and controlled RF energy is delivered to destroy 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 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

The Intracept System is comprised of two basic, sterile, single use components, both of which are currently cleared for marketing via 510(k). - The Intracept Easy Access Instrument Set (Instrument Set) is an instrument kit containing trocars, cannulas and guides that provide access to the intended site of radiofrequency (RF) ablation. - The Intracept Flexible Bi-Polar RF Probe (RF Probe) conducts RF energy to the target location. Additionally, a commercially available, legally marketed RF Generator provides RF energy to the RF Probe. An Interconnect Cable is provided to connect the RF Generator. The only RF Generator currently recommended for use with the Intracept System is the Stockert Neuro N50 (K070336). 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 Instrument Set, a minimally invasive, "transpedicular approach" is used to allow the placement of a cannula into the vertebral body, and a path or channel is created to the terminus of the basivertebral foramen. An RF Probe is then placed into this channel at the terminus of the basivertebral foramen, and controlled RF energy is delivered to destroy the basivertebral nerve where it enters the vertebral body. This nerve has been identified as a proprioceptive sensory nerve with innervation of the vertebral endplates.

The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

The Relievant INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The device is a modification to the Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set incorporating upgraded access and deployment instrumentation. The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lesions in soft tissue. The Instrument Sets are used to provide access to the target tissue.

The INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set 1s ıntended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues

The Relievant INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Sets are used in comunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lessons 11 soft tissue The device is a modification to the Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set to incorporate a curved instrument set and a more flexible tip of the radiofrequency probe The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lessons in soft tissue The Instrument Sets are used to provide access to the target tissue

The INTRACEPT Bi-Polar RF Probe and Instrument Set is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

The Relievant INTRACEPT Bi-Polar RF Probe and Instrument Sets are used in conjunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lesions in soft tissue. The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lesions in soft tissue. The Instrument Sets are used to provide access to the target tissue and are available in a Standard Length and an Extra Length version.