(214 days)
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.
This document is a 510(k) summary for the Intracept Intraosseous Nerve Ablation System (specifically the Intracept RF Probe component), submitted to the FDA by Relievant Medsystems, Inc. It describes the device's technical characteristics and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
The provided text does not contain information about a study that assesses the device's performance against clinical acceptance criteria or involves human readers (MRMC study or standalone study). The device described is a medical instrument used in a surgical procedure, not an AI or imaging diagnostic device that would typically have acceptance criteria based on accuracy, sensitivity, or specificity of interpretation. Instead, the focus of this 510(k) submission is on demonstrating the device's safety and technical performance through non-clinical testing to establish substantial equivalence to a previously cleared predicate device.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set sample size, and ground truth for training set) are not applicable to the information presented in this 510(k) summary.
Here's a breakdown of the relevant information from the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on its compliance with various international standards and internal performance specifications for safety, biocompatibility, and functional integrity. The "reported device performance" indicates that the device met these specifications.
| Test Category | Acceptance Criteria/Test Method Summary | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Patient contact materials classified as tissue/bone/dentin |
§ 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).