SGN · High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

Neurology · 21 CFR 882.4420 · Class 2

Overview

Identification

The Neurolyser XR is a high intensity focused ultrasound system for peripheral neural tissue ablation. It is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling. It is indicated for the thermal ablation (neurolysis) of the medial branch nerve of the lumbar facet joint(s) (L1 to L5) for the treatment of chronic, facet-mediated low back pain of at least 6 months duration and a confirmed diagnosis based on positive response to lumbar branch block or denervation.

Classification Rationale

FDA has determined that, for the previously stated indications for use, the Neurolyser XR can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the high intensity focused ultrasound system for peripheral neural tissue ablation is subject to the following special controls: (1) In vivo performance testing must demonstrate that the device performs as intended to deliver ablative energy and evaluate all adverse effects, including adverse tissue injury to target and non-target tissues. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including: (i) Characterization of acoustic pressure, including an acoustic map of relevant sections of the focal region, near-, and far-fields; (ii) Characterization of overall acoustic power output and reproducibility; (iii) Characterization of ultrasound induced focal temperature; (iv) Demonstration of device positioning and targeting accuracy; and (v) Assessment of ultrasound induced cavitation safety. (3) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Labeling must include: (i) Detailed description of the device components and technical parameters including targeting accuracy; and (ii) A shelf life for single use components.

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Top Applicants

• Fusmobile, Inc. — 1 clearance