(90 days)
The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.
The Nalu Lead Blank is an optional accessory to the Nalu Neurostimulation System (also referred to as the "Nalu System"), which is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation System incorporates a miniature implanted neurostimulator, powered by an externally worn device. The Nalu Lead Blank is an optional non-implantable surgical tool used during implant of the Nalu Neurostimulation System leads. The Nalu Lead Blank may be used to create a path for the lead in the epidural space.
This 510(k) submission is for the Nalu Lead Blank, an accessory to the Nalu Neurostimulation System, not an AI device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not applicable to the provided text.
The document describes the device, its intended use, and establishes substantial equivalence to a predicate device (Nalu Neurostimulation System K183047) and a reference device (Stimwave Freedom 8 SCS System K170141).
The "studies" conducted are nonclinical performance tests, primarily bench testing, sterilization validation, and biocompatibility testing, along with human factors and usability testing (including a cadaver lab evaluation). Animal testing and clinical performance data were not considered necessary for this device's clearance.
Since this is not an AI/ML device, the following points of your request cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance (in the context of AI metrics like sensitivity, specificity, etc.): Not applicable for a surgical accessory. The acceptance criteria relate to mechanical and biological safety, not diagnostic performance.
- Sample size used for the test set and data provenance: While non-clinical tests were performed, the concept of a "test set" for AI evaluation isn't relevant here.
- Number of experts used to establish ground truth: Not applicable. Ground truth for a surgical tool is its physical and biological performance attributes.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not a diagnostic AI device.
- Standalone (algorithm only without human-in-the-loop performance) was done: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI sense. Ground truth here relates to engineering specifications and biological compatibility.
- Sample size for the training set: Not applicable as there's no machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Acceptance / Performance Demonstration (based on provided text):
The Nalu Lead Blank underwent the following nonclinical performance testing to demonstrate its safety and effectiveness:
- Bench Testing: Mechanical tests to show the device met target specifications over a range of operating and storage conditions.
- Sterilization Validation: Ensures the device can be properly sterilized.
- Biocompatibility Testing: Followed ISO 10993-1:2009 standards.
- Categorization: Implant tool for tissue/bone contact for a limited duration (≤ 24 hours).
- Tests Included: Cytotoxicity, sensitization, intracutaneous reactivity, and systematic toxicity.
- Result: Biocompatibility was demonstrated.
- Human Factors and Usability Testing: Performed on the device, including evaluation in a Surgical Validation cadaver lab.
- Design Controls: Nalu followed 21 CFR 820.30, ISO 14971:2007, and ISO 13485:2016 for design control processes, ensuring proper planning, evaluation, and testing.
Conclusion stated by the sponsor: "The bench and non-clinical data support the safety of the device. The verification and validation demonstrated that the Nalu Lead Blank, which is part of the Nalu Neurostimulation System, performs as intended in the specified use conditions. The results do not raise new questions of safety and effectiveness."
The acceptance criteria for this device are implicitly tied to meeting the requirements of the standards and guidance documents listed (e.g., ISO 10993-1 for biocompatibility, mechanical test specifications, usability requirements), enabling the FDA to determine substantial equivalence to previously cleared predicate devices.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).