(376 days)
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu Neurostimulation System for Peripheral Nerve Stimulation (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu System incorporates a miniature implantable pulse generator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. The Nalu System is comprised of 5 elements: Nalu Implantable Pulse Generator, Leads, Surgical and Trial Tools, Externally worn Therapy Disc, and Clinician Programmer and Remote Control.
This document describes a 510(k) premarket notification for the Nalu Neurostimulation System for Peripheral Nerve Stimulation. The submission aims to establish substantial equivalence to a previously cleared predicate device (K183579), primarily focusing on an update to the device's Magnetic Resonance (MR) Conditional Labeling to include full body scans.
Based on the provided text, there is no acceptance criteria table or specific study performance data for a device meeting acceptance criteria in the traditional sense of an AI/ML model for diagnostic or predictive purposes. This document is a regulatory submission for a physical medical device (implantable neurostimulator) and its associated external components and software, not an AI/ML diagnostic software. The "performance" discussed here relates to the safety and functionality of the device itself, particularly its compatibility with MRI, rather than the accuracy of a diagnostic algorithm.
Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding the device's "performance" as presented in the context of this 510(k) submission, specifically concerning the MRI compatibility, as this is the primary change necessitating the resubmission.
Summary of Acceptance Criteria and Device (MRI) Performance:
Since this is not an AI/ML diagnostic device, the "acceptance criteria" are not framed in terms of metrics like accuracy, sensitivity, or specificity. Instead, they are related to established safety standards for medical devices, particularly regarding MRI compatibility. The "device performance" refers to the results of testing performed to ensure these safety standards are met.
1. Table of Acceptance Criteria and Reported Device Performance (Focusing on MRI Compatibility):
| Acceptance Criteria Category | Specific Criteria (Implicitly based on standards) | Reported Device Performance / Assessment |
|---|---|---|
| Magnetic Resonance (MR) Safety and Compatibility for Full Body Scans | Conformance to MR Conditional Labeling for full body scans. | Testing included in this submission demonstrates the safety and compatibility of the Nalu System for PNS in the Magnetic Resonance (MR) Environment for full body. |
| Magnetically Induced Displacement Force | Meet limits defined in ASTM F2052-15 | Testing performed to standard. |
| Magnetically Induced Torque | Meet limits defined in ASTM F2213-17 | Testing performed to standard. |
| MR Image Artifacts | Meet limits defined in ASTM F2119-2013 | Testing performed to standard. |
| Safety of Active Implantable Medical Device in MRI | Conformance to ISO/TS 10974 | Testing performed to standard. |
| General Device Safety and Performance | Conformance to ISO 14708 (Parts 1 & 3) | Testing performed to standard. |
| Design Controls | Adherence to 21 CFR 820.30 | Nalu follows these procedures. |
| Risk Management | Adherence to ISO 14971 | Nalu follows these procedures. |
| Quality Management System | Adherence to ISO 13485:2016 | Nalu follows these procedures. |
| Biocompatibility | Demonstrated through testing. | Testing performed. |
| Sterilization | Demonstrated through testing. | Testing performed. |
| Human Factors and Usability | Demonstrated through testing. | Testing performed. |
| Functional Specification | Device meets user needs. | Validation and performance testing demonstrate this. |
| Substantial Equivalence | Identical indications for use, performance, and technological characteristics to predicate. | Stated as "identical" and "no differences that would impact safety or effectiveness." The only noted difference is the updated MR Conditional Labeling, which is supported by new testing. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document does not specify the sample sizes used for the engineering tests (e.g., number of devices tested for MRI compatibility, displacement, torque, or artifacts). These are typically bench tests on physical units, not clinical data sets.
- Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based, non-clinical performance and bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. This is not a study assessing the performance of a diagnostic algorithm where expert ground truth is established for medical images. The "ground truth" for this device's performance relies on engineering measurements and adherence to international and national standards (e.g., ISO, ASTM) for device safety and functionality.
4. Adjudication Method for the Test Set:
- Not Applicable. As there are no human readers or diagnostic interpretations involved in the "test set" (which consists of physical device tests), no adjudication method is necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is typically done for diagnostic imaging devices or AI tools that assist human readers. This submission is for an implantable neurostimulation system, not a diagnostic imaging or AI assistance tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no "algorithm only" performance being evaluated in this submission in the context of diagnostic AI. The device's functionality (e.g., electrical stimulation parameters) and safety (e.g., MRI compatibility) are evaluated.
7. The Type of Ground Truth Used:
- The "ground truth" for the device's safety and performance is established through adherence to recognized international and national consensus standards (e.g., ISO/TS 10974, ISO 14708, ASTM F2052-15, ASTM F2213-17, ASTM F2119-2013) and engineering verification and validation testing. It is not based on expert consensus on medical image interpretations or clinical outcomes data in the context of diagnostic accuracy.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. (See point 8).
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).