(98 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 thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu Neurostimulation System (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 Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. Similar to the predicate StimQ, 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 Neurostimulation System is comprised of 5 elements:
- Nalu Implantable Pulse Generator: The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads to the desired peripheral nerve. The IPG is available in two different implant architectures: an “integrated" system with pre-attached leads and a "ported" system where leads may be attached, via connector ports. In addition, both of these versions are available in single or dual lead configurations. The hermetic IPG housing includes a ceramic enclosure and a feedthrough connected internally to a printed circuit board assembly. Wires leaving the IPG are encapsulated in polyurethane and a silicone over mold forms the final biocompatible surface of the IPG for direct patient tissue contact.
- Leads: Leads are implantable and are designed to deliver electrical pulses to the peripheral nerve via an array of eight cylindrical electrodes at the distal end. Leads may be integrated with or connected to the IPG. Both Trial and Permanent Implant leads are available for use. The leads use polyurethane insulation with Pt/Ir electrodes. The leads may be secured in place with the Nalu Lead Anchor.
- Surgical and Trial Tools: Implantation of the Nalu IPG and lead components for Peripheral Nerve Stimulation (PNS) is performed via standard PNS surgical techniques. The desired implant location is accessed via needle placement, followed by lead placement through an introducer. The leads are anchored and the IPG is placed in a subcutaneous pocket. Patient contacting materials include medical grade stainless steel, thermoplastic elastomers, ABS, silicone, and Urethane.
- Externally worn Therapy Discs: Two types of Therapy Disc are available. One is to be used during the trial phase (Trial Therapy Disc), and one is to be used after permanent IPG implantation (Therapy Disc). Both devices are worn by the patient using one of the Nalu-provided options The Therapy Discs house a rechargeable lithium ion battery, and electronics including a microcontroller running software for therapy control, patient interaction and communication with Nalu's Clinician Programmer and Remote Control devices. The Therapy Disc used to power and command the implant does so wirelessly using Radio Frequency (RF) and is held in place by an adhesive clip applied to the skin or a belt/cuff worn over clothing.
- Clinician Programmer and Remote Control: A Clinician Programmer Application is provided to configure the Trial Therapy Disc and Therapy Disc devices during surgery and programming. A Patient Remote Control Application is available to provide the patient with a convenient secondary option to control their system in addition to built-in controls on the Therapy Disc. The Clinician Programming Application runs on an Android tablet and communicates over a secure Bluetooth Low Energy link with the Trial Therapy Disc and Therapy Disc devices. The programmer is responsible for configuring the devices to deliver therapy according to clinician defined levels and patient preferences, and for managing patient and session records. The Patient Remote Control Application runs on iOS and Android platforms and offers basic control of the Trial Therapy Disc and Therapy Disc through a secure Bluetooth Low Energy link. The controls include selecting between clinician-defined therapy options (programs), turning stimulation on and off, and managing alerts.
The provided text is a 510(k) premarket notification for the Nalu Neurostimulation System for Peripheral Nerve Stimulation. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it explicitly states that no clinical performance data was deemed necessary for this submission.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor details about sample sizes, expert ground truth establishment, adjudication, MRMC studies, or standalone algorithm performance, as these were not part of the documented submission process for this device.
The section "5.9. Clinical Performance Data" clearly states:
"Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation System is as safe and effective as the predicate device. Note that the predicate device did not need clinical evidence to obtain a determination of substantial equivalence."
Based on the provided document, the device's acceptance was based on non-clinical performance (bench testing, animal studies, and compliance with standards).
Here's a breakdown of what can be extracted from the document regarding the device's safety and effectiveness without clinical data:
1. A table of acceptance criteria and the reported device performance:
As no clinical study was performed for this submission, there are no "acceptance criteria" related to a clinical performance study with human subjects, nor "reported device performance" in terms of clinical outcomes. The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices.
Table: Performance Evaluation based on Non-Clinical Testing and Substantial Equivalence
| Acceptance Criteria Category (based on Non-Clinical Testing) | Reported Device Performance (Nalu Neurostimulation System) |
|---|---|
| Functional and Electrical Performance | Verified to meet target specifications over a range of operating and storage conditions through electrical testing. |
| Mechanical Performance | Verified to meet target specifications over a range of operating and storage conditions through mechanical testing. |
| Software Verification & Validation | Demonstrated to perform as intended in the specified use conditions. |
| Biocompatibility | Demonstrated to be biocompatible based on testing (cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, implant studies, chemical characterization) according to ISO 10993-1:2009 and FDA guidance. This included testing for implant devices (IPG, Leads, Anchor, Extension: permanent contact), externally communicating devices (Needles, Sheaths, surgical tools: limited contact), and surface devices (Therapy Discs, adhesive clip: permanent intact skin contact). |
| Sterilization Validation | Validated using Ethylene Oxide (ISO 11135-1:2014). |
| Human Factors & Usability | Testing performed on the device to ensure it met user needs as reflected in the functional specification, adhering to IEC 60601-1-6:2010+A1:2013 and IEC 62366-1:2015, and FDA guidance. |
| Animal Study Findings (Pre-clinical Validation) | Six (6) Nalu Neurostimulation IPGs and Lead systems implanted in a porcine model for 90 days. All devices performed as expected without incident. No device- or procedure-related complications or premature deaths. Data collected at 30, 60, and 90-day intervals. This study covered surgical usability, RF communication and stimulation, implanted device stability, and tissue response. |
| Compliance with Standards | Compliance demonstrated with relevant standards (e.g., ISO 14708-1:2014, ISO 14708-3:2017, IEC 60601-1:2005:A2012, IEC 60601-1-11:2015, IEC 60601-1-2:2014, IEC 62304:2015, ISO 14971:2012/2007, ISO 11607-1/2:2006, CISPR 11, and FDA guidance on Cybersecurity). |
| Substantial Equivalence to Predicate | All physical and therapeutic attributes are within or equivalent to the parameters of the StimQ Peripheral Nerve Stimulator (PNS) System (K171366) and other reference devices (Medtronic Mattrix, Medtronic Xtrel, ANS Renew). Differences in lead length, diameter, electrode array length, number of electrodes, electrode surface area, lead extension, anchor, configurations, software platforms, and transmit frequency were deemed not to affect safety and effectiveness of the intended use, based on engineering analysis and comparison to a range of previously cleared devices. |
2. Sample size used for the test set and the data provenance:
- Test Set (Non-clinical):
- Animal Study: 6 Nalu Neurostimulation IPGs and Lead systems were implanted. Data provenance is a pre-clinical study conducted by Nalu Medical (presumably in the USA, as it's an FDA submission for a US company). It's a prospective study.
- Bench Testing: Quantities of devices or components used for electrical, mechanical, biocompatibility, sterilization, and human factors testing are not specified in numerical terms within this document. The provenance is internal testing by Nalu Medical.
- Training Set (Not applicable for this submission method): No training set data is referenced, as this is a 510(k) based on substantial equivalence to predicates, not a de novo clearance requiring clinical studies or algorithmic training data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for clinical ground truth. For the animal study, the "ground truth" was the observed performance of the device in a living model and tissue response, assessed by the study investigators. The qualifications of these experts are not detailed in the document.
- For engineering and performance testing, the ground truth is established by the design specifications, validated test methods, and industry standards, implemented and evaluated by qualified engineers and testers.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for clinical studies. For the non-clinical and animal studies, methods like peer review of study protocols, data analysis, and report generation would be in place, but a "2+1" or "3+1" adjudication method typically refers to radiologist consensus in image-based AI studies, which is not relevant here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for AI-powered diagnostic devices, which is not the case for this neurostimulation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a neurostimulation system, not an AI algorithm for diagnosis or interpretation. Its software controls the device's function, and its performance is evaluated in the context of device operation, not as a standalone diagnostic tool. The software was subject to verification and validation tests as per IEC 62304.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal study: The ground truth was based on direct observation of device performance, surgical usability, stability, tissue response, and lack of complications in the porcine model.
- For bench testing: Ground truth was based on established engineering specifications, validated test methods, and compliance with national and international standards.
8. The sample size for the training set:
- Not applicable. This submission is based on substantial equivalence and non-clinical data, not on an algorithm trained with a specific dataset.
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).