(29 days)
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories. Accessories for the StimRouter include a clinician programmer with software (CPS), a patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT). The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. Only the Procedure Manual has been modified to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated.
The complete StimRouter System consists of three kits: A Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the EPT which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.
The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.
The Clinician Kit is used for the programming of the StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT.
The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.
This document is a 510(k) premarket notification for a modified version of the StimRouter Neuromodulation System. It's a submission to the FDA to demonstrate substantial equivalence to a previously cleared device, not a report of a new clinical study proving effectiveness with specific acceptance criteria in the traditional sense of a clinical trial.
Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or directly provided in this type of regulatory document. This document focuses on demonstrating that a modification to an already cleared device does not introduce new questions of safety or effectiveness.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of quantitative acceptance criteria and reported device performance because it's a 510(k) submission for a modification to a previously cleared device (K190047). The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" to a predicate device, which largely relies on showing that the modifications do not raise new questions of safety or effectiveness and that the technological characteristics are similar or that any differences do not affect safety or effectiveness.
The document states:
- "As noted in the Predicate Device Comparison Matrix below, other than the update of the Procedure Manual to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated, there are no other modifications with respect to the K190047 predicate all other technological characteristics are equivalent."
- "The new procedure is being provided for situations in which the surgical field has been previously opened and does not introduce additional risks to the patient. Also, the new method of placing the Lead allows for similarly effective stimulation of target nerve and receipt of stimulation from EPT."
- "Bioness Inc. concludes that the Risks vs. Benefits assessment remains unchanged, where the benefits accrued from the use of the device outweigh any identified residual risk."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. This document is not a clinical study report with a test set of patients. It's a regulatory submission for a device modification. The assessment is based on design controls and a comparison to a predicate device.
- Data Provenance: Not applicable for a traditional test set. The "data" used for this submission are the design specifications, risk analysis, and comparison to the predicate device's existing clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. There is no traditional "test set" of medical cases requiring ground truth established by experts in the context of this 510(k) submission for a modification. The assessment of the modification's impact is internal to the manufacturer's design control process and reviewed by the FDA.
4. Adjudication Method for the Test Set:
- Not applicable for the same reasons as #3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted to evaluate diagnostic devices or imaging systems where human readers interpret results, often with and without AI assistance. The StimRouter Neuromodulation System is a therapeutic implantable device, and this submission concerns a change in its implantation procedure.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. The StimRouter is a physical neuromodulation system, not an algorithm, and its use inherently involves human practitioners (implanting physicians and patient interaction with the programmer).
7. The Type of Ground Truth Used:
- The "ground truth" implicitly used here relies on the established safety and effectiveness of the predicate device (K190047) and the engineering and clinical assessment that the proposed modification (alternative implantation procedure) does not alter that established safety and effectiveness or introduce new risks. The risk assessment considers potential harms, but clinical outcomes data from a specific study for this modification is not presented as "ground truth."
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 for the same reasons as #8.
In summary: This document is an FDA 510(k) premarket notification for a modification to an existing medical device. It relies on demonstrating substantial equivalence to a predicate device, which is different from a clinical study that establishes performance against specific acceptance criteria for a novel device or AI algorithm. The focus here is on showing that the minor change (an alternative implantation procedure described in updated labeling) does not negatively impact the safety and effectiveness profile already established for the predicate device.
§ 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).