LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    DEN170018
    Device Name
    NSS-2 System
    Manufacturer
    Innovative Health Solutions (IHS), Inc.
    Date Cleared
    2017-11-15

    (243 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Type
    Direct
    Panel
    Neurology
    Reference & Predicate Devices
    K140530
    Why did this record match?
    Device Name :

    NSS-2 System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.

    Device Description

    NSS-2 BRIDGE is a device that electrically stimulates branches of Cranial Nerves V. VII. IX and X, and the occipital nerves identified by transillumination through percutaneous electrodes to aid in the reduction of opioid withdrawal symptoms. The device consists of (1) a percutaneous nerve field stimulator (PNFS; Figure 1), (2) a multi-pin wire harness percutaneous electrode array (Figure 2), and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 3).

    AI/ML Overview

    Acceptance Criteria and Study for NSS-2 BRIDGE

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance/Study Findings
    EffectivenessThe device, when used as an aid to reduce symptoms of opioid withdrawal, should demonstrate a clinically significant reduction in opioid withdrawal symptoms. A COWS score change of 15% for a given individual is considered clinically significant.Clinical Study Results: A single-arm, open label, multi-center retrospective study (n=73) demonstrated a significant reduction in COWS scores:
    • Baseline: Mean COWS score of 20.1 (±6.1)
    • 20 minutes post-placement: Mean COWS score reduced to 7.5 (±5.9), a 62.7% reduction (p
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1