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510(k) Data Aggregation

    K Number
    DEN190055
    Device Name
    iotaSOFT Insertion System - Drive Unit, Controller and Accessories
    Manufacturer
    IotaMotion, Inc.
    Date Cleared
    2021-10-01

    (653 days)

    Product Code
    QQH,OOH
    Regulation Number
    874.4450
    Type
    Direct
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iotaSOFT™ Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. The iotaSOFT Insertion System is intended for use in cochlear implant patients ages 12 years and older during cochlear implant procedures using either a round window or cochleostomy approach.

    Device Description

    The iotaSOFT™ Insertion System is designed to assist the surgeon during cochlear implantation by controlling electrode array insertion speed. The system consists of a single-use, sterile drive unit (iotaSOFT™ DRIVE Unit) connected to a reusable, non-sterile touch screen control console and footpedal (iotaSOFT Controller and Accessories) (Figure 1).

    AI/ML Overview

    Device Acceptance Criteria and Performance Study: iotaSOFT™ Insertion System

    The iotaSOFT™ Insertion System is a powered insertion device designed to aid surgeons in placing cochlear implant electrode arrays. The acceptance criteria for this device and the studies conducted to prove it meets these criteria are detailed below, synthesizing information from the provided document.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the iotaSOFT™ Insertion System are primarily outlined in the "SPECIAL CONTROLS" section and implicitly through the "SUMMARY OF NONCLINICAL/BENCH STUDIES" and "SUMMARY OF CLINICAL TESTING" sections. The reported performance is extracted from the respective study summaries.

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Clinical PerformancePerforms as intended under anticipated conditions of use, including evaluation of all adverse events.- No clinically significant patient safety or outcomes differences based on surgeon experience.
    • Electrode array impedance measures within normal limits in all subjects at 1-month follow-up.
    • Neural response telemetry (NRT) measurements present in all subjects with normal cochlear anatomy (n=20/21) at post-operative follow-up.
    • Adverse events generally as expected for cochlear implant procedures (1 CSF leak noted, but not attributable to device use per instructions).
    • Insertion time ranged from 57 sec to 6 min, 1 sec (mean 3 min 15 sec).
    • Post-insertion cochlea view x-ray imaging satisfactory on all insertions with normal cochlear anatomy. |
      | Non-Clinical Performance| (i) Verification of CI attachment force, release force, and insertion speed. | - Insertion speed verified to be within 20% of both 0.1 and 1 mm/s.
    • Maximum insertion force (with array) of 80mN met at both 1mm/s and 0.1mm/s.
    • Maximum drive wheel pinch force of 80mN.
    • Maximum drive wheel pinch force
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