(653 days)
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.
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).
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 Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | Performs 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
§ 874.4450 Powered insertion system for a cochlear implant electrode array.
(a)
Identification. A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of all adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
(i) Verification of cochlear implant attachment force, release force, and insertion speed;
(ii) Testing to demonstrate the device does not damage or degrade the cochlear implant (including the lead and array portions of the cochlear implant); and
(iii) Comparison testing with manual insertion to evaluate:
(A) Differences in cochlear implant array insertion force associated with use of the device; and
(B) Intracochlear placement of the cochlear implant array (intended scala placement and array insertion depth, together with minimal array tip foldover and cochlear scala translocation).
(3) Usability testing in a simulated hospital environment with an anatomically relevant model (
e.g., cadaver testing) that evaluates the following:(i) Successful use to aid in placement of the electrode array into the cochlea; and
(ii) Harms caused by use errors observed.
(4) Changes in cochlear implant compatibility are determined to significantly affect the safety or effectiveness of the device and must be validated through performance testing or a rationale for omission of any testing.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
(7) The patient-contacting components of the device must be demonstrated to be sterile and non-pyrogenic.
(8) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(9) Software verification, validation, and hazard analysis must be performed for any software components of the device.
(10) Labeling must include:
(i) The recommended training for the safe use of the device;
(ii) Summary of the relevant clinical and non-clinical testing pertinent to use of the device with compatible electrode arrays; and
(iii) A shelf life.