21 CFR §874.4450

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of all adverse events.
   2. (2)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
      1. (i)Verification of cochlear implant attachment force, release force, and insertion speed;
      2. (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
      3. (iii)Comparison testing with manual insertion to evaluate:
         1. (A)Differences in cochlear implant array insertion force associated with use of the device; and
         2. (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. (3)Usability testing in a simulated hospital environment with an anatomically relevant model (e.g., cadaver testing) that evaluates the following:
      1. (i)Successful use to aid in placement of the electrode array into the cochlea; and
      2. (ii)Harms caused by use errors observed.
   4. (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. (5)The patient-contacting components of the device must be demonstrated to be biocompatible.
   6. (6)Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
   7. (7)The patient-contacting components of the device must be demonstrated to be sterile and non-pyrogenic.
   8. (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. (9)Software verification, validation, and hazard analysis must be performed for any software components of the device.
   10. (10)Labeling must include:
       1. (i)The recommended training for the safe use of the device;
       2. (ii)Summary of the relevant clinical and non-clinical testing pertinent to use of the device with compatible electrode arrays; and
       3. (iii)A shelf life.