Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
Flexi-Q DV Auto-injector Case Study - DALI Medical Devices Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
Usability Studies• Previous Issue:– Failure to accurately aspirate 1.0 mL (±5%) of solution– Related to patient/user performance – not auto-injectorfunctionality• Mitigation- Elcam instituted design change:– Dosing graduation line color was changed– Dosing graduation line thickness was enhanced• Elcam proposes to perform Summative Usability study:– Success of the design change mitigation– 60 devices operated by 10 participants (healthy and patients)– Comparison of usability to standard syringe (predicate device) andquantitative measurements18
Usability Study• Question to CDRH:Does the Agency agree that successful performance ofthe proposed summative usability study protocol, alongwith the two previous studies will be sufficient toestablish the usability of the device?• Agency answer:Never agrees… but accepted the overall approach.Asked to add clarifications to Risk Assessmentdocument, delay between training and trial injection,etc.19
- Page 1: Visit us @ Booth 320Flexi-Q DV Auto
- Page 7 and 8: Project History -General Top Level
- Page 10 and 11: The Problem• In a usability study
- Page 12 and 13: Verification TestsPerformance Testi
- Page 14 and 15: Device and Changes Validation• Si
- Page 16 and 17: Results1. No drug spillage has occu
- Page 20: New 510(k) submission• Usability
- Page 25 and 26: Study Procedure• Training by Heal
- Page 27 and 28: Study Conclusions• The study resu
- Page 29 and 30: Flexi-Q DV Design Characteristics -
- Page 31 and 32: Flexi-Q DV Design Characteristics -
- Page 33 and 34: Visit us @ Booth 320Summary: Elcam
- Page 35 and 36: Contacts• Dr. Menachem Zucker, VP
Usability <strong>Study</strong>• Question to CDRH:Does the Agency agree that successful performance ofthe proposed summative usability study protocol, alongwith the two previous studies will be sufficient toestablish the usability of the device?• Agency answer:Never agrees… but accepted the overall approach.Asked to add clarifications to Risk Assessmentdocument, delay between training and trial injection,etc.19
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