Flexi-Q DV Auto-injector Case Study - DALI Medical Devices

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Results1. No drug spillage has occurred(0/500 operations)2. Solution unrelated to labeling – no matter ifreading IFU…!3. Successful study510(k) submission (Jul’ 2009)July200916
Pre-IDE• FDA review: Main issue was related to theUsability <strong>Study</strong> (Feb’ 2010)• New Usability <strong>Study</strong> protocol was submitted aspart of pre-IDE meeting (Nov’ 2010) to avoid“surprises” in a new 510(k) submissionJuly2009Feb’2010Nov’201017
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 18 and 19: Usability Studies• Previous Issue
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

Flexi-Q DV Auto-injector Case Study - DALI Medical Devices

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