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

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New 510(k) submission• Usability Study was performed as agreed in pre-IDEmeeting• 100% success to perform all activation steps• Proved significantly better Flexi-Q DV efficiency andaccuracy compared to standard syringe• New 510(k) submission (May 2011)• Yet, CDRH requested additional information(July 2011)July2009Feb’2010Nov’2010May2011July201120
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 18 and 19: Usability Studies• Previous Issue
Page 23: Study Participants• Procrit ® -
Page 26 and 27: Study Results• Observed Practice
Page 28 and 29: FDA 510(k) Clearance• SE letter (
Page 30 and 31: Flexi-Q DV Design Characteristics -
Page 32 and 33: Lessons learned• Formative Study
Page 34 and 35: Acknowledgments• P/L Biomedical,
Page 36: Visit us @ Booth 320Thank You

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

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