Hi! I am new so please bear with me
A real-time study of 3yrs completed recently to confirm the results of an accelerated aging study. The sterile disposable single packaged device is 510(k) cleared and CE marked, labeled with 3yr shelf-life. The first real-time samples unfortunately were evaluated at the 3yr real-time timepoint and 4/58 exhibited test failure (dye penetration / perforation of foil.) Most likely due the cap damaging the seal (sterile barrier) which could occur during the transport simulation prior to placing devices on real-time study 3-yrs ago. The drop height sequence was 970 mm, part of standard testing (prior to placing the devices on test.) No field complaints noted in the 3yrs of displaced caps or torn packaging, etc. The company is conducting studies on a new pouch however that takes time.
The initial accelerated aging study demonstrated the sterile barrier was suitable however the real-time (pulled at 3-yrs) testing failed. Of course there is a risk of non-sterile product distributed over the prior 3yrs, and there is a new packaging evaluated due to the observed real-time 3yr packaging failures. The company believes that the shake test (per ISTA 2a) and transport simulation process (prior to placing on test) contributed to the cap of the guidewire dispenser damaging the pouch seal seam. There were no observed failures originally during the accelerated aging study submitted to the 510(k) 3-yrs ago.
In addition to what to do with remaining devices in the field, the question is how to share the pouch integrity issue with FDA and then if the new packaging (once validated and accelerated aging study is acceptable) is this a new 510(k) or LTF?
Any help appreciated! The device is also distributed in the EU.
Thanks,
AJ
A real-time study of 3yrs completed recently to confirm the results of an accelerated aging study. The sterile disposable single packaged device is 510(k) cleared and CE marked, labeled with 3yr shelf-life. The first real-time samples unfortunately were evaluated at the 3yr real-time timepoint and 4/58 exhibited test failure (dye penetration / perforation of foil.) Most likely due the cap damaging the seal (sterile barrier) which could occur during the transport simulation prior to placing devices on real-time study 3-yrs ago. The drop height sequence was 970 mm, part of standard testing (prior to placing the devices on test.) No field complaints noted in the 3yrs of displaced caps or torn packaging, etc. The company is conducting studies on a new pouch however that takes time.
The initial accelerated aging study demonstrated the sterile barrier was suitable however the real-time (pulled at 3-yrs) testing failed. Of course there is a risk of non-sterile product distributed over the prior 3yrs, and there is a new packaging evaluated due to the observed real-time 3yr packaging failures. The company believes that the shake test (per ISTA 2a) and transport simulation process (prior to placing on test) contributed to the cap of the guidewire dispenser damaging the pouch seal seam. There were no observed failures originally during the accelerated aging study submitted to the 510(k) 3-yrs ago.
In addition to what to do with remaining devices in the field, the question is how to share the pouch integrity issue with FDA and then if the new packaging (once validated and accelerated aging study is acceptable) is this a new 510(k) or LTF?
Any help appreciated! The device is also distributed in the EU.
Thanks,
AJ