Simulated Use Pre-conditioning

Before conducting other evaluations, test samples should undergo all the steps a finished device would go through before being implanted in the patient.

Test Procedure

Test articles shall represent, as closely as possible, the finished  system to be supplied for clinical use. This includes:

•  Exposure to the maximum number of allowed sterilization cycles (Done by client)
• Process chemicals (Done by client)
• Aging effects (Can be done by ViVitro Partner Organization)
• Shipping/handling (Likely done by client when shipping samples to ViVitro)
• Any loading and deployment steps  (Done by ViVitro)
  • Crimping or loading the implant into/onto a delivery catheter
  • Tracking through simulated delivery pathways
  • Implant shall be maintained in the crimped configuration for a duration that mimics the worst-case expected clinical procedure time
  • Retrieval and repositioning (if applicable)

Equipment

ViVitro  uses the Interventional Device Testing Equipment (IDTE)1000 to comparatively and quantitatively tests and records the performance features of interventional devices

Tortuous path

Measured Parameters

Speed rate

Distance

Scope

All Cardiovascular devices undergoing Verification and Validation testing (V&V) testing

Service Levels

• Standard Service
• Full Service

Applicable Standards

• ISO 25539-2:2020
  Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

• FDA-1608
  FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA

Related Tests

• Acute Particulate Matter Evaluation
• Pulsatile Flow Testing – Hydrodynamic Performance
• Radial Fatigue and Pulsatile Durability

OLE1325