Device Classification:
Class D
Technology Readiness Level:
TRL4
Active programmable device to automatically deliver bolus or basal quantity of drug to the region of interest within human body such as peritoneal cavity, spinal cord or other diseased regions
Key Characteristics
Configuration: Programmable
Flow Regime: Variable
Discharge Regime: Bolus/Basal/Priming
Patent Filed for "Implantable Micro Infusion Pump with Residual Volume Measurement" Patent Application No. 202041045741
Design Registration - "Collapsible type implantable infusion pump reservoir with magnetic locator, residual volume detector and needle stopper. Reg no 341393-001
The following evaluations as per ISO 14708-4 (Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps) are carried out to evaluate the performance and characteristics:
Minimum, Maximum flow characteristics
Accuracy, Repeatability & Reproducibility
Refill characteristics Test
Septum Puncture Test
Temperature Rise Test
Catheter Tensile Strength Test
Catheter Flexural Strength Test
Reservoir Pressure Test
Pump Tubing Durability Test
Pump Drive Durability Test
Leakage Characteristics Test
Atmospheric pressure Variation Test
Environment temperature variations Test
Fluid viscosity variation Test
Catheter Slit Opening Pressure Test
Battery Discharge Test
Device Electrical Characteristics Test
Wireless recharge characteristics
Biocompatibility Evaluations as per ISO 10993
Following activities to be carried out by Industry:
Preclinical Evaluations
Drug interactions studies
Clinical trials
Packaging
Regulatory documentation and submissions
Technology Transfer document with details on materials & consumables, equipment & utilities, SOPs / detailed procedures. Quality assurance, handling properties at the current level of development.
Training on the know how
Data on the evaluations done