Acute Particulate Tester

After navigating the tortuous path, the device is advanced into a mock vessel for deployment. Particles shed by the device during tracking and deployment flow directly into a debubbler and then through custom laser-based particle counters that both count and size particles into user-defined virtual bins.

Downstream of the particle counters, the particles are captured by optional particle capture filters, for SEM/EDX/FTIR analysis, giving you critical information about the composition of the shed particles.

After particulates have been captured for further analysis, the testing fluid flows into a capacitance tank to maintain temperature, and lastly through a 0.2 micron scrubbing filter. From the scrubbing filter, fluid re-enters the flow loop, providing a continual supply of particle-free water, while minimizing waste.

Dynatek’s real-time particle tracking system with bin allocation for particle sizes.

Particulate Matter Evaluation during Deployment and Withdrawal

Particulate Matter Evaluation during Deployment and Withdrawal at Dynatek Labs references the following standards and regulations:

i. ASTM F2394-07 (2017) – Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
ii. ISO 25539-2:2012 – Cardiovascular Implants – Endovascular Devices – Part 2: Vascular stents
iii. FDA Guidance for Industry and FDA Staff – Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, April 18, 2010
iv. FDA Guidance – Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Angioplasty (PTCA) Catheters
v. ASTM F2743-11 – Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
vi. AAMI TIR42:2010 – Evaluation of Particulates Associated with Vascular Medical Devices
vii. ASTM WK46148 – Standard Guide for Acute InVitro Evaluation of Drug Coated Balloons
viii. ISO 12417-1:2015 – Cardiovascular Implants and Extracorporeal Systems — Vascular device-drug combination products
ix. ISO/TS 17137:2014 – Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
x. ASTM F3036-13 – Standard Guide for Testing Absorbable Stents
xi. ASTM WK60510 – New Test Method for Simulated use testing of neurointerventional device in tortuous vasculature
xii. ASTM WK60511 – New Test Method for Particle evaluation and characterization for neurointerventional devices

Available Add-ons

• Eight-foot positive pressure flow hood to maximize working platform.
• Customized flow lines to discretely evaluate guide system particle contribution.
• Capture filter tower mounted within hood to facilitate easy capture filter replacement
• Alternative capacitance tanks and fluid heaters for elevated test temperatures.
• UPS (Uninterruptable Power Supply) system.
• Custom particle counter calibration for atypical particle size ranges.
• Capture filters to aid in chemical analysis of particles.
• Tortuous path to customer specifications; silicone or glass.
• Other custom modifications at customer request.

Silicone tortuous path according to ASTM F2394-07 or custom designed to meet client’s specifications. Silicone design can be adhered to a silicone base for stability or without.

Dynatek Labs Acute Phase Particulate Tester Specification

Description	Specifications	Additional Information
Deployment site configuration	Mock vessel or custom deployment model
Mock vessel configuration	Straight, curved, or bifurcated	Additional special configurations upon request
Typical number of flow paths	Up to 5	Customizable to accommodate various delivery accessories
Testing fluid	PBS or distilled water	Addition of glycerin possible
Fluid temperature	Ambient to ≤ 45 ⁰C	Temperature control accurate to +/- 1 °C of set temperature
Flow rate (at sensors)	500 mL/min standard	100 mL/min per sensor
Test monitoring	Pressure, temperature, flow rate, particle count and size

Dynatek Labs Particle Counter Product Specification

Description	Specifications	Additional Information
Number of particle counters	5	The use of 5 particle counters reduces cleaning time of each sample or experiment to 20% of the time needed with one counter.
Particle size range	5-900 micron	Size and count up to 100 micron Count up to 900 micron
Max. particle concentration	15,000 p/mL @ 10 microns	Approx. 8,000 p/mL above 150 microns
Particle bin range	2-6 bins	5 bins of 5-100 micron 1 bin for 100-900 micron
Particle counter calibration standard	USP <788>, ASTM F658
Sizing resolution	5-50 micron: +/- 1 micron 50-100 micron: +/- 5 micron
Capture filter assembly	47 mm diameter filter housing	Included filter allow easy swap without test interruption

*Specifications are subject to change without notice.