Acute Particulate Matter Evaluation

An in-line continuous particulate counting system is used to assess the number and sizes of  particles generated during simulated use in real-time inside an anatomical model.

Test Procedure

Baseline testing is conducted to determine the quantity and the size of particles released by devices and accessories when using a straight (unconstrainted) tubular model . In this case, the device is not constrained and not subjected to the stresses and strains of an anatomical track model.

Simulated use testing is conducted to determine the quantity and the size of particles released by devices and accessories when deployed in a 2D or 3D anatomical model.  In this case, the device is constrained and subjected to the stresses and strains of the track model.  The device is deployed according to the IFUs using all accessories required for the procedure.

Spiking and Recovery:

Particles injection and introduction sites are located upstream from the deployment/final site. In a first step, the flow through the deployment/final site is analyzed to verify it is sufficiently clean to allow for measurement of test setup baseline noise.

In a second step, a spiking and recovery method is used to verify that a known amount of injected particles upstream from the deployment/final site is correctly counted and recovered downstream from this site. Three different particles sizes are tested (10µm, 25µm and 70µm). Multiple (9 times, 3 times for each size) injections are performed upstream.

Equipment

An IN-LINE continuous flow particulate counting system is used to automatically measure and display real time particulate contamination levels in the circulating in the model fluid during testing. Particles are continuously monitored, counted and classified according to customizable size ranges.  The test is conducted on the IDTE 1000 frame which provides a platform to qualitatively measure the performance of catheters and delivery systems in 2D and 3D vascular models.

Measured Parameters

• Continuous Total Count – Total amount of particles released by the device are classified by size ranges (≥50µm, ≥25µm and ≥10µm or other, as specified in the test protocol)
• Continuous Step Count – Amount of particles released by the device at each deployment step are classified by size ranges (≥50µm, ≥25µm and ≥10µm or other, as specified in the test protocol)
• Flowrate
• Temperature

Learn more about Acceptance Criteria 

Scope

• PTA, PTCA, coronary and peripheral stent delivery systems
• Thrombectomy devices
• Guidewires
• Endoscopic devices
• RF ablation catheter
• Any interventional delivery systems

Service Levels

• Standard Service
• Full Service
• Full Service with ISO 17025

Applicable Standards

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

• FDA-1545
  FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff

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

• ASTM F2743-11(2018)
  Standard Guide For Coating Inspection And Acute Particulate Characterization Of Coated Drug-Eluting Vascular Stent Systems

• USP788
  Particulate Matter in injections

Related Tests

• Coating Integrity Optical Inspection
• Hydrophilic Coating Friction Test – Lubricity/Pinch Test
• Simulated Use Testing
• Chemical Characterization
• Trackability
• Scanning Electron Microscopy (SEM) and Optical Inspection
• Withdrawbility

OLE1032