The American Society for Testing and Materials, ASTM International, recently released F3575-24, the Standard Guide for Model Development for Particulate Generation Testing of Endovascular Devices. ASTM F3575-24 provides guidance on the design and development of coronary, peripheral, and neurovascular tracking pathways for simulated use models used in acute particulate testing. This standard guide provides a framework for establishing model credibility and communicating the suitability of a model to regulatory bodies.
ASTM F3575-24 is intended to support medical device manufacturers in their efforts to develop credible models for acute particulate generation testing. This critical test characterizes the risk of particulate generation associated with devices being advanced, delivered, and retracted from a treatment site. The goal of particulate testing is to quantify the amount of particulate released from implantable endovascular devices and accessory devices used within the cardiovascular system.
Considering anatomical variation, in terms of diameter and tortuosity, and the myriad of ways to justify the suitability of a tracking pathway model, the industry needed a common understanding of model credibility. Here, the concept of credibility, and how to build it, was inspired by a computational modeling standard, The American Society of Mechanical Engineers (ASME) V&V 40.
The Development Trajectory for Standard Guide ASTM F3575-24
In earlier attempts at standardizing simulated use models for bench testing, the ASTM F04.30 working group was focused on establishing a normalized set of geometries for vasculature. Considering the anatomical variation in human vasculature and the impact that the device under evaluation has on the anatomy during use, it was difficult to come to a consensus on how to accomplish that, and the effort stopped.
With clinical events in some coated coronary stents (early 2000s) and hydrophilic catheter coatings (2010s), the U.S. Food and Drug Administration (FDA) started requesting more documentation related to acute particulate testing, including information about tracking pathways and their credibility.
ASTM F3575-24 is the result of many years of collaboration between industry experts and regulators. This standard guide is intended to make it easier for all stakeholders to operate under a common set of expectations for the development, manufacturing, and justification of the tracking pathways used in acute particulate testing. With early awareness of regulatory expectations and concerns, you can design pathway models more efficiently and effectively.
BDC Laboratories was a leading voice in the development of ASTM F3575-24 and its complement, the original and 2021 revised versions of AAMI TIR 42 Evaluation of Particulates Associated with Vascular Medical Devices.
Acute Particulate Tracking Pathway Development and Testing with BDC Laboratories
BDC Laboratories is uniquely positioned to provide a comprehensive solution for the medical device community. The team has extensive experience designing and manufacturing acute particulate tracking pathways for numerous applications and has performed associated testing using proprietary ISO/IEC 17025:2017 accredited test methods for the past 12 years.
Here’s how BDC Laboratories is supporting manufacturers with tracking pathway development, manufacturing, and particulate generation testing for cardiovascular device development and regulatory submissions:
Tracking Pathway Design and Manufacturing
With an established library of clinical datasets, you can leverage the one(s) most relevant for your device application as a starting point for a tracking pathway design or opt for a custom tracking pathway designed around your company’s dataset. Using software tools, BDC Laboratories can modify vasculature to accommodate vessel straightening, optimize for recovery of particles, and incorporate a deployment site of suitable size and geometry, as needed. With a deep understanding of the standard guide, the final tracking pathway model will be in alignment with the relevant aspects of ASTM F3575-24.
Once the design has been established and approved by your team, BDC Laboratories will manufacture and dimensionally verify the tracking pathway. Prior to use, the engineering team will characterize and document the model’s use performance through spike-recovery validation.
Acute Particulate Testing
With years of experience, BDC Laboratories has a thorough and extensive understanding of acute particulate testing for medical devices, including:
The in-house engineering team drafts the test protocol with procedural steps in alignment with your device’s instructions for use (IFU), including the use of suitable accessories. With this comprehensive approach, BDC Laboratories establishes a true simulated use environment for evaluating the interaction between devices and accessories. Once testing is complete, the team compiles the data and constructs a final report in alignment with relevant regulatory expectations.
BDC Laboratories, an Expert Voice in Medical Device Quality
BDC Laboratories’ leadership team actively participates in the AAMI, ISO, and ASTM International’s Endovascular Device, Vascular Graft, and Heart Valve committees. They contribute technical expertise to support the ongoing improvement of medical device bench testing methods for design verification and safety evaluation. Reach out to our engineering team if you have any questions about ASTM F3575-24.
