Collaborators: Bhavneet Bola, Jeeda Sabri, Harleen Khangura, Matthew Huynh

My team and I designed a comprehensive design proposal for a steerable Percutaneous Transluminal Coronary Angioplasty (PTCA) catheter, aimed at improving navigation through complex and tortuous coronary arteries.

We identified key clinical challenges and translated them into user needs and design inputs for the steerable PTCA catheter.

Summary of Regulatory Analysis:

• There is a clinical need for improved PTCA catheter designs, especially for patients with complex coronary artery disease involving tortuous or calcified vessels.
  • Catheter limitations include: difficulty navigating tight turns or reaching distal lesions.
  • Steerability is a key functional enhancement to consider in improving catheter performance.
• FDA Product code = LOX, Regulation Number = 870.5100, Class II device
  • General and special controls need to be evaluated. Substantially equivalent devices need to be determined through 510(k) premarket notification process.
  • 3 substantially equivalent devices were found by Boston Scientific Corp., BrosMed Medical Company, and Biotronik Inc.
  • Another catheter device was considered to determine the tests and procedures needed to validate the steerable device features.
• The ISO 14971 Risk Assessment framework was used to detail the hazards related to the PTCA catheter. Severity and occurrence ratings & risk controls were identified.
  • Hazards considered include: kinking during navigation, vessel perforation, wire breakage.
• User needs and design inputs were determined using various ISOs and ASTM standards.
  • Sorted into categories like regulatory/non-clinical testing, customer needs, technical needs, and performance needs.
• A Verification & Validation plan was designed to link each design input to a test method, such as bench testing or tip deflection angle check.
  • Traceability matrix was used to map each design input + need to the appropriate design output, verification testing details (including the appropriate standard, sample size, and acceptance criteria), & validation tests.

For more details regarding our analysis, check out the following links!

Final Report

Appendix