Torque Strength

Rotate the proximal end of the catheter while the distal end is fixed and routed through a tortuous anatomy. The number of turns to failure is recorded.

Also known as Torsional Strength.

Test Procedure

Precondition delivery systems prior to testing by tracking through a tortuous path is recommended.

Measured Parameters

The number of turns to failure is recorded.

Scope

• PTA, PTCA, coronary and peripheral stent delivery systems – functional performance during simulated use
• TAVI and TMVR delivery systems – functional performance during simulated use
• Thrombectomy devices — functional performance during simulated use
• Guidewires testing – functional performance during simulated use
• Endoscopic devices – functional performance during simulated use
• RF ablation catheters testing – functional performance during simulated use
• Any interventional delivery systems – functional performance during simulated use

Service Levels

• Fast Track
• Standard Service
• Full Service

Applicable Standards

• 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

• FDA-16007
  FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling

• FDA-16013
  FDA Guidance: Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions

• FDA-1658
  FDA Guidance: Coronary and Carotid Embolic Protection Devices – Premarket Notification [510(k)] Submissions

Related Tests

• Torqueability
• Torsional Bond Strength

OLE1116