SEU · Peripheral Temporary And Retrievable Stent System

Cardiovascular · 21 CFR 870.5110 · Class 2

Overview

Identification

The Spur Peripheral Retrievable Stent System is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. It is intended as an adjunct to percutaneous transluminal angioplasty (PTA) to dilate stenoses in infrapopliteal arteries ranging in diameter from 2.5 mm to 4.5 mm. The device is designed to be retrieved and removed following successful treatment.

Classification Rationale

FDA concludes that this device should be classified into Class II. This order classifies the device into Class II with the establishment of special controls for Class II, which provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Analysis of all adverse events, including serious and non-serious complications; and (ii) Clinically meaningful endpoints that assess device performance and clinical benefit. (2) Animal performance testing must evaluate the device’s performance in a physiological environment, including assessing vascular compatibility, deployment and retrieval behavior, and acute and subacute adverse effects (e.g. dissection, perforation, spasm, hemorrhage, thrombosis, stenosis). Evaluations must include: (i) Post-procedural examination of the catheter for thrombus or damage; (ii) In-life clinical observations of the test animals; (iii) Clinical pathology assessment; (iv) Imaging to assess vascular response and patency; (v) Complete gross necropsy; (vi) Examination of downstream tissue beds for particulate or thromboembolic events; and (vii) Comprehensive target tissue histopathology and histomorphometry evaluation. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following characteristics must be evaluated: (i) Dimensional verification testing, including compatibility of the device with the intended anatomy and all labeled accessories; (ii) Mechanical integrity and bond strength testing of the entire device, including all joints and component interfaces, under tensile and torsional forces expected during challenging clinical use conditions; (iii) Simulated use testing, including insertion, tracking, activation, and removal without device damage, to demonstrate that the device is able to function as intended under challenging clinical use conditions; (iv) Device visibility testing under standard imaging modalities; (v) Kink resistance when subjected to clinically relevant tortuosity; (vi) Delivery catheter functional testing. If the delivery catheter utilizes a balloon component the following must be demonstrated: (A) Balloon inflates and deflates within clinically relevant timeframes; (B) Balloon withstands rated burst pressure without failure; (C) Balloon withstands repeated inflation/deflation cycles without degradation; and (D) Balloon inflates uniformly, meeting labeled diameter and compliance specifications for stent deployment; (vii) Durability testing under clinically relevant mechanical stresses over time; (viii) Coating integrity and particulate testing of any coatings on the delivery catheter or stent; and (ix) Material stability testing, including in situ stability and resistance to degradation (e.g. corrosion, wear, delamination) of all device materials. (4) All patient-contacting components of the device must be demonstrated to be biocompatible. (5) All patient-contacting components of the device provided sterile must be demonstrated to be sterile and non-pyrogenic. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the established shelf life. (7) Labeling must include: (i) A detailed summary of the device's technical parameters and materials; (ii) A summary of expected complications associated with the device; and (iii) A summary of the clinical performance testing conducted with the device, including device- and procedure-related adverse events.

Recent Cleared Devices (1 of 1)

Top Applicants

• Reflow Medical, Inc. — 1 clearance