section_subject: "Temporary catheter for embolic protection during transcatheter intracardiac procedures."
cfr_reference: "21 CFR 870.1251"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i)Simulated-use testing in a clinically relevant bench anatomic model to assess the following:
(A)Delivery, deployment, and retrieval, including quantifying deployment and retrieval forces, and procedural time; and
(B)Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.
(ii)Tensile strengths of joints and components, tip flexibility, torque strength, torque response, and kink resistance.
(A)The ability of the filter to not impede blood flow.
(B)The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.
(iv)Characterization and verification of all dimensions.
(2)Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:
(i)Delivery, deployment, and retrieval, including quantifying procedural time.
(ii)Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.
(A)The ability of the filter to not impede blood flow.
(B)The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.
(iv)Gross pathology and histopathology assessing vascular injury and downstream embolization.
(3)All patient contacting components of the device must be demonstrated to be biocompatible.
(4)Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(5)Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.