SBK · Artificial Chordae Tendineae Surgical Replacement System

Cardiovascular · 21 CFR 870.3490 · Class 2

Overview

Identification

An artificial chordae tendineae surgical replacement system is a standalone, prescription device consisting of nonabsorbable suture-based implant and suture placement device(s) that is used to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency. The device includes clips or fasteners to secure the suture that are not embedded in the cardiac tissue. The system is used via surgical approach under direct visualization and not via transcatheter or percutaneous access.

Classification Rationale

Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.

Special Controls

In combination with the general controls of the FD&C Act, the artificial chordae tendineae surgical replacement system use is subject to the following special controls: - (1) In vivo evaluation of the device must demonstrate that the device performs as intended under anticipated conditions of use. Testing must: - Demonstrate that the device performs as intended for atrioventricular valve (i) repair: - Demonstrate that the technology and techniques can be performed by the (ii) intended user population; and - Evaluate all adverse events, including device malfunctions, tissue or vessel (iii) damage, unanticipated surgical interventions, and relapse of atrioventricular valve regurgitation. - Simulated use testing must demonstrate the feasibility of device implantation and (2) translatability to clinical use under worst-case clinical conditions, considering indicated anatomies, surgical access, and visualization. - Non-clinical performance testing data must demonstrate that the device performs as (3) intended under anticipated conditions of use. The following performance characteristics must be tested: - (i) Verification of diameters, tensile strengths, and bond or joint strengths of sterile suture components; - (ii) Ability to orient the device appropriately to prevent damage to surrounding tissue structures: - Consistency and reliability of implant deployment to achieve the desired (iii) treatment effect, including implant locations, leaflet tethering, and implant fixation: - (iv) Mechanical integrity (e.g., tensile strength, fatigue or creep, bond failure) of the implant and placement devices to function under anticipated loading conditions; - (v) Assessment of implant-tissue separation force; - Durability of the implant; (vi) - (vii) Compatibility of the implant in a magnetic resonance environment, if the implant contains magnetic or metallic materials; and - (viii) Corrosion assessment, if the implant contains metal components. - (4) The patient-contacting components of the device must be demonstrated to be biocompatible. - Performance data must validate the sterility of the patient-contacting components of the (5) device. - (6) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. - (7) Labeling must include the following: - The recommended training for safe use of the device; (i) - A precaution to use clinical judgment in selecting patients eligible for (ii) atrioventricular valve surgery and suitable for the device; - (iii) A precaution to maintain direct visualization of the tissues to be treated during use of the device: - Identification of the maximum number of deployments and actuations for each (iv) device(s); and - A shelf life. (v)

Recent Cleared Devices (1 of 1)

Top Applicants

• Lsi Solutions, Inc. — 1 clearance