Carpentier-Edwards Physio Annuloplasty Ring (4450)

The Carpentier-Edwards Physio Annuloplasty Ring (Model 4450) is a mitral valve repair device made of Elgiloy bands separated by polyester film strips with a silicone rubber and polyester cloth sewing margin. It is kidney-shaped with differential flexibility, designed to support and stabilize the mitral annulus during repair of mitral valve insufficiency or mixed insufficiency and stenosis without replacing the natural valve.

The device has identical structure, materials of composition, sterilization method, size range, sizing accessories, packaging, and site of application as the predicate device (K926138). Both rings exhibit differential flexibility with a saddle-shaped curve for aortic root apposition and maintain a fixed maximum annular dimension while adapting to dynamic mitral annulus motion throughout the cardiac cycle.

Not stated in this summary. The document mentions MRI testing in accordance with applicable standards and guidance but does not cite specific standard numbers (ISO, IEC, ASTM, etc.).

Substantial equivalence is established because both the proposed device and predicate device are intended to repair a malfunctioning heart valve using identical technological characteristics, materials, construction, sterilization, sizing, and packaging. MRI compatibility testing was performed to verify safety and performance, confirming the device meets the same safety and effectiveness requirements as the predicate despite the lack of other specific comparative performance data presented.