(163 days)
The dETlogix annuloplasty ring, model 5100, is indicated for the correction of mitral valvular insufficiency where the lesions are not severe enough as to require total valve replacement.
The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and normal chordae tendineae.
The remodeling valvuloplasty technique with a prosthetic ring may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus.
For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.
The dETlogix™ annuloplasty ring, model 5100, is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber, covered with polyester velour cloth sewn with a single seam.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted using AI or human readers. The document is a 510(k) summary for the Edwards™™ dETlogix™™ annuloplasty ring, focusing on its substantial equivalence to predicate devices and its indications for use. It primarily discusses design, materials, and functional/safety testing in a general manner, without providing specific performance data or details of clinical trials that would involve AI or human reader assessments.
§ 870.3800 Annuloplasty ring.
(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”