(215 days)
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is indicated for the reconstruction and/or remodeling of the pathological mitral valve. Combined mitral valve stenosis and insufficiency may be corrected by appropriate commissurotomy and valvular remodeling.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is contraindicated for use under the following conditions: the presence of heavy valvular calcification, valvular retraction with severely reduced mobility and the presence of active bacterial endocarditis.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is constructed of a polyester fabric enclosing an open strip of pliable radiopaque sillicone elastomer impregnated with barium sulfate which enables radiographic visualization. The band is uniformly 3 mm in diameter and is provided in a single length of 63 mm. Colored suture markers, which facilitate implantation, are circumferentially located at the center of the band and at each end.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be offered in one length, 63 mm and will not be mounted onto a holder. No sizers will be offered with the posterior band configuration as only one length is available.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be supplied in a sterile double aseptic transfer pouch. The annuloplasty band will remain sterile if the pouch is undamaged and unopened.
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND uses the same materials and is processed, packaged and sterilized similarly to the MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING.
This document describes the pre-market submission for a medical device (MEDTRONIC® POSTERIOR ANNULOPLASTY BAND) and does not contain information about an AI/ML device. Therefore, it is not possible to describe acceptance criteria and study details as requested for an AI/ML device.
The provided text focuses on the device description, indications, contraindications, alternatives, potential adverse effects, and a summary of studies related to its safety and effectiveness based on material biocompatibility and manufacturing process qualification, drawing heavily on the similarity to an existing device (MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING).
There is no mention of algorithms, machine learning, or any form of AI, nor are there any performance metrics that would typically be associated with an AI/ML study (e.g., sensitivity, specificity, AUC). Consequently, the requested tables and details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI performance cannot be generated from this document.
§ 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.”