(79 days)
The Simplici-T™ Annuloplasty System is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.
The Simplici-TTM Annuloplasty System is a single use, permanent, flexible, implantable device intended for the repair of a patient's mitral and tricuspid valves. The Simplici-T™ Annuloplasty Band is a 100 mm long band, constructed from a double velour polyester fabric wrapped around a small radiopaque silicone marker strip. Two locking running stitches run the entire 100mm band length creating a flat, low profile. A whipstitch on the side closes the band together. Implantation of the band is aided with the disposable band holder. The band is released from the holder by depressing the thumb trigger found on the handle of the holder. By depressing the thumb trigger, the holder bottom fingers push the band off of pins attached to the holder top. The device is sterilized by Steam Sterilization and has a One-year shelf life. The device is packaged on a holder in double aseptic pouches and shipped within a shelf-carton that includes instructions for use and product traceability labels.
The provided document, K052970, for the Simplici-T™ Annuloplasty System (Model 670), primarily focuses on its substantial equivalence to predicate devices and describes the device itself. It does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the specific methodology for establishing ground truth.
The document states:
"The Simplici-TTM Annuloplasty System was subjected to verification and validation studies. The verification/validation studies demonstrate that the modifications to the predicated device are appropriate and do not affect the intended use or performance of the device."
This statement confirms that studies were conducted to ensure the device performs as intended and is safe, but it lacks the quantitative and methodological details to fulfill the request. Therefore, I cannot construct the requested table or provide the detailed information for points 2 through 9 based solely on the provided text.
The document is a 510(k) summary, which typically provides a high-level overview to establish substantial equivalence to a legally marketed predicate device rather than comprehensive study reports with detailed performance endpoint data.
§ 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.”