(27 days)
The RBM is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair. The indications for the RBM are for use as a suture retention device to facilitate percuraneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repar), rotator cuff repair, meniscal repair, and gastrostomy.
The RBM is a suture retention device manufactured from polyester suture, poly(L-lactide) bar, stainless steel needle and a plastic handle.
The provided text is a 510(k) summary for the RBM suture retention device. It describes the device, its intended use, and compares it to a predicate device (MR-III). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission for substantial equivalence based on technological characteristics and intended use alignment with a predicate device, rather than performance testing against specific acceptance criteria.
§ 878.4930 Suture retention device.
(a)
Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.