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The Altis® Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Coloplast Altis Single Incision Sling (SIS) System includes an implantable, non-absorbable, single incision mid-urethral sling and disposable introducer needles for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Altis sling is knitted to 1.1 cm width using a 0.08mm (nominal) diameter polypropylene filament and is 7.75 cm long. The Altis sling and Altis introducers are provided sterile (ethylene oxide sterilization) and are for single-use only.

The provided text is related to a 510(k) premarket notification for the "Altis® Single Incision Sling." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data for a new or modified device. As such, the document explicitly states:

"Performance data was not necessary for the substantial equivalence determination as the subject device and the predicate device have identical intended use, target population, sterilization technique, biocompatibility features, overall device design features, and duration of use."

Therefore, I cannot extract the information required to answer your questions about acceptance criteria and the study that proves the device meets them from this document. The document primarily discusses regulatory aspects of the device, specifically its substantial equivalence to a previously cleared predicate device due to identical technical characteristics and intended use. The only change mentioned is revised labeling to include information from a completed 522 study, but details of that study are not provided here.

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