(61 days)
The Kumar T-ANCHORS Hernia Set provides a means for fixation of prosthetic material and passage of sufure during repair of hernia and soft tissue.
Kumar T-Anchors Hernia Set supplies 8 T-Anchors that carry size 0 polyamide suture. These are deployed in pairs percutaneously through a 16 ga, needle. The sutures are tied to anchor the prosthetic material to the abdominal wall in repair of hernia or the soft tissues.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, as it does not include details on a performance study or testing with specific metrics.
The document is a 510(k) premarket notification letter from the FDA regarding the "Kumar T-ANCHORS Hernia Set". It primarily discusses the device's substantial equivalence to predicate devices and regulatory compliance.
Therefore, I cannot generate the requested table and information points.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.