(60 days)
The CapSure ™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
The CapSure™ Permanent Fixation System is a sterile single use device that delivers either 15 or 30 permanent fasteners via a straight shaft. The shaft of the CapSure™ Permanent Fixation System is 37 cm in length. The fasteners are designed with a 316L Stainless steel helical coil and polyetheretherketone (PEEK) cap on the proximal end to support mesh or tissue.
The provided document is a 510(k) premarket notification for the CapSure™ Permanent Fixation System. It focuses on demonstrating substantial equivalence to a predicate device (K142808 CapSure™ Permanent Fixation System) rather than presenting a study for initial market approval. Therefore, the information typically requested for a device's initial acceptance criteria and its demonstration through a study (especially regarding algorithm performance, ground truth establishment, sample sizes for training/test sets, and expert involvement for AI/diagnostic devices) is largely not applicable in this context.
This submission is about minor changes to an already cleared device, asserting that no technological characteristics have changed and that updated instructions for use are supported by adequate performance data from the previous 510(k).
However, I can extract the information related to performance data and acceptance criteria as presented for the original clearance (K142808) and affirmed for this submission.
Here's a breakdown based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | (Implicit: Meet ISO 10993 standards for non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, etc. for materials in contact duration categories) | All samples tested met the acceptance criteria. (Deployment device: tissue contacting |
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.