(11 days)
The 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
The Ethicon Endo-Surgery Ligamax 5 is a 5 mm endoscopic multiple clip applier. This sterile, single patient use, instrument is designed to provide a means of ligation on tubular structures or vessels through an appropriately-sized trocar. The instrument contains 15 medium-large titanium clips for occluding tissue, structures, and vessels.
The provided text describes a 510(k) Premarket Notification for the Ligamax™ 5 endoscopic multiple clip applier. However, it does not contain any information about specific acceptance criteria or a study designed to prove the device meets those criteria.
The "Performance Data" section merely states: "Bench testing was performed to demonstrate that the device will perform as intended." This is a general statement and lacks the detailed information required to answer your questions.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other specifics related to a study proving the device meets acceptance criteria. The document focuses on the device description, indications for use, and a comparison to a predicate device for the purpose of achieving substantial equivalence for regulatory clearance.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.