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Premium Surgiclip™ (All models) The Premium Surgiclip™ clip applier has application in many types of surgical procedures to occlude vessels and other tubular structures and for vagotomy, sympathectomy and radiographic markings

Endo Clip™ M, ML, L The Endo Clip™ clip applier has application in endoscopic procedures to achieve occlusion of vessels and other tubular structures, and for radiographic markings

Endo Clip™ 5mm The Endo Clip™ clip applier has applications in endoscopic procedures to achieve occlusion of vessels and other tubular structures and for radiographic markings

Endo Clip™ II The Endo Clip™ II clip applier has application in many types of endoscopic procedures to achieve occlusion of vessels and other tubular structures and for radiographic markings

AcuClip™ The instrument is primarily indicated for patients undergoing laparoscopic surqical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures. It can also be used to mark anatomical structures during surgery, and for radiographic marking.

The Premium Surgiclip™ clip applier consists of an applier shaft with attached handles and integrated cartridge containing 15 or 20 titanium clips. The clip applier jaw is placed around a vessel or other tubular structure. As the handles of the applier are brought together, the clip is closed around the vessel or structure. As the handles are released, a new clip is automatically loaded into the clip applier jaw.

Models available are:

Premium Surqiclip™ M – 11.5 and Premium Surgiclip™ II M-11.5 - medium sized clips with an 11.5 inch shaft

Premium Surgiclip™ M - 9.75 and Premium Surgiclip™ II M-9.75 - medium sized clips with an 9.75 inch shaft

Premium Surgiclip™ S-9.0 – small sized clips with an 9.0 inch shaft

Premium Surgiclip™ L-13.0 - large sized clips with an 13.0 inch shaft

The Endo Clip™ clip applier contains 20 titanium clips in the ML and M sizes, and 15 titanium clips in the L size. They are designed for introduction and use through all appropriately sized Covidien™ trocar sleeves, or larger sized trocar sleeves with the use of a converter.

The Endo Clip™ 5mm clip applier contains 12 titanium clips. The applier is designed for introduction and use through an appropriately sized Covidien™ trocar sleeve, or larger with the use of a converter. The overall length of the shaft is approximately 28 cm (11").

The Endo Clip™ II clip applier contains 20 titanium clips. The appliers are designed for introduction and use through all appropriately sized Covidien™ trocar sleeves, or larger sized trocar sleeves with the use of a converter.

The AcuClip™ right angle clip applier is loaded for delivery of twenty (20) 8 mm titanium ligating clips. It is designed for introduction and use through all appropriate sized Covidien™ trocar sleeves or larger trocar sleeves with the use of a converter. The distal portion of the AcuClip™ right angle clip applier forms a hook that is placed around the vessel or other tissue structure to be occluded. The clips are advanced into the jaws by squeezing the handle approximately half-way. The clips are then closed by fully depressing the handle.

This document is a 510(k) premarket notification for surgical clips and clip appliers. It is not a study that proves a device meets acceptance criteria but rather a submission to demonstrate substantial equivalence to previously cleared predicate devices. The document explicitly states that "In-vitro and In-vivo performance testing were not conducted as a requirement of the labeling change to add a contraindication."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because no new performance studies were conducted or reported in this document.

This submission focuses on a labeling change (specifically, the addition of a contraindication) for existing devices already marketed. The FDA's review in this case is to determine if the device, with the proposed labeling change, is still substantially equivalent to its predicates, not to re-evaluate its fundamental performance against criteria through new studies.

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