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The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners is intended to affix the stomach to the anterior abdominal wall facilitating primary placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes.

The Kimberly-Clark Enteral Access Dilation System is intended to facilitate stoma tract dilation prior to placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these dilator be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes

Device 1: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy* T-Fasteners
Device 2: Kimberly-Clark Enteral Access Dilation System

The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners consists of an internal retention T-Bar and an external suture-lock retention bolster connected by a length of resorbable suture. The T-Bar end is loaded onto the slot of a safety needle.

The Kimberly-Clark Enteral Access Dilation System is a stoma dilator with a peel-away sheath composed of a series of HDPE (high density polyethylene) telescoping dilator sleeves. It is available in 5 terminal sizes from 16FR up to 24FR (every even size).

This submission, K093312, indicates that no clinical or non-clinical laboratory testing was required to determine substantial equivalence because the subject devices (Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners and Kimberly-Clark Enteral Access Dilation System) are identical to components of the predicate device (Kimberly-Clark Introducer Kits, K080253).

Therefore, the acceptance criteria and study detailed in your request (including reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) are not applicable to this 510(k) submission. The FDA granted clearance based on the devices being identical in design, materials, sizes, and intended use as components of an already cleared device, without requiring new performance studies.

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