(47 days)
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.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.