(200 days)
The Endovive™ Initial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.
The Endovive™ Standard Profile Balloon Replacement Tube is indicated for use in percutaneous placement of an enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. Typical uses include the replacement of existing gastrostomy and/or jejunostomy feeding tubes. The Standard Profile Balloon Replacement Tube may also be used for decompression.
The Endovive™ Initial Placement Direct PEJ Kit is used during initial placement for direct feeding. The Endovive™ Standard Profile Balloon Replacement Tube is used for the replacement of direct feeding tubes used for direct feeding. The major components of these devices are the internal bolster and the feeding tube.
This 510(k) premarket notification for the Endovive™ Initial Placement Direct PEJ Kit and Endovive™ Standard Profile Balloon Replacement Tube does not contain information about a study proving the device meets acceptance criteria.
Instead of performing a study with acceptance criteria and reported device performance, Boston Scientific Corporation demonstrated substantial equivalence to predicate devices (the Endovive™ Initial Placement Gastrostomy Kit, Endovive™ Balloon Replacement Gastrostomy Tube, and Endovive™ Percutaneous Endoscopic Jejunostomy Device) based on their descriptive and technological characteristics. The FDA then issued a substantial equivalence determination.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for a study. The document focuses on regulatory approval through substantial equivalence, not a performance study as would be conducted for an AI/ML device.
§ 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.