The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication or decompression through an established gastrointestinal stoma tract.
The Entuit LP Patient Care Kit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Balloon Retention Feeding Tube.
The Entuit LP Patient Care Kit with ENFit Connection is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube.
The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract.
The PromaX LP Patient Care Kit with ENFit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration, or decompression through a PromaX Low Profile Gastrostomy Feeding Tube.
The proposed low profile devices are constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. At the distal end, a silicone balloon is bonded to the shaft using a silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the extension set connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.
In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque barium stripe present.
Accessories for the proposed devices include two extension set configurations (bolus and continuous, each available in both ENFit-compatible version and non-ENFit compatible version due to ENFit market transition status), an inflation syringe, a feeding syringe (similarly available in both ENFit compatible and non-ENFit compatible versions), gauzes, and a stoma measuring device (for the Entuit offering) to facilitate device placement and use.
This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of new medical devices to legally marketed predicate devices. As such, it does not contain the information requested regarding acceptance criteria and a study proving device meets acceptance criteria for an AI/ML powered medical device. The document pertains to physical medical devices (gastrostomy feeding tubes and kits).
Therefore, I cannot provide the requested information based on the given text.
The typical structure for a 510(k) submission for a physical device like a feeding tube involves demonstrating:
- Substantial equivalence to a predicate device already on the market.
- Performance testing (bench testing, e.g., tensile strength, leak testing, biocompatibility, sterilization validation) to show the device meets specifications and is safe and effective for its intended use.
- Clinical tests (if applicable): Often not required for Class II devices like these if bench data and substantial equivalence is strong.
The document you provided outlines exactly this:
- It identifies predicate and reference devices (Section 5.3, 5.4).
- It describes the proposed devices and their technological characteristics, comparing them to the predicate (Section 5.5, 5.7, 5.7a).
- It lists non-clinical tests performed (biocompatibility, sterilization, performance bench testing like tensile, leak, connector strength, dimensional testing per ISO standards, pinch clamp testing, and resistance to chemical exposure) (Section 5.8.1).
- It explicitly states that animal and clinical tests were not required (Section 5.8.2, 5.8.3), which is common for devices demonstrating substantial equivalence through robust bench testing.
Essentially, for these types of physical devices, the "acceptance criteria" are the specifications and performance standards met during the non-clinical bench testing, and the "study that proves the device meets the acceptance criteria" refers to the results of these bench tests demonstrating compliance with the standards and equivalence to the predicate. There is no AI/ML component described, so terms like "test set," "training set," "ground truth," "expert consensus," "MRMC study," or "standalone algorithm performance" are not applicable.
§ 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.