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Enteral feeding catheter is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route. The target population is adults and pediatrics.

The Enteral Feeding Catheter is composed of a feeding catheter and stylet and can be divided into Funnel type and Enfit type as per the structure of the feeding catheter. For Funnel type, the feeding catheter is composed of tip, body, Y connector. The Y connector has integrated protective cap and strap. For Enfit type, the feeding catheter is composed of tip, body, Y connector, protective cap, and strap. The feeding catheter is made of polyurethane tube with BNF-II-79 hydrophilic coating. The feeding catheter is available in sizes of 6Fr, 8Fr, 10Fr and lengths of 70cm, 100cm, 120cm and 140cm. The length is measured from the distal tip to the proximal hub. The distal end of the feeding catheter features a sideport and is a smooth rounded finish. The proximal end of the feeding catheter features a funnel Y connector that is made of polyurethane or Enfit Y connector that is made of polycarbonate. A stainless-steel stylet with a length corresponding to the feeding catheter is fit inside the feeding catheter. The subject device, Enteral Feeding Catheter, may be introduced directly when there is adequate peristalsis and no gastric outlet obstruction. Alternatively, the feeding catheter may be passed over a stylet. The feeding catheter is intended to be indwelling up to four weeks and is for single-use only.

The provided document is a 510(k) Premarket Notification from the FDA for an "Enteral Feeding Catheter." It is a regulatory submission for a medical device and describes the device, its intended use, and how it compares to a predicate device.

Crucially, this document does not contain the kind of information requested regarding AI device acceptance criteria, study performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies. The device discussed here is a physical medical device (a feeding tube), not an AI/ML-based diagnostic or therapeutic device. The "performance data" section refers to standard biocompatibility and bench testing for physical medical devices, not algorithm performance metrics.

Therefore, I cannot extract the requested information from this document because it is irrelevant to the type of device and study requested in the prompt.

The document discusses:

• Device: Enteral Feeding Catheter
• Intended Use: For intermittent or continuous tube feedings via nasogastric or nasoenteric route in adults and pediatrics.
• Predicate Device: Corpark Enteric Feeding Tube W/Guide Tip (K821906)
• Performance Data: Biocompatibility testing (e.g., cytotoxicity, implantation, sensitization) and Bench Testing (e.g., appearance, dimensions, tensile property, flow rate, sterility, shelf life validation) to demonstrate the physical and chemical properties of the feeding catheter.

No information regarding AI/ML efficacy or safety is present.

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