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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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The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 10 Fr and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.

The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

The ENvizion Medical ENvue System is an electro-mechanical device with embedded software designed to aid in the placement of the ENvizion Medical Enteral Feeding Tube (with or without stylet), which is an enteral feeding tube placed into the stomach or small intestine of patients requiring enteral feeding. The ENvue System tracks the Enteral Feeding Tube (EFT) as it progresses through the oro/nasoenteric route down the esophagus, into the stomach and to the small intestine anatomy and displays the placement pathway in real time during placement. Once the placement is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

This Special 510(k) notification adds 4 new models of EFTs, that include a stainless-steel stylet.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics that would typically be evaluated in a clinical study. Instead, it focuses on demonstrating substantial equivalence to a predicate device and reference devices by ensuring that the differences do not raise new questions of safety or effectiveness. The performance data section describes tests completed to demonstrate substantial equivalence, rather than defining strict numerical acceptance criteria for a new feature's performance.

However, based on the performance data listed, we can infer some criteria and the reported outcome:

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing (biocompatibility, mechanical testing, simulated use, shelf life) rather than a clinical study with a "test set" of patients. Therefore, specific sample sizes for a clinical test set are not applicable here.

The data provenance is from laboratory and engineering testing conducted by the manufacturer, ENvizion Medical Ltd., to demonstrate compliance with standards and equivalence to predicate devices. No information about country of origin for data is provided beyond the manufacturer's location (Israel), as these are internal product verification and validation tests. The tests were performed to address the addition of a new feature (stylet) to an already cleared device, not for initial market clearance based on extensive clinical data.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This submission focuses on non-clinical performance data and equivalence for an incremental change to a medical device, not a diagnostic AI device requiring expert consensus for ground truth. The "ground truth" here is established by engineering and biological testing standards and comparison to a known predicate.

4. Adjudication Method for the Test Set:

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study was not done. The device is not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement. The ENvizion Medical ENvue System aids in the physical placement of feeding tubes.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is an electro-mechanical system with embedded software designed to assist a qualified operator in a physical procedure (feeding tube placement), not a standalone algorithm providing diagnostic or predictive outputs without human intervention. The "performance data" presented relates to the physical and mechanical properties and safety of the device components.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through:

• Engineering specifications and test standards: For dimensional inspection, bond strength, tubing stiffness, and simulated use.
• Biological safety standards: ISO 10993-1 for biocompatibility.
• Comparison to predicate and reference devices: To demonstrate that the modified device performs "as well or better" and that differences do not raise new safety or effectiveness concerns.

8. Sample Size for the Training Set:

Not applicable. This submission is for an electro-mechanical device with embedded control software, not a machine learning or AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" in the context of this device and submission type.

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