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The ENvizion Medical ENvue System is designed to aid qualified operators in the ENvizion Medical Enteral Feeding Tube from 8 Fr to 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 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 510(k) notification adds an 8 Fr EFT with a stainless-steel stylet and changes the input source for patient posture from using the plate sensor to the marking stylus. The plate sensor has been removed from the system.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device and confirming safety and effectiveness through various tests and a retrospective clinical evaluation. The primary performance metric reported for the clinical evaluation is agreement with X-ray confirmation.

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

• Sample Size: 50 placements across 48 randomly selected patients (2 of the subjects had 2 placements each).
• Data Provenance: Retrospective, pseudonymized clinical evaluation. The country of origin is not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth (X-ray confirmation). It simply refers to "x-ray position confirmation." In a clinical setting, X-ray interpretation would typically be performed by qualified radiologists or other medical professionals with expertise in imaging diagnostics.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. It states "100% agreement between the system display and the x-ray position confirmation," implying a direct comparison without a need for resolving discrepancies between multiple expert readings or a specific adjudication protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the agreement between the device's display and X-ray confirmation, not on comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation of sorts was conducted, as the study explicitly measured the "agreement between the system display and the x-ray position confirmation." This directly assesses the device's ability to accurately indicate tube position on its own, independent of a human operator's judgment beyond the initial setup and interpretation of the X-ray for ground truth. The device is designed to aid qualified operators, suggesting a human-in-the-loop context for its overall use, but the reported study specifically focuses on the accuracy of the system's output.

7. The Type of Ground Truth Used

The ground truth used was X-ray position confirmation.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. This is a 510(k) submission for a modification to a previously cleared device, and the focus is on performance validation of the modified device rather than a de novo software development process.

9. How the Ground Truth for the Training Set Was Established

Since information about a training set is not provided, the method for establishing its ground truth is also not available in this document.

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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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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, 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 is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

Here's a breakdown of the acceptance criteria and study information for the ENvizion Medical ENvue System and Enteral Feeding Tube, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds) for the device's performance in terms of aiding tube placement. Instead, it focuses on the successful completion of various tests to demonstrate safety and effectiveness and states that "the device successfully passed all of the testing and the results demonstrate the device is safe, effective, and performs as well or better than the predicate device."

Here's a table summarizing the tests performed, which indirectly serve as acceptance criteria:

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

The "test set" for the human clinical study consisted of:

• Sample Size: Data pooled from 58 subjects.
• Data Provenance: The study was a prospective, single-center clinical trial. The country of origin is not explicitly stated in this summary, but the manufacturer is based in Israel.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. It mentions the system "is designed to aid qualified operators," but doesn't detail how the correctness of tube placement (ground truth) was definitively determined independent of the device. Given the nature of feeding tube placement, ground truth often relies on imaging (like X-ray) or pH testing by medical professionals, but this isn't detailed here.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set in terms of determining ground truth for tube placement outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study, as typically described for AI systems evaluating images, was not explicitly mentioned. The clinical study focused on the device's safety and effectiveness as an adjunct to current practices and its ability to guide placement, rather than comparing human performance with and without the device. The device itself aids in the placement process, not in interpreting diagnostic information where an MRMC reader study would be more common.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. The device, the ENvue System, is "designed to aid qualified operators" in the placement of the feeding tube. It is inherently a human-in-the-loop device, displaying the placement pathway in real-time for the user. Therefore, a standalone (algorithm only) performance assessment would not be relevant to its intended use.

7. The Type of Ground Truth Used

The type of ground truth used in the clinical study for verifying tube placement is not explicitly detailed. However, for feeding tube placement systems, common methods for confirming correct placement (i.e., ground truth) typically involve:

• X-ray imaging (radiography)
• pH testing of aspirate
• Auscultation (listening for air insufflation)

The document notes that the feeding tube itself is "radiopaque...for X-ray visualization," suggesting that X-ray confirmation would be a standard part of practice. The predicate device's indications also mention "confirmation or correct tube placement by acceptable hospital protocol is required."

8. The Sample Size for the Training Set

The document does not provide information on a "training set" sample size. The ENvizion Medical ENvue system is a device that utilizes electromagnetic sensing technology to guide tube placement. While it contains embedded software ("Software Validation" is listed as a test), this is not an AI/Machine Learning diagnostic device in the traditional sense that would require a large training dataset for model development. The software likely controls the electromagnetic tracking and display, and its validation would involve functional testing rather than a training dataset from patient cases.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set in the context of an AI/ML algorithm that learns from data, the concept of establishing ground truth for a training set is not applicable here. The system relies on physical electromagnetic principles to track the tube.

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