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510(k) Data Aggregation
(156 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety of the device (through various tests and clinical evaluation) | Device performed safely without any guidance-related adverse events. |
| Effectiveness in aiding tube placement (through various tests and clinical evaluation) | 100% agreement between system display and X-ray position confirmation. |
| Biocompatibility | Complies with ISO 10993-1, in accordance with FDA guidance. |
| Mechanical properties (e.g., tensile strength, flow rate, stiffness) | Successfully passed all testing. |
| Software validation | Successfully passed all testing. |
| Shelf-life | Successfully passed all testing. |
| Conformance to recognized consensus standards | Conforms to multiple listed ISO, IEC, BS/EN standards. |
| Equivalent performance for 8 Fr EFT with stylet | Bench testing demonstrates safety and performance, no new/modified risks. |
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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