(118 days)
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:
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Biocompatibility | Successfully passed |
| Dimensional Inspection | Successfully passed |
| Liquid Leakage Testing | Successfully passed |
| Visual Inspection | Successfully passed |
| Tensile Strength Testing | Successfully passed |
| Flow Rate Testing | Successfully passed |
| Tubing Stiffness Comparison | Successfully passed |
| Simulated Use | Successfully passed |
| Packaging Validation | Successfully passed |
| Shelf Life Validation | Successfully passed |
| Gastric Fluid Compatibility | Successfully passed |
| Software Validation | Successfully passed |
| IEC 60601-1 Electrical Safety | Successfully passed by conforming to standard |
| IEC 60601-1-2 Electromagnetic Compatibility (EMC) | Successfully passed by conforming to standard |
| Summative Usability | Successfully passed |
| Comparative Testing | Successfully passed |
| MR Compatibility Testing | Successfully passed |
| Human Clinical Study (Safety & Effectiveness) | "Showed no device guidance-related adverse events and no serious adverse events of any kind occurred...performed safely and effectively without any guidance related incidents." |
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.
§ 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.