(21 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 (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:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility | Complies with ISO 10993-1, no new/significantly modified risks |
| Dimensional Inspection | Successfully passed (for stylet only) |
| Bond Strength | Successfully passed (Stylet to connector hub) |
| Tubing Stiffness Comparison | Stiffness of ENvizion EFTs with stylet is less than CORFLO reference device, resulting in no new/significantly modified risks |
| Simulated Use | Confirmed no impact of stylet on tracking |
| Shelf Life Validation | Confirmed no impact of stylet on EFT shelf-life |
| Conformity to Standards | Continues to conform to BS/EN 1615:2000, BS/EN 1618:1997, ANSI/AAMI/ISO 10993-1:2009(R) 2013, IEC 60601-1, IEC 60601-1-2, IEC 62366-1:2015, ISO 80369-3: 2016 |
| Safety & Effectiveness | Differences do not raise new or different questions of safety and effectiveness; device is safe, effective, and performs as well or better than the predicate device. |
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.
§ 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.