(251 days)
The Vesco Medical Nasoenteric Feeding Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (
The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes) are non-sterile, single use devices consisting of flexible, radiopaque, polyurethane tubing adhered to a plastic male ENFit single-port connector with a tethered, twist-on cap. The plastic ENFit port allows for connection to enteral feeding sets and enteral-specific syringes while reducing the likelihood of misconnections to non-enteral devices. The cap allows for port coverage when enteral devices are not in use. The distal tip of the tubing is open and has four (4) evenly spaced, alternating eyelet openings to allow for first three inches of the distal tip are coated with a hydrophilic lubricant to aid in friction reduction during tube insertion. The tubing is printed with graduated markings in centimeters, the length from the distal tip in order to provide users with approximate insertion depth information. Certain models of the Vesco Medical Nasoenteric Feeding tube are provided with a stylet wire attached to a flow-through, ENFit hub. The stylet wire is intended to stiffen the tube during insertion and be removed after insertion is complete. The proposed device will be offered in sizes ranging between 8 French and 14 French.
This document is a 510(k) Premarket Notification from the FDA regarding the Vesco Medical Nasoenteric Feeding Tubes. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving an AI/ML device or its performance criteria in the way requested.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML device from this document. The document pertains to a traditional medical device (nasoenteric feeding tubes) and its regulatory clearance based on substantial equivalence and non-clinical performance testing.
However, I can extract information about the non-clinical performance testing that was done for this specific device, which serves as its "acceptance criteria" and "study" for regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Test/Standard) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility Testing: | |
| a. Cytotoxicity (ISO-10993-5) | Compliant. |
| b. Cytotoxicity, intracutaneous, maximization sensitization | Compliant (leveraged from Cedic for component materials). |
| c. ENFit connector material and colorant biocompatibility | Compliant (leveraged from Cedic's K140581). |
| d. Stylet wire, tubing, ink, lubricant, adhesive biocompatibility | Compliant (leveraged from K992494 due to material and manufacturing equivalence). |
| Visual and Physical Inspections: | |
| a. Visual inspection for bleeding of tube ink markings | Compliant per Vesco Medical Design Requirement. |
| b. Visual inspection for legibility of tube ink markings | Compliant per Vesco Medical Design Requirement. |
| c. Visual inspection for cracks or delamination of lubricous coating | Compliant per Vesco Medical Design Requirement. |
| d. Physical inspection for water activation of lubricious coating | Compliant per Vesco Medical Design Requirement. |
| e. Visual Inspection for adhesion between NE Tube and ENFit connector | Compliant per Vesco Medical Design Requirement. |
| f. Patency of stylet | Compliant per Vesco Medical Design Requirement. |
| g. Stylet removal force | Compliant per Vesco Medical Design Requirement. |
| Functional/Mechanical Testing: | |
| a. Patency of NE Tubes/flow rate testing (using water) | Compliant (compared against predicate). |
| b. Patency of NE Tubes/flow rate testing (using nutritional fluid) | Compliant (compared against predicate). |
| c. Leakage Testing (EN1615:2000 & EN1618:1997) | Compliant. |
| d. Tensile Testing (EN1615:2000 & EN1618:1997) | Compliant. |
| e. Resistance to Kinking (EN1615:2000 & EN 13868:2002) | Compliant (against predicate). |
| f. Fluid Leakage (ISO 80369-3:2016) | Compliant (performed by Cedic). |
| g. Stress Cracking (ISO 80369-3:2016) | Compliant (performed by Cedic). |
| h. Resistance to separation from axial load (ISO 80369-3:2016) | Compliant (performed by Cedic). |
| i. Resistance to separation from unscrewing (ISO 80369-3:2016) | Compliant (performed by Cedic). |
| j. Resistance to overriding (ISO 80369-3:2016) | Compliant (performed by Cedic). |
| k. Disconnection by unscrewing (ISO 80369-3:2016) | Compliant (performed by Cedic). |
| l. ENFit dimensional verification (ISO 80369-3:2016) | Compliant (performed by Cedic). |
| Other: | |
| a. Accelerated aging (18-month shelf life) | Substantiated an eighteen (18) month shelf life. |
| b. Risk Analysis (ISO 14971:2012) | Performed (Result: The conclusions drawn from the nonclinical tests demonstrate that the Vesco Medical Nasoenteric Feeding tubes are as safe, as effective, and perform as well as or better than the legally marketed devices). |
| c. Design Failure Modes and Effects Analysis (DFMEA) | Performed (Result: The conclusions drawn from the nonclinical tests demonstrate that the Vesco Medical Nasoenteric Feeding tubes are as safe, as effective, and perform as well as or better than the legally marketed devices). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical laboratory testing of physical samples of the device. It does not refer to a "test set" in the context of an AI/ML algorithm or patient data. The provenance of the testing data is not explicitly stated in terms of country of origin, but it is implied to be laboratory testing conducted for regulatory submission in the U.S. There is no concept of "retrospective or prospective" testing for these types of physical bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to the non-clinical physical device testing described. Ground truth for the performance of a physical device against a standard is established by the specifications of the standard itself and measurable physical properties, not expert consensus.
4. Adjudication method for the test set
Not applicable to non-clinical physical device testing. The "adjudication method" for these tests is whether the device passed or failed the specified criteria of the international standards and Vesco Medical's design requirements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests described is defined by:
- International Standards: ISO 80369-3, EN1615:2000, EN1618:1997, EN 13868:2002, ISO 10993-1, ISO 10993-5, ISO 14971:2012.
- Vesco Medical Design Requirements: For visual inspections, patency, and stylet removal force.
- Predicate Device Performance: Used as a benchmark for patency/flow rate and resistance to kinking, demonstrating "as well as or better than" performance.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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.