(283 days)
The Vesco Medical Extension Feeding Sets are intended for use as an extension set to other gastric feeding devices, incorporating safety connectors which may reduce the risk of accidental connection of an IV system, or the enteral system to the IV system.
The Vesco Medical Extension Feeding Set product line is comprised of a group of enteral tubes that will be used by trained caregivers for the delivery of nutrition and water. The Extension Sets will be used in a hospital or home environment. The Extension Sets will be provided non-sterile and are for single patient use. The Extension Sets will incorporate a male ENFit connector which is compatible with syringes and other devices that have female ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.
The Vesco Medical Extension Feeding Sets are non-sterile, single patient use devices consisting of a polyvinylchloride tube, ABS G-button connector, ENFit connector, cap and clamp. The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. The G-button connectors are to allow compatibility to the Mic-key and Mini low profile devices.
This document describes the FDA's 510(k) clearance for the Vesco Medical Extension Feeding Sets. The clearance is based on proving substantial equivalence to a predicate device (Aquarius Extension Feeding Sets cleared under K141631). Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and confirmation that the proposed device meets relevant standards and internal design requirements.
Here's a breakdown of the requested information based on the provided text:
- 1. A table of acceptance criteria and the reported device performance
The document states that the proposed device (Vesco Medical Extension Feeding Sets) is identical to its predicate device (Aquarius Extension Feeding Sets). Therefore, the "acceptance criteria" are implied to be the performance characteristics of the predicate device, and the "reported device performance" is that the Vesco Medical device matches these.
| Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (Vesco Medical Extension Feeding Sets) |
|---|---|
| Biocompatibility | Complies with ISO 10993 standards: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Material-Mediated Pyrogenicity. |
| Visual Inspection | No cracks, deformation, or other abnormalities after accelerated aging per ASTM F1980-07. |
| Flowrate | Complies with Vesco Medical's internal design requirement. |
| Pressure Leakage | Complies with EN1615:2000 and EN1618:1997. |
| Tensile Strength | Complies with EN1615:2000 and EN1618:1997. |
| Cleaning Instructions Validation | Validated per CDRH Guidance. |
| Conformance to ISO 80369 | Conforms to applicable parts of ISO 80369, specifically ISO 80369-3 for ENFit connectors. |
| Risk Analysis | Complies with ISO 14971:2012. |
| DFMEA | Complies with Vesco Medical's internal design requirements. |
| Non-IV Compatibility | Complies with ISO 80369-1 Annex B, AAMI/ANSI ID54, demonstrating non-compatibility with female luer connectors and intravenous sets. |
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the specific tests (e.g., how many units were tested for flow rate, tensile strength, or leakage). It lists the types of tests performed.
The data provenance is not specified in terms of country of origin or retrospective/prospective. The tests were performed by Vesco Medical, as indicated by "Vesco Medical's design requirement."
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable in this context. The "ground truth" for this device, a physical extension set, is established through compliance with recognized international standards (ISO, EN, ASTM) and the manufacturer's own design specifications, rather than expert consensus on interpretive data (like medical images).
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication of expert interpretations for ground truth, which is not relevant for this type of device submission.
- 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. This device is a physical medical component, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is not an algorithm or AI system. Its performance is evaluated through physical and chemical testing.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the Vesco Medical Extension Feeding Sets is primarily established by:
* International Standards: Compliance with standards like ISO 10993 (biocompatibility), EN 1615, EN 1618 (tensile, leakage), ISO 80369 (connector compatibility), ASTM F1980 (accelerated aging).
* Manufacturer Design Requirements: Internal specifications set by Vesco Medical for flow rate and DFMEA.
* Predicate Device Performance: The primary claim of substantial equivalence is based on the new device being identical in form, function, and materials to the already cleared predicate device, which itself met similar standards.
- 8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
- 9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.