(49 days)
The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) for patients in all age groups.
The Enteral Syringe with ENFit Connector (10 ml to 60 ml) and the Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) are both sterile, standard piston style enteral syringes with an integrated female ENFit compatible connector compliant to the requirements of ISO DIS 80369-3, First Edition, Small-bore Connectors for Liquids and Gases in Healthcare Applications – Part 3: Connectors for Enteral Applications and designed to be compatible with male ENFit connectors.
The Enteral Syringe with ENFit Connector has capacities of 10, 20, 30 and 60 ml and is available in two different connector confiqurations: Centerline and Offset.
The Enteral Syringe with ENFit Low Dose Tip is a low dose syringe and has capacities of 1. 3 and 5 ml. The ENFit Lose Dose tip is a modification of the ENFit connector designed for the delivery of low doses of fluids for enteral feeding.
The document describes the VR Medical Technology's Enteral Syringe with ENFit® Connector and Enteral Syringe with ENFit® Low Dose Tip. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria in the context of an effectiveness study for an AI/ML device.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of device submission. This document focuses on demonstrating compliance with recognized standards and biocompatibility.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table comparing acceptance criteria to device performance in the way typically seen for AI/ML device effectiveness studies. Instead, it lists various performance tests conducted according to international standards (ISO). The "acceptance criteria" are implied by compliance with these standards, and the "reported device performance" is indicated by the statement that these tests were "conducted" and supported a conclusion of substantial equivalence.
| Performance Test (as per ISO standard) | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity (ISO 10993-5) | Pass ISO 10993-5 | Conducted, met standard |
| Sensitization (ISO 10993-10) | Pass ISO 10993-10 | Conducted, met standard |
| Irritation (ISO 10993-10) | Pass ISO 10993-10 | Conducted, met standard |
| Tests per ISO 7886-1 | ||
| Cleanliness | Pass ISO 7886-1 | Conducted, met standard |
| Lubricant | Pass ISO 7886-1 | Conducted, met standard |
| Position of scale | Pass ISO 7886-1 | Conducted, met standard |
| Tolerance on graduated capacity | Pass ISO 7886-1 | Conducted, met standard |
| Dead space | Pass ISO 7886-1 | Conducted, met standard |
| Fit of piston in barrel | Pass ISO 7886-1 | Conducted, met standard |
| Slide force test | Pass ISO 7886-1 | Conducted, met standard |
| Freedom from air and liquid leakage | Pass ISO 7886-1 | Conducted, met standard |
| Limits for acidity or alkalinity | Pass ISO 7886-1 | Conducted, met standard |
| Limits of extractable metals | Pass ISO 7886-1 | Conducted, met standard |
| Printing Firmness | Pass ISO 7886-1 | Conducted, met standard |
| Tests per ISO DIS 80369-3 | ||
| Dimensional verification | Pass ISO DIS 80369-3 | Conducted, met standard |
| Positive pressure liquid leakage | Pass ISO DIS 80369-3 | Conducted, met standard |
| Stress cracking | Pass ISO DIS 80369-3 | Conducted, met standard |
| Resistance to separation from axial load | Pass ISO DIS 80369-3 | Conducted, met standard |
| Resistance to separation from unscrewing | Pass ISO DIS 80369-3 | Conducted, met standard |
| Resistance to overriding | Pass ISO DIS 80369-3 | Conducted, met standard |
| Disconnection by unscrewing | Pass ISO DIS 80369-3 | Conducted, met standard |
| For ENFit Connector | ||
| Risk Assessment (ISO 14971) | Compliant with ISO 14971 | Conducted, compliant |
| For ENFit Low Dose Tip | ||
| Low Dose Tip Misconnection Risk Management Reports | Addressed misconnection risks | Conducted, addressed risks |
| Usability Study for Low Dose Tip Design Feature | Usability validated | Conducted, validated |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For physical device testing against standards, specific sample sizes are typically defined within the test protocols associated with the ISO standards, but these details are not presented here. Data provenance is also not relevant in the context of these physical performance tests.
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 information is not applicable as this is a physical device, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on patient data. The "ground truth" here is compliance with engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this is a physical device, not an AI/ML diagnostic or prognostic tool.
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
This information is not applicable as this device is a physical enteral syringe, not an AI/ML system or a medical imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this device is a physical enteral syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the predefined requirements and specifications within the referenced ISO standards (ISO 10993-5, ISO 10993-10, ISO 7886-1, ISO DIS 80369-3, ISO 14971) and demonstrated through the physical performance and biocompatibility testing. In the case of the Usability Study, the "ground truth" would be the successful and safe use of the device by representative users.
8. The sample size for the training set
This information is not applicable as this is a physical device, not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is a physical device, not an AI/ML system.
§ 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.