(46 days)
Enteral Feeding Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians in all age groups.
The proposed device, Enteral Feeding Syringes with ENfit Connectors, is provided sterile, single use. It has 3 components: (1) barrel, (2) plunger, and (3) piston. The Enteral Feeding Syringes with ENfit Connectors is available in various size, including 1ml, 2.5ml, 5ml, 10ml, 20ml, 60ml and 100ml. In addition, it contains low dose enteral specific connectors. The Enteral Feeding Syringes with ENfit Connectors is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
The provided text describes a 510(k) summary for Enteral Feeding Syringes with ENFit Connectors, which are medical devices, not AI/ML-driven software. Therefore, the questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device are not applicable to this document. The document details the substantial equivalence of the proposed device to a predicate device based on non-clinical tests and conformance to established standards.
Here's an analysis of the provided information, focusing on the device's conformity to standards rather than AI-specific criteria.
Device: Enteral Feeding Syringes with ENFit Connectors
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria for this medical device are based on compliance with several ISO standards and specific performance tests. The device's reported performance demonstrates compliance with these standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | Complies with the standard |
| ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications | Complies with the standard |
| ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods | Complies with the standard |
| ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | No Cytotoxicity |
| ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | No Irritation to Skin, No significant evidence of sensitization |
| Dimension analysis | Complies with requirements |
| Dosing accuracy test | Complies with requirements |
| Connector incompatibility test | Complies with requirements |
| Sterilization Assurance Level (SAL) | 10⁻⁶ (EO Sterilized) |
| Endotoxin Limit | 20 EU per device |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test conducted. It states that "Non clinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data is from in-house non-clinical testing performed by Jiangsu Kangbao Medical Equipment Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is not an AI/ML system requiring expert-established ground truth for a test set. The validation relies on technical specifications and international standards, which are evaluated by engineers and quality control personnel.
4. Adjudication method for the test set
This question is not applicable as there is no mention of a human-based adjudication process for the non-clinical tests described. Compliance is determined by adherence to established measurement and testing protocols defined by the ISO standards.
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 question is not applicable as the device is not an AI/ML system, and no human readership studies are referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" for non-clinical performance and safety is defined by the established international standards (ISO standards) and engineering specifications. For biocompatibility, this is determined by laboratory tests for cytotoxicity, irritation, and sensitization as per ISO 10993. For sterilization, it's about achieving a specific SAL.
8. The sample size for the training set
This question is not applicable as the device is not an AI/ML system and does not involve a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is not an AI/ML system and does not involve a training set.
§ 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.