(112 days)
The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
To facilitate the interconnection between newly-released feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed enteral feeding tubes, the proposed device is designed with the mating component of an ENFit female connector, designed and tested in accordance with ISO 80369-3 and ISO 80369-20, at one of its ends, and the mating component of a non-ISO 80369-1 compliant funnel feeding port, a stepped tip connector, at its other end. It can prevent an interruption or delay in patient care by allowing fitment of enteral feeding sets with ISO 80369-3 compliant ENFit female connectors to existing enteral feeding tubes with non-ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports" which are still available for use in healthcare setting.
The proposed device is sterile or non-sterile device is sterilized by ethylene oxide to achieve a SAL 10- and supplied in sterility maintenance package which maintain the sterility of the device during the shelf life 5 years.
No DEHP, BPA and Natural Rubber Latex are added in the device.
The provided text is a 510(k) summary for the ENFit Adaptor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/ML device from this document.
The document discusses non-clinical tests to verify design specifications and compliance with various ISO standards for mechanical performance, biocompatibility, sterilization, shipping, and shelf-life of the physical adaptor. These tests are performed to demonstrate that the device itself is safe and effective as a physical connector, not as an AI-powered diagnostic or therapeutic tool.
For instance, the document mentions:
- Performance tests: Fluid Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Disconnection by Unscrewing, Connector Incompatibility Test, Materials Used for Small-bore Connectors, Dimensional analysis, Compatibility and Usability Test.
- Biocompatibility tests: Cytotoxicity, Irritation, Skin Sensitization.
- Sterilization, Shipping and Shelf-Life tests: Ethylene oxide sterilization residuals, seal leak detection, seal strength, seal integrity, Bacterial Endotoxins Test.
These are all physical and chemical property tests for a medical device connector, not performance metrics of an AI/ML algorithm.
§ 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.