(23 days)
The Monoject™ Enteral 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, either orally or enterally, into the gastrointestinal system of a patient. The orallenteral 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.
Not Found
This document is an FDA 510(k) clearance letter for the Monoject™ Enteral Syringe with ENFit Connector. It does not contain any information regarding acceptance criteria or a study proving that a device meets those criteria for software or AI/ML-enabled devices.
The letter is a regulatory document indicating that the FDA has determined the device to be substantially equivalent to a legally marketed predicate device. This process primarily focuses on comparing the new device's intended use, technological characteristics, and safety and effectiveness to an existing, legally marketed device.
Therefore, I cannot provide the requested information from this document. The document discusses regulatory aspects like:
- Trade/Device Name
- Regulation Number and Name
- Regulatory Class
- Product Code
- Indications for Use
- General controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, misbranding, adulteration)
- Quality System (QS) regulation requirements
- Unique Device Identification System (UDI Rule)
- Medical Device Reporting (MDR)
- Contact information for the FDA.
However, none of these sections detail acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications as typically provided for AI/ML device submissions.
§ 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.