(257 days)
The Disposable 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 feeding syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
The proposed device is a disposable enteral feeding syringe provided in a variety of size from 1ml-60ml (1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 30ml, 50ml and 60ml). The device is composed by barrel with ENFit connector, piston (plunger and plunger stopper), lubricant and tip cap (with or without). The piston is made of polyisoprene synthetic rubber, without DEHP or natural latex. This device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit connector. They are two types of syringe: Side connector ENFit syringe and central connector ENFit syringe. The size of the central connector ENFit syringes range from 1ml to 5ml, and they are the low dose tip syringes; and side connector ENFit syringes range from 10ml to 60ml, and they are the standard syringes. The Disposable Enteral Feeding Syringe with Enfit Connector relies on the interference matching between piston and inner chamber wall of the barrel to ensure the sealing of liquid in the inner chamber of the barrel. The plunger and the plunger stopper constitute a sealing assembly. By pushing and pulling the plunger, the plunger stopper can be driven to move freely inside the barrel, similar to the piston structure, so as to realize the suction and infusion of fluid. The proposed syringe is sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 ° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf of five years.
The provided text is a 510(k) Premarket Notification for a Disposable Enteral Feeding Syringe with Enfit Connector. It details the device, its intended use, comparison to a predicate device, and performance data to support substantial equivalence.
However, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, ground truth, etc., particularly in the context of an AI/human-in-the-loop study) is not present in this document.
This document describes a medical device, which is a physical product (a syringe), and not a software device or an AI/ML algorithm that would typically involve the type of study details you are asking for. The performance data presented (biocompatibility, sterilization, shelf life, and bench performance testing like connector and syringe testing) are standard for physical medical devices and do not involve AI assistance, human readers, or image interpretation.
Therefore, I cannot provide the requested information based on the given input.
Reasoning for lack of information:
- Device Type: The device is a "Disposable Enteral Feeding Syringe with Enfit Connector," a physical medical device. The types of acceptance criteria and studies you're asking about (MRMC, human readers, AI assistance, ground truth for training sets) are typically relevant for AI/ML-enabled medical devices, often in diagnostic imaging or other data interpretation fields.
- Study Types Mentioned: The studies mentioned are:
- Biocompatibility testing (ISO 10993)
- Sterilization testing (ISO 11135)
- Shelf life testing (accelerated aging)
- Bench performance testing (ISO 80369-3, ISO 80369-20, ISO 7886-1)
- No clinical studies were deemed necessary due to substantial equivalence to a predicate device, and certainly no studies involving AI or multi-reader interpretations.
If you have a document describing an AI/ML medical device, I would be happy to analyze it against your criteria.
§ 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.