(78 days)
NeoConnectTM Enteral Syringe with ENFit™ Connector:
The device is indicated for use as a dispenser, a measuring 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) in all age groups.
NeoConnect™ NeoSecure™ Tip Cap:
A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.
The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector are standard piston style syringes consisting of a syringe barrel with an integral ENFit™ syringe tip, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 0.5 mL to 100 mL nominal capacity. The integral syringe tip is a female ENFit™ connector which is compatible only with enteral access devices having ENFit™ male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.
The NeoConnect™ NeoSecure™ Tip Cap is supplied with the NeoConnect™ Enteral Syringe with ENFit™ connector or sold separately (sterile or non-sterile). It is an ENFit™ compatible closure cap for the tip of the syringe.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification letter and a summary for an enteral syringe and tip caps. It discusses substantial equivalence to predicate devices and lists various performance tests conducted. However, it does not provide acceptance criteria, reported device performance in a comparative table, details about specific study designs (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or information about MRMC comparative effectiveness studies or standalone algorithm performance.
§ 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.