(58 days)
The Medline ENFit OTC Feeding Syringe is intended for Over-The-Counter use to measure and administer enteral nutrition.
The device that is the subject of this submission is the same device as the Medline ENFit Syringe cleared under K160642, but rather than being intended for prescription use only, is instead intended for over-the-counter use. The Medline ENFit OTC Feeding Syringe (the subject device) is a standard piston syringe which incorporates a female ENFit connector designed to interal access devices (i.e. feeding tubes) and ENFit compatible enteral feeding extension sets. The design consists of a polypropylene barrel and plunger rod, a polyisoprene plunger seal or stopper, an ISO 80369-3 compliant female ENFit connector, and a threaded cap. The Medline ENFit OTC Feeding Syringe is available in one size (60mL) and will be sold as a single use, non-sterile device.
The provided document pertains to a 510(k) premarket notification for a medical device, the "Medline ENFit OTC Feeding Syringe." This submission focuses on expanding the intended use of an already cleared device (Medline ENFit Syringe, K160642) to include Over-The-Counter (OTC) use.
The document does not describe an AI/ML-based medical device and therefore does not contain information related to acceptance criteria, study design, ground truth establishment, or performance for such a device. The tests performed are standard for physical medical devices like syringes (biocompatibility, mechanical performance, stability, and usability for OTC labeling).
Therefore, I cannot extract the requested information about acceptance criteria, study that proves the device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types and establishment methods, as these details are not relevant or present in the context of this traditional medical device submission.
§ 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.