(214 days)
Tamper Evident Cap For use with ENFit® Syringes is indicated for use to prevent fluid loss and contamination of syringe contents until ready for use with evidence of access.
Tamper Evident Cap For use with ENFit® Syringes is a sterile, single use disposable device for use as a closure cap with evidence of access for Enteral Syringes with ENFit™ Connectors. Removal of the cap is achieved by removing a restrictive sleeve covering the ENFit™ Lock Cap. A damaged or missing restrictive sleeve indicates potential tampering. A non-sterile version of the device is also offered.
The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (Tamper Evident Cap For use with ENFit® Syringes) and focuses on demonstrating substantial equivalence to a predicate device.
Specifically, the document lists various performance bench tests that were conducted (Liquid Leakage, Stress Cracking, Resistance to Separation from Axial Load, etc., as per AAMI/ISO 80369-3, and additional internal specifications like Visual Indication of Tamper Evidence). However, it does not provide specific acceptance criteria values or the reported performance data in a tabular format as requested. It only states that the device "meets the bench testing requirements" and "passed all biocompatibility tests."
Therefore, I cannot populate the requested table or provide details on sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information.
§ 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.