(179 days)
The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector are intended for enteral feeding to deliver enteral nutrition, liquid or medication to patient from an enteral feeding syringe or feeding set designed with a connector for enteral applications.
The device is intended for pediatric patients who require enteral feeding.
The Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit Connector are sterile, disposable medical devices designed to deliver nutrition to patients who cannot obtain nutrition by mouth, are unable to chew or swallow safely, or need nutritional supplementation. The device is designed with a single lumen Polyvinyl Chloride (PVC) or Polyurethane (PU) tubes with ENFit male small bore connector at proximal end.
The provided text is a 510(k) premarket notification for a medical device (feeding tubes) and does not contain information about the acceptance criteria and study proving a device meets acceptance criteria in the context of an AI/ML algorithm or software validation. The document describes the substantial equivalence of new feeding tubes with an ENFit connector to previously marketed predicate devices, focusing on manufacturing, materials, and physical properties.
Therefore, I cannot extract the information required by your request, as it pertains to a different type of device validation (e.g., for AI models) than what is described in this regulatory filing.
Specifically, the document does NOT contain:
- A table of acceptance criteria and reported device performance for an AI/ML system.
- Information on sample size, data provenance, number/qualifications of experts, or adjudication methods for a test set in the context of AI/ML validation.
- Details on MRMC comparative effectiveness studies or standalone AI performance.
- The type of ground truth used (expert consensus, pathology, outcomes data) in an AI context.
- Training set details (sample size, ground truth establishment) for an AI model.
The "Nonclinical testing" section primarily discusses bench testing for physical aspects of the feeding tubes (biocompatibility, stability, dimensional analysis, fluid leakage, tensile strength, etc.) and risk assessments related to the ENFit connector. The "Clinical testing" section explicitly states: "Clinical evaluations were not relied upon for the determination of substantial equivalence to the predicate device based on the device classification, sufficient safety and functional performance information provided in the 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.