(73 days)
The Initial Placement PEG is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.
The EndoVive Standard Percutaneous Endoscopic Gastrostomy (PEG) Kit with ENFit and Safety PEG Kit with ENFit are single-use, sterile, disposable kits. These kits contain a feeding tube, accessories used during initial placement of the tube, and accessories used after placement to aid in the provision of nutrition and medication directly into the stomach of adult and pediatric patients who are unable to consume nutrition by conventional means. In addition to the accessories packaged with the kits, replacement Y-Ports, c-clamps and round external bolsters are also available separately.
The Y-Port accessory, which is attached to the external end of the feeding tube to allow connection with other enteral feeding devices, is being modified to comply with the new ISO/DIS 80369-3.2 standard requirements to reduce the risk of misconnection with non-enteral feeding devices. The change to the Y-Port is to add the ISO/DIS 80369-3.2 ENFit thread design and to manufacture it in a more rigid material. Neither the feeding tube nor the accessories used for tube placement within these kits is changing. Other than the Y-Port, all other accessories in the Standard and Safety PEG Kits with ENFit are identical to the predicates.
The provided text describes a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML powered medical device. The document pertains to a traditional medical device (Gastrointestinal tube and accessories) and focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing of physical characteristics and compliance with established standards (e.g., ISO for connectors and biological evaluation).
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML powered medical device. The document does not discuss:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI model metrics.
- Sample size, data provenance, or ground truth establishment for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- Ground truth establishment for a training set.
The "Performance Data" section lists various standards to which the device was tested (e.g., biological evaluation, sterilization residuals, small bore connectors), and bench tests like "Resistance to separation from unscrewing," "Tensile strength," "Liquid leakage," and "Flow rate." These are physical and functional performance criteria for a mechanical device, not AI/ML performance metrics.
§ 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.