(87 days)
The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector is intended to deliver liquid nutrition formula to an enteral access device (a feeding tube).
The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end and a hanging ring at the other. A silicone valve is mounted in the inner lumen of the connector to reduce the risk of formula leakage. The outer lumen (spout) of the ENFit® connector is covered with a foil tamperevidence seal. The pouch is designed such that it can be provided pre-filled with Trovita Health Science acidified liquid nutrition formula for tube feeding.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically the Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector.
The request asks for information typically found in studies for AI/machine learning diagnostic devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance). However, the provided document does not describe an AI/machine learning device. Instead, it concerns a physical medical device used for delivering liquid nutrition.
Therefore, the requested information (acceptance criteria for an AI device, study design, expert involvement, etc.) cannot be extracted from this document as it pertains to a different type of medical device and regulatory process.
The document discusses "performance data" (Section 6.6) for the physical device, including:
- Risk Analysis (FMEA)
- ENFit® Connector Dimensional Analysis
- Flow Rate Analysis
- Valve Performance Testing
- Performance Testing per ISO 80369-3:2016 (e.g., Falling Drop Positive Pressure Liquid Leakage, Stress Cracking, Resistance to Separation)
- Biocompatibility Testing per ISO 10993-1:2009 (Cytotoxicity, Irritation/Intracutaneous Reactivity, Sensitization)
- Human Factors and Usability Validation
- Packaging and Shipping Testing
These are engineering and material performance tests for a physical product, not clinical validation or AI model performance studies.
Therefore, I cannot fulfill your request based on the provided input. The information you are asking for (acceptance criteria and study details for an AI-powered diagnostic device) is not present in this regulatory document about a medical nutrition delivery pouch.
§ 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.