(214 days)
The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.
The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end. The EnteraLoc Flow pouch is provided with a tamper evident cap. The pouch is designed to be pre-filled with liquid nutrition formula for tube feeding. EnteraLoc Flow is a single use device.
EnteraLoc Flow spouted pouch with ENFit® Connector is designed as a single use, over-the-counter device. The pouches will be available in a range of sizes, with a range of nutritional values (based upon the formula which the pouch is filled). Based upon the required nutritional intake requirements, the user will select the proper size pouch and quantity for feeding.
The provided document is a 510(k) premarket notification decision letter from the FDA regarding the "EnteraLoc Flow" device, which is an enteral nutrition dispensing pouch. The document details the device's indications for use, comparison to predicate devices, and a list of performance tests conducted.
However, the document does not contain the level of detail requested for the acceptance criteria and study that proves the device meets those criteria, particularly within the context of an AI/ML-based medical device. Specifically, it lacks information on:
- A table of acceptance criteria and reported device performance with specific quantitative metrics. The document lists types of tests (e.g., Flow Rate Analysis, Biocompatibility Testing, Performance Testing per ISO standards) but does not provide the pass/fail criteria or the actual results obtained.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance. This is explicitly an AI/ML-specific question, and the device described is a physical medical device, not an AI/ML diagnostic tool.
- Whether a standalone performance study was done (algorithm only without human-in-the-loop performance). Again, this is an AI/ML-specific question.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and various physical and biological performance tests relevant to a non-AI/ML medical device.
Therefore, it is impossible to extract the requested information from the provided text as it pertains to an AI/ML product's acceptance criteria and study details. The device in question, the "EnteraLoc Flow" spouted pouch with ENFit® Connector, is a physical device for dispensing enteral nutrition, not an AI/ML diagnostic or assistive tool. The questions are tailored for evaluating an AI/ML-based medical device.
§ 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.