(262 days)
The Low Profile Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. The Low Profile Balloon Feeding Device is intended for all age groups.
The Low Profile Balloon Feeding Device is used to provide nutrition, medication, and decompression access into the stomach through a secured (initial placement) or formed (replacement) stoma. The Low Profile Balloon Feeding Device consists of an external bolster, feeding catheter, and internal retention balloon, similar to the predicate devices. The feeding catheter is inserted into the stomach through a stoma and is held in place with an internal retention balloon. The device can have an MR Conditional balloon fill-valve or will be MR Safe when assembled with the Invisi-Valve. The devices are provided in a number of sizes to accommodate different stoma diameters and lengths and can have either a blunt or tapered tip balloon. The catheter tubes range in diameter from 10Fr to 24Fr, which is the same as the primary predicate. The stoma lengths are available in a wider range of options, from 0.5cm to 10.0 cm.
The provided text describes a 510(k) submission for a "Low Profile Balloon Feeding Device" and does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
The document is a traditional medical device submission (K161413) to the FDA, demonstrating substantial equivalence to predicate devices, rather than an AI/ML device requiring performance evaluation against specific metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the requested information (points 1-9) which are relevant to AI/ML device studies. The document focuses on:
- Device Description: What the device is and how it works.
- Intended Use: The medical purpose of the device.
- Technological Characteristics: Materials, sizes, and features.
- Biocompatibility Testing: Ensuring the materials are safe for patient contact, detailed with ISO standards used.
- Performance Testing: Bench tests to confirm the physical integrity and function of the device components, such as balloon burst strength, pullout strength, and flow rates.
- Substantial Equivalence: Comparison to existing devices on the market.
None of these sections discuss AI/ML models, algorithms, or their 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.