(85 days)
The Aspire Venting Tube is intended for use in adult patients who require gastric decompression.
The Aspire Venting Tube is a gastrostomy tube used to provide secured access to the stomach through the initial placement or a formed stoma. The tube is designed to facilitate decompression.
The provided document is a 510(k) premarket notification for a medical device called the "Aspire Venting Tube". This type of document is for demonstrating substantial equivalence to a predicate device, not typically for AI/ML device performance studies. As such, the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable to this document.
The document discusses "Performance Testing" for the device, but this refers to engineering and biocompatibility tests for the physical device itself, not performance of an AI/ML algorithm.
Specifically, the document states:
- "Performance Testing: Verification and validation of the Aspire Venting Tube to the product specifications and risk mitigation requirements demonstrate that the device is safe and effective for its intended use. Engineering testing, biocompatibility and sterilization validation have all been performed and successfully passed with all requirements met. The performance data detailed in the 510(k) submission demonstrate substantial equivalence to the predicated devices. The following is a list of testing performed: EtO Sterilization, Shelf Life (Accelerated, Real Time), Verification Testing (Bond Strength (Pull Test), Bumper Pull Through, Leak Test, Flow Test)."
- "Clinical Testing: Not applicable to this device."
Therefore, I cannot provide the requested information from this document because it pertains to a physical medical device and its predicate equivalence, not an AI/ML-driven diagnostic or treatment support system.
§ 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.