(15 days)
The Safety Trocar Cannula is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (percutaneous Endoscopic Gastrotomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.
The Safety Trocar Cannula is a sterile, single used for guidewire introduction during a gastrointestinal procedure. The device consists of a safety trocar with passive sharps protection and a cannula.
During a gastrointestinal procedure requiring access via a guidewire, the device is inserted into the stomach under direct visualization via an endoscope. Once inserted, the safety trocar is removed from the cannula that provides smooth surface for the needle to slide out during removal as well as a lumen to facilitate guidewire introduction. The passive safety feature of the proposed Safety Trocar Cannula is activated when the safety trocar is separated from the cannula.
The provided text describes a 510(k) premarket notification for a medical device called "Safety Trocar Cannula." It details the device's intended use, technological characteristics, and evidence for substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving that a device meets those acceptance criteria in the context of an AI/ML algorithm.
The document is for a physical medical device, specifically a "Safety Trocar Cannula," and the performance data presented is for benchtop testing, biocompatibility, and sterilization testing of this physical device. It does not involve any artificial intelligence, machine learning, or software-driven diagnostic capabilities that would require the kind of performance evaluation requested in the prompt.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.
The information provided in the document is about the physical device itself.
§ 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.