(274 days)
The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.
Not Found
The provided FDA document, K220165, describes a premarket notification for an Enteral Transition Adaptor. This device is a component of a medical system and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving device meets acceptance criteria" as it relates to performance metrics for AI/ML algorithms, ground truth establishment, training/test sets, expert adjudication, or comparative effectiveness studies with human readers, does not apply to this regulatory submission.
The FDA 510(k) clearance process for devices like the Enteral Transition Adaptor focuses on establishing substantial equivalence to a predicate device. This typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness.
The document states:
- Trade/Device Name: Enteral Transition Adaptor
- Regulation Number: 21 CFR 876.5980
- Regulation Name: Gastrointestinal tube and accessories
- Regulatory Class: Class II
- Product Code: PIO
- Indications for Use: The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.
Therefore, the standard questions related to acceptance criteria and studies for AI/ML performance (such as those outlined in your prompt) are not applicable here. The "study" proving the device meets acceptance criteria would be a demonstration of its compatibility and fit with the specified connectors, and its adherence to relevant standards for medical device accessories, rather than a performance study involving diagnostic accuracy.
§ 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.