(154 days)
The Giltech Plus Connecting Tube Sets will consist of: (a) Insufflation Tubing Sets (b) Suction / Irrigation Sets (c) Urinary Extension Tubing (d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.
Not Found
I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, or a study conducted to prove the device meets any criteria.
The document is an FDA 510(k) clearance letter for the "Giltech Plus Connecting Tube Set." This letter primarily:
- Confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976.
- Outlines general regulatory obligations for the manufacturer.
- Lists the "Indications For Use" for the device, which describes its intended functions and types of tubing sets included.
The document does not contain details about:
- Acceptance criteria or reported device performance.
- Sample size or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size or ground truth establishment for a training set.
§ 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.