(216 days)
The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile is a single use, sterile, naso-gastric double balloon tube that can be passed nasally or orally into the stomach suitable for use in the management of bleeding esophageal varices.
The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile consists of a radiopaque (BaSO2) soft red rubber tube which is rounded and sealed at the distal end and belled out to form a funnel at the proximal end. Four elongated eyes are cut in the tube between the distal end and the cuffs. Two SILKOLATEX™ cuffs are inflated via separate color identified funnels using any Luer syringe; pilot balloons are provided to indicate cuff inflation. A fourth lumen is provided for suctioning of saliva from just above the esophageal cuff.
I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Rüsch Blakemore Tube - 4 Lumen), and it primarily focuses on establishing substantial equivalence to a predicate device. This type of submission, popular prior to the mid-2010s, does not typically include detailed information on acceptance criteria, a standalone study, or the comprehensive data provenance and expert adjudication methods that would be present in a submission for an AI/ML-powered device.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and reported device performance: This document does not specify any performance acceptance criteria or report results of a performance study. Its focus is on demonstrating equivalence based on materials, manufacturing, and intended use.
- Sample size and data provenance for the test set: No information on a test set, sample size, or data origin is provided as no performance study is described.
- Number of experts and their qualifications for ground truth: No ground truth establishment is described.
- Adjudication method for the test set: Not applicable as no test set or adjudication is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study. This is a traditional medical device, not an AI/ML product where such studies are common.
- Standalone algorithm-only performance: The device is a physical tube, not an algorithm.
- Type of ground truth used: Not applicable as no ground truth is established or discussed.
- Sample size for the training set: Not applicable as no training set is relevant to this device.
- How the ground truth for the training set was established: Not applicable as no training set is relevant to this device.
The document is a regulatory submission for a physical medical device, not software or an AI/ML product. The regulatory pathway in 1998 was based on demonstrating substantial equivalence to a predicate device, which did not typically involve the type of performance studies and detailed data analysis commonly required for AI/ML devices today.
§ 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.