(113 days)
The Andersen® Nasogastric Tube is indicated in those situations where the physician desires to keep the stomach continuously and completely evacuated of swallowed air, swallowed saliva, gastric secretions or fresh blood in a fasting patient for a prolonged period, such as pancreatitis. cholecyctitis, post-operative ileus and non-operative management of peptic ulcer. It is also indicated to keep the stomach evacuated of fresh blood once clots have been removed.
Sterile, disposable, bilumenal, medical grade vinyl nasogastric tube with radiopaque vent tube, 24 round aspirating ports, and anti-reflux filter. Includes a lubricated polyethylene stylet. The tubes are marked to aid in positioning the tube during passage.
The provided text describes a 510(k) summary for the Andersen® Nasogastric Tube with Stylet, which is a medical device. This document is a regulatory submission for premarket notification to the FDA. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the way one might expect for a software or AI-driven device.
Therefore, many of the requested points related to AI performance, sample sizes for training/test sets, expert adjudication, and ground truth establishment are not applicable to this type of device and submission.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| New Risks Added | "No new risks were added by the modification." (This is more a statement of compliance with safety, rather than a quantifiable performance criterion.) |
| Safety and Effectiveness | "Based on the indications for use and comparison to its predicate device, the Andersen® Nasogastric Tube with Stylet has been shown to be safe and effective for its intended use." (This is a conclusion based on substantial equivalence claim, not specific performance metrics.) |
| Design Control Compliance | "Andersen Products, Inc. has provided a declaration of conformity to 21 CFR § 820.30 Design Control requirements." (This is a regulatory compliance criterion, not a performance metric.) |
| Substantial Equivalence | The device was found substantially equivalent to the predicate device Andersen® Nasogastric Tube with Stylet (AN 10S), K935688. This is the primary "acceptance criterion" for a 510(k). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a traditional medical device (nasogastric tube), not a device that processes data or uses AI. The submission relies on a comparison to a predicate device and a declaration of conformity to design controls, not on a clinical test set with associated data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no test set data requiring ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as there is no AI component involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as there is no algorithm or AI component involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no ground truth data is established or used in this type of submission for this device. The regulatory pathway is based on substantial equivalence to a legally marketed predicate, meaning it asserts that the new device is as safe and effective as the existing one.
8. The sample size for the training set
Not applicable, as there is no AI component requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no AI component and therefore no training set with ground truth.
§ 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.