(222 days)
To permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril.
The Knott NG tube is designed to permit withdrawal or introduction of fluids through a tube which is inserted through the nostril and into the stomach.
The provided document is a 510(k) premarket notification for the "Knott Nasogastric Tube," seeking clearance based on substantial equivalence to a predicate device. It is not a study reporting device performance against acceptance criteria in the manner typically associated with clinical trials or diagnostic algorithm evaluations.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication, and comparative effectiveness (MRMC) or standalone studies cannot be extracted from this document because such studies were not conducted or reported for this type of device submission.
This document focuses on demonstrating substantial equivalence in design, materials, and intended use as per FDA 510(k) requirements, not on presenting performance data from a clinical study with predefined acceptance criteria.
However, I can extract the following relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" for performance in a quantitative sense as would be found in a clinical trial evaluating a novel diagnostic or therapeutic device. Instead, it compares the attributes of the proposed device to a predicate device to establish substantial equivalence.
| Attribute | Acceptance Criteria (based on predicate device) | Reported Device Performance (Knott NG Tube) |
|---|---|---|
| Provided in various diameters | Yes (like predicate) | Yes |
| Double lumen tube | Yes (like predicate) | Yes |
| One lumen for suction or fluids / one for venting | Yes (like predicate) | Yes |
| Connects to various vacuum sources | Yes (like predicate) | Yes |
| Tip has various holes leading to each lumen | Yes (like predicate) | Yes |
| May be packaged with reflux valve | Yes (like predicate) | Yes |
| Tubing has marking for assisting clinician | Yes (like predicate) | Yes |
| Pre-formed tip to help with insertion and advancement | Yes (like predicate) | Yes |
| Made of PVC | Yes (like predicate) | Yes |
| Provided sterile | Yes (like predicate) | Yes |
| Performance Standards/Specification applicable under Section 514 | None applicable (like predicate) | None applicable |
2. Sample sized 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 510(k) premarket notification for a medical device (nasogastric tube), not a study involving a test set of data or human subjects for performance evaluation in the described manner. The submission relies on a comparison to a legally marketed predicate device.
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. No "test set" or "ground truth" in this context as it's not a diagnostic or AI-based device performance study.
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. This device is not an AI-assisted diagnostic tool, and no MRMC study was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "proof" of meeting criteria for this device is based on demonstrating substantial equivalence to a legally marketed predicate device through comparison of attributes (design, materials, intended use), rather than clinical performance against a ground truth.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied for this device's submission.
9. How the ground truth for the training set was established
Not applicable.
§ 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.