(245 days)
The Device is intended for introduction into the Naris (Nostril) and is is used in the introduction of various commercial or compounded enteral diets to appropriate sites along the Ailimentary tract of the patient.
The subject devices are weighted or unweighted, thermoplastic or elastomer tubes. The distal outlet of the tube may be closed in a spherical tip or opened and polished to facilitate passage through the mucosal tissues of the nose or esophagus. A series of side outlets may be perforated through the side wall of the tubing to allow for dispersion of the enteral diet around the distal end of the tube. A stainless steel stylet may or may not be included with the product for aid in placement
This is a 510(k) summary for a medical device submitted to the FDA, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and a study proving those criteria are met in the way a structured clinical trial or performance study would.
Instead, this document focuses on establishing substantial equivalence to a predicate legally marketed device. The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device.
Here's an attempt to answer your questions based on the provided text, recognizing the limitations of this type of submission:
1. A table of acceptance criteria and the reported device performance
This document does not present explicit "acceptance criteria" in a quantitative, measurable format like a performance study might (e.g., "device must achieve sensitivity of X%"). Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
The "reported device performance" is essentially that the device is "equivalent in design and construction" to the predicate.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Device's intended use must be the same as the predicate. | "The device is intended for introduction into the naris (nostril) and is used in the introduction of various commercial and/or compounded enteral diets to appropriate sites along the alimentary tract of the patient." (Identical to predicate's likely intended use). |
| Technological Characteristics: Device must have similar technological characteristics to the predicate, or any differences must not raise new questions of safety or effectiveness. | "The device is equivalent in design and construction to the Entech Enteral Feeding Tube. It comes in a range of sizes from 6 to 20FR and from 6" to 72" in length." |
| Safety and Effectiveness: Implied to be at least as safe and effective as the predicate device. | Not explicitly stated with performance metrics, but assumed through the claim of equivalent design and construction and the FDA's clearance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. This document does not describe a performance or clinical study with a "test set" of patient data. It is a submission for regulatory clearance based on substantial equivalence.
- Data provenance: Not applicable.
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 ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described.
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 an enteral feeding tube, not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an enteral feeding tube, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No patient data or ground truth determination is described in this 510(k) summary. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not a machine learning or AI device 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.