(34 days)
The Through-The-PEG (TTP) Jejunal Feeding Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.
The TTP Jejunal Feeding Tube consists of a three-port device designed to be placed through a Boston Scientific gastrostomy tube to provide enteral access for decompression and delivery of nutrition and/or medication. The TTP Jejunal Feeding Tube Kit is available in two tip configurations, a pigtail tip and a bent tip. It may be placed by either the tether or guidewire techniques.
The provided text is related to a 510(k) submission for a medical device, the EndoVive™ Through-The-PEG (TTP) Jejunal Feeding Tube Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical study for a novel AI/software device.
Therefore, many of the requested categories (such as sample sizes for test and training sets, number of experts, adjudication methods, multi-reader multi-case studies, and ground truth types) are not applicable to this particular document as it does not describe an AI or software algorithm performance study.
Here's a breakdown of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (design, materials, manufacturing processes) | The proposed TTP Jejunal Feeding Tube Kit is similar in design, materials, and manufacturing processes to the predicate 3-Port TTP Jejunal Feeding Tube Kit (K072476). |
| Meeting required specifications for in-vitro tests | In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. |
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. The submission relies on substantial equivalence and in-vitro testing, not a clinical test set with human 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. Ground truth for a clinical test set is not discussed in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is not relevant to this type of device submission.
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
- No. This is not an AI-assisted device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this submission revolves around the product meeting its design specifications and demonstrating substantial equivalence to a predicate device, rather than a clinical ground truth.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth establishment described.
§ 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.