(257 days)
AQUARIUS™ Enternal Extension Set is intended for use as an extension set for AQUARIUSTM G-button' or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an intravenous therapy system to the enteral system, or the enteral system to intravenous therapy system.
Not Found
This FDA 510(k) clearance document for the AQUARIUS™ Enternal Extension Set is a premarket notification, indicating substantial equivalence to a predicate device. It does not include detailed information on acceptance criteria or the specific studies performed to demonstrate performance.
Therefore, the requested information cannot be fully extracted from the provided text. The document primarily focuses on regulatory approval based on equivalence and administrative details.
Here's what can be stated based on the provided text, and what cannot:
What can be extracted:
- Device Name: AQUARIUS™ Enternal Extension Set
- Regulatory Class: II
- Product Code: KNT
- Indication for Use: "AQUARIUS™ Enternal Extension Set is intended for use as an extension set for AQUARIUSTM G-button' or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an intravenous therapy system to the enteral system, or the enteral system to intravenous therapy system."
- Type of Use: Prescription Use
What cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance: This document is a regulatory approval letter, not a detailed study report. It states that the device is "substantially equivalent" to a legally marketed predicate device, but does not provide specific performance metrics or acceptance criteria for that equivalence.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method: Not available.
- 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 is not an AI device or an imaging device requiring reader studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used: Not available. The clearance is based on substantial equivalence, implying performance similar to a predicate device, but the specific "ground truth" for the current device's testing is not detailed here.
- The sample size for the training set: Not applicable. This is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.
Conclusion:
The provided document is a 510(k) clearance letter from the FDA. It confirms that the AQUARIUS™ Enternal Extension Set is substantially equivalent to a predicate device for its stated indications for use. However, it does not contain the detailed technical or clinical study data, including acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert qualifications, that would typically be found in a study report. This kind of detailed information is part of the 510(k) submission, but not part of the publicly released clearance letter.
§ 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.