(108 days)
The Aquarius™ Nasal Feeding Tubes, /Nasogastric & Nasojejunal / provide nutritional support for patients who require liquid feedings as a substitution for solid food. Intended for enteral administration of nutrients. fluids and/or medications into alimentary tract via natural nasoenteric route.
The Aquarius™ Nasogastric Tubes are for the administration of nutrition. fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Nasogastric feeding tube is designated for patients who require intermittent or continued feeding/and or medication into the stomach.
The Aquarius™ Nasojejunal Feeding Tubes are for the administration of . nutrition, fluids and/or medications by the natural naso-enteric route for the patients who are physically unable to ingest enough nutrients through normal mastication and deglutition. Designated for patients who are critically ill and require early enteral feeding/and or medication into the small intestine; may be with a dual tube allowing simultaneous gastric drainage.
The Aquarius™ Nasal Tube / Nasoqastric Tube (NG-Tube) & Nasojejunal Tube (NJ Tube) / are enteral feeding tubes comprised of flexible tubes and ENFit enteral specific connection access. The tubing part of the devices is constructed with radiopaque polyurethane material and with a hydrophilic coating at the distal end to assist the easy insertion of the tube. The Nasogastric Tube may be with metal stylet and/ or with weighted tip to assist the tube insertion and to maintain the tube in the place. The Nasoieiunal Tube is with stylet and with radiopaque polyurethane antenna tip at the distal end of the tubing to assist to advance the tube into the jejuna. There is an external marking on both NG & NJ-Tubes for measuring of the tube length inserted into the alimentary tract.
This document describes the Aquarius™ Nasal Feeding Tubes (Nasogastric & Nasojejunal) and their substantial equivalence to predicate devices, based on nonclinical testing. It does not contain information about studies proving the device meets acceptance criteria or details regarding human reader performance, AI-assistance, or ground truth establishment for AI/ML-based devices.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted, implying these tests serve as acceptance criteria. However, explicit numerical acceptance criteria and the quantitative reported performance for each are not provided in this document. Instead, it states that the device was "found to be in compliance with the design and performance requirements."
| Acceptance Criteria (Implied from Tests Performed) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-5, -10, -6, -11, -3) | Found to be in compliance |
| Leakage testing | Found to be in compliance |
| Stress Cracking | Found to be in compliance |
| Resistance to separation from axial load | Found to be in compliance |
| Resistance to separation from unscrewing | Found to be in compliance |
| Resistance to overriding | Found to be in compliance |
| Disconnection by unscrewing | Found to be in compliance |
| ENFIT dimensional verification | Found to be in compliance |
| Flow rate testing | Found to be in compliance |
| Device dimensional verification | Found to be in compliance |
| Tensile testing | Found to be in compliance |
| Tubing resistance to kinking | Found to be in compliance |
| Misconnection testing | Found to be in compliance |
| Risk Analysis (ISO 14971:2012) | Found to be in compliance |
2. Sample Size Used for the Test Set and Data Provenance:
This document summarizes nonclinical testing. It does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for the tests conducted. These tests are typically performed on physical samples of the device, not patient data in the context of an AI/ML device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the document describes nonclinical, physical device testing, not an AI/ML study requiring expert ground truth for patient data.
4. Adjudication Method for the Test Set:
This information is not applicable as the document describes nonclinical, physical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This document describes the 510(k) premarket notification for a physical medical device (feeding tubes), not an AI/ML-driven diagnostic or assistive system that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance study was not done. This is not an AI/ML device.
7. The Type of Ground Truth Used:
The "ground truth" for the nonclinical tests would be the established engineering specifications and international standards (e.g., ISO 80369-1:2010, EN1615:2000, ISO 10993 series, ISO 14971:2012). The device's physical properties and performance during these tests are compared against these predetermined specifications.
8. The Sample Size for the Training Set:
This information is not applicable as this is not an AI/ML device and therefore does not have a training set in that context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as this is not an AI/ML device.
§ 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.