(40 days)
AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.
The Aquarius™ Extension Feeding Set comprise from the hollow Tube with Connector and Funnel at the ends. The Funnel connects to delivery source of nutrition and the Connector connects to a gastric feeding device. The Aquarius™ Extension Feeding Set is compatible with Aquarius™ Gastrostomy Button (G-Button) and any castric feeding device with Mc-Key™ connection ring. A device is for single patient use only.
This document describes a Special 510(k) submission for the AQUARIUS™ Extension Feeding Set, focusing on its non-clinical summary. The submission asserts that the device is substantially equivalent to a predicate device (K132686).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance (Test Results) | Studied Device Component | Standard Reference |
|---|---|---|---|
| Biocompatibility: | |||
| Non-cytotoxic | Demonstrated toxicological safety | Proposed device | ISO 10993-5 |
| Non-irritating | Demonstrated toxicological safety | Proposed device | ISO 10993-10 |
| Non-sensitizing | Demonstrated toxicological safety | Proposed device | ISO 10993-10 |
| Functional Performance: | |||
| Adequate Tensile Strength | Compliance with performance specification | Not specified (likely entire device) | Not specified |
| Adequate Flow Rate | Compliance with performance specification | Not specified (likely entire device) | Not specified |
| No Leakage | Compliance with performance specification | Not specified (likely entire device) | Not specified |
| Safety Connectors: | |||
| Non-compatibility with female luer connectors | Demonstrated non-compatibility | Proposed device | ISO 80369-1, Annex B |
| Non-compatibility with other intravenous sets | Demonstrated non-compatibility | Proposed device | AAMI/ANSI ID54 |
2. Sample Size and Data Provenance for Test Set
The document does not provide specific sample sizes for each test mentioned (e.g., number of devices tested for tensile strength, flow rate, leakage, or biocompatibility tests). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective. The non-clinical summary suggests these were laboratory-based tests conducted on the proposed device.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
This study involves non-clinical (laboratory) testing, not assessments that require human expert interpretation of results to establish ground truth in the way medical imaging or diagnostic tests do. Therefore, the concept of "experts used to establish ground truth" with specific qualifications (like radiologists) is not applicable here. The ground truth is established by the objective measurements and observations against pre-defined engineering and safety standards.
4. Adjudication Method for Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., when multiple readers assess images and their opinions need reconciliation). As this is a non-clinical, laboratory-based study focusing on device performance and safety, an adjudication method is not applicable. The results are based on direct measurements and adherence to specified standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This device is an extension feeding set, and the evaluation is based on its physical properties, biocompatibility, and functional performance, not on diagnostic accuracy requiring human interpretation or comparison with AI assistance.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was conducted. This is a medical device (hardware), not an algorithm or AI software. Therefore, this section is not applicable.
7. Type of Ground Truth Used
The ground truth used in these non-clinical studies is based on:
- Standardized Test Methods and Criteria: These are established by international and national standards such as ISO 10993-5, ISO 10993-10, ISO 80369-1 Annex B, and AAMI/ANSI ID54.
- Objective Measurements: Results are derived from quantitative and qualitative measurements (e.g., tensile strength values, flow rates, visual inspection for leakage, assays for cytotoxicity, irritation, sensitization, and physical connection tests for compatibility).
- Compliance with Specifications: The device's performance is compared directly against pre-defined engineering and safety specifications derived from the predicate device and relevant standards.
8. Sample Size for the Training Set
This product is a physical medical device. The concept of a "training set" is typically associated with machine learning algorithms. Therefore, a training set as understood in that context is not applicable. The device's design and manufacturing processes are likely informed by prior engineering knowledge and predicate device characteristics, but there isn't a "training set" in the AI sense.
9. How Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI algorithm, the method for establishing its ground truth is not applicable. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, regulatory requirements, and the performance characteristics of the predicate 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.