(228 days)
The Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port is indicated for use in an established gastrostomy tract as a replacement tube for the administration of nutrition, fluids, and medications to the stomach of a patient, 2 years and older, that are physically unable to manage nutritional intake through normal mastication and deglutition.
The Kangaroo™ Gastrostomy Feeding Tube is a silicone qastrostomy tube with a balloon retention device located at the tip of the tube. An external skin disc is provided on the outer lumen of the device and is used in conjunction with the balloon to provide a secure retention system for the Kanqaroo™ Gastrostomy Feeding Tube. The ENFit Y-Port Enteral Adapter is secured within the funnel end of the Gastrostomy Tube Lumen. The Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port is packaged with a packet of water-soluble jelly used to ease the insertion of the device.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, formatted as requested:
This document is a 510(k) summary for a medical device (Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port) which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI performance, expert review, and clinical studies are not applicable or cannot be extracted from this document.
The "acceptance criteria" for this device are essentially compliance with recognized standards and demonstration of comparable performance to the predicate device through non-clinical (laboratory) testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards & Performance Characteristics) | Reported Device Performance (Demonstrated by Testing) |
|---|---|
| Compliance with Standards: | Device demonstrated compliance with: |
| - EN 1615:2000 (Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing) | Met requirements of EN 1615:2000 |
| - ASTM F 2528-06 (Standard Test Methods for Enteral Feeding Devices with a Retention Balloon) | Met requirements of ASTM F 2528-06 |
| - ISO 80369-3 (Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications) | Met requirements of ISO 80369-3 |
| Device Performance Characteristics (Tested features): | Testing demonstrated device performance for: |
| - Positive pressure liquid leak | Testing conducted |
| - Leak Test for G-tube 12Fr & 28 Fr | Testing conducted |
| - Resistance to separation from axial load | Testing conducted |
| - Resistance to separation from unscrewing | Testing conducted |
| - Resistance to overriding | Testing conducted |
| - Disconnection by unscrewing | Testing conducted |
| - Stress Cracking | Testing conducted |
| - Tensile strength | Testing conducted |
| - Tensile strength of the connections of G-tube 12Fr & 28 Fr | Testing conducted |
| - Dimension verification | Testing conducted |
| - Balloon burst volume for G-tube 12Fr & 28 Fr | Testing conducted |
| - Flow rate | Testing conducted |
| - Simulated Gastric fluids for G-tube 12Fr, 16Fr, 18Fr, & 24Fr | Testing conducted |
| - Biocompatibility evaluation | Testing conducted |
| - Shelf-life (5 years) | Testing conducted |
| Overall: Substantial equivalence to predicate device (K143378) | Comparison verification testing demonstrates substantial equivalence and that the device does not raise new questions of safety and efficacy. |
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: Not explicitly stated as a number of devices or units tested for each specific test. The document refers to "the proposed device" and specific French sizes (12Fr, 16Fr, 18Fr, 24Fr, 28Fr) being tested, implying multiple samples of varying sizes were subjected to the tests.
- Data Provenance: The tests were "Laboratory testing" conducted to support substantial equivalence. No information on country of origin or whether it was retrospective/prospective is provided, as it's non-clinical bench testing.
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)
- This information is not applicable and not provided. The study is non-clinical bench testing of a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided, as this is non-clinical bench testing of a physical medical device.
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, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense of AI/diagnostic devices. The "ground truth" for this device's performance is defined by the technical specifications outlined in recognized standards (EN 1615:2000, ASTM F 2528-06, ISO 80369-3) and the performance of the legally marketed predicate device (AQUARIUS™ Gastrostomy Replacement Tube, K143378).
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical 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.