(506 days)
The Kangaroo™ Feeding Tube with IRIS Technology utilizes a video stream to aid a trained user during placement into the stomach or small bowels for the administration of nutrition, fluids, and medications by the naso-enteric route for patients aged 18 years and older who have an intact gastrointestinal tract, but are physically unable to manage nutritional intake through normal mastication and deglutition. Prior to commencing administration, confirm correct tube placement per institutional protocol. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement.
The Kangaroo™ Feeding Tubes with IRIS Technology are small bore nasogastric enteral access catheters. These gastrointestinal tubes include an external proximal access port for connection to enteral feeding sets and to syringes with either oral tip or catheter tip designs. The tubing is constructed with a radiopaque material and with a hydrophilic coating to assist with insertion of the tube. The stylet is made of specially designed metal wire which may be utilized to assist with tube placement. The tubes are each equipped with external markings in units of centimeters to assist in measuring the length of tube inserted into the alimentary tract. These devices may connect to a console which allows for viewing a video stream and capture of camera images from the distal end of the feeding tube during placement. In order to transmit the images, an interface cable connects the feeding tube to the console. LED light is incorporated into the distal tip of the tubes and the light will power on only when properly connected to the console with the interface cable.
This document is a 510(k) summary for the Kangaroo™ Feeding Tube with IRIS Technology. It explicitly states that "Clinical evaluations were not relied upon for evidence of safety or effectiveness, nor for a determination of substantial equivalence." Therefore, there is no study described within this document that proves the device meets specific performance acceptance criteria.
The submission focuses instead on non-clinical testing and comparison to legally marketed predicate devices to demonstrate substantial equivalence.
Here's a breakdown based on the provided text, indicating what information is not available as a clinical study was not performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance | Not specified for clinical performance |
| Non-Clinical Performance: | |
| Compliance with EN1615:2000 (Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing) | Device evaluated and meets this standard. |
| Biocompatibility per FDA Blue Book Memorandum #G95-1 (Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) | Device demonstrated to meet guidelines. |
| Safety of medical electrical equipment per AAMI ES60601-1:2005 and IEC 60601-1-2:2007 | Device evaluated to these requirements. |
| Software lifecycle processes per IEC 62304:2006 | Imaging system software developed under this framework. |
2. Sample size used for the test set and the data provenance
- Not applicable. No clinical test set or clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set or clinical study was performed requiring ground truth established by experts.
4. Adjudication method for the test set
- Not applicable. No clinical test set or clinical study was performed.
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. An MRMC study was not conducted as no clinical evaluations were relied upon. The device is referred to as "Kangaroo™ Feeding Tubes with IRIS Technology," where IRIS implies an imaging system, potentially a form of AI or image-guided assistance. However, its effectiveness in this regard was not clinically evaluated.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. No standalone algorithm performance study was mentioned or relied upon. The device's "video stream feature is intended as an adjunct to current placement practices for assisting clinical practitioners."
7. The type of ground truth used
- Not applicable. No clinical study was performed requiring a ground truth (e.g., expert consensus, pathology, outcomes data).
8. The sample size for the training set
- Not applicable. No clinical study or algorithm training based on clinical data was mentioned or relied upon.
9. How the ground truth for the training set was established
- Not applicable. No clinical study or algorithm training based on clinical data was mentioned or relied upon.
§ 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.