FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

The Kangaroo™ Feeding Tube with IRIS Technology is a small-bore nasogastric enteral access catheter. The gastrointestinal tube includes an external proximal access port for connection to enteral feeding sets and to syringes with ENFit connector. 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 tube is equipped with external markings in units of centimeters to assist in estimating the length of tube inserted into the alimentary tract. The device may be connected to a console, which allows for viewing a video stream and capture of camera images an interface cable connects the feeding tube to the console. LED light is incorporated into the distal tip of the tube and the light will power on only when properly connected to the console with the interface cable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Kangaroo™ Feeding Tube with IRIS Technology. This submission is for a modified version of an already marketed predicate device (K123555).

The key takeaway is that no clinical data or clinical studies were relied upon for demonstrating safety, effectiveness, or substantial equivalence. The acceptance criteria and the study proving the device meets them are based entirely on non-clinical performance data and bench testing.

Therefore, many of the specific questions about clinical study design (sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission as no human clinical studies were performed or used.

Here's a breakdown of the acceptance criteria and the "study" (non-clinical performance testing) based on the provided text:

Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on design modifications and non-clinical testing for substantial equivalence to a predicate device, the "acceptance criteria" are implicitly the demonstration that the modified device continues to meet existing product specifications and relevant performance standards, and that the modifications do not raise new questions of safety and efficacy. The "reported device performance" is the successful completion of these non-clinical tests.

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance (as stated in document)
General Safety & Efficacy	No new questions of safety and efficacy compared to predicate.	"Verification testing completed on the modified Kangaroo™ Feeding Tube with IRIS Technology demonstrates that the modifications do not raise new questions of safety and efficacy and that the proposed device is as safe and effective as the legally marketed K123555 Kangaroo™ Feeding Tube with IRIS Technology."
Electrical Safety	Compliance with relevant electrical safety and EMC standards.	Test performed:

ISO 60601-1 3rd Ed.:2005 (Medical Electrical Equipment Safety and Essential Performance)
ISO 60601-1-2 Ed. 3.0:2007 (Electromagnetic compatibility)
Leakage Current Testing
Dielectric Voltage Withstand
Evaluation of Magnetic Field Interactions, Heating, and Artifacts
Result: Tests successfully completed to demonstrate compliance. |
| Storage & Stability | Maintain performance and integrity over shelf life. | Test performed:
Storage Stability
ISTA 2A Functional Evaluation
Result: Tests successfully completed. |
| Feeding Tube Bench Testing| Mechanical integrity, fluid isolation, stylet performance, illumination, temperature. | Tests performed:
Feeding Tube Fluid Isolation Test Report
Feeding Tube Wire Slip in Co-extrusion
Feeding Tube Stylet Penetration Force
Feeding Tube Conductors Break Strength
Feeding Tube Anatomical Insertion Force Test
Feeding Tube Placement and Useful Life
Feeding Tube Water Leak Test (30 Day Gastric)
Feeding Tube Distal Subassembly Tensile Test
Stylet Introduction Force
Stylet Removal Force
Flow and Functionality Analysis
Image Head Length Test Report
Image Head Illumination Output
Image Head External Temperature
Electrical Continuity Analysis
Result: Tests successfully completed to demonstrate the modified device continues to meet product specifications. |
| Optical Bench Testing | Image capture quality, depth of field, field of view. | Tests performed:
Image Head Capture
Image Head Depth of Field Test Report
Image Head Field of View Test Report
MRI Image Testing
Result: Tests successfully completed. The device has "improved visual optics as compared to the predicate device." |
| Biocompatibility | Safety in contact with tissue. (Implied by animal test) | Test performed:
Temperature Testing of IRIS Technology Feed Tube in Porcine Tissue
Result: Test successfully completed. |
| Standard Compliance | Adherence to recognized medical device standards. | Tested against:
IEC 60601-1:2005 (General requirements for basic safety and essential performance)
IEC 60601-1-2:2007 (EMC)
FDA Guidance for Industry, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (2008)
EN 1615:2000 (Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing)
BS EN 1618:1997 (Catheters Other than Intravascular Catheters - Test Methods for Common Properties)
AAMI/CN3 (PS):2014 Part 3 (Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications)
Result: Device demonstrates compliance with these standards. |

Study Details (Non-Clinical Performance Data)

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but standard engineering and medical device testing practices would involve sufficient samples to ensure statistical validity and representativeness of the manufacturing process for each specific test (e.g., usually N=3 or N=5 for physical properties, or larger for destructive testing if statistical confidence is required).
- Data Provenance: Laboratory testing conducted internally by Covidien (dba Medtronic). This is non-clinical/bench data, not human subject data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was entirely non-clinical bench testing and engineering analysis. No "ground truth" established by human experts in a clinical context was used for the substantial equivalence determination for this 510(k). The "ground truth" is implied by the technical specifications and performance characteristics defined by the manufacturer and relevant consensus standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was non-clinical bench testing. Adjudication methods are relevant for clinical studies, especially those involving subjective interpretations or multiple readers.
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 was a 510(k) based on non-clinical data, comparing a modified device to a predicate. No AI component or human reader study was conducted or submitted as evidence.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm mentioned or evaluated independently of the device's physical function. The "IRIS Technology" refers to the built-in video stream and improved optics, which is an integral part of the physical device's function to "aid a trained user."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this 510(k) submission, the "ground truth" is based on engineering specifications, direct physical measurements, and adherence to established industry performance standards (e.g., IEC, EN, AAMI standards). The device's performance was compared against these objective criteria rather than subjective human assessment or pathological confirmation.
The sample size for the training set:
- Not applicable. Since no clinical data or machine learning components were used for this 510(k) submission, there was no "training set."
How the ground truth for the training set was established:
- Not applicable. As no training set was used.

Summary

Regulation Number and Section

§ 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.