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 ArtifactsResult: Tests successfully completed to demonstrate compliance.
Storage & Stability	Maintain performance and integrity over shelf life.	Test performed:- Storage Stability- ISTA 2A Functional EvaluationResult: 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 AnalysisResult: 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 TestingResult: 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 TissueResult: 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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 16, 2017

Covidien (dba Medtronic) Alexis Erazo Sr. Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048

Re: K163002

Trade/Device Name: Kangaroo™ Feeding Tube with IRIS Technology Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, PIF Dated: April 12, 2017 Received: April 13, 2017

Dear Alexis Erazo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Benjamin/R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163002

Device Name Kangaroo™ Feeding Tube with IRIS Technology

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Kangaroo™ Feeding Tube with IRIS Technology

Preparation date:

May 9, 2017

Manufacturer's Name:

Covidien 15 Hampshire Street Mansfield, MA 02048

Corresponding Official:

Alexis Erazo Sr. Regulatory Affairs Specialist Phone: 508-452-4673 Alexis.erazo@medtronic.com

Name of Medical Device:

Trade Name:	Kangaroo™ Feeding Tube with IRIS Technology
Common Name:	Tubes, gastrointestinal
Classification Name:	Gastrointestinal tube and accessories
Regulation Number:	21 CFR 876.5980
Product Code:	KNT
	PIF (Secondary)
Class:	II

Identification of Predicate Device:

510(k) Number	K123555
Device Description	Kangaroo™ Feeding Tube with IRIS Technology
Submitter	Covidien

Device Description:

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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.

The Kangaroo Feeding Tube with IRIS Technology will continue to be available in three (3) sizes and three (3) lengths: 8 Fr, 10 Fr, 12 Fr and 36", 43″ and 55″. The Kangaroo Feeding Tube with IRIS Technology is not made with DEHP and are nonsterile. The product and packaging is not made with natural rubber latex.

Intended Use/Indications for Use:

Product Comparison Summary:

The modified Kangaroo™ Feeding Tube with IRIS Technology has the same intended use and improved visual optics as compared to the predicate device (K123555). 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.

	PredicateKangaroo Feeding Tube withIRIS Technology (K1235555)	ProposedKangaroo Feeding Tube with IRISTechnology
Intended Use/Indications forUse	The Kangaroo™ Feeding Tube withIRIS Technology utilizes a videostream to aid a trained user duringplacement into the stomach or smallbowels for the administration ofnutrition, fluids, and medications by	The Kangaroo™ Feeding Tube withIRIS Technology utilizes a videostream to aid a trained user duringplacement into the stomach or smallbowels for the administration ofnutrition, fluids, and medications by
	PredicateKangaroo Feeding Tube withIRIS Technology (K123555)	ProposedKangaroo Feeding Tube with IRISTechnology
	the naso-enteric route for patientsaged 18 years and older who have anintact gastrointestinal tract, but arephysically unable to managenutritional intake through normalmastication and deglutition. Prior tocommencing administration, confirmcorrect tube placement perinstitutional protocol. Placement ofthe tip of the device into the smallbowel should only be attempted byclinicians with expertise in smallbowel placement.	the naso-enteric route for patientsaged 18 years and older who have anintact gastrointestinal tract, but arephysically unable to managenutritional intake through normalmastication and deglutition. Prior tocommencing administration, confirmcorrect tube placement perinstitutional protocol. Placement ofthe tip of the device into the smallbowel should only be attempted byclinicians with expertise in smallbowel placement.
ClassificationName	Tubes, Gastrointestinal (andAccessories)	Tubes, Gastrointestinal (andAccessories)
RegulationReference	21 CFR 876.5980	21 CFR 876.5980
Product Code	KNT	KNT, PIF
Classification	II	II
Prescription Use	Rx	Rx
Sterilization	Non-Sterile	Non-Sterile
Labeled SingleUse	Single Use	Single Use
Shelf Life	2 Years	2 Years
French Sizes	8Fr10Fr12Fr	8Fr10Fr12Fr
Available TubeLengths	36"43"55"	36"43"55"
Proximal EndConnections	ENFit Connection System	ENFit Connection System
Proximal AccessPort (ENFit)	Yes, allows for irrigation (flushing),manual fluid/ medication access,and aspirate collection	Yes, allows for irrigation (flushing),manual fluid/ medication access,and aspirate collection
ISO 80369-3Compliance (ENFitConnection)	Yes	Yes
Placement StyletIncluded	Yes	Yes
Shaft Design	Single lumen	Single lumen
Shaft Flow Outlet	2 eyes at distal end	2 eyes at distal end
MeasurementMarkings	Yes, cm units	Yes, cm units
	PredicateKangaroo Feeding Tube withIRIS Technology (K123555)	ProposedKangaroo Feeding Tube with IRISTechnology
Camera andElectronics	Yes	Yes
Coating (tip)	Water-activated Hydromerlubricant	Water-activated Hydromer lubricant

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Non-Clinical Performance Data:

Laboratory testing was completed to support substantial equivalence between the modified device and the predicate device. The modified device was evaluated to demonstrate compliance to the below standards.

IEC 60601-1:2005 with corrigenda and U.S. national deviations were considered . against standard AAMI ES60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
. FDA's Guidance for Industry, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued on August 21, 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

The following testing was conducted to demonstrate that the modified device continues to meet product specifications and support the determination of substantial equivalence.

Electrical Safety

. ISO 60601-1 3rd Ed.:2005 and ISO 60601-1-2 Ed. 3.0:2007 Medical Electrical Equipment Safety and Essential Performance
Leakage Current Testing
Dielectric Voltage Withstand
Evaluation of Magnetic Field Interactions, Heating, and Artifacts

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Storage and Stability

Storage Stability ●
. ISTA 2A Functional Evaluation

Optical Bench Testing

Image Head Capture
Image Head Depth of Field Test Report
Image Head Field of View Test Report ●
MRI Image Testing

Animal Testing

Temperature Testing of IRIS Technology Feed Tube in Porcine Tissue

Clinical Data:

Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.

Conclusion:

Based on the nonclinical tests performed on the proposed device, the modified Kangaroo Feeding Tube with IRIS Technology is as safe and effective as the legally marketed Kangaroo Feeding Tube with IRIS Technology (K123555). The information provided within this 510(k) demonstrates that the modified Kangaroo Feeding Tube with IRIS Technology is equivalent to the predicate device.

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.