The Kangaroo™ Enteral Feeding Set with ENFit connectors delivers nutritional formula to the gastrointestinal system of a patient age Infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.

Device Description

Enteral Feeding sets for use with Kangaroo Feeding pumps. The pump set incorporates 5 basic segments: Fluid reservoir(s), which may be an attached bag (500ml or 1000ml) or a spike for connection to a formula container; Tubing from fluid reservoir to pump (9 or 24 inch); Pump interface module (peristaltic tubing); Tubing from pump to patient connector (66 inches); Patient connector (ENFit connector compliant to ISO 80369-3).

AI/ML Overview

I am sorry, but based on the provided document, I cannot fulfill your request. This document is a 510(k) premarket notification for a medical device (Kangaroo™ Enteral Feeding Sets with ENFit connectors) and does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/algorithm-driven device.

The document primarily focuses on:

Substantial equivalence to a predicate device.
Device description and intended use.
Comparison of technological characteristics between the proposed and predicate devices, highlighting the change to an ENFit connector compliant with ISO 80369-3.
Nonclinical testing (biocompatibility, stability, usability/human factors related to the ENFit connector).
Explicitly stating that clinical testing was not relied upon for evidence of safety, effectiveness, or substantial equivalence.

Therefore, there is no information regarding:

A table of acceptance criteria and reported device performance for an algorithm.
Sample sizes for test or training sets, data provenance, ground truth establishment, or expert involvement for an AI study.
MRMC comparative effectiveness studies or standalone algorithm performance.

Summary

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

December 23, 2014

Covidien Mr. Jim Welsh Vice President, Regulatory Affairs 15 Hampshire Street Mansfield, MA 02048

Re: K141479

Trade/Device Name: Kangaroo™ Enteral Feeding Sets with ENFit connectors Regulation Number: 21 CFR 880.5725 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: LZH Dated: November 20, 2014 Received: November 21, 2014

Dear Mr. Welsh:

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.

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Page 2 - Mr. Welsh

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-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141479

Device Name

KangarooTM Enteral Feeding Sets with ENFit small bore connectors

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Kangaroo Enteral Feeding Set with ENFit connectors

In accordance with section 513(i) of the SMDA and as defined in 21CFR Part 807.92 this summary is submitted by:

Covidien 15 Hampshire Street Mansfield, MA 02048 Date Prepared: December 23, 2014

a. Contact Person

Jim Welsh VP, Regulatory Affairs Covidien Telephone: (508) 261-8532 Fax: (508) 261-8461

b. Name of Medical Device

Common Name: tube, feeding

U.S. FDA Classification Product Code: LZH
U.S. Regulation Description: Infusion Pump, 21 CFR 880.5725

Proprietary / Trade Name: Kangaroo™ Enteral Feeding Set with ENFit connectors

c. Identification of Legally Marketed Device(s)

Covidien Kangaroo™ ePump Enteral Feeding Pump and Enteral Feeding Set, K040196

d. Device comparison summary

The table below provides a comparison of the key attributes of the predicate and proposed devices.

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Device Comparison Summary
	Predicate Device	Proposed Device
Device Name	Kangaroo™ e-pump	Kangaroo™ Enteral FeedingSet with ENFit connectors
Device Description	Enteral feeding pump anddisposable enteral feeding sets	Enteral Feeding sets for usewith Kangaroo Feeding pumps
Intended Use	Intended for use in patientswith any condition requiringenteral feeding and/or enteralhydration, which can beaccomplished by means of anenteral feeding, pump andpump set. The pump andfeeding sets are intended to beused in alternate, acute andhome care settings by usersranging from laypersons toclinicians. The purpose of thisdevice is to deliver enteralnutrition at a controlled rate toa patients gastrointestinalsystem.	Intended for use in patientsage Infant and older with anycondition requiring enteralfeeding and/or enteralhydration, which can beaccomplished by means of anenteral feeding, pump andpump set. Not for use withneonates. The feeding sets areintended to be used in clinicalor home care settings by usersranging from laypersons toclinicians. The purpose of thisdevice is to deliver enteralnutrition to a patient'sgastrointestinal system.
Sterility	Includes sterile and non-sterilefeeding sets	Non-sterile
Technological Characteristics	The feeding sets are based onperistaltic pumping using arotating wheel which pressesagainst the tubing and movesthe fluid at a controlled rate.The connection to the patiententeral access device is astepped connector.	The feeding sets are based onperistaltic pumping using arotating wheel which pressesagainst the tubing and movesthe fluid at a controlled rate.The connection to the patiententeral access device is anENFit Connector compliant toISO 80369-3
Design	The pump set incorporates 5basic segments:● Fluid reservoir(s),which may be anattached bag (500ml or1000ml) or a spike forconnection to aformula container● Tubing from fluidreservoir to pump (24inch)	The pump set incorporates 5basic segments:● Fluid reservoir(s),which may be anattached bag (500ml or1000ml) or a spike forconnection to aformula container● Tubing from fluidreservoir to pump (9 or24 inch)
	Pump interface module•(peristaltic tubing)Tubing from pump to•patient connector (66 inches)Patient connector•(stepped connector)	Pump interface module•(peristaltic tubing)Tubing from pump to•patient connector (66 inches)Patient connector (ENFitconnector compliant to ISO80369-3)
Materials/Chemical composition	Polyvinyl chloride (PVC)	Polyvinyl chloride (PVC)
	Feeding bags and caps•	Feeding bags and caps•
	Tubing•	Tubing•
	Patient connector•Silicone	Drip Chamber•Silicone
	Peristaltic tubing•	Peristaltic tubing•
	Polycarbonate	Polycarbonate
	Valve body•	Valve body•
	HDPE	HDPE
	Valve stem•	Valve stem•
	LDPE	Feeding container•
	Dust Cover•	LDPE
	ABS	Dust Cover•
	Spike•	Hanger strap•
	Strontium Ferrite / nylon	ABS
	Set ID magnets•	Spike•
		Strontium Ferrite / nylon
		Set ID magnets•
		Copolyester
		ENFit connector•
		PE/EVA/EPE
		Spike seal washer•
		Polystyrene
		Roller clamp•

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e. Discussion of technological differences
The Kangaroo™ Enteral Feeding Set with ENFit connectors are intended for use with existing feeding pumps, and as such the technological differences are limited to the incorporation of the new ENFit connector which is compliant to ISO 80369-3. This connector is part of an industry wide effort to address misconnections by adopting a uniform connector that has been engineered to meet the objective of ISO 80369-1, small-bore connectors for liquids and gases in healthcare applications - part 1: general requirements

f. Discussion of Nonclinical testing

Biocompatibility testing in accordance with ISO 10993-1:2009, Biological Evaluation of ● medical Devices- Part 1: Evaluation and Testing has demonstrated the biological safety of parts of the medical device which may indirectly contact the patient, and is consistent with FDA "Draft Guidance for Industry and FDA staff, Use of international Standard ISO 10993 'Biological Evaluation of medical Devices Part 1: Evaluation and Testing,"' issued on April 23, 2013. Similar testing had been conducted for the predicate device.
. Stability testing of the proposed device evaluated the key performance properties of the feeding set after accelerated aging in support of the expiration date which will be applied to the device.
. Usability and human factors testing was conducted as part of the design of the ENFit connector.

Clinical testing g.

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

h. Conclusions

This information provided within this pre-market notification demonstrates that the Kangaroo™ Enteral Feeding Set with ENFit connectors is as effective, and performs as well as or better than the legally marketed device. I find the subject device to be substantially equivalent to the predicate device. The addition of the ENFit connector, which is compliant with ISO 80369-3 is intended to improve device performance by addressing the risk of misconnections.

End of Summary

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).