The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets 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 pump and feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.

Device Description

Enteral feeding pump and disposable enteral feeding sets

AI/ML Overview

I am sorry, but the provided text does not contain the specific information required to generate a table of acceptance criteria and reported device performance for a medical device that meets the requested parameters related to AI/algorithm studies (standalone, MRMC, sample sizes, ground truth establishment, expert qualifications, etc.).

The document is a 510(k) summary for the Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Feeding Sets. It details the device's intended use, technological characteristics, and nonclinical testing performed to demonstrate substantial equivalence to a predicate device.

While it mentions software verification and validation, and studies on infusion delivery accuracy, it does not describe:

Specific acceptance criteria with numerical targets for performance metrics.
A study explicitly designed to prove the device meets acceptance criteria in the context of an AI/algorithm.
Any AI or algorithm-driven components in the way typically discussed for image analysis or diagnostic support systems. The software mentioned is for operating the pump and setting feed rates, not for making diagnostic or interpretive decisions.
Sample sizes for test sets (in the context of AI/algorithm evaluation).
Data provenance for test sets.
Number or qualifications of experts for ground truth establishment.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for a training set (as no AI training appears to be the focus here).
How ground truth for a training set was established.

The studies described are typical for an infusion pump, focusing on biocompatibility, stability, human factors, electrical safety, software verification, battery evaluation, infusion accuracy, fluid ingress protection, and sensor performance. These are functional and safety performance tests for a physical medical device, not evaluative studies for an AI/ML algorithm's diagnostic or predictive performance.

Summary

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

May 29, 2015

Covidien Ms. Karin Desjardins Manger, Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K143263

Trade/Device Name: Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Feeding Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZH Dated: April 27, 2015 Received: April 29, 2015

Dear Ms. Desjardins:

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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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 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/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 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 vours.

Tina
Kiang -S

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) K143263

Device Name

KangarooTM Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets

Indications for Use (Describe)

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

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

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

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510(k) Summary: K143263

Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Enteral Feeding Sets

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: May 21, 2015

a. Contact Person
Karin Desjardins Manager, Regulatory Affairs Patient Monitoring & Recovery Medtronic Telephone: (508) 261-1856 Fax: (508) 261-8461
b. Name of Medical Device
Common Name: Enteral Feeding pump, Infusion pump

U.S. FDA Classification Product Code: LZH

U.S. Regulation Description: Infusion Pump, 21 CFR 880.5725

Proprietary / Trade Name: Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Feeding Sets

c. Identification of Legally Marketed Device(s)

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

d. Device Brief Description

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 (K040196)	Proposed Device (K143263)
Device Name	Kangaroo™ e-pump	Kangaroo™ Connect EnteralFeeding Pump and Kangaroo™Connect Enteral Feeding Sets
Device Description	Enteral feeding pump anddisposable enteral feeding sets	Enteral feeding pump anddisposable enteral feeding sets
Intended use	Intended for use in patients withany condition requiring enteralfeeding and/or enteral hydration,which can be accomplished bymeans of an enteral feeding,pump and pump set. The pumpand feeding sets are intended tobe used in alternate, acute andhome care settings by usersranging from laypersons toclinicians. The purpose of thisdevice is to deliver enteralnutrition at a controlled rate to apatients gastrointestinal system.	Intended for use in patients ageInfant and older with anycondition requiring enteralfeeding, which can beaccomplished by means of anenteral feeding pump and pumpset. Not for use with neonates.The feeding pumps and sets areintended to be used in clinical orhome 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 feeding sets
TechnologicalCharacteristics	The feeding sets are based onperistaltic pumping using arotating wheel which pressesagainst the tubing and moves thefluid at a controlled rate.The connection to the patiententeral access device is a steppedconnector.	The feeding sets are based onperistaltic pumping using arotating wheel which pressesagainst the tubing and moves thefluid at a controlled rate.The connection to the patiententeral access device is anENFit Connector compliant toISO 80369-3.
Design (Pump)	The pump incorporates a menucontrolled operating systemwhich contains on board customsoftware designed to allow theuser to set feed rates and volumesas well as other feeding options.The device incorporatesultrasonic sensors to detect the airand blockages in the feeding set.	The pump incorporates a menucontrolled operating systemwhich contains on board customsoftware designed to allow theuser to set feed rates andvolumes as well as other feedingoptions. The device incorporatesultrasonic sensors to detect theair and blockages in the feedingset.
Rechargeable battery	nickel cadmium	lithium ion
Graphic display	monochrome	multi-color
Water ingress rating	IPX1	IP26
Device Comparison Summary
	Predicate Device (K040196)	Proposed Device (K143263)
Design (Feeding set)	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 (24 inch) Pump interface module (peristaltic tubing) Tubing from pump to patient connector (66 inches) Patient connector (stepped connector)	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 (14 inch) Cassette containing pump interface module (peristaltic tubing) Tubing from pump to patient connector (66 inches) Patient connector (ENFit connector compliant to ISO 80369-3)
Includes anti-free flow valve	Yes	Yes
Materials/Chemicalcomposition	Polyvinyl chloride (PVC) Feeding bags and caps Tubing Patient connector Silicone Peristaltic tubing Polycarbonate Valve body HDPE Valve stem LDPE Dust Cover ABS Spike Strontium Ferrite / nylon Set ID magnets	Polyvinyl chloride (PVC) Feeding bags and caps Tubing Silicone Peristaltic tubing Diaphragm valve Polycarbonate Cassette body CoPolyester Patient connector ABS Spike Tube holder and Cap Strontium Ferrite / nylon Set ID magnets

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e. Statement of Intended Use

f. Discussion of Technological Differences

Both proposed and predicate pumps perform the same primary function. The proposed device includes 2 ultrasonic sensors to detect both upstream and downstream occlusions vs. one sensor in the predicate device. Additionally, the pump uses a cassette based feeding set where the silicone tube interface with the rotor is contained within the cassette where the predicate device required the user to stretch tubing around the rotor. The proposed device is smaller and lighter, and has longer battery life. The proposed device has a higher water ingress protection rating in accordance with ANSI/IEC 60529-2004 Degrees of Protection Provided by Enclosures (IP Code). The proposed device does not support feed/flush capability, which exists in the predicate device. The proposed feeding set includes 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 IS0 80369-1, small-bore connectors for liquids and gases in healthcare applications - part 1: general requirements

g. Discussion of Nonclinical testing

The following testing was the basis for the substantial evaluation determination:

Biocompatibility testing of the Kangaroo™ Connect Feeding Sets in accordance with o 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. In accordance with ISO 10993. the feeding sets are categorized as a surface device (category C), permanent use (< 30 days).
o Cleaning and disinfection instructions and validation documentation.
Stability testing of the proposed device evaluated the key performance properties of o the feeding set after accelerated aging in support of the expiration date which will be applied to the device.
Human factors testing was conducted to evaluate the usability of the device as well as o the ENFit connector.
0 Electrical Safety testing was conducted in accordance with applicable IEC standards.

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Software verification and validation testing was completed, as recommended by the o FDA guidance document Infusion Pump Total Product Life Cycle.
The battery was evaluated in accordance with UL 2054, 2nd Edition, household and o commercial batteries.
Evidence was provided to demonstrate the functionality and infusion delivery o accuracy of the Kangaroo Connect System with over 35 representative nutritional formulas that might be prescribed.
o Infusion delivery accuracy testing included an evaluation of accuracy at low and high temperatures using low and high viscosity fluids.
Verification of the fluid ingress protection rating was confirmed on test samples that o were preconditioned with mechanical stress tests defined in ANSI/AAMI ED 60601-1. Preconditioning tests included push test, impact test, drop test and mold stress.
Performance and reliability of the sensors was confirmed when the device is used as o labeled.
A safety assurance case for the Kangaroo Connect Enteral Feeding Pump and Feeding o Sets was provided, as recommended by the FDA guidance document. Infusion Pumps Total Product Life Cycle.
h. Clinical testing

Clinical evaluations were not submitted.

i. Conclusions
This information provided within this pre-market notification demonstrates that the Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Enteral Feeding Sets are substantially equivalent to the legally marketed predicate device.

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).