The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets is intended to deliver 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 physicians.

Device Description

The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal consists of a wireless enabled enteral feeding pump and disposable enteral feeding sets that deliver formula via rotary peristaltic tension loop pumping to provide nutrition for those who do not have the ability to orally ingest food. The new Kangaroo™ Connect Enteral Feeding Pump wireless accessories include a communication hub and the Kangaroo™ Connect Portal. The communication hub collects short-range data from the pump through a Zigbee signal and sends the data through either WiFi or a cellular signal to the device cloud where the Kangaroo™ Connect Portal can access the data for monitoring. The wireless enabled pump, when used in conjunction with the wireless accessories, will provide a platform for remote data collection allowing clinicians to more efficiently monitor feeding rates and review actual history of nutritional delivery.

AI/ML Overview

The provided document is a 510(k) summary for the Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal (K153074). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance statistics for each feature.

Therefore, the information requested in the prompt, especially specific numerical acceptance criteria, reported device performance for those criteria, and detailed study parameters (like sample sizes for test/training sets, data provenance, expert ground truth details, MRMC studies, standalone performance, and ground truth establishment methods), is not explicitly available within this 510(k) summary.

However, I can extract the general categories of performance testing that were conducted to support the device's safety and effectiveness. The document refers to a "safety assurance case" and "Performance Testing evidence."

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific numerical acceptance criteria and reported performance metrics are not provided in this summary. The summary describes categories of tests conducted.

Acceptance Criteria (Category)	Reported Device Performance (Summary)
Flow Rate Accuracy	Performance testing conducted to evaluate essential performance attributes. Specific accuracy metrics are not listed.
Downstream Occlusion Detection	Performance testing conducted to evaluate essential performance attributes. Specific detection metrics are not listed.
Pump Alarms	Performance testing conducted for various alarms (Feed Bag Empty, Supply Tube Blocked, Cassette Dislodged, Rotor Stuck, Cassette Error). Specific performance metrics for alarms are not listed.
Cleaning and Disinfection Validation	Validation performed to ensure appropriate cleaning and disinfection.
Human Factors Testing	Conducted to evaluate the usability of the device.
Electrical Safety Testing	In accordance with IEC 60601-1:2005 (AAMI ES 60601-1:2005).
Electromagnetic Compatibility	In accordance with IEC 60601-1-2:2014.
Software Verification and Validation	Conducted as recommended by FDA guidance.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified.
Data provenance: Not specified. The studies mentioned (e.g., system verification and validation activities, performance testing) would typically be conducted by the manufacturer (Covidien/Medtronic) without specific country of origin or retrospective/prospective details being disclosed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The assessment of device performance for general medical devices like enteral feeding pumps typically relies on objective physical measurements and engineering standards rather than expert-established ground truth in the way it's used for AI/diagnostic devices. Human factors testing involves users, but the specifics of expert qualifications are not within the scope of this type of summary.

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the type of performance testing (e.g., flow rate accuracy, electrical safety) described for an enteral feeding pump. Adjudication methods are more commonly associated with subjective assessments or diagnostic interpretability studies.

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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices involving human readers. The Kangaroo™ Connect Enteral Feeding Pump is a medical device for delivering nutritional formula, and its wireless accessories are for remote data collection and monitoring, not for diagnostic interpretation by human readers. The summary mentions human factors testing to evaluate usability, which is different from an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, implicitly. The performance testing described (e.g., "Flow Rate Accuracy," "Downstream Occlusion Detection," "Pump Alarms") would typically be conducted on the device (pump and software/firmware) independently of human interaction, to ensure the device itself performs according to its specifications. The "wireless enabled-disabled performance testing of essential performance attributes" refers to the inherent function of the device and its system. These tests assess the algorithm's performance in controlling the pump and detecting issues.

7. The type of ground truth used

The "ground truth" for the performance testing of this device would be established by engineering standards and objective measurements. For example:
- Flow Rate Accuracy: Measured flow rates would be compared against the programmed rates using calibrated instruments.
- Occlusion Detection: Artificially induced occlusions would be tested for detection by the device's sensors.
- Alarms: Specific conditions (e.g., empty bag, blocked tube) would be simulated or created to verify alarm functionality.
- Electrical Safety/EMC: Compliance with relevant IEC standards would be assessed through standardized test procedures and equipment.
- Software Verification/Validation: Code reviews, unit testing, integration testing, and system testing against design specifications.

8. The sample size for the training set

This information is not provided and generally not applicable in the context of traditional medical device development where specific "training sets" are primarily associated with machine learning or AI algorithm development. While there are software elements (mentioned as "on board custom software"), the development process described is standard software verification and validation, not a machine learning model training process that would require a distinct "training set" in the AI sense.

9. How the ground truth for the training set was established

This information is not provided and generally not applicable (see point 8). The "ground truth" for ensuring the functionality of the device's software would be its design specifications and requirements.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.

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

July 6, 2016

Covidien Ms. Karin Desjardins Regulatory Affairs Manager 15 Hampshire Street Mansfiled, Massachusetts 02048

Re: K153074

Trade/Device Name: Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZH Dated: May 16, 2016 Received: May 17, 2016

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.

{1}------------------------------------------------

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,

Tina Kiang -

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153074

Device Name

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

Indications for Use (Describe)

The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets is intended to deliver 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 physicians.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K153074 510(K) SUMMARY

Manufacturer's Name:	Covidien15 Hampshire StreetMansfield, MA 02048
Corresponding Official:	Karin DesjardinsManager, Regulatory AffairsPatient Monitoring & RecoveryMedtronic
Telephone Number:E-mail:	(508) 452-1856karin.d.desjardins@medtronic.com
Preparation Date:	June 28, 2016
Trade Name:	Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™Connect Feeding Sets and Kangaroo™ Connect Portal
Common or UsualName:	Enteral Feeding pump, Infusion pump
Classification Name andNumber:	Infusion Pump21 CFR 880.5725Class IIProduct Code: LZH
Primary PredicateDevice:	K143263 - Kangaroo™ Connect Enteral Feeding Pump withKangaroo™ Connect Feeding Sets
Secondary PredicateDevice:	K141789 - Plum 360™ Infusion system with Hospira MedNet™Smart Card Plug 'n' Play CE 3.0 Module

Device Description

{4}------------------------------------------------

Intended Use

	Primary PredicateDevice	Secondary PredicateDevice	Subject Device
510(k) Number	K143263	K141789	K153074
Device Name	Kangaroo™ ConnectEnteral Feeding Pump,Kangaroo™ ConnectEnteral Feeding Sets	Plum 360™ Infusion systemwith Hospira MedNet™ /Smart Card Plug 'n' PlayCE 3.0 Module	Kangaroo™ ConnectEnteral Feeding Pump,Kangaroo™ ConnectEnteral Feeding Sets, andKangaroo™ Connect Portal
Device Description	Enteral feeding pump anddisposable enteral feedingsets	Infusion Pumps, Infusionsafety managementsoftware & IntravascularAdministration Sets	Enteral feeding pump anddisposable enteral feedingsets
Intended Use	The Kangaroo™ ConnectEnteral Feeding Pump withKangaroo Connect™ FeedingSets is intended to delivernutritional formula to thegastrointestinal system of apatient age infant and olderwho is physically unable toeat and swallow. Not for usewith neonates. The feedingpump and feeding sets areintended to be used inclinical or home caresettings by users rangingfrom laypersons to clinicians	Indicated for use inparenteral, enteral andepidural therapies and theadministration of wholeblood and blood products.	The Kangaroo™ ConnectEnteral Feeding Pump withKangaroo™ Connect FeedingSets is intended to delivernutritional formula to thegastrointestinal system of apatient age infant and olderwho is physically unable toeat and swallow. Not for usewith neonates. The feedingpump and feeding sets areintended to be used inclinical or home care settingsby users ranging fromlaypersons to physicians
Intent of WirelessConnectivity	Not applicable - no wirelessfeatures	Allows communicationbetween the InfusionPump, Hospira MedNet™server and the facility'scommunication systems.	Provide a platform forremote data collection.
Sterility	Non Sterile feeding sets	Not known	Non Sterile feeding sets
	Primary PredicateDevice	Secondary PredicateDevice	Subject Device
TechnologicalCharacteristics	The feeding sets arebased on peristalticpumping using a rotatingwheel which pressesagainst the tubing andmoves the fluid at acontrolled rate.The connection to thepatient enteral accessdevice is an ENFitConnector compliant toISO 80369-3.	Not known	The feeding sets arebased on peristalticpumping using a rotatingwheel which pressesagainst the tubing andmoves the fluid at acontrolled rate.The connection to thepatient enteral accessdevice is an ENFitConnector compliant toISO 80369-3.
Design (pump)	The pump incorporates amenu controlledoperating system whichcontains on board customsoftware designed toallow the user to set feedrates and volumes as wellas other feeding options.The device incorporatesultrasonic sensors todetect the air andblockages in the feedingset.	Not known	The pump incorporates amenu controlled operatingsystem which contains onboard custom softwaredesigned to allow the userto set feed rates andvolumes as well as otherfeeding options. Thedevice incorporatesultrasonic sensors todetect the air andblockages in the feedingset.
RechargeableBattery	lithium ion	Not known	lithium ion
Graphic Display	multi-color	Not known	multi-color
Water Ingress Rating	IP26	Not known	IP26
Design (feeding set)	The pump set incorporates 5basic segments:• Fluid reservoir(s), whichmay be an attached bag(500ml or 1000ml) or aspike for connection toa formula container• Tubing from fluidreservoir to pump (14inch)• Cassette containingpump interface module(peristaltic tubing)• Tubing from pump topatient connector (66inches)• Patient connector (ENFitconnector compliant toISO 80369-3)	Not known	The pump set incorporates 5basic segments:• Fluid reservoir(s), whichmay be an attached bag(500ml or 1000ml) or aspike for connection toa formula container• Tubing from fluidreservoir to pump (14inch)• Cassette containingpump interface module(peristaltic tubing)• Tubing from pump topatient connector (66inches)• Patient connector (ENFitconnector compliant toISO 80369-3)
	Primary PredicateDevice	Secondary PredicateDevice	Subject Device
Includes Anti-FreeFlow Valve	Yes	Not known	Yes
Materials/ChemicalComposition	Polyvinyl chloride (PVC)• Feeding bags and caps• Tubing	Not known	Polyvinyl chloride (PVC)• Feeding bags and caps• Tubing
	Silicone• Peristaltic tubing• Diaphragm valve		Silicone• Peristaltic tubing• Diaphragm valve
	Polycarbonate• Cassette body		Polycarbonate• Cassette body
	CoPolyester• Patient connector		CoPolyester• Patient connector
	ABS• Spike• Tube holder and Cap		ABS• Spike• Tube holder and Cap
	Strontium Ferrite / nylon• Set ID magnets		Strontium Ferrite / nylon• Set ID magnets

Substantial Equivalence Discussion

{5}------------------------------------------------

{6}------------------------------------------------

Discussion of Differences

There are no differences between the indications for use of the predicate, K143263 and the subject device. The primary difference between the predicate Kangaroo™ Connect Enteral Feeding Pump cleared under K143263 and the proposed Kangaroo™ Connect Pump is an enabled wireless processor. To facilitate wireless capability, Covidien intends to introduce new accessories to be used in conjunction with the wireless-enabled Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets. the new accessories include a communication hub and Connect Portal. The wireless enabled pump, in conjunction with new wireless accessories, will provide a platform for remote data collection allowing clinicians to more efficiently monitor feeding rates and review actual history to help improve patient outcomes.

Discussion of Performance Testing

A safety assurance case as recommended by the FDA quidance document, Infusion Pumps Total Product Life Cycle was provided for the Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets. The stated top-level claim of the assurance case is:

The Kangaroo" Connect system is acceptably safe for its intended use, within its environment of use, when being used by intended users, over the lifecvcle of the product.

The assurance case defined the device system, including the indications for use, system definition, operational description, patient populations, and use environments.

{7}------------------------------------------------

The following assurance claims were used to support the design safety goals:

System design is acceptably safe .
- o All relevant hazards have been identified and controlled
  - l System wise hazard analyses are adequate
  - All identified hazards have at least one corresponding control .
  - . All requirements have been implemented and verified
- o Device design ensures safe behavior
  - Reliability requirements are met
. System in use is acceptably safe

Development and supporting processes are adequate ●
- Quality assurance is adequate o
- Software development is adequate o
- Risk Management process is adequate o
  - . Hazard identification and mitigation are complete
  - . All controls have been correctly implemented in the final device design

The assurance case also included additional goals, which were not relied on to support the design safety review, but were included to support the top level structure.

Manufactured System is acceptably safe .
System disposal is acceptably safe .

The following Performance Testing evidence was included in the assurance case:

System Verification and Validation activities .
Wireless enabled-disabled performance testing of essential performance attributes .
- o Flow Rate Accuracy
- o Downstream Occlusion Detection
- Pump Alarms (Feed Bag Empty, Supply Tube Blocked, Cassette Dislodged, Rotor o Stuck, Cassette Error)
. Cleaning and disinfection validation and instructions
. Human factors testing to evaluate the usability of the device
. Electrical Safety testing in accordance with applicable IEC standards (IEC 60601-1:2005 AAMI ES 60601-1:2005, Medical electrical equipment-Part1: General requirements for basic safety and essential performance)
Electromagnetic compatibility evaluation in accordance with applicable standards (IEC . 60601-1-2:2014, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests.)
Software verification and validation testing, as recommended by the FDA quidance . document Infusion Pump Total Product Life Cycle

Clinical Testing

Clinical evaluations were not submitted and not needed.

Conclusions

{8}------------------------------------------------

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

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).