Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients. Some patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.

The Kangaroo OMNI™ Enteral Feeding Pump and Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.

Device Description

The Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories consist of an enteral feeding pump and disposable enteral feeding sets along with accessories that deliver fluids via rotary peristaltic tension loop pumping to provide hydration and nutrition for those who do not have the ability to orally ingest food or drinks.

AI/ML Overview

This document is a 510(k) Summary for the Kangaroo OMNI™ Enteral Feeding Pump and related accessories. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment.

The "Performance Testing" section primarily focuses on engineering and regulatory compliance tests for the physical device, not software performance related to AI or diagnostic accuracy. It mentions software verification and validation but within the context of general medical device software guidance, not AI-specific performance metrics like sensitivity, specificity, or accuracy for a diagnostic task.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI-powered device using the provided text. The document describes a traditional medical device (an enteral feeding pump) and its associated accessories, and the testing outlined is typical for such a device (electrical safety, EMC, human factors, biocompatibility, battery testing, and essential performance requirements like flow rate accuracy and alarm detection).

Specifically, the document does not contain the following information relevant to AI device studies:

A table of acceptance criteria and reported device performance (for an AI component): While there's a table comparing features, it lists physical and operational characteristics of the pump, not AI performance metrics.
Sample size used for the test set and data provenance: Not applicable as it's not an AI test set.
Number of experts used to establish ground truth and qualifications: Not applicable.
Adjudication method for the test set: Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or mentioned.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document states "Clinical Testing: Not Applicable," further indicating that this submission does not involve clinical performance data for a diagnostic or AI-driven device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2022

Cardinal Health LLC Varela Fredy Manager, Regulatory Affairs 3651 Birchwood Drive Waukegan. Illinois 60085

Re: K221603

Trade/Device Name: Kangaroo OMNI™ Enteral Feeding Pump (385400):Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF):Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™ ENPlus Spike Set with Flush Bag ( BSPFFF);Kangaroo OMNI™ ENtelliSet ENPlus Spike with Flush Bag (ESPFF);Kangaroo OMNI™ Thick Formula ENtelliSet 500ml (E5FDR);Kangaroo OMNI™ Thick Formula ENtelliSet 500ml with Flush Bag (E5FFR);Kangaroo OMNI™ Thick Formula ENtelliSet 1000ml (E10FDR);Kangaroo OMNI™ Thick Formula ENtelliSet 1000ml with Flush Bag (E10FFR):Kangaroo OMNI™ Burette ENtelliSet (ER100);Kangaroo™ Power Cord with Adapter (384491);Kangaroo™ Adjustable Pole Clamp (384492):

Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZH Dated: December 1, 2022 Received: December 2, 2022

Dear Varela Fredy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

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product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221603

Device Name

Kangaroo™ Omni Enteral Feeding Pump, Kangaroo™ Omni Feeding Sets, and Kangaroo™ Accessories

Indications for Use (Describe)

Intended for delivery of enteral fluids, including nutritional fluids and/or water to the gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes. Not for use with neonates. Intended for any patients ages infant, child/adolescent and adult who are physically unable to eat and swallow or who are unable to get sufficient nutrition through eating and swallowing. Intended to be used in hospital and acute care settings, as well as long term and home care settings by users ranging from clinicians to laypersons and patients may need a caregiver to support using the device. It is intended to be used in both stationary and ambulatory conditions including ground and air transport while using backpack accessory.

The Kangaroo OMNI™ Enteral Feeding Set are intended to be used together as a system. Kangaroo OMNI™ Enteral Feeding Sets for administration of standard formula are able to be connected to access devices of all sizes that are ENFit™ compatible. The Kangaroo OMNI™ Thick Formula Feeding Sets for administration of thick formula can be used with access devices 8 Fr size or greater that are ENFit™ compatible.

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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K221603 510(K) SUMMARY

Manufacturer's Name:	Cardinal Health LLC3651 Birchwood DriveWaukegan, IL 60085
Corresponding Official:	Fredy VarelaManager, Regulatory Affairs
Telephone Number:E-mail:	847.887.5781fred.varela@cardinalhealth.com
Preparation Date:	December 19, 2022
Trade Name:	Kangaroo OMNITM Enteral Feeding Pump, Kangaroo OMNITM FeedingSets and KangarooTM Accessories
Common or UsualName:	Enteral Feeding pump, Infusion pump
Classification Name andNumber:	Infusion Pump21 CFR 880.5725Class IIProduct Code: LZH
Primary PredicateDevice:	KangarooTM Connect Enteral Feeding Pump with KangarooTMConnect Feeding Sets and KangarooTM Connect Portal
Reference Device:	Kendall ePump Enteral Feeding Pump and Enteral Feeding Sets

Device Description

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Intended Use/Indications for Use

Feature	Predicate DeviceKangaroo™ConnectK153074	Subject DeviceKangaroo™ OMNIK221603 (current submission)	Subject vs. Predicate Device DifferencesSubstantial Equivalence
IntendedUse/Indicationsfor Use	Intended todeliver nutritionalformula at acontrolled rate tothegastrointestinalsystem of apatient who isphysically unableto eat andswallow. Not foruse with neonates.The feeding pumpand feeding setsare intended to beused in clinical orhome caresettings by usersranging fromlaypersons tophysicians.	Intended for delivery of enteral fluids,including nutritional fluids and/or water tothe gastrointestinal system via nasogastric,orogastric, nasojejunal, gastrostomy, andjejunostomy tubes. Not for use withneonates. Intended for any patients agesinfant, child/adolescent and adult who arephysically unable to eat and swallow or whoare unable to get sufficient nutritionthrough eating and swallowing. Intended tobe used in hospital and acute care settings,as well as long term and home care settingsby users ranging from clinicians tolaypersons and patients. Some patients mayneed a caregiver to support using thedevice. It is intended to be used in bothstationary and ambulatory conditionsincluding ground and air transport whileusing backpack accessory.The Kangaroo OMNI™ Enteral Feeding Pumpand Feeding Set are intended to be usedtogether as a system. Kangaroo OMNI™Enteral Feeding Sets for administration ofstandard formula are able to be connectedto access devices of all sizes that are ENFit™compatible. The Kangaroo OMNI™ ThickFormula Feeding Sets for administration ofthick formula can be used with accessdevices 8 Fr size or greater that are ENFit™compatible.	General purpose of the subject device or itsfunction, condition and patient population arethe same as predicate device. Subject devicefeature is substantially equivalent to that ofthe predicate device
TechnologicalCharacteristics	Peristalticpumping action	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Design (Pump)	The pumpincorporates amenu-controlled,operating systemwhich contains onboard customsoftware designedto allow the user	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Feature	Predicate DeviceKangaroo™ConnectK153074	Subject DeviceKangaroo™ OMNIK221603 (current submission)	Subject vs. Predicate Device DifferencesSubstantial Equivalence
	to set feed ratesand volumes aswell as otherfeeding options
Free FlowMechanism	Anti-Free FlowValve	Stopcock Valve	Difference does not introduce or raise concernsregarding the safe and effective use of thesubject device.
FeedCapability	Yes	Same	Subject device feature is substantiallyequivalent to that of the predicate device
Feed and FlushCapability	No	Yes	Difference is considered an addedbenefit/option for the user, and does notintroduce or raise concern regarding the safeand effective use of the subject device
Thick FormulaCapability	No	Yes	Difference is considered an addedbenefit/option for the user, and a designimprovement that does not introduce or raiseconcern regarding the safe and effective use ofthe subject device. Clinical benefits offered bythick formula feeding option outweigh the risksassociated with it.
FlowMonitoring	Yes, 2 Ultrasonicsensors	Same 2 ultrasonic sensors and 1 new forcesensor	Difference is considered a design improvementthat does not introduce or raise concernsregarding the safe and effective use of thesubject device.
OcclusionDetection	Yes, Upstream andDownstream	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Accuracy(StandardFormulaFeeding Sets)	$\pm$ 5%	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Accuracy(Thick FormulaFeeding Sets)	N/A	±10%	Difference is considered a design improvementthat does not introduce or raise concernregarding the safe and effective use of thesubject device
Delivery RateRange	1-600ml in 1mlincrements	1 to 400mL per hour in 1mL increments(Standard Formula Feeding Sets)1 to 200mL per hour in 1mL increments(Thick Formula Feeding Sets)	Difference is considered a design improvementthat does not introduce or raise concernregarding the safe and effective use of thesubject device
Dose Range	1-3000ml in 1mlincrements	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Powerrequirements	120V, 60Hz, 1Amp	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Autoprime	Yes	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Display	Color TFT(320x240pixels)	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
MaximumOcclusionPressure	20 psi	16 psi	Difference is considered a design improvementthat does not introduce or raise concernsregarding the safe and effective use of thesubject device.
Feature	Predicate DeviceKangaroo™ConnectK153074	Subject DeviceKangaroo™ OMNIK221603 (current submission)	Subject vs. Predicate Device DifferencesSubstantial Equivalence
Size	3.9" x 6.1" x 1.6"	5.5" x 6.8" x 2.6"	Differences do not introduce or raise concernregarding the safe and effective use of thesubject device. Subject device feature issubstantially equivalent to that of thepredicate device
Weight	0.73 lbs (0.33 kg)	1.7 lbs (770 grams)	Differences do not introduce or raise concernregarding the safe and effective use of thesubject device. Subject device feature issubstantially equivalent to that of thepredicate device
Pole ClampMountable	Yes	same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Battery Life	24 hours	20 hours	Difference is considered a design improvementthat does not introduce or raise concernregarding the safe and effective use of thesubject device
BatteryRecharge Time	7 hours	12 hours	Difference is considered a design improvementthat does not introduce or raise concernregarding the safe and effective use of thesubject device
BatteryOperationIndicator	Yes	same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
OperatingTemperatureRange	5°-40°C (41°-104ºF) at 93% R.H.(non-condensing)	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
StorageTemperatureRange	0°-50°C (32°-122°F) at 93% R.H.(non-condensing)	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Medical andElectricalSafetyStandards	IEC 60601-1ANSI/AAMI ES60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8IEC 60601-1-11IEC 60601-2-24IEC 62304IEC 62366	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Degree ofProtectionAgainstElectricalShock	Class 2 Type BHper IEC StandardsPass	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Degree ofProtection forliquid ingress	IP26 = Water Jetproof per IEC60529Pass	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
EMC/ EMI andESD standards	IEC 60601-1-2Parts 1 and 2	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
Power Adapter	Yes	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of thepredicate device
RechargeableBattery	Lithium Ion	Same	Subject device feature is the same as thepredicate device. Subject device feature issubstantially equivalent to that of the
Feature	Predicate DeviceKangaroo™ConnectK153074	Subject DeviceKangaroo™ OMNIK221603 (current submission)	Subject vs. Predicate Device DifferencesSubstantial Equivalence
			predicate device
Pump ControlAlarms andNotifications	Alarms:System ErrorFeed Bag EmptySupply TubeBlockedPatient TubeBlockedCassette DislodgedCassette ErrorRotor StuckDead Battery	Alarms:System ErrorDead BatteryValve ErrorRotor StuckCassette DislodgedCassette ErrorSensor Error (1 - 3)Patient Tube BlockedFeed ErrorFlush ErrorLow Battery CautionLow Battery NoticePump Inactive	Differences are considered designimprovements that do not introduce or raiseconcerns regarding the safe and effective useof the subject device.
	Notifications:Feeding CompleteFeedingIncompleteLow BatteryPump Inactive	Notifications:Feeding CompleteFeeding IncompleteSettings Locked
Timed PauseFeature	Displayed as KTOVol delivered atmaximum timeinterval	Displayed as Timed Pause Vol delivered atmaximum time interval	Difference does not introduce or raise concernregarding the safe and effective use of thesubject device. Subject device feature issubstantially equivalent to that of thepredicate device

Substantial Equivalence Discussion

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Performance Testing

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

The Kangaroo OMNI™ System is acceptably safe for its intended use, within its environment of use, when being used by intended users, over the lifecycle of the product.

The following specific evidence was included within the assurance case to demonstrate that the subject device is verified and validated for its intended use, and to demonstrate substantial equivalence to the predicate device.

Software	Software verification and validation per FDA guidance for the "Content of premarketsubmissions for software contained in medical devices" for a Major Level of Concern andFDA guidance document "Infusion pump total product life cycle"
Electrical Safety	The electrical safety evaluation of the medical electrical equipment was performed perstandards IEC60601-1 medical electrical equipment part1: General requirements for basicsafety and essential performance
EMC	The Kangaroo OMNI™ Enteral Feeding Pump was evaluated to IEC 60601-1-2: Medicalelectrical equipment - Part 2: General requirement for basic safety and essentialperformance - Collateral standard: electromagnetic compatibility - Requirements andtests.

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Device Performance	The essential performance requirements of the device (including feeding sets) wereverified through performance testing in accordance with the intended use of the deviceand in accordance with the FDA Guidance “Infusion Pumps Total Product Life Cycle”including:Performance testing of essential performance attributes Reliability testing Flow rate accuracy testing across all operating conditions Alarm detection
Human Factors	Follow FDA Guidance Applying Human Factors and Usability Engineering to MedicalDevices (February 3, 2016), the human factors studies were conducted with the intendeduser population, use environment, and use scenarios to simulate clinical conditions.Results of the human factors testing demonstrate validation of the device per theintended use.
Biocompatibility	The biocompatibility test reports provided were conducted per ISO10993 series standardfollowing Good Laboratory Practices and the representative product tested passed allacceptance criteria.
Battery Testing	The battery pack has been tested in accordance with IEC 62133.

Clinical Testing

Not Applicable

Conclusions

The differences between the predicate and the subject device do not introduce or raise concerns regarding the safe and effective use of the subject device.

The subject device, Kangaroo OMNI™ Enteral Feeding Pump, Kangaroo OMNI™ Feeding Sets and Kangaroo™ Accessories is substantially equivalent to the legally marketed predicate device, Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets and Kangaroo™ Connect Portal (K153074) with respect to the intended use/indications for use,target populations,treatment method,and technological characteristics.

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).