(201 days)
Kendall ePump Enteral Feeding Pump and Enteral Feeding Sets
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The pumping mechanism is described as rotary peristaltic tension loop pumping, which is a mechanical process.
No.
The device is used to deliver fluids for nutrition and hydration, which supports physiological function but does not directly treat a disease or medical condition.
No.
The device is described as an enteral feeding pump intended for the delivery of nutritional fluids and water to the gastrointestinal system, and its description focuses on fluid delivery and accuracy, not diagnosis.
No
The device description explicitly states it consists of an "enteral feeding pump and disposable enteral feeding sets along with accessories," indicating hardware components are integral to the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of fluids (nutritional fluids and water) to the gastrointestinal system. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device is described as an enteral feeding pump and feeding sets that deliver fluids. It doesn't perform any tests on biological samples to provide diagnostic information.
- Lack of Diagnostic Activities: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis, monitoring, or screening.
- Performance Metrics: The key metrics provided are related to the accuracy of fluid delivery (flow rate accuracy), which is relevant to the device's function as a pump, not as a diagnostic tool.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to provide nutrition and hydration directly to the patient's gastrointestinal system.
N/A
Intended Use / Indications for Use
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.
Product codes
LZH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal system via nasogastric, orogastric, nasojejunal, gastrostomy, and jejunostomy tubes.
Indicated Patient Age Range
any patients ages infant, child/adolescent and adult. Not for use with neonates.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Software: Software verification and validation per FDA guidance for the "Content of premarket submissions for software contained in medical devices" for a Major Level of Concern and FDA guidance document "Infusion pump total product life cycle".
- Electrical Safety: The electrical safety evaluation of the medical electrical equipment was performed per standards IEC60601-1 medical electrical equipment part1: General requirements for basic safety and essential performance.
- EMC: The Kangaroo OMNI™ Enteral Feeding Pump was evaluated to IEC 60601-1-2: Medical electrical equipment - Part 2: General requirement for basic safety and essential performance - Collateral standard: electromagnetic compatibility - Requirements and tests.
- Device Performance: The essential performance requirements of the device (including feeding sets) were verified through performance testing in accordance with the intended use of the device and 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 Medical Devices (February 3, 2016), the human factors studies were conducted with the intended user population, use environment, and use scenarios to simulate clinical conditions. Results of the human factors testing demonstrate validation of the device per the intended use.
- Biocompatibility: The biocompatibility test reports provided were conducted per ISO10993 series standard following Good Laboratory Practices and the representative product tested passed all acceptance criteria.
- Battery Testing: The battery pack has been tested in accordance with IEC 62133.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Accuracy (Standard Formula Feeding Sets): +/- 5%
- Accuracy (Thick Formula Feeding Sets): +/- 10%
Predicate Device(s)
Reference Device(s)
Kendall ePump Enteral Feeding Pump and Enteral Feeding Sets
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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
3
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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4
K221603 510(K) SUMMARY
| Manufacturer's Name: | Cardinal Health LLC
3651 Birchwood Drive
Waukegan, IL 60085 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Fredy Varela
Manager, Regulatory Affairs |
| Telephone Number:
E-mail: | 847.887.5781
fred.varela@cardinalhealth.com |
| Preparation Date: | December 19, 2022 |
| Trade Name: | Kangaroo OMNITM Enteral Feeding Pump, Kangaroo OMNITM Feeding
Sets and KangarooTM Accessories |
| Common or Usual
Name: | Enteral Feeding pump, Infusion pump |
| Classification Name and
Number: | Infusion Pump
21 CFR 880.5725
Class II
Product Code: LZH |
| Primary Predicate
Device: | KangarooTM Connect Enteral Feeding Pump with KangarooTM
Connect Feeding Sets and KangarooTM Connect Portal |
| Reference Device: | Kendall ePump Enteral Feeding Pump and Enteral Feeding Sets |
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.
5
Intended Use/Indications for Use
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.
| Feature | Predicate Device
Kangaroo™
Connect
K153074 | Subject Device
Kangaroo™ OMNI
K221603 (current submission) | Subject vs. Predicate Device Differences
Substantial Equivalence |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | Intended to
deliver nutritional
formula at a
controlled rate to
the
gastrointestinal
system of a
patient 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. | 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. | General purpose of the subject device or its
function, condition and patient population are
the same as predicate device. Subject device
feature is substantially equivalent to that of
the predicate device |
| Technological
Characteristics | Peristaltic
pumping action | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Design (Pump) | The pump
incorporates a
menu-controlled,
operating system
which contains on
board custom
software designed
to allow the user | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Feature | Predicate Device
Kangaroo™
Connect
K153074 | Subject Device
Kangaroo™ OMNI
K221603 (current submission) | Subject vs. Predicate Device Differences
Substantial Equivalence |
| | to set feed rates
and volumes as
well as other
feeding options | | |
| Free Flow
Mechanism | Anti-Free Flow
Valve | Stopcock Valve | Difference does not introduce or raise concerns
regarding the safe and effective use of the
subject device. |
| Feed
Capability | Yes | Same | Subject device feature is substantially
equivalent to that of the predicate device |
| Feed and Flush
Capability | No | Yes | Difference is considered an added
benefit/option for the user, and does not
introduce or raise concern regarding the safe
and effective use of the subject device |
| Thick Formula
Capability | No | Yes | Difference is considered an added
benefit/option for the user, and a design
improvement that does not introduce or raise
concern regarding the safe and effective use of
the subject device. Clinical benefits offered by
thick formula feeding option outweigh the risks
associated with it. |
| Flow
Monitoring | Yes, 2 Ultrasonic
sensors | Same 2 ultrasonic sensors and 1 new force
sensor | Difference is considered a design improvement
that does not introduce or raise concerns
regarding the safe and effective use of the
subject device. |
| Occlusion
Detection | Yes, Upstream and
Downstream | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Accuracy
(Standard
Formula
Feeding Sets) | $\pm$ 5% | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Accuracy
(Thick Formula
Feeding Sets) | N/A | ±10% | Difference is considered a design improvement
that does not introduce or raise concern
regarding the safe and effective use of the
subject device |
| Delivery Rate
Range | 1-600ml in 1ml
increments | 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 improvement
that does not introduce or raise concern
regarding the safe and effective use of the
subject device |
| Dose Range | 1-3000ml in 1ml
increments | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Power
requirements | 120V, 60Hz, 1Amp | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Autoprime | Yes | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Display | Color TFT
(320x240
pixels) | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Maximum
Occlusion
Pressure | 20 psi | 16 psi | Difference is considered a design improvement
that does not introduce or raise concerns
regarding the safe and effective use of the
subject device. |
| Feature | Predicate Device
Kangaroo™
Connect
K153074 | Subject Device
Kangaroo™ OMNI
K221603 (current submission) | Subject vs. Predicate Device Differences
Substantial Equivalence |
| Size | 3.9" x 6.1" x 1.6" | 5.5" x 6.8" x 2.6" | Differences do not introduce or raise concern
regarding the safe and effective use of the
subject device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Weight | 0.73 lbs (0.33 kg) | 1.7 lbs (770 grams) | Differences do not introduce or raise concern
regarding the safe and effective use of the
subject device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Pole Clamp
Mountable | Yes | same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Battery Life | 24 hours | 20 hours | Difference is considered a design improvement
that does not introduce or raise concern
regarding the safe and effective use of the
subject device |
| Battery
Recharge Time | 7 hours | 12 hours | Difference is considered a design improvement
that does not introduce or raise concern
regarding the safe and effective use of the
subject device |
| Battery
Operation
Indicator | Yes | same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Operating
Temperature
Range | 5°-40°C (41°-
104ºF) at 93% R.H.
(non-condensing) | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Storage
Temperature
Range | 0°-50°C (32°-
122°F) at 93% R.H.
(non-condensing) | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Medical and
Electrical
Safety
Standards | IEC 60601-1
ANSI/AAMI ES
60601-1
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-1-11
IEC 60601-2-24
IEC 62304
IEC 62366 | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Degree of
Protection
Against
Electrical
Shock | Class 2 Type BH
per IEC Standards
Pass | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Degree of
Protection for
liquid ingress | IP26 = Water Jet
proof per IEC
60529
Pass | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| EMC/ EMI and
ESD standards | IEC 60601-1-2
Parts 1 and 2 | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Power Adapter | Yes | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the
predicate device |
| Rechargeable
Battery | Lithium Ion | Same | Subject device feature is the same as the
predicate device. Subject device feature is
substantially equivalent to that of the |
| Feature | Predicate Device
Kangaroo™
Connect
K153074 | Subject Device
Kangaroo™ OMNI
K221603 (current submission) | Subject vs. Predicate Device Differences
Substantial Equivalence |
| | | | predicate device |
| Pump Control
Alarms and
Notifications | Alarms:
System Error
Feed Bag Empty
Supply Tube
Blocked
Patient Tube
Blocked
Cassette Dislodged
Cassette Error
Rotor Stuck
Dead Battery | Alarms:
System Error
Dead Battery
Valve Error
Rotor Stuck
Cassette Dislodged
Cassette Error
Sensor Error (1 - 3)
Patient Tube Blocked
Feed Error
Flush Error
Low Battery Caution
Low Battery Notice
Pump Inactive | Differences are considered design
improvements that do not introduce or raise
concerns regarding the safe and effective use
of the subject device. |
| | Notifications:
Feeding Complete
Feeding
Incomplete
Low Battery
Pump Inactive | Notifications:
Feeding Complete
Feeding Incomplete
Settings Locked | |
| Timed Pause
Feature | Displayed as KTO
Vol delivered at
maximum time
interval | Displayed as Timed Pause Vol delivered at
maximum time interval | Difference does not introduce or raise concern
regarding the safe and effective use of the
subject device. Subject device feature is
substantially equivalent to that of the
predicate device |
Substantial Equivalence Discussion
6
7
8
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 premarket
submissions for software contained in medical devices" for a Major Level of Concern and
FDA guidance document "Infusion pump total product life cycle" |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | The electrical safety evaluation of the medical electrical equipment was performed per
standards IEC60601-1 medical electrical equipment part1: General requirements for basic
safety and essential performance |
| EMC | The Kangaroo OMNI™ Enteral Feeding Pump was evaluated to IEC 60601-1-2: Medical
electrical equipment - Part 2: General requirement for basic safety and essential
performance - Collateral standard: electromagnetic compatibility - Requirements and
tests. |
9
| Device Performance | The essential performance requirements of the device (including feeding sets) were
verified through performance testing in accordance with the intended use of the device
and 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 Medical
Devices (February 3, 2016), the human factors studies were conducted with the intended
user population, use environment, and use scenarios to simulate clinical conditions.
Results of the human factors testing demonstrate validation of the device per the
intended use. |
| Biocompatibility | The biocompatibility test reports provided were conducted per ISO10993 series standard
following Good Laboratory Practices and the representative product tested passed all
acceptance 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.