(258 days)
Not Found
No
The summary describes a wireless-enabled pump for data collection and monitoring, but there is no mention of AI or ML being used for analysis, decision-making, or any other function.
No.
The device delivers nutritional formula and monitors feeding rates, serving as a life-sustaining support system rather than a device for treating or diagnosing a specific disease or condition.
No
The device is described as an enteral feeding pump intended to deliver nutritional formula, not to diagnose a medical condition.
No
The device description explicitly states it consists of a "wireless enabled enteral feeding pump and disposable enteral feeding sets," which are hardware components. While it includes software (Kangaroo™ Connect Portal) and wireless accessories (communication hub), the core device is a physical pump.
Based on the provided information, the Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver nutritional formula to the gastrointestinal system of a patient. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a pump and feeding sets that deliver formula. This aligns with a medical device used for treatment or support, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Kangaroo™ Connect Enteral Feeding Pump is a medical device used for delivering nutrition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal system
Indicated Patient Age Range
infant and older. Not for use with neonates.
Intended User / Care Setting
clinical or home care settings by users ranging from laypersons to physicians.
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)
A safety assurance case as recommended by the FDA guidance 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 lifecycle of the product.
The assurance case defined the device system, including the indications for use, system definition, operational description, patient populations, and use environments.
The following assurance claims were used to support the design safety goals:
- System design is acceptably safe
- All relevant hazards have been identified and controlled
- System wise hazard analyses are adequate
- All identified hazards have at least one corresponding control.
- All requirements have been implemented and verified
- Device design ensures safe behavior
- Reliability requirements are met
- All relevant hazards have been identified and controlled
- System in use is acceptably safe
- Development and supporting processes are adequate
- Quality assurance is adequate
- Software development is adequate
- Risk Management process is adequate
- 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
- Flow Rate Accuracy
- Downstream Occlusion Detection
- Pump Alarms (Feed Bag Empty, Supply Tube Blocked, Cassette Dislodged, Rotor 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 guidance document Infusion Pump Total Product Life Cycle
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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) |
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3
K153074 510(K) SUMMARY
| Manufacturer's Name: | Covidien
15 Hampshire Street
Mansfield, MA 02048 |
|------------------------------------|------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Karin Desjardins
Manager, Regulatory Affairs
Patient Monitoring & Recovery
Medtronic |
| Telephone Number:
E-mail: | (508) 452-1856
karin.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 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: | K143263 - Kangaroo™ Connect Enteral Feeding Pump with
Kangaroo™ Connect Feeding Sets |
| Secondary Predicate
Device: | K141789 - Plum 360™ Infusion system with Hospira MedNet™
Smart Card Plug 'n' Play CE 3.0 Module |
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.
1
4
Intended Use
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.
| | Primary Predicate
Device | Secondary Predicate
Device | Subject Device |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K143263 | K141789 | K153074 |
| Device Name | Kangaroo™ Connect
Enteral Feeding Pump,
Kangaroo™ Connect
Enteral Feeding Sets | Plum 360™ Infusion system
with Hospira MedNet™ /
Smart Card Plug 'n' Play
CE 3.0 Module | Kangaroo™ Connect
Enteral Feeding Pump,
Kangaroo™ Connect
Enteral Feeding Sets, and
Kangaroo™ Connect Portal |
| Device Description | Enteral feeding pump and
disposable enteral feeding
sets | Infusion Pumps, Infusion
safety management
software & Intravascular
Administration Sets | Enteral feeding pump and
disposable enteral feeding
sets |
| Intended Use | 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 clinicians | Indicated for use in
parenteral, enteral and
epidural therapies and the
administration of whole
blood and blood products. | 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 |
| Intent of Wireless
Connectivity | Not applicable - no wireless
features | Allows communication
between the Infusion
Pump, Hospira MedNet™
server and the facility's
communication systems. | Provide a platform for
remote data collection. |
| Sterility | Non Sterile feeding sets | Not known | Non Sterile feeding sets |
| | Primary Predicate
Device | Secondary Predicate
Device | Subject Device |
| Technological
Characteristics | The feeding sets are
based on peristaltic
pumping using a rotating
wheel which presses
against the tubing and
moves the fluid at a
controlled rate.
The connection to the
patient enteral access
device is an ENFit
Connector compliant to
ISO 80369-3. | Not known | The feeding sets are
based on peristaltic
pumping using a rotating
wheel which presses
against the tubing and
moves the fluid at a
controlled rate.
The connection to the
patient enteral access
device is an ENFit
Connector compliant to
ISO 80369-3. |
| Design (pump) | The pump incorporates a
menu controlled
operating system which
contains on board custom
software designed to
allow the user to set feed
rates and volumes as well
as other feeding options.
The device incorporates
ultrasonic sensors to
detect the air and
blockages in the feeding
set. | Not known | The pump incorporates a
menu controlled operating
system which contains on
board custom software
designed to allow the user
to set feed rates and
volumes as well as other
feeding options. The
device incorporates
ultrasonic sensors to
detect the air and
blockages in the feeding
set. |
| Rechargeable
Battery | 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 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) | Not known | 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) |
| | Primary Predicate
Device | Secondary Predicate
Device | Subject Device |
| Includes Anti-Free
Flow Valve | Yes | Not known | Yes |
| Materials/Chemical
Composition | 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
- o All relevant hazards have been identified and controlled
- . 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.