Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal

K153074 · Covidien · LZH · Jul 6, 2016 · General Hospital

Device Facts

• Record ID: K153074
• Device Name: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
• Applicant: Covidien
• Product Code: LZH · General Hospital
• Decision Date: Jul 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Enteral feeding pump delivers nutritional formula via rotary peristaltic tension loop pumping; uses disposable feeding sets. New wireless-enabled version includes communication hub and Kangaroo™ Connect Portal. Hub collects pump data via Zigbee; transmits via WiFi/cellular to cloud for remote monitoring. Used in clinical or home settings by laypersons or physicians. Clinicians access portal to monitor feeding rates and review delivery history; facilitates improved patient outcomes through remote data collection. Pump features menu-controlled OS, ultrasonic sensors for air/blockage detection, and anti-free flow valve.

Clinical Evidence

No clinical data submitted. Evidence consists of a safety assurance case, system verification and validation, wireless performance testing, human factors usability testing, electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2).

Technological Characteristics

Peristaltic pump with rotating wheel; ultrasonic sensors for air/blockage detection. Materials: PVC (bags/tubing), silicone (peristaltic tubing/diaphragm), polycarbonate (cassette), CoPolyester (connector), ABS (spike/cap), Strontium Ferrite/nylon (magnets). Connectivity: Zigbee (pump-to-hub), WiFi/cellular (hub-to-cloud). Power: Lithium-ion battery. IP26 water ingress rating. Patient interface: ENFit connector (ISO 80369-3).

Indications for Use

Indicated for delivery of nutritional formula to the gastrointestinal system of patients (infant and older) physically unable to eat/swallow. Contraindicated for neonates.

Regulatory Classification

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.

Predicate Devices

• Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets (K143263)
• Plum 360™ Infusion system with Hospira MedNet™ / Smart Card Plug 'n' Play CE 3.0 Module (K141789)

Submission Summary (Full Text)

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size: 10pt;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
| | <span> <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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#### K153074 510(K) SUMMARY

| Manufacturer's Name: | Covidien<br>15 Hampshire Street<br>Mansfield, MA 02048 |
|------------------------------------|------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Karin Desjardins<br>Manager, Regulatory Affairs<br>Patient Monitoring & Recovery<br>Medtronic |
| Telephone Number:<br>E-mail: | [phone]<br>[e-mail] |
| Preparation Date: | June 28, 2016 |
| Trade Name: | Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™<br>Connect Feeding Sets and Kangaroo™ Connect Portal |
| Common or Usual<br>Name: | Enteral Feeding pump, Infusion pump |
| Classification Name and<br>Number: | Infusion Pump<br>21 CFR 880.5725<br>Class II<br>Product Code: LZH |
| Primary Predicate<br>Device: | K143263 - Kangaroo™ Connect Enteral Feeding Pump with<br>Kangaroo™ Connect Feeding Sets |
| Secondary Predicate<br>Device: | K141789 - Plum 360™ Infusion system with Hospira MedNet™<br>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.

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### 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<br>Device | Secondary Predicate<br>Device | Subject Device |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K143263 | K141789 | K153074 |
| Device Name | Kangaroo™ Connect<br>Enteral Feeding Pump,<br>Kangaroo™ Connect<br>Enteral Feeding Sets | Plum 360™ Infusion system<br>with Hospira MedNet™ /<br>Smart Card Plug 'n' Play<br>CE 3.0 Module | Kangaroo™ Connect<br>Enteral Feeding Pump,<br>Kangaroo™ Connect<br>Enteral Feeding Sets, and<br>Kangaroo™ Connect Portal |
| Device Description | Enteral feeding pump and<br>disposable enteral feeding<br>sets | Infusion Pumps, Infusion<br>safety management<br>software & Intravascular<br>Administration Sets | Enteral feeding pump and<br>disposable enteral feeding<br>sets |
| Intended Use | The Kangaroo™ Connect<br>Enteral Feeding Pump with<br>Kangaroo Connect™ Feeding<br>Sets is intended to deliver<br>nutritional formula to the<br>gastrointestinal system of a<br>patient age infant and older<br>who is physically unable to<br>eat and swallow. Not for use<br>with neonates. The feeding<br>pump and feeding sets are<br>intended to be used in<br>clinical or home care<br>settings by users ranging<br>from laypersons to clinicians | Indicated for use in<br>parenteral, enteral and<br>epidural therapies and the<br>administration of whole<br>blood and blood products. | The Kangaroo™ Connect<br>Enteral Feeding Pump with<br>Kangaroo™ Connect Feeding<br>Sets is intended to deliver<br>nutritional formula to the<br>gastrointestinal system of a<br>patient age infant and older<br>who is physically unable to<br>eat and swallow. Not for use<br>with neonates. The feeding<br>pump and feeding sets are<br>intended to be used in<br>clinical or home care settings<br>by users ranging from<br>laypersons to physicians |
| Intent of Wireless<br>Connectivity | Not applicable - no wireless<br>features | Allows communication<br>between the Infusion<br>Pump, Hospira MedNet™<br>server and the facility's<br>communication systems. | Provide a platform for<br>remote data collection. |
| Sterility | Non Sterile feeding sets | Not known | Non Sterile feeding sets |
| | Primary Predicate<br>Device | Secondary Predicate<br>Device | Subject Device |
| Technological<br>Characteristics | The feeding sets are<br>based on peristaltic<br>pumping using a rotating<br>wheel which presses<br>against the tubing and<br>moves the fluid at a<br>controlled rate.<br>The connection to the<br>patient enteral access<br>device is an ENFit<br>Connector compliant to<br>ISO 80369-3. | Not known | The feeding sets are<br>based on peristaltic<br>pumping using a rotating<br>wheel which presses<br>against the tubing and<br>moves the fluid at a<br>controlled rate.<br>The connection to the<br>patient enteral access<br>device is an ENFit<br>Connector compliant to<br>ISO 80369-3. |
| Design (pump) | The pump incorporates a<br>menu controlled<br>operating system which<br>contains on board custom<br>software designed to<br>allow the user to set feed<br>rates and volumes as well<br>as other feeding options.<br>The device incorporates<br>ultrasonic sensors to<br>detect the air and<br>blockages in the feeding<br>set. | Not known | The pump incorporates a<br>menu controlled operating<br>system which contains on<br>board custom software<br>designed to allow the user<br>to set feed rates and<br>volumes as well as other<br>feeding options. The<br>device incorporates<br>ultrasonic sensors to<br>detect the air and<br>blockages in the feeding<br>set. |
| Rechargeable<br>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<br>basic segments:<br>• Fluid reservoir(s), which<br>may be an attached bag<br>(500ml or 1000ml) or a<br>spike for connection to<br>a formula container<br>• Tubing from fluid<br>reservoir to pump (14<br>inch)<br>• Cassette containing<br>pump interface module<br>(peristaltic tubing)<br>• Tubing from pump to<br>patient connector (66<br>inches)<br>• Patient connector (ENFit<br>connector compliant to<br>ISO 80369-3) | Not known | The pump set incorporates 5<br>basic segments:<br>• Fluid reservoir(s), which<br>may be an attached bag<br>(500ml or 1000ml) or a<br>spike for connection to<br>a formula container<br>• Tubing from fluid<br>reservoir to pump (14<br>inch)<br>• Cassette containing<br>pump interface module<br>(peristaltic tubing)<br>• Tubing from pump to<br>patient connector (66<br>inches)<br>• Patient connector (ENFit<br>connector compliant to<br>ISO 80369-3) |
| | Primary Predicate<br>Device | Secondary Predicate<br>Device | Subject Device |
| Includes Anti-Free<br>Flow Valve | Yes | Not known | Yes |
| Materials/Chemical<br>Composition | Polyvinyl chloride (PVC)<br>• Feeding bags and caps<br>• Tubing | Not known | Polyvinyl chloride (PVC)<br>• Feeding bags and caps<br>• Tubing |
| | Silicone<br>• Peristaltic tubing<br>• Diaphragm valve | | Silicone<br>• Peristaltic tubing<br>• Diaphragm valve |
| | Polycarbonate<br>• Cassette body | | Polycarbonate<br>• Cassette body |
| | CoPolyester<br>• Patient connector | | CoPolyester<br>• Patient connector |
| | ABS<br>• Spike<br>• Tube holder and Cap | | ABS<br>• Spike<br>• Tube holder and Cap |
| | Strontium Ferrite / nylon<br>• Set ID magnets | | Strontium Ferrite / nylon<br>• Set ID magnets |

#### Substantial Equivalence Discussion

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## 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.

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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

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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.