(202 days)
Not Found
No
The document describes a standard enteral feeding set and pump system with no mention of AI or ML capabilities.
No.
This device delivers nutritional formula and does not treat or cure a disease or condition.
No
This device is an enteral feeding set used to deliver nutritional formula, not to diagnose a medical condition.
No
The device description clearly outlines physical components such as fluid reservoirs, tubing, a pump interface module, and a patient connector. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver nutritional formula to the gastrointestinal system. This is a therapeutic/supportive function, not a diagnostic one.
- Device Description: The description details components for delivering fluid (reservoir, tubing, pump interface, connector). There are no components or functions related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to examine specimens derived from the human body in vitro to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Kangaroo™ Enteral Feeding Set with ENFit connectors delivers 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 sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.
Product codes
LZH
Device Description
Enteral Feeding sets for use with Kangaroo Feeding pumps. 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 (9 or 24 inch); Pump interface module (peristaltic tubing); Tubing from pump to patient connector (66 inches); Patient connector (ENFit connector compliant to ISO 80369-3). 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.
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
laypersons to clinicians / clinical or home care settings
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
Biocompatibility testing in accordance with ISO 10993-1:2009. Stability testing. Usability and human factors testing. Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
Covidien Mr. Jim Welsh Vice President, Regulatory Affairs 15 Hampshire Street Mansfield, MA 02048
Re: K141479
Trade/Device Name: Kangaroo™ Enteral Feeding Sets with ENFit connectors Regulation Number: 21 CFR 880.5725 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: LZH Dated: November 20, 2014 Received: November 21, 2014
Dear Mr. Welsh:
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
Page 2 - Mr. Welsh
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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) K141479
Device Name
KangarooTM Enteral Feeding Sets with ENFit small bore connectors
Indications for Use (Describe)
The Kangaroo™ Enteral Feeding Set with ENFit connectors delivers 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 sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Kangaroo Enteral Feeding Set with ENFit connectors
In accordance with section 513(i) of the SMDA and as defined in 21CFR Part 807.92 this summary is submitted by:
Covidien 15 Hampshire Street Mansfield, MA 02048 Date Prepared: December 23, 2014
a. Contact Person
Jim Welsh VP, Regulatory Affairs Covidien Telephone: (508) 261-8532 Fax: (508) 261-8461
b. Name of Medical Device
Common Name: tube, feeding
- U.S. FDA Classification Product Code: LZH
- U.S. Regulation Description: Infusion Pump, 21 CFR 880.5725
Proprietary / Trade Name: Kangaroo™ Enteral Feeding Set with ENFit connectors
c. Identification of Legally Marketed Device(s)
Covidien Kangaroo™ ePump Enteral Feeding Pump and Enteral Feeding Set, K040196
d. Device comparison summary
The table below provides a comparison of the key attributes of the predicate and proposed devices.
4
| Device Comparison Summary | ||
|---|---|---|
| Predicate Device | Proposed Device | |
| Device Name | Kangaroo™ e-pump | Kangaroo™ Enteral Feeding |
| Set with ENFit connectors | ||
| Device Description | Enteral feeding pump and | |
| disposable enteral feeding sets | Enteral Feeding sets for use | |
| with Kangaroo Feeding pumps | ||
| Intended Use | Intended for use in patients | |
| with any condition requiring | ||
| enteral feeding and/or enteral | ||
| hydration, which can be | ||
| accomplished by means of an | ||
| enteral feeding, pump and | ||
| pump set. The pump and | ||
| feeding sets are intended to be | ||
| used in alternate, acute and | ||
| home care settings by users | ||
| ranging from laypersons to | ||
| clinicians. The purpose of this | ||
| device is to deliver enteral | ||
| nutrition at a controlled rate to | ||
| a patients gastrointestinal | ||
| system. | Intended for use in patients | |
| age Infant and older with any | ||
| condition requiring enteral | ||
| feeding and/or enteral | ||
| hydration, which can be | ||
| accomplished by means of an | ||
| enteral feeding, pump and | ||
| pump set. Not for use with | ||
| neonates. The feeding sets are | ||
| intended to be used in clinical | ||
| or home care settings by users | ||
| ranging from laypersons to | ||
| clinicians. The purpose of this | ||
| device is to deliver enteral | ||
| nutrition to a patient's | ||
| gastrointestinal system. | ||
| Sterility | Includes sterile and non-sterile | |
| feeding sets | Non-sterile | |
| 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 a | ||
| stepped connector. | 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 | 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 (24 | ||
| inch) | 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 (9 or | ||
| 24 inch) | ||
| Pump interface module | ||
| • | ||
| (peristaltic tubing) | ||
| Tubing from pump to | ||
| • | ||
| patient connector (66 inches) | ||
| Patient connector | ||
| • | ||
| (stepped connector) | Pump interface module | |
| • | ||
| (peristaltic tubing) | ||
| Tubing from pump to | ||
| • | ||
| patient connector (66 inches) | ||
| Patient connector (ENFit | ||
| connector compliant to ISO | ||
| 80369-3) | ||
| Materials/Chemical composition | Polyvinyl chloride (PVC) | Polyvinyl chloride (PVC) |
| Feeding bags and caps | ||
| • | Feeding bags and caps | |
| • | ||
| Tubing | ||
| • | Tubing | |
| • | ||
| Patient connector | ||
| • | ||
| Silicone | Drip Chamber | |
| • | ||
| Silicone | ||
| Peristaltic tubing | ||
| • | Peristaltic tubing | |
| • | ||
| Polycarbonate | Polycarbonate | |
| Valve body | ||
| • | Valve body | |
| • | ||
| HDPE | HDPE | |
| Valve stem | ||
| • | Valve stem | |
| • | ||
| LDPE | Feeding container | |
| • | ||
| Dust Cover | ||
| • | LDPE | |
| ABS | Dust Cover | |
| • | ||
| Spike | ||
| • | Hanger strap | |
| • | ||
| Strontium Ferrite / nylon | ABS | |
| Set ID magnets | ||
| • | Spike | |
| • | ||
| Strontium Ferrite / nylon | ||
| Set ID magnets | ||
| • | ||
| Copolyester | ||
| ENFit connector | ||
| • | ||
| PE/EVA/EPE | ||
| Spike seal washer | ||
| • | ||
| Polystyrene | ||
| Roller clamp | ||
| • |
5
6
- e. Discussion of technological differences
The Kangaroo™ Enteral Feeding Set with ENFit connectors are intended for use with existing feeding pumps, and as such the technological differences are limited to the incorporation of the new ENFit connector which is compliant to ISO 80369-3. This connector is part of an industry wide effort to address misconnections by adopting a uniform connector that has been engineered to meet the objective of ISO 80369-1, small-bore connectors for liquids and gases in healthcare applications - part 1: general requirements
f. Discussion of Nonclinical testing
- Biocompatibility testing in accordance with ISO 10993-1:2009, Biological Evaluation of ● medical Devices- Part 1: Evaluation and Testing has demonstrated the biological safety of parts of the medical device which may indirectly contact the patient, and is consistent with FDA "Draft Guidance for Industry and FDA staff, Use of international Standard ISO 10993 'Biological Evaluation of medical Devices Part 1: Evaluation and Testing,"' issued on April 23, 2013. Similar testing had been conducted for the predicate device.
- . Stability testing of the proposed device evaluated the key performance properties of the feeding set after accelerated aging in support of the expiration date which will be applied to the device.
- . Usability and human factors testing was conducted as part of the design of the ENFit connector.
Clinical testing g.
Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.
h. Conclusions
This information provided within this pre-market notification demonstrates that the Kangaroo™ Enteral Feeding Set with ENFit connectors is as effective, and performs as well as or better than the legally marketed device. I find the subject device to be substantially equivalent to the predicate device. The addition of the ENFit connector, which is compliant with ISO 80369-3 is intended to improve device performance by addressing the risk of misconnections.
End of Summary