(197 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The performance studies focus on standard medical device testing like biocompatibility, electrical safety, and infusion accuracy.
No
The device delivers nutritional formula to the gastrointestinal system for patients unable to eat, which is supportive care rather than treating a disease or condition.
No
The device is an enteral feeding pump used to deliver nutritional formula, not to diagnose a condition.
No
The device description explicitly states "Enteral feeding pump and disposable enteral feeding sets," indicating it includes hardware components (the pump and feeding sets) in addition to any potential software.
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 function, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: It's an enteral feeding pump and disposable feeding sets. This aligns with a device used for delivering substances into the body, not for analyzing samples from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device's function is to provide nutritional support, which is a treatment or management activity, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets 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 pump and 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
The Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Enteral Feeding Sets consist of an enteral feeding pump and disposable enteral feeding sets. 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. 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 air and blockages in the feeding set. It has a lithium ion rechargeable battery and a multi-color graphic display. The water ingress rating is IP26. The pump set incorporates 5 basic segments: Fluid reservoir(s) (either an attached bag 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), and Patient connector (ENFit connector compliant to ISO 80369-3). It includes an anti-free flow valve and is non-sterile.
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 clinicians.
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)
Nonclinical testing was conducted, which included:
- Biocompatibility testing of the Kangaroo™ Connect Feeding Sets in accordance with ISO 10993-1:2009.
- Cleaning and disinfection instructions and validation documentation.
- Stability testing of the proposed device to evaluate key performance properties after accelerated aging.
- Human factors testing to evaluate the usability of the device and the ENFit connector.
- Electrical Safety testing in accordance with applicable IEC standards.
- Software verification and validation testing.
- Battery evaluation in accordance with UL 2054, 2nd Edition.
- Functionality and infusion delivery accuracy testing with over 35 representative nutritional formulas, including evaluation at low and high temperatures using low and high viscosity fluids.
- Verification of the fluid ingress protection rating on test samples preconditioned with mechanical stress tests defined in ANSI/AAMI ED 60601-1 (push test, impact test, drop test, and mold stress).
- Performance and reliability of the sensors confirmed when the device is used as labeled.
- A safety assurance case for the Kangaroo Connect Enteral Feeding Pump and Feeding Sets was provided.
Clinical evaluations were not submitted.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are black and are arranged in a way that suggests depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2015
Covidien Ms. Karin Desjardins Manger, Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K143263
Trade/Device Name: Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Feeding Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZH Dated: April 27, 2015 Received: April 29, 2015
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 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 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/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 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 vours.
Tina
Kiang -S
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) K143263
Device Name
KangarooTM Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets
Indications for Use (Describe)
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets delivers 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 clinicians.
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)
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)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary: K143263
Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Enteral Feeding Sets
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: May 21, 2015
-
a. Contact Person
Karin Desjardins Manager, Regulatory Affairs Patient Monitoring & Recovery Medtronic Telephone: (508) 261-1856 Fax: (508) 261-8461 -
b. Name of Medical Device
Common Name: Enteral Feeding pump, Infusion pump
U.S. FDA Classification Product Code: LZH
U.S. Regulation Description: Infusion Pump, 21 CFR 880.5725
Proprietary / Trade Name: Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Feeding Sets
c. Identification of Legally Marketed Device(s)
Covidien Kangaroo™ ePump Enteral Feeding Pump and Enteral Feeding Set, K040196
d. Device Brief Description
The table below provides a comparison of the key attributes of the predicate and proposed devices.
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| Device Comparison Summary | ||
|---|---|---|
| Predicate Device (K040196) | Proposed Device (K143263) | |
| Device Name | Kangaroo™ e-pump | Kangaroo™ Connect Enteral |
| Feeding Pump and Kangaroo™ | ||
| Connect Enteral Feeding Sets | ||
| Device Description | Enteral feeding pump and | |
| disposable enteral feeding sets | Enteral feeding pump and | |
| disposable enteral feeding sets | ||
| 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, which can be | ||
| accomplished by means of an | ||
| enteral feeding pump and pump | ||
| set. Not for use with neonates. | ||
| The feeding pumps and 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 feeding sets | |
| 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 (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. | 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 | nickel cadmium | lithium ion |
| Graphic display | monochrome | multi-color |
| Water ingress rating | IPX1 | IP26 |
| Device Comparison Summary | ||
| Predicate Device (K040196) | Proposed Device (K143263) | |
| 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 (24 inch) Pump interface module (peristaltic tubing) Tubing from pump to patient connector (66 inches) Patient connector (stepped connector) | 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) | ||
| Includes anti-free flow valve | Yes | Yes |
| Materials/Chemical | ||
| composition | Polyvinyl chloride (PVC) Feeding bags and caps Tubing Patient connector Silicone Peristaltic tubing Polycarbonate Valve body HDPE Valve stem LDPE Dust Cover ABS Spike Strontium Ferrite / nylon Set ID magnets | Polyvinyl chloride (PVC) Feeding bags and caps Tubing Silicone Peristaltic tubing Diaphragm valve Polycarbonate Cassette body CoPolyester Patient connector ABS Spike Tube holder and Cap Strontium Ferrite / nylon Set ID magnets |
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e. Statement of Intended Use
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets 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 pump and feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to physicians.
f. Discussion of Technological Differences
Both proposed and predicate pumps perform the same primary function. The proposed device includes 2 ultrasonic sensors to detect both upstream and downstream occlusions vs. one sensor in the predicate device. Additionally, the pump uses a cassette based feeding set where the silicone tube interface with the rotor is contained within the cassette where the predicate device required the user to stretch tubing around the rotor. The proposed device is smaller and lighter, and has longer battery life. The proposed device has a higher water ingress protection rating in accordance with ANSI/IEC 60529-2004 Degrees of Protection Provided by Enclosures (IP Code). The proposed device does not support feed/flush capability, which exists in the predicate device. The proposed feeding set includes 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 IS0 80369-1, small-bore connectors for liquids and gases in healthcare applications - part 1: general requirements
g. Discussion of Nonclinical testing
The following testing was the basis for the substantial evaluation determination:
- Biocompatibility testing of the Kangaroo™ Connect Feeding Sets in accordance with o 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. In accordance with ISO 10993. the feeding sets are categorized as a surface device (category C), permanent use (