(203 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a syringe, with no mention of AI or ML.
No.
The device delivers nutritional formula, it does not treat or cure a disease or condition.
No
The document describes a device used for delivering nutritional formula directly to the gastrointestinal system. Its purpose is therapeutic ("to administer enteral nutrition"), not diagnostic.
No
The device description clearly states it is a disposable enteral feeding syringe, which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Kangaroo™ Enteral Feeding Syringe with ENFit Connector is used to deliver nutritional formula directly into a patient's gastrointestinal system. It is a delivery device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states it "delivers nutritional formula" and is used to "administer enteral nutrition." This is a therapeutic or supportive function, not a diagnostic one.
The device's purpose is to provide nutrition, not to diagnose or test for any condition.
N/A
Intended Use / Indications for Use
The Kangaroo™ Enteral Feeding Syringe with ENFit Connector delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. The feeding syringes are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians (under the supervision of a clinician), to administer enteral nutrition. The syringe is intended for all age groups.
Product codes (comma separated list FDA assigned to the subject device)
PNR, PIF
Device Description
The Kangaroo™ Enteral Feeding Syringe with ENFit Connector consists of disposable enteral feeding syringes that deliver formula to provide nutrition for those who do not have the ability to orally ingest food. The device incorporates a female ENFit connector for connection to an enteral access device.
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
all age groups
Intended User / Care Setting
clinical or home care settings by users ranging from laypersons to clinicians (under the supervision of a clinician)
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 performed.
- Biocompatibility testing demonstrated the biological safety of parts of the medical device which may indirectly contact the patient.
- Stability testing evaluated the properties of the enteral feeding syringes after accelerated aging in support of the labeling.
- Dimensional analysis was conducted for critical dimensions of the Kangaroo™ Enteral Feeding Syringes with ENFit Connectors, in accordance with ISO 80369-3. The testing demonstrates the proposed devices conform to Table B.2 of ISO 80963-3.
- Testing performed on the Kangaroo™ Enteral Feeding Syringes with ENFit Connectors included: Fluid Leakage, Stress Cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Disconnection by unscrewing. These tests were in accordance with ISO 80369-3 and ISO 80369-20. The testing demonstrates the proposed devices conform to the requirements of ISO 80963-3.
- Minimum through diameter flow testing was conducted and demonstrates the Kangaroo™ Enteral Feeding Syringes with ENFit Connectors exceeds the performance of the predicate device.
- The risk associated with the misconnection of the ENFit connector has been assessed at length and captured in the following documents: PG Lock Misconnection Data with FMEA 2014-01-9, 3595-0501-04 Enteral Connector Misconnection Assessment, Enteral Connection Risk Management Report Rev 2.0, PG Lock Misconnection Risk Assessment Report 041513.
- Usability and human factors testing was conducted as part of the ENFit connector, and is captured in the Human Factors Validation Study Enteral Connectors Final Report.
Clinical evaluations were not relied upon for evidence of safety or effectiveness, or for a determination of substantial equivalence.
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.
BD™ Oral/Enteral Syringe with BD UniVia™ Connection, K112434
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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2016
Covidien Shannon Green Sr. Regulatory Affairs Product Specialist 15 Hampshire Street Mansfield, MA 02048
Re: K142128
Trade/Device Name: Kangaroo™ Enteral Feeding Syringe with ENFit Connector Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: January 15, 2015 Received: January 16, 2015
Dear Shannon Green,
This letter corrects our substantially equivalent letter of February 23, 2015.
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 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely,
For Division
Douglas Silverst 2016.09 29 08:02:4
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
Indications for Use
510(k) Number (if known): K142128
Device Name:
Kangaroo™ Enteral Feeding Syringe with ENFit Connector
The Kangaroo™ Enteral Feeding Syrinqe with ENFit Connector delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. The feeding syringes are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians (under the supervision of a clinician), to administer enteral nutrition. The syringe is intended for all age groups.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
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510(k) Summary
Kangaroo™ Enteral Feeding Syringe with ENFit Connector
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: July 31, 2014
-
a. Contact Person
Shannon Green Sr. Regulatory Affairs Specialist Covidien Telephone: (508) 261-8587 Fax: (508) 261-8461 -
b. Name of Medical Device
Common Name: Gastrointestinal tubes with enteral specific connectors
U.S. FDA Classification Product Code: PIF
U.S. Regulation Description: Gastrointestinal tube and accessories, 21 CFR 876.5980
Proprietary / Trade Name: Kangaroo™ Enteral Feeding Syringe with ENFit Connector
c. Identification of Legally Marketed Device(s)
BD™ Oral/Enteral Syringe with BD UniVia™ Connection, K112434
d. Device Brief Description
The Kangaroo™ Enteral Feeding Syringe with ENFit Connector consists of disposable enteral feeding syringes that deliver formula to provide nutrition for those who do not have the ability to orally ingest food. The device incorporates a female ENFit connector for connection to an enteral access device.
4
e. Device Intended Use
The Kangaroo™ Enteral Feeding Syringe with ENFit Connector delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. The feeding syringes are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians (under the supervision of a clinician), to administer enteral nutrition. The syringe is intended for all age groups.
f. Product Comparison Summary
The proposed and predicate enteral feeding svringes are intended for patients who require enteral feeding due to illness or injury which prevents normal chewing and swallowing. These products are enteral feeding syringes that have the same intended use, the same function, and the same general characteristics.
g. Nonclinical testing
- o Biocompatibility testing has demonstrated the biological safety of parts of the medical device which may indirectly contact the patient.
- . Stability testing evaluated the properties of the enteral feeding syringes after accelerated aging in support of the labeling.
- . Dimensional analysis was conducted for critical dimensions of the Kangaroo™ Enteral Feeding Syringes with ENFit Connectors, in accordance with ISO 80369-3. Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications. The testing demonstrates the proposed devices conform to Table B.2 of ISO 80963-3.
- . Testing performed on the Kangaroo™ Enteral Feeding Syringes with ENFit Connectors included the items listed below, in accordance with ISO 80369-3, Smallbore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20. Smallbore connectors for liguids and gases in healthcare applications - Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80963-3.
| Test | 80369-3 Requirement
is in: | 80369-20 Test Method
is in: |
|---------------------------------------------|-------------------------------|--------------------------------|
| Fluid Leakage | Clause 6.2 | Annex C |
| Stress Cracking | Clause 6.3 | Annex E |
| Resistance to separation
from axial load | Clause 6.4 | Annex F |
| Resistance to separation
from unscrewing | Clause 6.5 | Annex G |
| Resistance to overriding | Clause 6.6 | Annex H |
| Disconnection by
unscrewing | Clause 6.7 | Annex I |
5
- Minimum through diameter flow testing was conducted and demonstrates the . Kangaroo™ Enteral Feeding Syringes with ENFit Connectors exceeds the performance of the predicate device.
- . The risk associated the misconnection of the ENFit connector has been assessed at length and captured in the following documents, which are located in Mater File 2258.
- PG Lock Misconnection Data with FMEA 2014-01-9 o
- 3595-0501-04 Enteral Connector Misconnection Assessment o
- Enteral Connection Risk Management Report Rev 2.0 o
- PG Lock Misconnection Risk Assessment Report 041513 o
- Usability and human factors testing was conducted as part of the ENFit . connector, and is captured in the following document, which is located in the Master File 2258.
- o Human Factors Validation Study Enteral Connectors Final Report
h. Clinical testing
Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.
i. Conclusions
The information provided within this pre-market notification demonstrates that the Kangaroo™ Enteral Feeding Syringe with ENFit Connector has no difference that would affect the safety of effectiveness of the devices as compared to the predicate device.
End of Summary