The Kangaroo™ Feeding Tube Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications.

The device is intended for neonates and infants who require enteral feeding.

Device Description

The Kangaroo™ Feeding Tube Extension Sets with ENFit small bore connectors are sterile, disposable medical devices designed to deliver nutrition to patients who cannot obtain nutrition or liquid by mouth, are unable to swallow safely, or need nutritional supplementation. The proposed set is intended as a conduit between the enteral feeding formula container (mostly enteral feeding syringe) and feeding tube. The device is designed with a single lumen microbore PVC tube with ENFit small bore connectors at both ends. During enteral feeding therapy, mainly for neonates and infants, there are situations when the feeding tube extension set is required to connect the syringe to patient feeding tube when the distance between the patient and the source of enteral feeding demands additional length of tube.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors." As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria in the way generally understood for AI/ML device performance studies (e.g., diagnostic accuracy, sensitivity, specificity against a clinical ground truth).

The information provided describes non-clinical testing performed to show that the new device (with ENFit connectors) is functionally equivalent and safe compared to the predicate device and compliant with relevant ISO standards for small-bore connectors.

Therefore, the requested information elements (especially those related to AI/ML performance, ground truth, expert adjudication, MRMC studies, and training sets) are not directly applicable or available in this type of FDA submission. I will extract the closest available information based on the context of this document.

Here's an attempt to answer your questions based on the provided text, reinterpreting "acceptance criteria" as compliance with ISO standards and functional performance metrics for a hardware device:

Acceptance Criteria and Study for Kangaroo™ Feeding Tube Extension Sets

This document describes the non-clinical testing performed to demonstrate that the Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors are substantially equivalent to a legally marketed predicate device (Covidien Kangaroo™ Enteral Feeding Extension Sets, K9733409) and meet relevant international standards for safety and performance.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are primarily defined by compliance with ISO 80369-3 (Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications) and ISO 80369-20 (Common test methods), as well as biocompatibility, stability, and functional equivalence (flow testing). The document states the device conforms to these requirements.

Acceptance Criteria (Defined in ISO 80369-3 / FDA expectations)	Reported Device Performance (as stated in submission)
Biocompatibility	Demonstrated biological safety.
Stability (to support expiration date)	Evaluated properties after accelerated aging; supports product expiration date.
Dimensional Analysis (ISO 80369-3, Table B.2)	Conforms to criteria in Table B.2 of ISO 80369-3.
Fluid Leakage (ISO 80369-3 Clause 6.2, Test Method Annex C of ISO 80369-20)	Conforms to requirements of ISO 80369-3.
Stress Cracking (ISO 80369-3 Clause 6.3, Test Method Annex E of ISO 80369-20)	Conforms to requirements of ISO 80369-3.
Resistance to separation from axial load (ISO 80369-3 Clause 6.4, Test Method Annex F of ISO 80369-20)	Conforms to requirements of ISO 80369-3.
Resistance to separation from unscrewing (ISO 80369-3 Clause 6.5, Test Method Annex G of ISO 80369-20)	Conforms to requirements of ISO 80369-3.
Resistance to overriding (ISO 80369-3 Clause 6.6, Test Method Annex H of ISO 80369-20)	Conforms to requirements of ISO 80369-3.
Disconnection by unscrewing (ISO 80369-3 Clause 6.7, Test Method Annex I of ISO 80369-20)	Conforms to requirements of ISO 80369-3.
Flow Performance (compared to predicate)	Substantially equivalent to the performance of the predicate device.
Risk Management (related to misconnection of ENFit connector)	Assessed and captured in various documents (e.g., FMEA, Misconnection Assessment, Risk Management Report).
Usability/Human Factors (related to ENFit connector)	Conducted as part of design, captured in Human Factors Validation Study.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each specific test (e.g., number of extension sets tested for fluid leakage, stress cracking, etc.). It generally refers to "the proposed extension sets" or "the proposed devices" being tested.

Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer (Covidien). The country of origin of the data is not specified, but the manufacturer is based in Mansfield, MA, USA. The studies are prospective in the sense that they were designed and executed to test the new device's compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to this submission. For a hardware device, "ground truth" is typically defined by adherence to objective engineering and chemical standards (e.g., ISO dimensional tolerances, flow rates, material composition, breakage forces) rather than expert consensus on a subjective outcome like image interpretation. The testing was performed in accordance with established international standards (ISO).

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., by radiologists) to reach a consensus ground truth. For the described tests (fluid leakage, dimensions, etc.), the results are objectively measured against defined criteria within the ISO standards; there is no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance with an AI device compares to their performance without one. This device is a physical medical device (feeding tube extension set), not an AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

International Standards: Specifically, the requirements and test methods defined in ISO 80369-3 (for enteral connectors) and ISO 80369-20 (common test methods for small-bore connectors).
Biocompatibility Standards: General standards for material safety in contact with biological systems.
Functional Equivalence: Direct comparison of key performance characteristics (like flow) to the predicate device, which is already legally marketed and established as safe and effective.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical medical device, not an AI algorithm developed through machine learning. Therefore, there is no "training set" in the context of an AI/ML model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for an AI/ML model.

Summary

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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 design of three human profiles facing right, stacked on top of each other. The profiles are connected and form a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 2, 2015

Covidien Wei Zhao, M.D. Senior Director, Regulatory Affairs 15 Hampshire Street Mansfeild, MA 02048

Re: K143018

Trade/Device Name: Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: March 3, 2015 Received: March 6, 2015

Dear Wei Zhao,

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.

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.

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Page 2 - Wei Zhao, M.D.

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" (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 vours.

Herbert P. Lerner -S

for

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

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Indications for Use

510(k) Number (if known) K143018

Device Name

Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors.

Indications for Use (Describe)

The device is intended for neonates and infants who require enteral feeding.

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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2.0 510(k) Summary

Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore 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: October 17, 2014

a. Contact Person

Wei Zhao, M.D. Senior Director, Regulatory Affairs Covidien Telephone: (508) 261-8404 Fax: (508) 261-8461

b. Name of Medical Device
Common Name: tube, feeding

U.S. FDA Classification Product Code: PIF

U.S. Regulation Description: Gastrointestinal tube and accessories, 21 CFR 876.5980
Proprietary / Trade Name: Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors

c. Identification of Legally Marketed Device(s)

Covidien KangarooTM Enteral Feeding Extension Sets, K973409

d. Device Brief Description

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distance between the patient and the source of enteral feeding demands additional length of tube.

Device Intended Use

The device is intended for neonates and infants who require enteral feeding.

Product Comparison Summary e.

The proposed and predicate enteral feeding devices are all intended for patients who cannot obtain nutrition by mouth, are unable to swallow safely, or need nutritional supplementation. These products have the same intended use, the same function, and the same general technological characteristics. Both the predicate and proposed products are designed with the single lumen microbore PVA tubing. They both are intended for connection with a syringe operated with syringe pump at proximal end and an enteral feeding tube at the distal end. The majority of the parts for both the proposed and predicate sets are made with the same material. The variation of the materials for certain components has been proven biocompatible and effective. The major technological enhancement is the incorporation of new ENFit connectors which are compliant to ISO 80369-3, into the proposed Kangaroo™ Feeding Tube Extension Sets. The ENFit connectors are 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. At the proximal end of the device, a female syringe luer lock connector is designed for the predicate extension set. A male ENFit connector is offered for the proposed extension set. At the distal end of the product, the connection design for the predicate extension set is a non-IV compatible stepped connector. For the proposed extension design is a female ENFit connector. Other additions to the proposed products include two lengths, option of a medication port with male ENFit connector, and slide clamps to the tubing. These variations do not alter the intended use of the device, nor impact the safety and effectiveness of the product.

f. Nonclinical testing

Biocompatibility testing has demonstrated the biological safety of parts of the ● proposed extension sets which may indirectly contact the patient.
Stability testing evaluated the properties of the Kangaroo™ Feeding Tube Extension ● Sets after accelerated aging in support of the product expiration date.
Dimensional analysis was conducted for critical dimensions of the KangarooTM ● Feeding Tube Extension Sets, in accordance with ISO 80369-3, Small-bore

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connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications. The testing demonstrates the proposed devices conform to the criteria in Table B.2 of ISO 80963-3.

Study performed on the Kangaroo™ Feeding Tube Extension Sets with ENFit . Connectors included the tests listed below, in accordance with ISO 80369-3, Smallbore connectors for liguids and gases in healthcare applications - Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80963-3.

Individual Test Definedin ISO 80369-3	Requirement Definedin ISO80369-3	Test Method Definedin ISO 80369-20
Fluid Leakage	Clause 6.2	Annex C
Stress Cracking	Clause 6.3	Annex E
Resistance to separationfrom axial load	Clause 6.4	Annex F
Resistance to separationfrom unscrewing	Clause 6.5	Annex G
Resistance to overriding	Clause 6.6	Annex H
Disconnection byunscrewing	Clause 6.7	Annex I

Flow testing was conducted and has demonstrated that the proposed extension sets are substantially equivalent to 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 Master File 2258.
- PG Lock Misconnection Data with Failure Modes and Effects Analysis o (FMEA) 2014-01-9
- 3595-0501-04 Enteral Connector Misconnection Assessment o
- o Enteral Connection Risk Management Report Rev 2.0
- o PG Lock Misconnection Risk Assessment Report 041513
. Usability and human factors testing was conducted as part of the design 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
g. Clinical testing

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Clinical evaluations were not relied upon for the determination of substantial equivalence to the predicate device based on the device classification, sufficient safety and functional performance information provided in the submission.

h. Conclusions

The information provided within this pre-market notification demonstrates that the Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors have no difference that would affect the safety or effectiveness of the devices as compared to the predicate devices and provides reasonable assurance of the safety and effectiveness of the device to demonstrate substantial equivalence.

End of Summary

Regulation Number and Section

§ 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.