The Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port is indicated for use in an established gastrostomy tract as a replacement tube for the administration of nutrition, fluids, and medications to the stomach of a patient, 2 years and older, that are physically unable to manage nutritional intake through normal mastication and deglutition.

Device Description

The Kangaroo™ Gastrostomy Feeding Tube is a silicone qastrostomy tube with a balloon retention device located at the tip of the tube. An external skin disc is provided on the outer lumen of the device and is used in conjunction with the balloon to provide a secure retention system for the Kanqaroo™ Gastrostomy Feeding Tube. The ENFit Y-Port Enteral Adapter is secured within the funnel end of the Gastrostomy Tube Lumen. The Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port is packaged with a packet of water-soluble jelly used to ease the insertion of the device.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, formatted as requested:

This document is a 510(k) summary for a medical device (Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port) which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI performance, expert review, and clinical studies are not applicable or cannot be extracted from this document.

The "acceptance criteria" for this device are essentially compliance with recognized standards and demonstration of comparable performance to the predicate device through non-clinical (laboratory) testing.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standards & Performance Characteristics)	Reported Device Performance (Demonstrated by Testing)
Compliance with Standards:	Device demonstrated compliance with:
- EN 1615:2000 (Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing)	Met requirements of EN 1615:2000
- ASTM F 2528-06 (Standard Test Methods for Enteral Feeding Devices with a Retention Balloon)	Met requirements of ASTM F 2528-06
- ISO 80369-3 (Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications)	Met requirements of ISO 80369-3
Device Performance Characteristics (Tested features):	Testing demonstrated device performance for:
- Positive pressure liquid leak	Testing conducted
- Leak Test for G-tube 12Fr & 28 Fr	Testing conducted
- Resistance to separation from axial load	Testing conducted
- Resistance to separation from unscrewing	Testing conducted
- Resistance to overriding	Testing conducted
- Disconnection by unscrewing	Testing conducted
- Stress Cracking	Testing conducted
- Tensile strength	Testing conducted
- Tensile strength of the connections of G-tube 12Fr & 28 Fr	Testing conducted
- Dimension verification	Testing conducted
- Balloon burst volume for G-tube 12Fr & 28 Fr	Testing conducted
- Flow rate	Testing conducted
- Simulated Gastric fluids for G-tube 12Fr, 16Fr, 18Fr, & 24Fr	Testing conducted
- Biocompatibility evaluation	Testing conducted
- Shelf-life (5 years)	Testing conducted
Overall: Substantial equivalence to predicate device (K143378)	Comparison verification testing demonstrates substantial equivalence and that the device does not raise new questions of safety and efficacy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as a number of devices or units tested for each specific test. The document refers to "the proposed device" and specific French sizes (12Fr, 16Fr, 18Fr, 24Fr, 28Fr) being tested, implying multiple samples of varying sizes were subjected to the tests.
Data Provenance: The tests were "Laboratory testing" conducted to support substantial equivalence. No information on country of origin or whether it was retrospective/prospective is provided, as it's non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The study is non-clinical bench testing of a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided, as this is non-clinical bench testing of a physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI-assisted device, and no MRMC study was conducted.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense of AI/diagnostic devices. The "ground truth" for this device's performance is defined by the technical specifications outlined in recognized standards (EN 1615:2000, ASTM F 2528-06, ISO 80369-3) and the performance of the legally marketed predicate device (AQUARIUS™ Gastrostomy Replacement Tube, K143378).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 23, 2018

Covidien Alexis Erazo Principal Regulatory Affairs Specialist 15 Hampshire Street Mansfield. Massachusetts 02048

Re: K180622

Trade/Device Name: Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT, PIF Dated: September 11, 2018 Received: September 12, 2018

Dear Alexis Erazo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Daniel G. Walter Jr -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180622

Device Name

Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 Drug 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™ Gastrostomy Feeding Tube with ENFit Y-Port, K180622

Preparation date:

October 17, 2018

Manufacturer's Name:

Covidien 15 Hampshire Street Mansfield, MA 02048

Corresponding Official:

Alexis Erazo, Principal Requlatory Affairs Specialist Phone: 508-452-4673 Alexis.erazo@cardinalhealth.com

Name of Medical Device:

Trade Name:	Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port
Common Name:	Tubes, gastrointestinal
Classification Name:	Gastrointestinal tube and accessories
Regulation Number:	21 CFR 876.5980
Product Code:	KNT, PIF
Class:	II

ldentification of Predicate Device:

510(k) Number:	K143378
Device Description:	AQUARIUS™ Gastrostomy Replacement Tube
Submitter:	Degania Silicone Ltd

ldentification of Reference Devices:

510(k) Number:	K161413
Device Description:	Low Profile Balloon Feeding Device
Submitter:	Applied Medical Technology, INC.

510(k) Number:	K951489
Device Description:	MRI'S All Silicone Gastrostomy Tube
Submitter:	Manufacturing & Research, Inc.

510(k) Number:	K913784
Device Description:	Dobbhoff Single Pass PEG Kit
Submitter:	Biosearch Medical Products, Inc.

{4}------------------------------------------------

Device Description:

Intended Use/Indications for Use:

Product Comparison Summary:

The proposed Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port has the same intended use and same general fundamental technological characteristics and as compared to the predicate AQUARIUS™ Gastrostomy Replacement Tube (K143378). Comparison verification testing demonstrates that the Kanqaroo™ Gastrostomy Feeding Tube with ENFit Y-Port does not raise new questions of safety and efficacy that it is as safe and effective as the predicate. Furthermore, the comparison verification testing demonstrates that the performance of the proposed device is substantially equivalent as that of the legally marketed K143378 AQUARIUS™ Gastrostomy Replacement Tube.

Non-Clinical Performance Data:

Laboratory testing was completed to support substantial equivalence between the proposed device and the predicate device. The proposed device was evaluated to show compliance to the standards requirements (listed below) as well as performance characteristics related to the modification of the device.

. EN 1615:2000, Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
. ASTM F 2528-06 Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
. ISO 80369- 3 Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications

The following testing was conducted to demonstrate that the device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence.

. Positive pressure liquid leak
Leak Test for G-tube 12Fr & 28 Fr

{5}------------------------------------------------

Resistance to separation from axial load
Resistance to separation from unscrewing
. Resistance to overriding
. Disconnection by unscrewing
. Stress Cracking
. Tensile strength
. Tensile strength of the connections of G-tube 12Fr & 28 Fr
Dimension verification
. Balloon burst volume for G-tube 12Fr & 28 Fr
. Flow rate
. Simulated Gastric fluids for G-tube 12Fr, 16Fr, 18Fr, & 24Fr
Biocompatibility evaluation ●
. Shelf-life (5 years)

Clinical Data:

Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.

Conclusion:

The proposed Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port has the same intended use and same qeneral fundamental technological characteristics as compared to the predicate AQUARIUS™ Gastrostomy Replacement Tube (K143378). Comparison verification testing provided demonstrates that the Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port does not raise new questions of safety and efficacy, and that it is as safe and effective as the predicate. Furthermore, the comparison verification testing demonstrates that the performance of the proposed device is substantially equivalent as that of the legally marketed K143378 AQUARIUS™ Gastrostomy Replacement Tube. In addition, the Kangaroo™ Gastrostomy Feeding Tube with ENFit Y-Port has the similar indications for use as the legally marketed Low Profile Balloon Feeding Device by Applied Medical Technologies (K161413). Furthermore, the device design and materials are identical to those of reference devices MRI'S All Silicone Gastrostomy Tube (K951489) and Dobbhoff Single Pass PEG Kit (K913784).

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.