The Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector are indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract.

The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract.

The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.

Device Description

The Gastrostomy Feeding Tube (G-tube) consists of two product versions (models): a Bi-Funnel G-Tube and a Tri-Funnel G-Tube. Each G-Tube version is offered in varying shaft French (FR) sizes and balloon sizes. Both versions are offered in the same functional length. The overall difference between the Bi-Funnel and Tri-Funnel G-tubes is that the Tri-Funnel G-Tube allows for simultaneous delivery of feeding solutions and medications while the Bi-Funnel G-Tube allows for delivery of either feeding solutions or medications at a time. Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external bolster and balloon. The funnel for the Bi-Funnel G-Tube has two ports: one port houses the balloon inflation valve which allows for balloon inflation and deflation, and the other port houses the male ENFit connector which allows for delivery of feeding solutions and medication. The funnel for the Tri-Funnel G-Tube has three ports: one port houses the balloon inflation valve, the center port houses the male ENFit connector which allows for delivery of feeding solutions, and the last (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The same ENFit connector, tether and cap components are used for both Bi-Funnel and Tri-Funnel G-Tubes. The remaining components (shaft, adjustable bolster and balloon) are commonly shared for the Bi-Funnel and Tri-Funnel G-Tubes and are identical in both versions.

The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated to the rated volume using sterile or distilled water and the bolster adjusted down to the skin to secure the device in place. The funnel has three ports. One port contains the inflation valve and used for inflation of the balloon. The center port houses the male ENFit connector which allows for the delivery of feeding solutions. The third (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The funnel configuration and ENFit connectors/caps are identical to the Tri-Funnel Gastrostomy Feeding Tube with ENFit connector discussed in 5.4.1 above.

AI/ML Overview

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for medical devices. It describes the devices, their intended use, and substantial equivalence to previously marketed devices. However, it does not include details on acceptance criteria and a study proving that the device meets those criteria, as it relates to performance metrics in terms of sensitivity, specificity, or similar statistical measures. It also does not contain information on sample size, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

Summary

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Public Health Service

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

June 6, 2017

Xeridiem Medical Devices Steve Murrav Regulatory Affairs Specialist 4700 S. Overland Dr. Tucson, Arizona 85714

Re: K171347

Trade/Device Name: Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF Dated: May 5, 2017 Received: May 8, 2017

Dear Steve Murray:

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 devicerelated 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,

Joyce M. Whang -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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4.0 Indications for Use Statement

Bi-Funnel/Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector 4.1

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
-------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------

Indications for Use

510(k) Number (if known)	K171347
Device Name	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector

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:

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"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."

FORM FDA 3881 (8/14)

ﻟﻠﻘﻀ

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Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® 4.2 Connection

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
Indications for Use
510(k) Number (if known)	K171347
Device Name	Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection
Indications for Use (Describe)	The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract.
	The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.
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."

FORM FDA 3881 (8/14) Page 1 of 1

(End of Section)

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5.0 510(k) SUMMARY

5.1 General Information

Date Prepared:	May 4, 2017
510(k) Submitter:	Xeridiem Medical Devices4700 S. Overland Dr.Tucson, AZ 85714

Contact Person:	Steve Murray, Regulatory Affairs Specialist
	(520) 882-77694 ext. 178
	smurray@xeridiem.com

5.2 Device Information

5.2.1 Bundled Device 1

Trade Name:	Bi-Funnel Gastrostomy Feeding Tube with ENFit®connector and Tri-Funnel Gastrostomy Feeding Tubewith ENFit® connector
Common Name:	Gastrostomy Feeding Tube
Classification Name:	Gastrointestinal tube and accessories(21 CFR 876.5980, Product Code PIF)
Classification Panel:	Gastroenterology/Urology

5.2.2 Bundled Device 2

Trade Name:	Entuit® Gastrostomy BR Balloon Retention FeedingTube with ENFit® Connection
Common Name:	Gastrostomy Feeding Tube
Classification Name:	Gastrointestinal tube and accessories(21 CFR 876.5980, Product Code PIF)
Classification Panel:	Gastroenterology/Urology

5.3 Predicate Device Information (Device Being Modified)

Bundled Device 1 5.3.1

Trade Name:	Bi-Funnel Gastrostomy Feeding Tube andTri-Funnel Gastrostomy Feeding Tube
Common Name:	Balloon Gastrostomy Feeding Tube

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Classification Name:	Gastrointestinal tube and accessories(21 CFR 876.5980, Product Code PIF)
Classification Panel:	Gastroenterology/Urology
510(k) Number:	K142075/A001

5.3.2 Bundled Device 2

Trade Name:	Entuit™ Thrive Balloon Retention GastrostomyFeeding Tube
Common Name:	Gastrostomy Tube
Classification Name:	Gastrointestinal tube and accessories(21 CFR 876.5980, Product Code KNT)
Classification Panel:	Gastroenterology/Urology
510(k) Number:	K130611/A001

5.4 Device Description

Bi-Funnel Gastrostomy Feeding Tube with ENFit® connector and Tri-Funnel 5.4.1 Gastrostomy Feeding Tube with ENFit® connector

ModelP/N	Device Description	French SizeOfferings(FR)	BalloonRecommendedFill Volume(mL)	FunctionalLength (in)
70-0047	Bi-Funnel Gastrostomy	12	5	10
	Feeding Tube	14
	16
		18	20
	20
	22
		24
70-0048	Tri-Funnel	12	5	10
	Gastrostomy Feeding	14
	Tube	16

Table 5.4.1 - Device Offerings for Bi-Funnel/Tri-Funnel G-Tubes

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ModelP/N	Device Description	French SizeOfferings(FR)	BalloonRecommendedFill Volume(mL)	FunctionalLength (in)
		18	20
		20
		22
		24

Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external bolster and balloon. The funnel for the Bi-Funnel G-Tube has two ports: one port houses the balloon inflation valve which allows for balloon inflation and deflation, and the other port houses the male ENFit connector which allows for delivery of feeding solutions and medication. The funnel for the Tri-Funnel G-Tube has three ports: one port houses the balloon inflation valve, the center port houses the male ENFit connector which allows for delivery of feeding solutions, and the last (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The same ENFit connector, tether and cap components are used for both Bi-Funnel and Tri-Funnel G-Tubes. The remaining components (shaft, adjustable bolster and balloon) are commonly shared for the Bi-Funnel and Tri-Funnel G-Tubes and are identical in both versions.

5.4.2 Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection

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Table 5.4.2 - Device Offerings for Entuit® Gastrostomy BR Balloon Retention
Feeding Tube with ENFit® Connection

Model P/N	French Size (FR)	RecommendedBalloon FillVolume (mL)	Functional Length(in)
70-0060	12	5 - 7	10
	14
	16
	18	5 - 10
	20	20
	22
	24

The funnel has three ports. One port contains the inflation valve and used for inflation of the balloon. The center port houses the male ENFit connector which allows for the delivery of feeding solutions. The third (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The funnel configuration and ENFit connectors/caps are identical to the Tri-Funnel Gastrostomy Feeding Tube with ENFit connector discussed in 5.4.1 above.

5.5 Intended Use/Indications for Use

Bi-Funnel Gastrostomy Feeding Tube with ENFit® connector and Tri-Funnel 5.5.1 Gastrostomy Feeding Tube with ENFit® connector

5.5.2 Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection

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K171347 Page 5 of 6

administration or decompression through an established gastrointestinal stoma tract.

5.6 Technological Characteristics - Limited Device Modification

The device modification for both devices bundled in this premarket notification is changing the ENFit connector and cap material from ABS LG HF-380 to Nylon Vydyne 21X1. Otherwise, each device and its predicate is identically the same. There is no other change in technological characteristics and no change in intended use or indications for use. The extent of the material change is summarized in the table below.

Table 5.6 ENFit Connector Material Change
Device	Material Description
	Proposed	Predicate
Bi-Funnel and Tri-FunnelGastrostomy FeedingTubes with ENFit®connector	Nylon Vydyne 21X1(MEVOPUR VioletAB4M665085 colorant)	ABS LG HF-380(MEVOPUR VioletSB4M664930 colorant)
Entuit® Gastrostomy BRBalloon RetentionFeeding Tube withENFit® Connection	Nylon Vydyne 21X1	ABS LG HF-380

Table 5.6 - ENFit® Connector Material Change

5.6 Compliance with Design Controls

Substantial equivalence of the proposed devices with the predicate devices are by compliance to the required design control activities for the device modification. These activities are summarized in the table below.

Table 5.6 – Design Control Activities
Design ControlRequirement	Design Control Activities	Status
Design andDevelopment Planning	Design and Development Plan – outline scope of project andmajor milestones, including risk management plan andanalysis	Completed
Design Input	Traceability Matrix update – add new design inputs for ENFitconnector robustness requirement under high torque andcertain chemical exposure conditions	Completed
Design Output	Traceability Matrix update - specify design outputs for theadded design inputs; update risk analysis (user and designFMEAs) appropriately to address the change	Completed
Design Review	Design reviews conducted for key milestones such as designinputs, design outputs, design verification completion, etc.	Completed
Design Verification	Documented in Verification and Validation Plan, summarizedin Table 12.2	Completed

Table 5.6 - Design Control Activities

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K171347

Design ControlRequirement	Design Control Activities	Status
Design Validation	Subject modification does not alter ENFit connector geometryso there is no effect on validation previously conducted forclearances K142075 and K130611	Completed

As summarized in the table above, required design controls activities were completed, including passing any required design verification activities.

5.6 Substantial Equivalence Conclusion

Based on successful completion of the required design control activities for the device modification that is the subject of this Special 510(k) premarket notification, it may be concluded that the following modified devices are substantially equivalent to their respective predicate devices:

Bi-Funnel Gastrostomy Feeding Tube with ENFit® connector and Tri-Funnel Gastrostomy Feeding Tube with ENFit® connector

Enuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection

(End of Section)

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.