The G-Tube is indicated for placement in adult populations that require enteral feeding, medication or gastric 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-Tube 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 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 (also known as PG Lock* connector) which allows for delivery of feeding solutions and medication. 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 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 identical in both versions.

AI/ML Overview

The document describes a 510(k) submission for the Bi-Funnel Gastrostomy Feeding Tube and Tri-Funnel Gastrostomy Feeding Tube, hereafter referred to as "the device". The submission aims to demonstrate substantial equivalence to a predicate device, the Flow-Thru (Compat®) Balloon Replacement Gastrostomy Tubes (K885339).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with pass/fail thresholds for each test. Instead, it describes the types of performance characteristics tested and generally concludes that the proposed device performed "equivalent to or better than" the predicate device.

Performance Characteristic Tested	Reported Device Performance	Acceptance Criteria (Implied)
ASTM F2528 Testing	Performed equivalent to or better than the predicate device.	Device meets or exceeds the performance of the predicate device for these critical functional aspects.
O Flow rate	Performed equivalent to or better than the predicate device.
O Balloon burst volume	Performed equivalent to or better than the predicate device.
O Balloon volume maintenance	Performed equivalent to or better than the predicate device.
O Balloon concentricity	Performed equivalent to or better than the predicate device.
O Balloon size over shaft size	Performed equivalent to or better than the predicate device.
O Balloon integrity in water	Performed equivalent to or better than the predicate device.
O Balloon integrity in simulated gastric fluid	Performed equivalent to or better than the predicate device.
ENFit Performance Testing	Performed equivalent to or better than the predicate device.	Ensures safety and efficacy related to enteral connections, preventing misconnections.
O Falling drop test	Performed equivalent to or better than the predicate device.
O Stress cracking	Performed equivalent to or better than the predicate device.
O Resistance to axial load	Performed equivalent to or better than the predicate device.
O Resistance to separation from unscrewing	Performed equivalent to or better than the predicate device.
O Resistance to overriding	Performed equivalent to or better than the predicate device.
O Disconnection by unscrewing	Performed equivalent to or better than the predicate device.
Tensile testing	Performed equivalent to or better than the predicate device.
Leak testing	Performed equivalent to or better than the predicate device.
Simulated use (human factors)	Performed equivalent to or better than the predicate device.	Device is safe and effective in simulated use scenarios. The Human Factors Validation Study confirms this.
Shelf life testing	Met required standards.	Device maintains sterility and functionality over its specified shelf life.
Sterilization	Met required standards.	Device can be effectively sterilized.
Packaging validation	Met required standards.	Packaging maintains sterility and protects the device.
Biocompatibility	Met required standards.	Device materials are biocompatible and safe for patient contact.
Enteral Connector Misconnection Assessment	Findings contributed to the conclusion of no new issues of safety or effectiveness.	The new ENFit connectors effectively prevent misconnections.
Enteral Connector Risk Management Report	Findings contributed to the conclusion of no new issues of safety or effectiveness.	Risks associated with enteral connectors are appropriately managed.
ENFit Misconnection data with FMEA	Data supports the safety and effectiveness of the ENFit connectors.	The ENFit system successfully mitigates misconnection risks.

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

The document mentions "nonclinical (bench) test results" but does not specify the sample sizes used for any of the individual tests. Similarly, it does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests appear to be laboratory-based bench tests, implying they are prospective in nature, but this is not explicitly stated.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy or clinical interpretation. The testing described is primarily engineering and performance-based (e.g., physical properties, and functional capabilities). Human factors testing is mentioned, which would involve human users, but the role of "experts" in establishing a ground truth for interpretation is not relevant or described.

4. Adjudication Method for the Test Set

As the testing is primarily bench-based and performance-oriented rather than involving subjective interpretation, an adjudication method for a "test set" in the traditional sense (e.g., 2+1, 3+1 for clinical image review) is not applicable and therefore not described in the document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance testing revolved around the physical and functional characteristics of the device itself and its connectors, rather than diagnostic interpretation by human readers. The mention of "Human Factors Validation Study" implies testing with human users to ensure safe and effective use, but this is distinct from an MRMC study comparing human interpretive performance with and without AI assistance.

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

This question is not applicable to the device described. The device is a medical tube, not an AI algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would have been established by engineering specifications, validated test methods (like ASTM F2528), and industry standards. For example, a balloon's burst volume would be compared against a predefined specification derived from the predicate device's performance or relevant safety standards.

For ASTM F2528 and other physical tests: The ground truth would be the defined physical properties (e.g., flow rate, burst volume, tensile strength) as measured by calibrated equipment and compared against established engineering specifications or the predicate device's performance.
For Biocompatibility: The ground truth is established through validated biological testing methods and compliance with ISO 10993 series standards.
For Sterilization and Packaging: The ground truth is validated through established sterilization cycles and packaging integrity tests, ensuring sterility assurance levels (SALs) and barrier integrity.
For Misconnection Assessment: The ground truth in this context would be the successful prevention of misconnections when using the ENFit connectors as designed, as demonstrated through testing scenarios.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical tube, not an AI system that requires a training set.

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

This question is not applicable as there is no training set for this device.

Summary

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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 in profile, with three overlapping faces suggesting a sense of community and care. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

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

January 8, 2015

Xeridiem (formerly Mri) Jesus Valencia RA Specialist 4700 S. Overland Drive Tucson, AZ 85714

Re: K142075

Trade/Device Name: Bi-Funnel Gastrostomy Feeding Tube and Tri-Funnel Gastrostomy Feeding Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: December 11, 2014 Received: December 12, 2014

Dear Jesus Valencia,

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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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 yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017

See PRA Statement below.

510(k) Number (if known)	K142075
--------------------------	---------

Device Name

Bi-Funnel Gastrostomy Feeding Tube and Tri-Funnel Gastrostomy Feeding Tube

Indications for Use (Describe)

The G-Tube is indicated for placement in adult populations that require enteral feeding, medication or gastric decompression through an established gastrointestinal stoma tract.

Type of Use (Select one or both, as applicable)

X 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

PSC Publishing Services (301) 443-6740 EF

(End of Section)

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510(k) Summary

As required by 21 CFR 807.92, this "510(k) Summary" provides a basis for the substantial equivalence determination of the device listed below.

General Information

Date Prepared:	January 6th, 2015
510(k) Submitter:	Xeridiem4700 S. Overland Dr.Tucson, AZ 85714Contact: Jesus Valencia, RA Specialist(520) 882-7794 ext. 135jvalencia@xeridiem.com
510(k) Correspondent:	Same as above

Device Information

Trade Name:	Bi-Funnel Gastrostomy Feeding Tube andTri-Funnel Gastrostomy Feeding Tube
Common Name:	Balloon Gastrostomy Feeding Tube
Classification Name:	Gastrointestinal Tubes and Accessories[21 CFR 876.5980, Product Code PIF]
Classification Panel:	Gastroenterology/Urology
Class:	Class II

Predicate Device Information

Trade Name:	Flow-Thru (Compat®) Balloon Replacement Gastrostomy Tubes
Common Name:	Balloon Gastrostomy Feeding Tube
Classification Name:	Tubes, gastrointestinal (and accessories)[21 CFR 876.5980, Product Code KNT]
Classification Panel:	Gastroenterology/Urology
Class:	Class II
510(k) Number:	K885339

Device Description

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Model P/N:	Device Description	French SizeOfferings (FR)	Balloon RecommendedFill Volume (mL)	FunctionalLength (cm)
70-0047	Bi-FunnelGastrostomyFeeding Tube	12	5	10
		14
		16
		18	20
		20
		22
		24
70-0048	Tri-FunnelGastrostomyFeeding Tube	12	5	10
		14
		16
		18	20
		20
		22
		24

Table 5.1 – Proposed Device Offerings

Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external 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 (also known as PG Lock* connector) which allows for delivery of feeding solutions and medication. 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 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 identical in both versions.

. *Note: The term "PG Lock" was the qeneric name used to describe the enteral connectors attached to the proposed device before these had an industry trade name. After commencing the design and development project for the proposed device, the Global Enteral Device Supplier Association (GEDSA) settled on an industry trade name for the enteral connectors and termed these connectors "ENFit". Within the body of this submission and within the supporting documentation, both "PG Lock" and "ENFit" connectors are used interchangeably; however, both terms refer to the same enteral connectors.
In use, the distal end of the G-Tube is inserted through a gastrointestinal stoma tract and into the stomach. Once the device is inside the stomach, a male luer slip or luer lock syringe is connected to the balloon inflation valve and the balloon is inflated with sterile or distilled water to the recommended fill volume printed on the balloon inflation port. Then, the G-Tube is withdrawn until the balloon stops against the inner stomach wall and lastly the external bolster adjusted flush against the abdomen by sliding down the shaft of the G-Tube. The shaft is printed with the rated shaft French size and graduation marks as a reference for identifying the diameter and length of the stoma tract. Once secured in place, the G-Tube will serve as a channel for administering nutrients and medication into the stomach and for gastric decompression. Enteral administration sets and syringes incorporating female ENFit connectors will be connected to the male ENFit connectors on the G-Tubes for delivering feeding solutions, medications, and for tube flushing. The male ENFit connection system was designed with the purpose of preventing unwanted misconnections with non-enteral connectors (i.e., luers delivering !.V. fluids). When device replacement is deemed necessary, the balloon is deflated and the G-Tube is pulled out of the stoma tract. The G-Tube is then replaced as previously described above. A more detailed device description with drawings is included in Section 11 of this 510(k).

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Intended Use

The Gastrostomy Feeding Tube (G-Tube) is intended to provide enteral feeding, medication administration and gastric decompression.

Indications for Use

The G-Tube is indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract.

Technological Characteristics

The device comparison table below provides a general summary of the technological characteristics of the Gastrostomy Feeding Tube (proposed) device compared to the predicate device.

	Gastrostomy Feeding Tube	Flow-Thru (Compat®) Balloon Replacement Gastrostomy Tubes
	(Proposed device)	(Predicate Device) - K885339
FDA Class	Same as K885339	Class II
FDA Product Code	PIF	KNT
FDA Regulation	Same as K885339	876.5980 - Tubes, gastrointestinal (and accessories)
510k #	N/A	K885339
Indications for Use	The G-Tube is indicated for placement in adult	The Compat® Replacement Gastrostomy Tube is used as a
	populations that require enteral feeding,	replacement for surgically, laparoscopically or endoscopically
	medication administration or gastric	placed gastrostomy tubes when an established, well-healed and
	decompression through an established	mature tract (i.e. stoma tract) between the stomach and external
	gastrointestinal stoma tract.	body surface exists. The device delivers enteral formula and
		medications directly into the stomach and is intended for single
		patient use.
User Population	Same as K885339	Adult
Operating principle	Same as K885339	Device tip enters though the stoma tract and into the stomach,
		then the device is secured in place by inflating the balloon and
		adjusting the external bolster. Once secured in place, the device
		serves as a channel for administering nutrients and medication into
		the stomach and for gastric decompression
Single Patient Use	Same as K885339	Yes
Sterile	Same as K885339	Yes (ETO)
Shaft	Same as K885339	Silicone 70D
External Bolster	Same as K885339	Silicone 40D
Balloon	Same as K885339	Silicone 24D
Funnel	Same material as K885339 with slight	Silicone 60D
	difference in profiles
Radiopaque Marker	Same as K885339	Barium Sulfate
Connectors	ABS (Connectors/Caps) & LLDPE (Tether)	Polyvinyl Chloride Connectors & Polycarbonate Barbed Adaptor
Balloon Inflation Valve	Same material types as K885339 with slight	Thermoplastic inflation valve
	difference in profiles
Product Offerings	12 - 24 French Sizes (Shaft)	14 - 24 French Sizes (Shaft)
	0 - 10 cm (Functional Length)	0 - 10 cm (Functional Length)
	5 & 20 mL (Balloon Recommended Fill Volume)	5 & 15 mL (Balloon Recommended Fill Volume)
Packaging	Same as K885339	Poly/Tyvek Chevron Pouch (1 unit and two labeling inserts inside
		pouch)
Kit Components	Same as K885339	None

		Table 5.2 - Device Comparison Table

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Performance Characteristics

Nonclinical bench testing was conducted for supporting substantial equivalence between the proposed and predicate devices. The bench tests addressed device performance characteristics such as:

ASTM F2528 testing ●
- O Flow rate
- Balloon burst volume O
- Balloon volume maintenance O
- Balloon concentricity O
- O Balloon size over shaft size
- Balloon integrity in water O
- Balloon integrity in simulated gastric fluid O
- ENFit performance testing
  - Falling drop test O
  - O Stress cracking
  - Resistance to axial load O
  - Resistance to separation from unscrewing O
  - Resistance to overriding O
  - O Disconnection by unscrewing
Tensile testing
Leak testing

●

Simulated use (human factors)
Shelf life testing
Sterilization
Packaging validation
Biocompatibility
Enteral Connector Misconnection Assessment
. Enteral Connector Risk Management Report
Human Factors Validation Study
ENFit Misconnection data with FMEA

A more detailed description of the performance testing is included in Section 18 of this 510(k). In conclusion, the proposed device performed equivalent to or better than the predicate device.

Device Comparison

As outlined in Table 5.2, the proposed device is substantially equivalent to the legally marketed predicate device. Specifically, the proposed device have has the same intended use, in as far as that both are used for administration of enteral nutrition and gastric decompression, and similar indications, technological characteristics, and principles of operation as the previously cleared predicate device. A substantial equivalence device comparison table comparing the similarities and differences between the proposed device and its predicate is provided in Table 5.2 above. The proposed device differs from the predicate device in certain funnel and connector design features which are required to reduce the likelihood of enteral misconnections and the profile of the funnel and connector ports. The minor differences identified in the technological characteristics do not raise new questions of safety or efficacy. Performance (bench) testing demonstrates that the proposed device is as safe and effective as its predicate device.

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Substantial Equivalence - Comparison to Predicate Device

In order to support substantial equivalence of the proposed device to its predicate, the following are provided among the information and summary tables included in this 510(k) submission: 1.) device description, 2.) indications for use, 3.) device comparison tables, 4.) material information, 5.) nonclinical (bench) test results, and 6.) product labeling. In particular, nonclinical test results demonstrate that there were no differences that are critical to the intended use of the proposed device or that affect the safety and effectiveness of the proposed device when used as labeled.

The proposed and predicate devices have the same intended use, in as far as that both are used for administration of enteral nutrition and gastric decompression, and similar indications, technological characteristics and principles of operation. The minor differences in technological characteristics have been identified and do not present any new issues of safety or effectiveness. Thus, the Gastrostomy Feeding Tube is substantially equivalent to the Flow-Thru (Compat®) Balloon Replacement Gastrostomy Tubes (K885339).

(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.