The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.

Device Description

These enteral feeding sets are designed to be used with or without an enteral feeding pump, (pump is not in scope for this 510k) model specific. Refer to diagrams below for explanation of components. The enteral sets terminate in a bonded conical connector, the ENFit connector; that is designed to be incompatible with ISO 594-1/2 and other non-enteral feeding connections. The ENFit connector is a new connector and it is anticipated that not all patient feeding tubes will be compatible with it, so the administration sets include an adapter that connects to the ENFit connector on one end while providing the traditional "Christmas Tree" shaped transitional stepped connector on the other.

AI/ML Overview

This document appears to be a 510(k) summary for an enteral feeding set, which is a medical device. Based on the provided text, the device is not an AI/ML device. Therefore, the specific criteria for AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable or detailed in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This is achieved through non-clinical performance data.

Here's an analysis of the acceptance criteria and supporting study information, focusing on the available details from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed to support substantial equivalence. While specific quantitative acceptance criteria are not explicitly stated in a table format in the provided text, the performance is reported as "Passed" or "Acceptable" for each test.

Test Category	Reported Device Performance
Mechanical/Physical Integrity
Bond Strength	Passed
Leak Testing	Passed
Volumetric accuracy testing	Passed
Dimensional analysis	Passed
Accelerated Aging	Passed
Biocompatibility
Biocompatibility	Passed
Connection Safety
Misconnection assessment	Passed
Enteral Connector Risk Management Report	Acceptable
Human Factors
Human Factors Testing	Acceptable
Failure Modes and Effects Analysis (FMEA)	Acceptable
ISO 80369-3 Compliant Testing
Falling drop positive pressure liquid leakage	Passed
Stress cracking	Passed
Resistance to separation from axial load	Passed
Resistance to unscrewing	Passed
Resistance to overriding	Passed
Disconnection by unscrewing	Passed
Falling drop positive pressure liquid leakage after 20 cycles of connection and separation	Passed

2. Sample size used for the test set and the data provenance

Not applicable for an AI/ML device. For this physical medical device, specific sample sizes for tests like bond strength or leak testing are not provided in the summary. The provenance would be the manufacturing facility where the tests were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device, and its performance is evaluated against engineering specifications and industry standards, not through expert-labeled ground truth in the context of an AI/ML model.

4. Adjudication method for the test set

Not applicable. This is a physical 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/ML device.

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

No. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device is defined by:

Engineering specifications: The device's design inputs and required performance characteristics.
Industry standards: Notably ISO 80369-3 for small-bore connectors.
Predicate device performance: The new device is compared to a legally marketed predicate device (K012147) to demonstrate similar safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary for the provided document:

The document describes an enteral feeding set, which is a physical medical device, not an AI/ML device. Therefore, most of the requested information pertaining to AI/ML device studies (such as test/training set sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not relevant or available in this submission.

The device's conformity is established through non-clinical performance data, showing that it "Passed" or was "Acceptable" for a series of tests related to its physical integrity, biocompatibility, connection safety (especially ISO 80369-3 compliance), human factors, and risk management. The "ground truth" here refers to the device meeting its design specifications and applicable industry standards. The submission asserts substantial equivalence to a predicate device based on these non-clinical tests, without requiring clinical testing.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.

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

January 8, 2015

Zevex, Inc. Dianne Batch Director, RA/QA 4314 Zevex Park Lane Salt Lake City, UT 84123

Re: K142539

Trade/Device Name: Enteralite Infinity Enteral Pump Delivery Set, 1200 ML Enteral Feeding Delivery Set Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: PIF, PIO Dated: November 28, 2014 Received: November 28, 2014

Dear Dianne Batch,

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. 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

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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,

Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -A" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.

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) K142539

Device Name

Enteralite Infinity Enteral Pump Delivery Set, 1200 ML Enteral Feeding Delivery Set

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

for

Enteral Feeding Sets

1. Submission Sponsor

Zevex, Inc. 4314 Zevex Park Lane Salt Lake City, Utah 84123 USA Phone: 801.201.6928 Fax: 801.264.1051 Contact: Dianne Batch, Director, RA/QA

2. Date Prepared

September 5, 2014

3. Device Identification

Trade/Proprietary Name:	EnteraLite Infinity Enteral Pump Delivery Sets
	1200 mL Enteral Feeding Delivery Set
Common/Usual Name:	Enteral Feeding Sets
Classification Name:	Gastrointestinal Tubes and Accessories
Classification Regulation:	876.5980
Feeding Set Product Code: PIF
Transition Connector
Product Code:	PIO
Device Class:	Class II
Classification Panel:	Gastroenterology/Urology

4. Legally Marketed Predicate Device(s)

K012147, Zevex, Inc., Enteral Feeding Sets for Gravity and Pump Use

5. Device Description

6.

Indication for Use Statement

The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with

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the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.

7. Substantial Equivalence Discussion

The following table compares the Enteral Feeding Sets to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

In the 'Significant Differences' column of the table, list the differences between the device and the predicate and briefly justify why these differences do not raise safety and effectiveness concerns.

Manufacturer	Moog Medical Devices	Moog Medical Devices	Significant
	Group	Group	Differences
Trade Name	Enteral Feeding Sets	Zevex, Inc., Enteral
		Feeding Sets For Gravity
		And Pump Use
510(k) Number	K142539	K012147	N/A
Product Code	PIF, PIO	KNT	Updated Codes from FDA
Regulation	876.5980	876.5980	Same
Number
Regulation Name	Gastrointestinal Tubes	Tubes, Gastrointestinal	Same
	and Accessories	(and Accessories)
Indications for	The devices in this	The devices in this product	The difference is in the
Use	product family are used	family are used to	distal (or patient) end of
	to dispense liquid	dispense liquid nutrients	the device. Where the
	nutrients (feeding	(feeding solution) at a	predicate terminates
	solution) at a	preprogrammed pump or	only in a traditional
	preprogrammed pump or	user controlled rate.	stepped connector, the
	user controlled rate.	These enteral feeding sets	proposed device
	These enteral feeding	interface with the	terminates in a bonded
	sets interface with the	patient's feeding tube and	ENFit connector which is
	patient's feeding tube	may use gravity or an	designed to be
	and may use gravity or an	enteral feeding pump to	incompatible with all
	enteral feeding pump to	dispense feeding solution.	other defined connectors
	dispense feeding	The devices may include a	available. The ENFit
	solution. The devices	bag to contain the feeding	connector is designed to
	may include a bag to	solution and/or a spike to	comply with ISO 80369-3.
	contain the feeding	connect to a prefilled	GI Tubes that are
	solution and/or a spike to	container.	compatible with the ISO
	connect to a prefilled		80369-3 compliant
	container.		design will be able to
Manufacturer	Moog Medical DevicesGroup	Moog Medical DevicesGroup	SignificantDifferences
Trade Name	Enteral Feeding Sets	Zevex, Inc., EnteralFeeding Sets For GravityAnd Pump Use
			connect directly to theENFit connector. NonISO 80369-3 compliant GItubes will be able toconnect to thetransitional steppedconnector which isdesigned to adapt to theENFit connector.
Material	Non-DEHP PVC tubing,extruded film (bags), inletport and outlet port;Polyethylene inlet portcap; polycarbonateconnector/pumpinterface (cassette);silicone pump tubingsegment; ABS distal(stepped) connector.	Non-DEHP PVC tubing,extruded film (bags), inletport and outlet port;Polyethylene inlet portcap; polycarbonateconnector/pump interface(cassette); silicone pumptubing segment; ABS distal(stepped) connector.	Similar; the differencesbetween them are thatthe ABS formulation (HF380) and color of theENFit connector (purple,Remofin VioletPE43076356-ZT)) aredifferent from the ABSformulation (CYCOLACHMG47MD 6H3C106,pre-colored) used in thecurrent stepped adapter.
Sterile	Non-sterile	Non-sterile	Same
Overall Design
Length	Set length varies, tubinglengths same aspredicate; connector isslightly shorter (~ 0.82"vs. ~2.0") than thecurrent stepped adapter,but with the adapter(~1.74") the overall setlength will be less than1/4" different.	Set length variesdepending onconfiguration.	SameThe EnFit connector has aslightly larger ID, whichhas shown no negativeimpact on flow rates.
Diameter	EnFit connector ID is0.116".	Distal connector ID is0.10".
Single-Use	Yes	Yes	Same
Shelf Life	1 yr.	1 yr. (minimum)	Same
Manufacturer	Moog Medical Devices	Moog Medical Devices	Significant
	Group	Group	Differences
Trade Name	Enteral Feeding Sets	Zevex, Inc., Enteral
		Feeding Sets For Gravity
		And Pump Use
Latex Free	Yes	Yes	Same
Complies with ISO	Yes	Yes	Same
10993-1

Table 5A – Comparison of Characteristics

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8. Non-Clinical Performance Data

The following testing has been performed to support substantial equivalence:

Bond Strength - Passed
Leak Testing - Passed
Volumetric accuracy testing Passed ●
Biocompatibility - Passed
Misconnection assessment - Passed
Dimensional analysis — Passed
Enteral Connector Risk Management Report Acceptable ●
Human Factors Testing – Acceptable
Failure Modes and Effects Analysis (FMEA) – Acceptable
Accelerated Aging - Passed
ISO 80369-3 Testing as follows:
- . Falling drop positive pressure liquid leakage - Passed
- Stress cracking - Passed
- Resistance to separation from axial load – Passed
- Resistance to separation from unscrewing – Passed
- Resistance to overriding - Passed
- Disconnection by unscrewing - Passed
- Falling drop positive pressure liquid leakage after 20 cycles of connection and separation - Passed

As part of demonstrating safety and effectiveness of Enteral Feeding Sets and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Zevex completed a number of tests. The Enteral Feeding Sets meets all the requirements for overall design, functionality, biocompatibility, and confirms that the output meets the design inputs and specifications. The Enteral Feeding Sets passed all testing stated above as shown by the acceptable results obtained.

The Enteral Feeding Sets along with the ENFit connector and adapter complies with the applicable voluntary standards for biocompatibility. The devices passed all the testing in accordance with national and international standards.

9. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

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10. Statement of Substantial Equivalence

It has been shown in this 510(k) submission that the difference between the Enteral Feeding Sets and the predicate devices do not raise any questions regarding its safety and effectiveness. The Enteral Feeding Sets, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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.