The sets are constructed from flexible, medical grade, Non-DEHP tubing in various configurations with a stepped connector at one end. One configuration may include an Enteral solution container constructed of a laminate material with a stepped connector to connect to a gastric tube (or an extension set) or another configuration may simply be an administration set which connects the patient gastric tube to the nutrition liquid container.

AI/ML Overview

The document describes Gravity Enteral Feeding Sets, which are intended to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube). The submission is a Traditional 510(k) for substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study data provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Form/Construction	Stepped Adaptor meets AAMI/ANSI ID54:1996/(R)2012	Device meets the requirements of AAMI/ANSI ID54:1996/(R)2012
Form/Construction	Safety Screw Connector meets AAMI/ANSI/ISO 80369-1	Device meets the requirements of AAMI/ANSI/ISO 80369-1
Drop Factor Accuracy	Accuracy of the current drop factor on gravity feed sets	"A study of the accuracy of the current drop factor given on gravity feed sets" (Validation 703V was performed). Specific quantitative results are not provided in this summary.
Manufacturing Process	Qualification of the manufacturing process for Gravity Set w/ Bag	"A Study to qualify the process to manufacture Gravity Set w/ Bag" (Validation Protocol 868V was performed). Specific details of the qualification are not provided in this summary.
Substantial Equivalence	Equivalent in principle of materials, operation, and intended use to commercially marketed Abbott Nutrition sets.	The Gravity Enteral Feeding Sets are "substantially equivalent to commercially marketed Abbott Nutrition sets in terms of principle of materials, operation, and intended use." Minor or no differences in design, materials, or chemical composition compared to predicate devices.

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

Sample Size: The document does not explicitly state the sample sizes used for "Validation 703V" (drop factor accuracy) or "Validation Protocol 868V" (manufacturing process qualification).
Data Provenance: The studies are described as "bench test reports" performed by The Metrix Company, the submitter, to support the performance characteristics. No information is provided regarding the country of origin of the data, nor whether it was retrospective or prospective, though bench tests are generally prospective.

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

This analysis is not applicable to the provided information. The studies described are bench tests focused on engineering specifications (e.g., connector standards, drop factor accuracy, manufacturing process qualification) rather than clinical evaluations requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication method for the test set:

This is not applicable. The studies are bench tests for engineering compliance and manufacturing process qualification, not clinical studies requiring adjudication of outcomes or interpretations.

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:

This is not applicable. The device is a physical medical device (enteral feeding sets), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant to this submission.

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

This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

Bench Test Standards: The "ground truth" for the stepped adaptor and safety screw connector appears to be the requirements stipulated by recognized international standards (AAMI/ANSI ID54:1996/(R)2012 and AAMI/ANSI/ISO 80369-1).
Internal Validation: For the drop factor accuracy and manufacturing process qualification, the "ground truth" would be the pre-defined internal specifications and acceptance limits established by The Metrix Company for these performance characteristics.

8. The sample size for the training set:

This is not applicable. The device is a physical medical device, not a machine learning or AI model that requires a training set. The submission focuses on demonstrating substantial equivalence through comparison of technological characteristics and performance testing to established standards and predicate devices.

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

This is not applicable, as there is no training set for a physical device like this.

Summary

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5.0 510(k) Summary

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 51(k) Summary for the Gravity Enteral Feeding Sets is provided below.

Date Prepared:	June 28, 2013
Device Common Name:	Gastrointestinal tubes and accessories
Device Proprietary Name:	METRIXCARE™
Submitter:	The Metrix Company4400 Chavenelle RdDubuque, IA 52002
Contact:	Nicholas J. SpechtQuality Assurance ManagerThe Metrix CompanyPhone: 563-556-8800Fax: 563-556-4704nspecht@metrixco.com
Classification
Regulation:	21 CFR 876.5980
Panel:	Gastroenterology/Urology
Product Code:	KNT
Indication for Use:	The device is intended to deliver liquid nutritionalformulas or water to a patient's enteral accessdevice (feeding tube).

CONFIDENTIAL INFORMATION

This document Includes confidential and proprietary business information that is account from disclosure
under the U.S. Freedom of Information Act (FOIA). Prior to any (The Metrix Company) for a pre-release review pursuant 21 CFR §20.61.

FEB 1222014

Page 17 of 46

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The sets are constructed from flexible, medical grade, Device Description: Non-DEHP tubing in various configurations with a stepped connector at one end. One configuration may include an Enteral solution container constructed of a laminate material with a stepped connector to connect to a gastric tube (or an extension set) or another configuration may simply be an administration set which connects the patient gastric tube to the nutrition liquid container.

Performance Testing Summary:

Stepped Adaptor: The stepped adaptor meets the requirements of AAMI/ANSI ID54:1996/(R)2012, Enteral Feeding Set Adapters and Connectors.

Safety Screw Connector: The safety screw connector meets the requirements of AAMI/ANSI/ISO 80369-1, Small-Bore Connectors For Liquids and Gases In Healthcare Applications - Part 1 : General Requirements.

The following bench test reports are provided in Appendix A and B of this submission to support the performance characteristics of the proposed sets.

1. Validation 703V A study of the accuracy of the current drop factor given on gravity feed sets.
1. Validation Protocol 868V: A Study to qualify the process to manufacture Gravity Set w/ Bag.

Substantial Equivalence: The Gravity Enteral Feeding Sets are substantially equivalent to commercially marketed Abbott Nutrition sets in terms of principle of materials, operation, and intended use.

CONFIDENTIAL INFORMATION

This document includes confidential and proprietary business information that is exempt from disclasure under the U.S. Freedom of Information Act (FOIA). Prior to Boy FOIA response, contact the submitter (The Metrix Company) for a pre-release review pursuant 21 CFR §20.61.

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The Metrix Company Traditional 510(k) Submission

Technological Charachteristics:

TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO PREDICATE
THE METRIXCOMPANYMODELSEEKINGCLEARANCE	DESCRIPTION	PREDICATEMODEL: ROSSLABORATORIESAND/OR ABBOTT	DIFFERENCES INDESIGN	DIFFERENCES INMATERIALS(All materialsused In all theproduct are listedin Table B.)	DIFFERENCES INCHEMICALCOMPOSITION	DIFFERENCES INENERGY SOURCE
70010	500ml Enteral Bag withGravity Set	51584	None - Product andcomponentdimensions areIdentical.	None - Both madefrom the samematerials from thesame source.	None - Both madefrom the samematerials from thesame source.	None - Flow rate ofboth determinedby gravity.
70020	1000ml Enteral Bag withGravity Set	00056	None - Product andcomponentdimensions areIdentical.	None - Both madefrom the samematerials from thesame source.	None - Both madefrom the samematerials from thesame source.	None - Flow rate ofboth determinedby gravity.
70030	1000ml Enteral Bag withScrew Cap & Gravity Set	00089	None - Product andcomponentdimensions areIdentical.	None - Both madefrom the samematerials from thesame source.	None - Both madefrom the samematerials from thesame source.	None - Flow rate ofboth determinedby gravity.
70040	Gavity Set with FeedingCap	00061	None - Product andcomponentdimensions areIdentical.	None - Both madefrom the samematerials from thesame source.	None - Both madefrom the samematerials from thesame source.	None - Flow rate ofboth determinedby gravity.
70050	Gravity Set with CrossScrew Connector	62562	None - Product andcomponentdimensions areIdentical.	None - Both madefrom the samematerials from thesame source.	None - Both madefrom the samematerials from thesame source.	None - Flow rate ofboth determinedby gravity.

CONFIDENTIAL INFORMATION

This document includes confidential and proprietary business information that is secures the submitter (The Metrix Company) for a pre-release review pursuant 21 CFR 520.61.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three wing-like extensions.

Public Health Service

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

February 12, 2014

The Metrix Company Nicholas Specht Quality Assurance Manager 4400 Chavenelle Road Dubuque, IA 52002

Re: K132424

Trade/Device Name: Gravity Enteral Feeding Sets Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 6, 2014 Received: January 7, 2014

Dear Nicholas Specht,

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 - Nicholas Specht

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the text "Benjamin Fisher-S" in a bold, sans-serif font. The words are arranged horizontally, with "Benjamin" on the left, followed by "Fisher" in the middle, and "-S" on the right. The word "Fisher" is stylized with a decorative, geometric pattern filling the letters.

Beniamin 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

510(k) Number (if known): K132424

Device Name: Gravity Enteral Feeding Sets

Indications For Use:

The device is intended to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Page 1 of 1

CONFIDENTIAL INFORMATION

This document includes confidential and proprietary business information that is exempt from disclosure under the U.S. Freedom of Information Act (FOIA). Prior to any FOIA response, contact the submitter (The Metrix Company) for a pre-release review pursuant 21 CFR §20.61.

Page 16 of 46

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.