METRIXCARE

K132424 · The Metrix Company · KNT · Feb 12, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K132424
• Device Name: METRIXCARE
• Applicant: The Metrix Company
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Feb 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Gravity Enteral Feeding Sets consist of flexible, non-DEHP medical-grade tubing with a stepped connector; some configurations include a laminate enteral solution container. The device connects a nutrition liquid container to a patient's gastric tube. Operation relies on gravity to deliver liquid nutrition or water to the patient. Used in clinical or home settings; operated by healthcare providers or patients/caregivers. The device facilitates enteral feeding by providing a controlled path for nutritional delivery. No electronic components or active power sources are involved.

Clinical Evidence

Bench testing only. Validation studies included testing the accuracy of the drop factor for gravity feed sets and qualifying the manufacturing process for the gravity set with bag. Compliance with AAMI/ANSI ID54:1996/(R)2012 and AAMI/ANSI/ISO 80369-1 standards was demonstrated.

Technological Characteristics

Flexible, non-DEHP medical-grade tubing; laminate enteral solution container; stepped connectors. Complies with AAMI/ANSI ID54:1996/(R)2012 (Enteral Feeding Set Adapters and Connectors) and AAMI/ANSI/ISO 80369-1 (Small-Bore Connectors). Gravity-driven flow; no energy source. Manual operation.

Indications for Use

Indicated for patients requiring delivery of liquid nutritional formulas or water via an enteral feeding tube.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Abbott Nutrition sets (51584, 00056, 00089, 00061, 62562)

Submission Summary (Full Text)

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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 Company<br>4400 Chavenelle Rd<br>Dubuque, IA 52002 |
| Contact: | Nicholas J. Specht<br>Quality Assurance Manager<br>The Metrix Company<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Classification | |
| Regulation: | 21 CFR 876.5980 |
| Panel: | Gastroenterology/Urology |
| Product Code: | KNT |
| Indication for Use: | The device is intended to deliver liquid nutritional<br>formulas or water to a patient's enteral access<br>device (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

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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.
- 2) 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 METRIX<br>COMPANY<br>MODEL<br>SEEKING<br>CLEARANCE | DESCRIPTION | PREDICATE<br>MODEL: ROSS<br>LABORATORIES<br>AND/OR ABBOTT | DIFFERENCES IN<br>DESIGN | DIFFERENCES IN<br>MATERIALS<br>(All materials<br>used In all the<br>product are listed<br>in Table B.) | DIFFERENCES IN<br>CHEMICAL<br>COMPOSITION | DIFFERENCES IN<br>ENERGY SOURCE |
| 70010 | 500ml Enteral Bag with<br>Gravity Set | 51584 | None - Product and<br>component<br>dimensions are<br>Identical. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Flow rate of<br>both determined<br>by gravity. |
| 70020 | 1000ml Enteral Bag with<br>Gravity Set | 00056 | None - Product and<br>component<br>dimensions are<br>Identical. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Flow rate of<br>both determined<br>by gravity. |
| 70030 | 1000ml Enteral Bag with<br>Screw Cap & Gravity Set | 00089 | None - Product and<br>component<br>dimensions are<br>Identical. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Flow rate of<br>both determined<br>by gravity. |
| 70040 | Gavity Set with Feeding<br>Cap | 00061 | None - Product and<br>component<br>dimensions are<br>Identical. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Flow rate of<br>both determined<br>by gravity. |
| 70050 | Gravity Set with Cross<br>Screw Connector | 62562 | None - Product and<br>component<br>dimensions are<br>Identical. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Both made<br>from the same<br>materials from the<br>same source. | None - Flow rate of<br>both determined<br>by 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 [phone] or [phone] 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.

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