ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

K191387 · Envizion Medical , Ltd. · KNT · Jun 14, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K191387
• Device Name: ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
• Applicant: Envizion Medical , Ltd.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jun 14, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 10 Fr and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes. The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

Device Story

ENvue System is an electro-mechanical device aiding enteral feeding tube (EFT) placement; tracks EFT in real-time via electromagnetic (EM) sensing technology; displays placement pathway on screen. System comprises EM field generator (transmitter) and receivers, including one integrated into the EFT distal tip. Subject device adds four EFT models incorporating stainless-steel stylets for increased stiffness during insertion. Used in hospitals/healthcare facilities by physicians, technicians, and nutritionists. Clinicians use real-time visual feedback to guide tube navigation through esophagus into stomach or small intestine. Post-placement, ENvue is disconnected from EFT; EFT connects to feeding pump via ENFit connector. Benefits include improved placement accuracy and reduced reliance on traditional methods.

Clinical Evidence

Bench testing only. Verification and validation performed per 820.30. Testing included biocompatibility (stylet/connector), dimensional inspection, bond strength, tubing stiffness comparison, simulated use (tracking impact), and shelf-life validation. Results demonstrate performance equivalent to the predicate.

Technological Characteristics

Electromagnetic tracking system; rechargeable battery-powered. EFTs are polyurethane, radiopaque, 10/12 Fr, with optional stainless-steel stylet. Connectors are ENFit (ISO 80369-3). Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), and BS/EN 1615/1618. Non-sterile.

Indications for Use

Indicated for adult patients requiring enteral feeding via the oro/nasoenteric route into the stomach or small intestine. Intended for use with a feeding pump; not compatible with gravity-based feeding bags.

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

• ENvizion Medical ENvue System and Enteral Feeding Tube (K182915)

Reference Devices

• CORPAK CORFLO Nasoenteric Feeding Tubes (K821906)
• Cediflo Enteral Feeding Tubes (K181787)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 14, 2019

Envizion Medical Ltd. % Clay Anselmo Principal Consultant Shriner & Associates 429 Whitepine Creek Road Trout Creek, Montana 59872

Re: K191387

Trade/Device Name: ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT, PIF Dated: May 24, 2019 Received: May 24, 2019

Dear Clay Anselmo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Shani P. Haugen, Ph.D. Acting, Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K191387

Device Name

ENvizion Medical ENvue System ENvizion Medical Enteral Feeding Tube

Indications for Use (Describe)

The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 10 Fr and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.

The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| 区 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."

{3}------------------------------------------------

# 510(k) Summary

# Introduction:

This document contains the 510(k) Summary for the ENvizion Medical ENvue and ENvizion Medical Enteral Feeding Tube. The content of this summary is based on the requirements set forth in 21 CFR 807.92(c).

# SUBMITTER INFORMATION

| Applicant / Manufacturer<br>Name and Address | ENvizion Medical Ltd.<br>7 Haarad Street<br>Tel Aviv, 6971060<br>Israel<br>Phone [phone] |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) contact person | Clay Anselmo<br>Principal Quality and Regulatory Consultant<br>Shriner & Associates<br>429 Whitepine Creek Road<br>Trout Creek, MT 59874<br>[e-mail]<br>[phone] |
| Date prepared | May 24, 2019 |
| DEVICE IDENTIFICATION | |
| Trade names | ENvizion Medical ENvue SYSTEM<br>ENvizion Medical Enteral Feeding Tube |
| Common name | Gastrointestinal tube and accessories |
| Classification name | Gastrointestinal Tubes And Accessories |
| Regulation Number | 21 CFR Part 876.5980 |
| Classification | Class II |

# PREDICATE DEVICE

| Trade names | ENvizion Medical ENvue<br>ENvizion Medical Enteral Feeding Tube |
|---------------|-----------------------------------------------------------------|
| 510(k) number | K182915 |

{4}------------------------------------------------

# DEVICE DESCRIPTION

The ENvizion Medical ENvue System is an electro-mechanical device with embedded software designed to aid in the placement of the ENvizion Medical Enteral Feeding Tube (with or without stylet), which is an enteral feeding tube placed into the stomach or small intestine of patients requiring enteral feeding. The ENvue System tracks the Enteral Feeding Tube (EFT) as it progresses through the oro/nasoenteric route down the esophagus, into the stomach and to the small intestine anatomy and displays the placement pathway in real time during placement. Once the placement is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

This Special 510(k) notification adds 4 new models of EFTs, that include a stainless-steel stylet.

#### INDICATIONS FOR USE

The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 10 Fr and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes.

The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.

# TECHNOLOGICAL CHARACTERISTICS COMPARISON

Substantial Equivalence: The modified version of the ENvizion Medical ENvue with ENvizion Medical Enteral Feeding Tubes is substantially equivalent to the unmodified version of the device (ENvizion Medical ENvue with ENvizion Medical Enteral Feeding Tubes).

The 510(k) Substantial Equivalence Decision-making Process (detailed) from the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] was followed as described below:

- The ENvue device has the same intended use and the same indications for use as the Predicate device.
- The ENvue device uses the same fundamental technology as the Predicate device and very similar detailed technological characteristics. The only difference between the devices is the addition of 4 new EFT models incorporating a stainless-steel stylet to address some customer's preference for a stiffer tube during insertion. The stylet being added to these 4 new models is identical in technology, materials, manufacturing methods, and specifications, with the exception of length, to the stylet used in the Cediflo device cleared in K181787.
- The small differences between the ENvue device and the Predicate do not raise new types of questions of safety or effectiveness
- The biocompatibility of both products' patient contact materials complies with ISO O 10993-1 in accordance with FDA guidance related to the application of this standard.
- The stylet being added to the EFTs is equivalent to the stylet being used in the cited O reference devices and the stiffness of the ENvizion EFTs with the stylet is less than

CONFIDENTIAL

{5}------------------------------------------------

the CORFLO reference device, resulting in no new / significantly modified risks as a result of the modification.

#### PERFORMANCE DATA

There are no known performance standards for this device.

The Enteral Feeding Tube were verified and validated in accordance with 820.30. The following tests were completed to demonstrate substantial equivalence and that any technological differences do not raise new or different questions of safety and effectiveness. The device successfully passed all of the testing and the results demonstrate the device is safe, effective, and performs as well or better than the predicate device.

- Biocompatibility – Stylet and connector hub only
- Dimensional Inspection Stylet only .
- Bond strength – Stylet to connector hub
- Tubing Stiffness Comparison - Impact of Stylet on tubing stiffness
- Simulated Use - Confirm no impact of stylet on tracking
- . Shelf Life Validation – Impact of stylet on EFT shelf-life

The device continues to conform to the following voluntary recognized consensus standards:

- BS/EN 1615:2000 – Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing.
- BS/EN 1618:1997 – Catheters other than intravascular catheters. Test methods for common properties.
- ANSI/AAMI/ISO 10993-1:2009(R) 2013 Biological evaluation of medical devices Part 1: ● Evaluation and testing within a risk management process
- IEC 60601-1, Ed. 3: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; Corrigendum 1(2006): Corrigendum 2 (2007)
- IEC 60601-1-2 Ed 4.0: Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 62366-1:2015: Medical devices -- Part 1: Application of usability engineering to medical devices
- . ISO 80369-3: 2016: Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications

| Characteristic | ENvizion Medical™<br>ENvue<br>(Predicate Device) | CORPAK CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference Device) | Cediflo Enteral<br>Feeding Tubes<br>(Reference Device) | Modified ENvizion<br>Medical™ ENvue<br>(Subject Device) | Comparison<br>to Predicate<br>/ Reference<br>Device |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182915 | K821906 | K181787 | N/A | N/A |
| Regulation<br>Number | 21 CFR 876.5980 | 21 CFR 876.5980 | 21 CFR 876.5980 | 21 CFR 876.5980 | Identical |
| Characteristic | ENvizion Medical™<br>ENvue<br>(Predicate Device) | CORPAK CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference Device) | Cediflo Enteral<br>Feeding Tubes<br>(Reference Device) | Modified ENvizion<br>Medical™ ENvue<br>(Subject Device) | Comparison<br>to Predicate<br>/ Reference<br>Device |
| Classification<br>Name | Gastrointestinal<br>Tube and<br>Accessories. | Gastrointestinal<br>Tube and<br>Accessories. | Gastrointestinal<br>Tube and<br>Accessories. | Gastrointestinal<br>Tube and<br>Accessories. | Identical |
| Product<br>Classification<br>Code | KNT, PIF | KNT | PIF | KNT | Identical to<br>Predicate |
| Regulatory Class | Class II | Class II | Class II | Class II | Identical |
| Intended Use | Aids qualified<br>operators in the<br>placement of the of<br>nasoenteral<br>feeding tubes into<br>the stomach or<br>small intestine of<br>patients requiring<br>enteral feeding. | Delivery of<br>nutrition, fluids,<br>and medications to<br>the stomach or<br>bowel | Delivery of nutrition,<br>fluids, and<br>medications to the<br>stomach or bowel | Aids qualified<br>operators in the<br>placement of the of<br>enteral feeding<br>tubes into the<br>stomach or small<br>intestine of<br>patients requiring<br>enteral feeding. | Identical to<br>Predicate |
| Indications for<br>Use | The ENvizion Medical<br>ENvue System is designed<br>to aid qualified operators<br>in the placement of the<br>ENvizion Medical Enteral<br>Feeding Tube of 10 Fr and<br>12 Fr into the stomach or<br>small intestine of adult<br>patients requiring enteral<br>feeding. The ENvizion<br>Medical ENvue System is<br>intended as an adjunct to<br>current placement<br>practices for assisting<br>clinical practitioners who<br>place feeding tubes.<br><br>The ENVIZION MEDICAL<br>Enteral Feeding Tube (EFT)<br>has been specifically<br>designed for use with the<br>ENvue System and is<br>intended for placement in<br>the stomach or small<br>intestine. It is intended for<br>use in adult patients who<br>require intermittent or<br>continuous feeding via the<br>oro/nasoenteric route.<br>The EFT is intended only to<br>be used with a feeding<br>pump and is not<br>compatible with gravity-<br>based feeding bags | The CORFLO Nasoenteric<br>Feeding Tube is intended<br>for use in those patients<br>who require intermittent<br>or continuous tube<br>feedings via the<br>nasogastric or nasoenteric<br>feeding route. | The Cediflo Enteral Feeding<br>Tubes are intended for the<br>administration of enteral<br>nutrition, fluids, and/or<br>medications by the<br>nasoenteric route into the<br>stomach or small intestine.<br>Indicated for patients 2 years<br>and above which require<br>nutritional support, are not<br>able to meet their nutritional<br>requirements by oral intake<br>and have functioning and<br>accessible gastrointestinal<br>tract. Maximum duration of<br>use: 42 days. | The ENvizion Medical<br>ENvue System is designed<br>to aid qualified operators<br>in the placement of the<br>ENvizion Medical Enteral<br>Feeding Tube of 10 Fr and<br>12 Fr into the stomach or<br>small intestine of adult<br>patients requiring enteral<br>feeding. The ENvizion<br>Medical ENvue System is<br>intended as an adjunct to<br>current placement<br>practices for assisting<br>clinical practitioners who<br>place feeding tubes.<br><br>The ENVIZION MEDICAL<br>Enteral Feeding Tube (EFT)<br>has been specifically<br>designed for use with the<br>ENvue System and is<br>intended for placement in<br>the stomach or small<br>intestine. It is intended for<br>use in adult patients who<br>require intermittent or<br>continuous feeding via the<br>oro/nasoenteric route.<br>The EFT is intended only to<br>be used with a feeding<br>pump and is not<br>compatible with gravity-<br>based feeding bags | Identical to<br>Predicate |
| Characteristic | ENvizion Medical™<br>ENvue<br>(Predicate Device) | CORPAK CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference Device) | Cediflo Enteral<br>Feeding Tubes<br>(Reference Device) | Modified ENvizion<br>Medical™ ENvue<br>(Subject Device) | Comparison<br>to Predicate<br>/ Reference<br>Device |
| Operating<br>Principle and<br>design | Rechargeable battery<br>powered<br>electromagnetic (EM)<br>system sensing<br>technology to track and<br>display path of feeding<br>tube using an EM<br>Tracking System,<br>Computer and Display.<br>The EM Transmitter is<br>the Field Generator and<br>the system uses<br>multiple EM Receivers<br>including one<br>integrated in the tube<br>distal tip.<br>A single-use | A single-use<br>polyurethane<br>radiopaque tube and<br>tip (for X-ray<br>visualization).<br>Nutrition is<br>administered with the<br>polymeric tubing<br>providing a fluid path<br>between the nutritional<br>supplement source (e.g.<br>feeding bag or feeding<br>pump) and the stomach<br>or small intestine of the<br>patient. | The Cediflo Enteral<br>Feeding Tubes are sterile,<br>single use devices<br>intended for use in acute<br>care facilities, long-term<br>care facilities, and home.<br>They are made from<br>radiopaque polyurethane<br>tubing printed with<br>centimeter markings and<br>bonded at the proximal<br>end to a rigid male ENFit<br>connector with a tethered<br>cap. These tubes are<br>supplied with or without a<br>guidewire. | Rechargeable battery<br>powered<br>electromagnetic (EM)<br>system sensing<br>technology to track and<br>display path of feeding<br>tube using an EM<br>Tracking System,<br>Computer and Display.<br>The EM Transmitter is<br>the Field Generator and<br>the system uses<br>multiple EM Receivers<br>including one<br>integrated in the tube<br>distal tip.<br>A single-use | Substantially<br>Equivalent.<br>EFT's with<br>stylet are<br>equivalent to<br>Reference<br>Devices<br>Differences<br>do not raise<br>new or<br>different<br>questions<br>regarding<br>safety or |
| | polyurethane<br>radiopaque tube and<br>tip (for X-ray<br>visualization). Nutrition<br>is administered with<br>the polymeric tubing<br>providing a fluid path<br>between the nutritional<br>supplement source (i.e.<br>feeding pump) and the<br>stomach or small<br>intestine of the patient. | | | polyurethane<br>radiopaque tube and<br>tip (for X-ray<br>visualization) available<br>with and without stylet.<br>Nutrition is<br>administered with the<br>polymeric tubing<br>providing a fluid path<br>between the nutritional<br>supplement source (i.e.<br>feeding pump) and the<br>stomach or small<br>intestine of the patient. | effectiveness |
| Tube Type | Multi Lumen<br>without stylet | Single lumen with<br>stylet | Single lumen with<br>and without stylet | Multi Lumen with<br>and without<br>optional stylet | Equivalent to<br>Reference<br>Devices |
| Tube Outer<br>Diameter | 10 and 12Fr | 8 to 12 Fr | 5 to 16Fr | 10 and 12Fr | Identical to<br>Predicate |
| Tube Usable<br>Length | 36 to 55 in<br>91 to 140 cm | 36 to 55 in<br>91 to 140 cm | 20 to 47in<br>50cm to 120cm | 36 to 55 in<br>91 to 140 cm | Identical to<br>Predicate |
| Patient<br>contacting tubing<br>material | Polyurethane | Polyurethane | Polyurethane | Polyurethane | Identical |
| Biocompatibility | FDA application of<br>ISO 10993 | ISO 10993 | FDA application of<br>ISO 10993 | FDA application of<br>ISO 10993 | Identical to<br>Predicate |
| Feeding<br>Connector | 80369-3 Connector<br>- ENFit | 80369-3 Connector<br>- ENFit | 80369-3 Connector<br>- ENFit | 80369-3 Connector<br>- ENFit | Identical |
| Sterilization | Non-sterile | Non-sterile | Sterile | Non-sterile | Identical to<br>Predicate |
| Target User | Intended for use by<br>physicians | Intended for use by<br>physicians | Intended for use by<br>physicians | Intended for use by<br>physicians | Identical |
| Characteristic | ENvizion Medical™<br>ENvue<br>(Predicate Device) | CORPAK CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference Device) | Cediflo Enteral<br>Feeding Tubes<br>(Reference Device) | Modified ENvizion<br>Medical™ ENvue<br>(Subject Device) | Comparison<br>to Predicate<br>/ Reference<br>Device |
| technicians and<br>nutritionists. | technicians and<br>nutritionists. | technicians and<br>nutritionists. | technicians and<br>nutritionists. | technicians and<br>nutritionists.…