ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube

K203133 · Envizion Medical , Ltd. · KNT · Mar 24, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K203133
• Device Name: ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
• Applicant: Envizion Medical , Ltd.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Mar 24, 2021
• Decision: SESE
• Submission Type: Traditional
• 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 from 8 Fr to 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

System aids clinical practitioners in placing enteral feeding tubes (EFT) into stomach/small intestine; uses electromagnetic (EM) tracking to display tube pathway in real-time. Components: EM field generator, EM receivers (one in tube tip), computer, display. Operator tracks tube progression via oro/nasoenteric route; disconnects system post-placement. Modification adds 8 Fr EFT with stainless-steel stylet; changes patient posture input from plate sensor to marking stylus. Used in hospitals/healthcare facilities by physicians, technicians, nutritionists. Output allows visual confirmation of tube path; aids clinical decision-making regarding correct placement; benefits patient by reducing risk of malposition.

Clinical Evidence

Retrospective clinical evaluation of 50 placements in 48 adult patients. Primary endpoint: agreement between system display and X-ray confirmation. Results: 100% agreement; no device-related adverse events reported.

Technological Characteristics

Rechargeable battery-powered EM tracking system. Polyurethane radiopaque feeding tubes (8-12 Fr) with stainless-steel stylet. ENFit connectors (ISO 80369-3). Non-sterile. Complies with IEC 60601-1, IEC 60601-1-2, ISO 10993-1, BS/EN 1615, BS/EN 1618.

Indications for Use

Indicated for adult patients requiring intermittent or continuous enteral feeding via the oro/nasoenteric route, specifically for placement of 8 Fr to 12 Fr feeding tubes into the stomach or small intestine.

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 (K191387)

Reference Devices

• CORPAK CORFLO Nasoenteric Feeding Tubes (K821906)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

March 24, 2021

ENvizion Medical Ltd. % John Mann Director Evergreen Research, Inc. 433 Park Point Drive, Suite 140 Golden, CO 80401

Re: K203133

> Trade/Device Name: ENvizion Medical ENvue 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: October 15, 2020 Received: October 19, 2020

Dear John Mann:

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

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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

Shanil P. Haugen, Ph.D. Assistant 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203133

Device Name ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube

#### Indications for Use (Describe)

The ENvizion Medical ENvue System is designed to aid qualified operators in the ENvizion Medical Enteral Feeding Tube from 8 Fr to 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 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K203133 Page 1 of 8

# 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 | John Mann<br>Director<br>Evergreen Research, Inc.<br>433 Park Point Drive, Suite 140<br>Golden CO 80401<br>[e-mail]<br>[phone] |
| Date prepared | March 12, 2021 |
| DEVICE IDENTIFICATION | |
| Trade names | ENvizion Medical ENvue<br>ENvizion Medical Enteral Feeding Tube |
| Common name | Gastrointestinal tubes and accessories |
| Classification name | Gastrointestinal tubes and accessories |
| Regulation Number | 21 CFR Part 876.5980 |
| Classification | Class II |
| Product Code | KNT, PIF |

#### PREDICATE DEVICE

| Trade names | ENvizion Medical ENvue<br>ENvizion Medical Enteral Feeding Tube |
|---------------|-----------------------------------------------------------------|
| 510(k) number | K191387 |

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K203133 Page 2 of 8

#### 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 510(k) notification adds an 8 Fr EFT with a stainless-steel stylet and changes the input source for patient posture from using the plate sensor to the marking stylus. The plate sensor has been removed from the system.

# INDICATIONS FOR USE

The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube from 8 Fr to 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 similar 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. Both products use electromagnetic fields and receivers to provide placement pathway of the tube through the patient's naso/oro enteral anatomy.
- The small differences between the ENvue device and the Predicate do not raise new or different questions of safety or effectiveness
- The biocompatibility of both products' patient contact materials complies with ISO 10993- O 1 in accordance with FDA guidance related to the application of this standard.
- O Bench testing demonstrates the safety and performance of the 8 Fr EFT and the stylus providing patient posture resulting in no new / significantly modified risks as a result of the modification.

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K203133 Page 3 of 8

- O Clinical evaluation demonstrates the safety and effectiveness of the system using the electromagnetic field and receivers for providing the placement pathway of the tube through the patient's anatomy.
#### 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 subject 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
- Dimensional Inspection
- Visual Inspection
- Liquid Leakage Testing
- Tensile Strength Testing
- Flow Rate Testing
- Extended 30-day Gastric Compatibility
- Tubing Stiffness Comparison
- Shelf-Life Validation
- Simulated Use
- Software validation
- . Retrospective clinical evaluation study

To provide confirmatory evidence of the safety and effectiveness of the ENvue device, an on-label, retrospective, pseudonymized clinical evaluation was performed with 50 placements across 48 randomly selected patients (2 of the subjects had 2 placements each). An analysis of the data gathered from the 50 placements showed 100% agreement between the system display and the x-ray position confirmation. A review of the data showed the device performed safely and effectively without any guidance related adverse events.

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)

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#### K203133 Page 4 of 8

- . 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

# SUBSTANTIAL EQUIVALENCE COMPARISON

| Characteristic | ENvizion Medical™<br>ENvue<br>(Predicate Device) | CORPAK<br>CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference<br>Device) | Modified ENvizion<br>Medical™ ENvue<br>(Subject Device) | Comparison to<br>Predicate /<br>Reference<br>Device |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K191387 | K821906 | N/A | N/A |
| Regulation<br>Number | 21 CFR 876.5980 | 21 CFR<br>876.5980 | 21 CFR 876.5980 | Identical to<br>Predicate |
| Classification<br>Name | Gastrointestinal<br>tube and<br>accessories. | Gastrointestin<br>al tube and<br>accessories. | Gastrointestinal<br>tube and<br>accessories. | Identical to<br>Predicate |
| Product<br>Classification<br>Code | KNT | KNT | KNT | Identical to<br>Predicate |
| Regulatory Class | Class II | Class II | Class II | Identical to<br>Predicate |
| Characteristic | ENvizion Medical™ ENvue<br>(Predicate Device) | CORPAK<br>CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference Device) | Modified ENvizion Medical™ ENvue<br>(Subject Device) | Comparison to<br>Predicate / Reference<br>Device |
| Intended Use | Aids qualified<br>operators in the<br>placement of the of<br>nasoenteral feeding<br>tubes into the<br>stomach or small<br>intestine of patients<br>requiring enteral<br>feeding. | Delivery of<br>nutrition,<br>fluids, and<br>medications<br>to the<br>stomach or<br>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 patients<br>requiring enteral<br>feeding. | Identical to<br>Predicate |
| Indications for<br>Use | The ENvizion Medical ENvue<br>System is designed to aid<br>qualified operators in the<br>placement of the ENvizion<br>Medical Enteral Feeding<br>Tube of 10 Fr and 12 Fr into<br>the stomach or small<br>intestine of adult patients<br>requiring enteral feeding.<br>The ENvizion Medical ENvue<br>System is intended as an<br>adjunct to current<br>placement practices for<br>assisting clinical<br>practitioners who place<br>feeding tubes.<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. The<br>EFT is intended only to be<br>used with a feeding pump<br>and is not compatible with<br>gravity-based feeding bags. | The CORFLO<br>Nasoenteric<br>Feeding Tube is<br>intended for use in<br>those patients who<br>require intermittent<br>or continuous tube<br>feedings via the<br>nasogastric or<br>nasoenteric feeding<br>route. | The ENvizion Medical ENvue<br>System is designed to aid<br>qualified operators in the<br>placement of the ENvizion<br>Medical Enteral Feeding<br>Tube of from 8 Fr to 12 Fr<br>into the stomach or small<br>intestine of adult patients<br>requiring enteral feeding.<br>The ENvizion Medical ENvue<br>System is intended as an<br>adjunct to current<br>placement practices for<br>assisting clinical<br>practitioners who place<br>feeding tubes.<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. The<br>EFT is intended only to be<br>used with a feeding pump<br>and is not compatible with<br>gravity-based feeding bags. | Substantially<br>Equivalent<br><br>8 Fr EFT with<br>stylet are<br>equivalent to the<br>Predicate and<br>Reference<br>Devices<br><br>Differences do<br>not raise new or<br>different<br>questions<br>regarding safety<br>or effectiveness |
| Characteristic | ENvizion Medical™<br>ENvue<br>(Predicate Device) | CORPAK<br>CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference<br>Device) | Modified ENvizion<br>Medical™ ENvue<br>(Subject Device) | Comparison to<br>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 multiple<br>EM Receivers including<br>one integrated in the<br>tube distal tip.<br>A single-use<br>polyurethane<br>radiopaque tube and tip<br>(for X-ray visualization)<br>available with and<br>without stylet. Nutrition<br>is 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. | A single-use<br>polyurethane<br>radiopaque tube<br>and tip (for X-ray<br>visualization).<br>Nutrition is<br>administered<br>with the<br>polymeric tubing<br>providing a fluid<br>path between the<br>nutritional<br>supplement<br>source (e.g.<br>feeding bag or<br>feeding pump)<br>and the stomach<br>or small intestine<br>of the patient. | 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 multiple<br>EM Receivers including<br>one integrated in the<br>tube distal tip.<br>A single-use<br>polyurethane<br>radiopaque tube and tip<br>(for X-ray visualization)<br>available with and<br>without stylet. Nutrition<br>is 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. | Substantially<br>equivalent<br>Differences do<br>not raise new or<br>different<br>questions<br>regarding safety<br>or effectiveness |
| Tube Type | Multi Lumen with<br>and without<br>optional stylet | Single lumen<br>with stylet | Multi Lumen with<br>and without<br>optional stylet | Identical to<br>Predicate |
| Characteristic | ENvizion Medical™<br>ENvue<br>(Predicate Device) | CORPAK<br>CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference<br>Device) | Modified ENvizion<br>Medical™ ENvue<br>(Subject Device) | Comparison to<br>Predicate /<br>Reference<br>Device |
| Tube Outer<br>Diameter | 10 and 12Fr | 8 to 12 Fr | 8 to 12Fr | Substantially<br>Equivalent<br><br>8 Fr EFT with<br>stylet are<br>equivalent to the<br>Reference<br>Devices<br><br>Differences do<br>not raise new or<br>different<br>questions<br>regarding safety<br>or effectiveness |
| Tube Usable<br>Length | 36 to 55 in<br>91 to 140 cm | 36 to 55 in<br>91 to 140 cm | 36 to 55 in<br>91 to 140 cm | Identical to<br>Predicate |
| Patient<br>contacting<br>tubing material | Polyurethane | Polyurethane | Polyurethane | Identical to<br>Predicate |
| Biocompatibility | FDA application of<br>ISO 10993 | ISO 10993 | FDA application of<br>ISO 10993 | Identical to<br>Predicate |
| Feeding<br>Connector | 80369-3 Connector -<br>ENFit | 80369-3<br>Connector -<br>ENFit | 80369-3 Connector -<br>ENFit | Identical to<br>Predicate |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Identical to<br>Predicate |
| Characteristic | ENvizion Medical™<br>ENvue<br>(Predicate Device) | CORPAK<br>CORFLO<br>Nasoenteric<br>Feeding Tubes<br>(Reference<br>Device) | Modified ENvizion<br>Medical™ ENvue<br>(Subject Device) | Comparison to<br>Predicate /<br>Reference<br>Device |
| Target User | Intended for use by<br>physicians,<br>technicians and<br>nutritionists. | Intended for<br>use by<br>physicians,<br>technicians<br>and<br>nutritionists. | Intended for use by<br>physicians,<br>technicians and<br>nutritionists. | Identical to<br>Predicate |
| Use<br>Environment | Hospitals and other<br>healthcare facilities | Hospitals and<br>other<br>healthcare<br>facilities | Hospitals and other<br>healthcare facilities | Identical to<br>Predicate |
| Access /<br>Anatomical Site | Oro / Nasoenteric | Nasoenteric | Oro / Nasoenteric | Identical to<br>Predicate |
| Energy Type -<br>For EFT Tracking | Electromagnetic<br>Field | Electromagnet<br>ic Field | Electromagnetic<br>Field | Identical to<br>Predicate |
| Patient<br>Population | Adults | Adults | Adults | Identical to<br>Predicate |

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The modified ENvizion Medical ENvue System and Enteral Feeding Tube is substantially equivalent with respect to the indication for use, technological characteristics, target user, and use environment to the following legally marked Predicate devices:

- Predicate: ENvizion Medical ENvue System and Enteral Feeding Tube, K191387 ●
- Reference Device: CORPAK CORFLO Nasoenteric Feeding Tubes, K821906

# CONCLUSION

The modified ENvizion Medical ENvue and Enteral Feeding Tube are substantially equivalent to the unmodified version of the ENvizion Medical ENvue System and Enteral Feeding Tube.