Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes an electro-mechanical device with embedded software for tracking tube placement, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No.
Explanation: The device is designed to aid in the placement of an enteral feeding tube for adult patients, which is a diagnostic/placement aid, not a therapeutic device. The feeding tube itself provides therapy, but the system described here is for tube placement.

Diagnostic

No

The device is designed to aid in the physical placement of an enteral feeding tube and track its progression in real-time, not to diagnose a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the ENvizion Medical ENvue System is an "electro-mechanical device with embedded software," indicating it includes hardware components in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The ENvizion Medical ENvue System is an electro-mechanical device designed to aid in the physical placement of a feeding tube within the patient's body. It tracks the tube's location in real-time.
Lack of Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely focused on guiding a physical device (the feeding tube) within the patient's anatomy.

Therefore, the ENvizion Medical ENvue System falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ENvizion Medical ENvue System is designed to aid qualified operators in 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 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.

Product codes (comma separated list FDA assigned to the subject device)

KNT

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, 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 is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

stomach or small intestine; oro/nasoenteric route

Indicated Patient Age Range

adult patients

Intended User / Care Setting

Qualified operators, clinical practitioners, physicians, technicians and nutritionists.
Hospitals and other healthcare facilities

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

To provide confirmatory evidence of the safety and effectiveness of the ENvue device, two clinical studies were executed and the data pooled from 58 subjects. Each of the studies was a prospective, single center, non-randomized clinical trial in subjects that required placement of a enteral feeding tube as a result of their current medical condition. The study included placements through both the oro and naso routes.

An analysis of the data gathered from 54 placements during the clinical study showed no device guidance-related adverse events and no serious adverse events of any kind occurred during the study. There were thirteen alleged device malfunctions; twelve of the thirteen tube placements occurred were determined not to be adverse events per the case report forms. One incident was identified as an adverse event; however, upon further reviewed was determined not to be a serious adverse event and was identified as a manufacturing nonconformance. A review of the CRF's and associated procedural data showed the device performed safely and effectively without any guidance related incidents.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K080679 (CORTRAK Enteral Access Device), K821906 (CORFLO NasoEnteric Feeding Tube)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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.

February 13, 2019

ENvizion Medical Ltd. % Clay Anselmo Principle Consultant Shriner & Associates 429 Whitepine Creek Road Trout Creek, MT 59874

Re: K182915

Trade/Device Name: ENvizion Medical ENvizion Medical Enteral Feeding Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: January 18, 2019 Received: January 23, 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 statutes and regulations administered by other Federal agencies.

1

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or (301) 796-7100).

Sincerely,

Mark J. Antonino -S

for

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

2

Indications for Use

510(k) Number (if known) K182915

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 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 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)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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
Name and Address | ENvizion Medical Ltd.
7 Haarad Street
Tel Aviv, 6971060
Israel
Phone +972 72-2288240 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) contact person | Clay Anselmo
Principal Quality and Regulatory Consultant
Shriner & Associates
429 Whitepine Creek Road
Trout Creek, MT 59874
Clay.anselmo@yahoo.com
(303) 907-2955 |
| Date prepared | 10/11/2018 |
| DEVICE IDENTIFICATION | |
| Trade Names | ENvizion Medical ENvue
ENvizion Medical Enteral Feeding Tube |
| Regulation Name | Gastrointestinal tube and accessories |

Tubes, Gastrointestinal (and Accessories)

21 CFR Part 876.5980

Class II

KNT

Product Code

Classification

Regulation Number

PREDICATE DEVICE

Product Code Device Name

| Trade names | CORTRAK Enteral Access Device and CORFLO
Nasoenteric Feeding Tubes with
Electromagnetic Transmitting Stylet |
|---------------|-------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K080679 (CORTRAK Enteral Access Device)
K821906 (CORFLO NasoEnteric Feeding Tube) |

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, 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 is completed, the user disconnects the ENvue from the EFT. The EFT connects to a feeding pump using ENFit connections.

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 ENvizion Medical ENvue is substantially equivalent to the CORTRAK Enteral Access Device and CORTRAK CORFLO NasoEnteric feeding tubes with transmitting stylet

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 similar indications for use asthe Predicate device.
The ENvue device uses the same fundamental technology as the Predicate device and very similar detailed technological solutions as follows: 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 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.
- Both products have certification to medical device safety standards for 60601-1 O Electrical Safety and 60601-1-2 EMC

For a more detailed comparison, refer to the Substantial Equivalence table below.

PERFORMANCE DATA

There are no known performance standards for this device.

The ENvizion Medical ENvue and 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.

5

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
Dimensional Inspection ●
Liquid Leakage Testing
Visual Inspection ●
Tensile Strength Testing
Flow Rate Testing
Tubing Stiffness Comparison
Simulated Use
. Packaging Validation
Shelf Life Validation
Gastric Fluid Compatibility
Software Validation
IEC 60601-1 Electrical Safety
IEC 60601-1-2 Electromagnetic Compatibility (EMC)
Summative Usability
. Comparative Testing
MR Compatibility Testing
Human Clinical Study

To provide confirmatory evidence of the safety and effectiveness of the ENvue device, two clinical studies were executed and the data pooled from 58 subjects. Each of the studies was a prospective, single center, non-randomized clinical trial in subjects that required placement of a enteral feeding tube as a result of their current medical condition. The study included placements through both the oro and naso routes.

An analysis of the data gathered from 54 placements during the clinical study showed no device guidance-related adverse events and no serious adverse events of any kind occurred during the study. There were thirteen alleged device malfunctions; twelve of the thirteen tube placements occurred were determined not to be adverse events per the case report forms. One incident was identified as an adverse event; however, upon further reviewed was determined not to be a serious adverse event and was identified as a manufacturing nonconformance. A review of the CRF's and associated procedural data showed the device performed safely and effectively without any guidance related incidents.

The device has been designed in conformance to the following voluntary recognized consensus standards:

o 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.

6

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 62304:2015, Medical Device Software Software Lifecycle Processes ●
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 | CORPAK CORTRAK
(Predicate Device) | ENvizion Medical™ ENvue
(Subject Device) | Comparison
to Predicate |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K080679 (CORTRAK 2 Enteral
Access Device)
K821906* (CORFLO Feeding
Tube) | K182915 | N/A |
| Regulation Number | 21 CFR 876.5980 | 21 CFR 876.5980 | Identical |
| Classification Name | Gastrointestinal tube and
accessories. | Gastrointestinal tube and
accessories. | Identical |
| Product
Classification Code | KNT | KNT | Identical |
| Regulatory Class | Class 2 | Class 2 | Identical |
| Intended Use | Aids qualified operators in the
placement of the of
nasoenteral feeding tubes
into the stomach or small
intestine of patients requiring
enteral feeding. | Aids qualified operators in the
placement of the of enteral
feeding tubes into the
stomach or small intestine of
patients requiring enteral
feeding. | Identical |
| Indications for Use | The CORTRAK System is an
electrical device designed to
aid qualified operators in the
placement of the VIASYS
MedSystems feeding tubes of
8 FR or greater into the
stomach or small bowel of
patients requiring enteral
feeding. Prior to commencing
the delivery of food,
confirmation or correct tube
placement by acceptable
hospital protocol is required. | 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. | Substantially
Equivalent
Differences
do not raise
new or
different
questions
regarding
safety or
effectiveness |
| Characteristic | CORPAK CORTRAK
(Predicate Device) | ENvizion Medical™ ENvue
(Subject Device) | Comparison
to Predicate |
| Operating Principle
and design | Rechargeable battery
powered electromagnetic
(EM) system sensing
technology to track and
display path of feeding tube
using an EM Tracking System,
Computer and Display.

The EM Transmitter is
integrated into the feeding
tube distal tip and the EM
Receiver is placed externally
on the Xiphoid Process. | 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.

Rechargeable battery
powered electromagnetic
(EM) system sensing
technology to track and
display path of feeding tube
using an EM Tracking System,
Computer and Display.

The EM Transmitter is the
Field Generator and the
system uses multiple EM
Receivers including one
integrated in the tube distal
tip. | Substantially
Equivalent

Differences
do not raise
new or
different
questions
regarding
safety or
effectiveness |
| | A single-use polyurethane
radiopaque tube and tip (for
X-ray visualization).
Nutrition is administered with
the polymeric tubing
providing a fluid path
between the nutritional
supplement source (e.g.
feeding bag or feeding pump)
and the stomach or small
intestine of the patient. | A single-use polyurethane
radiopaque tube and tip (for
X-ray visualization). Nutrition
is administered with the
polymeric tubing providing a
fluid path between the
nutritional supplement source
(i.e. feeding pump) and the
stomach or small intestine of
the patient. | |
| Tube Type | Single lumen | Multi Lumen | Substantially
equivalent

7

8

Note: Indications for Use statement for K821906 are not currently available.

The 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:

Corpak CORTRAK Enteral Access Device (K080679)
. Corpak CORTRAK CORFLO feeding tube (K821906)

CONCLUSION

The ENvizion Medical ENvue and Enteral Feeding Tube are substantially equivalent to the CORTRAK Enteral Access Device and CORTRAK CORFLO NasoEnteric Feeding Tube with Transmitting Stylet.