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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ENvizion Medical ENvue System and Enteral Feeding Tube, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds) for the device's performance in terms of aiding tube placement. Instead, it focuses on the successful completion of various tests to demonstrate safety and effectiveness and states that "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."

Here's a table summarizing the tests performed, which indirectly serve as acceptance criteria:

Acceptance Criteria (Tests Performed)	Reported Device Performance
Biocompatibility	Successfully passed
Dimensional Inspection	Successfully passed
Liquid Leakage Testing	Successfully passed
Visual Inspection	Successfully passed
Tensile Strength Testing	Successfully passed
Flow Rate Testing	Successfully passed
Tubing Stiffness Comparison	Successfully passed
Simulated Use	Successfully passed
Packaging Validation	Successfully passed
Shelf Life Validation	Successfully passed
Gastric Fluid Compatibility	Successfully passed
Software Validation	Successfully passed
IEC 60601-1 Electrical Safety	Successfully passed by conforming to standard
IEC 60601-1-2 Electromagnetic Compatibility (EMC)	Successfully passed by conforming to standard
Summative Usability	Successfully passed
Comparative Testing	Successfully passed
MR Compatibility Testing	Successfully passed
Human Clinical Study (Safety & Effectiveness)	"Showed no device guidance-related adverse events and no serious adverse events of any kind occurred...performed safely and effectively without any guidance related incidents."

2. Sample Size Used for the Test Set and Data Provenance

The "test set" for the human clinical study consisted of:

Sample Size: Data pooled from 58 subjects.
Data Provenance: The study was a prospective, single-center clinical trial. The country of origin is not explicitly stated in this summary, but the manufacturer is based in Israel.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. It mentions the system "is designed to aid qualified operators," but doesn't detail how the correctness of tube placement (ground truth) was definitively determined independent of the device. Given the nature of feeding tube placement, ground truth often relies on imaging (like X-ray) or pH testing by medical professionals, but this isn't detailed here.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the test set in terms of determining ground truth for tube placement outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study, as typically described for AI systems evaluating images, was not explicitly mentioned. The clinical study focused on the device's safety and effectiveness as an adjunct to current practices and its ability to guide placement, rather than comparing human performance with and without the device. The device itself aids in the placement process, not in interpreting diagnostic information where an MRMC reader study would be more common.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. The device, the ENvue System, is "designed to aid qualified operators" in the placement of the feeding tube. It is inherently a human-in-the-loop device, displaying the placement pathway in real-time for the user. Therefore, a standalone (algorithm only) performance assessment would not be relevant to its intended use.

7. The Type of Ground Truth Used

The type of ground truth used in the clinical study for verifying tube placement is not explicitly detailed. However, for feeding tube placement systems, common methods for confirming correct placement (i.e., ground truth) typically involve:

X-ray imaging (radiography)
pH testing of aspirate
Auscultation (listening for air insufflation)

The document notes that the feeding tube itself is "radiopaque...for X-ray visualization," suggesting that X-ray confirmation would be a standard part of practice. The predicate device's indications also mention "confirmation or correct tube placement by acceptable hospital protocol is required."

8. The Sample Size for the Training Set

The document does not provide information on a "training set" sample size. The ENvizion Medical ENvue system is a device that utilizes electromagnetic sensing technology to guide tube placement. While it contains embedded software ("Software Validation" is listed as a test), this is not an AI/Machine Learning diagnostic device in the traditional sense that would require a large training dataset for model development. The software likely controls the electromagnetic tracking and display, and its validation would involve functional testing rather than a training dataset from patient cases.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set in the context of an AI/ML algorithm that learns from data, the concept of establishing ground truth for a training set is not applicable here. The system relies on physical electromagnetic principles to track the tube.

Summary

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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.

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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

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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.

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 / ManufacturerName and Address	ENvizion Medical Ltd.7 Haarad StreetTel Aviv, 6971060IsraelPhone +972 72-2288240
510(k) contact person	Clay AnselmoPrincipal Quality and Regulatory ConsultantShriner & Associates429 Whitepine Creek RoadTrout Creek, MT 59874Clay.anselmo@yahoo.com(303) 907-2955
Date prepared	10/11/2018
DEVICE IDENTIFICATION
Trade Names	ENvizion Medical ENvueENvizion 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 CORFLONasoenteric Feeding Tubes withElectromagnetic Transmitting Stylet
510(k) number	K080679 (CORTRAK Enteral Access Device)K821906 (CORFLO NasoEnteric Feeding Tube)

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DEVICE DESCRIPTION

INDICATIONS FOR USE

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.

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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.

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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)	Comparisonto Predicate
510(k) Number	K080679 (CORTRAK 2 EnteralAccess Device)K821906* (CORFLO FeedingTube)	K182915	N/A
Regulation Number	21 CFR 876.5980	21 CFR 876.5980	Identical
Classification Name	Gastrointestinal tube andaccessories.	Gastrointestinal tube andaccessories.	Identical
ProductClassification Code	KNT	KNT	Identical
Regulatory Class	Class 2	Class 2	Identical
Intended Use	Aids qualified operators in theplacement of the ofnasoenteral feeding tubesinto the stomach or smallintestine of patients requiringenteral feeding.	Aids qualified operators in theplacement of the of enteralfeeding tubes into thestomach or small intestine ofpatients requiring enteralfeeding.	Identical
Indications for Use	The CORTRAK System is anelectrical device designed toaid qualified operators in theplacement of the VIASYSMedSystems feeding tubes of8 FR or greater into thestomach or small bowel ofpatients requiring enteralfeeding. Prior to commencingthe delivery of food,confirmation or correct tubeplacement by acceptablehospital protocol is required.	The ENvizion Medical ENvueSystem is designed to aidqualified operators in theplacement of the ENvizionMedical Enteral Feeding Tubeof 10 Fr and 12 Fr into thestomach or small intestine ofadult patients requiringenteral feeding. The ENvizionMedical ENvue System isintended as an adjunct tocurrent placement practicesfor assisting clinicalpractitioners who placefeeding tubes.	SubstantiallyEquivalentDifferencesdo not raisenew ordifferentquestionsregardingsafety oreffectiveness
Characteristic	CORPAK CORTRAK(Predicate Device)	ENvizion Medical™ ENvue(Subject Device)	Comparisonto Predicate
Operating Principleand design	Rechargeable batterypowered electromagnetic(EM) system sensingtechnology to track anddisplay path of feeding tubeusing an EM Tracking System,Computer and Display.The EM Transmitter isintegrated into the feedingtube distal tip and the EMReceiver is placed externallyon the Xiphoid Process.	The ENVIZION MEDICALEnteral Feeding Tube (EFT)has been specifically designedfor use with the ENvueSystem and is intended forplacement in the stomach orsmall intestine. It is intendedfor use in adult patients whorequire intermittent orcontinuous feeding via theoro/nasoenteric route. TheEFT is intended only to beused with a feeding pump andis not compatible withgravity-based feeding bags.Rechargeable batterypowered electromagnetic(EM) system sensingtechnology to track anddisplay path of feeding tubeusing an EM Tracking System,Computer and Display.The EM Transmitter is theField Generator and thesystem uses multiple EMReceivers including oneintegrated in the tube distaltip.	SubstantiallyEquivalentDifferencesdo not raisenew ordifferentquestionsregardingsafety oreffectiveness
	A single-use polyurethaneradiopaque tube and tip (forX-ray visualization).Nutrition is administered withthe polymeric tubingproviding a fluid pathbetween the nutritionalsupplement source (e.g.feeding bag or feeding pump)and the stomach or smallintestine of the patient.	A single-use polyurethaneradiopaque tube and tip (forX-ray visualization). Nutritionis administered with thepolymeric tubing providing afluid path between thenutritional supplement source(i.e. feeding pump) and thestomach or small intestine ofthe patient.
Tube Type	Single lumen	Multi Lumen	SubstantiallyequivalentDifferencesdo not raisenew ordifferentquestions
Characteristic	CORPAK CORTRAK(Predicate Device)	ENvizion Medical™ ENvue(Subject Device)	Comparisonto Predicate
Tube OuterDiameter	8 to 12 Fr	10 and 12Fr	SubstantiallyequivalentDifferencesdo not raisenew ordifferentquestionsregardingsafety oreffectiveness
Tube Usable Length	36 to 55 in91 to 140 cm	36 to 55 in91 to 140 cm	Identical
Patient contactingtubing material	Polyurethane	Polyurethane	Identical
Biocompatibility	ISO 10993	FDA application of ISO 10993	SubstantiallyEquivalent
Feeding Connector	80369-3 Connector - ENFit	80369-3 Connector - ENFit	Identical
Sterilization	Non-sterile	Non-sterile	Identical
Target User	Intended for use byphysicians, technicians andnutritionists.	Intended for use byphysicians, technicians andnutritionists.	Identical
Use Environment	Hospitals and otherhealthcare facilities	Hospitals and otherhealthcare facilities	Identical
Access / AnatomicalSite	Nasoenteric	Oro / Nasoenteric	SubstantiallyEquivalent
Energy Type	Electromagnetic Field	Electromagnetic Field	Identical
Patient Population	Adults	Adults	Identical

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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.

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.