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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on demonstrating substantial equivalence to a predicate device and confirming safety and effectiveness through various tests and a retrospective clinical evaluation. The primary performance metric reported for the clinical evaluation is agreement with X-ray confirmation.

Acceptance Criteria (Implied)	Reported Device Performance
Safety of the device (through various tests and clinical evaluation)	Device performed safely without any guidance-related adverse events.
Effectiveness in aiding tube placement (through various tests and clinical evaluation)	100% agreement between system display and X-ray position confirmation.
Biocompatibility	Complies with ISO 10993-1, in accordance with FDA guidance.
Mechanical properties (e.g., tensile strength, flow rate, stiffness)	Successfully passed all testing.
Software validation	Successfully passed all testing.
Shelf-life	Successfully passed all testing.
Conformance to recognized consensus standards	Conforms to multiple listed ISO, IEC, BS/EN standards.
Equivalent performance for 8 Fr EFT with stylet	Bench testing demonstrates safety and performance, no new/modified risks.

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

Sample Size: 50 placements across 48 randomly selected patients (2 of the subjects had 2 placements each).
Data Provenance: Retrospective, pseudonymized clinical evaluation. The country of origin is not specified in the provided text.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth (X-ray confirmation). It simply refers to "x-ray position confirmation." In a clinical setting, X-ray interpretation would typically be performed by qualified radiologists or other medical professionals with expertise in imaging diagnostics.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. It states "100% agreement between the system display and the x-ray position confirmation," implying a direct comparison without a need for resolving discrepancies between multiple expert readings or a specific adjudication protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the agreement between the device's display and X-ray confirmation, not on comparing human readers with and without AI assistance.

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

Yes, a standalone performance evaluation of sorts was conducted, as the study explicitly measured the "agreement between the system display and the x-ray position confirmation." This directly assesses the device's ability to accurately indicate tube position on its own, independent of a human operator's judgment beyond the initial setup and interpretation of the X-ray for ground truth. The device is designed to aid qualified operators, suggesting a human-in-the-loop context for its overall use, but the reported study specifically focuses on the accuracy of the system's output.

7. The Type of Ground Truth Used

The ground truth used was X-ray position confirmation.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. This is a 510(k) submission for a modification to a previously cleared device, and the focus is on performance validation of the modified device rather than a de novo software development process.

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

Since information about a training set is not provided, the method for establishing its ground truth is also not available in this document.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 / ManufacturerName and Address	ENvizion Medical Ltd.7 Haarad StreetTel Aviv, 6971060IsraelPhone +972 72-2288240
510(k) contact person	John MannDirectorEvergreen Research, Inc.433 Park Point Drive, Suite 140Golden CO 80401jmann@evergreenresearch.com(720) 287-8751
Date prepared	March 12, 2021
DEVICE IDENTIFICATION
Trade names	ENvizion Medical ENvueENvizion 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 ENvueENvizion Medical Enteral Feeding Tube
510(k) number	K191387

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K203133 Page 2 of 8

DEVICE DESCRIPTION

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.

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™ENvue(Predicate Device)	CORPAKCORFLONasoentericFeeding Tubes(ReferenceDevice)	Modified ENvizionMedical™ ENvue(Subject Device)	Comparison toPredicate /ReferenceDevice
510(k) Number	K191387	K821906	N/A	N/A
RegulationNumber	21 CFR 876.5980	21 CFR876.5980	21 CFR 876.5980	Identical toPredicate
ClassificationName	Gastrointestinaltube andaccessories.	Gastrointestinal tube andaccessories.	Gastrointestinaltube andaccessories.	Identical toPredicate
ProductClassificationCode	KNT	KNT	KNT	Identical toPredicate
Regulatory Class	Class II	Class II	Class II	Identical toPredicate
Characteristic	ENvizion Medical™ ENvue(Predicate Device)	CORPAKCORFLONasoentericFeeding Tubes(Reference Device)	Modified ENvizion Medical™ ENvue(Subject Device)	Comparison toPredicate / ReferenceDevice
Intended Use	Aids qualifiedoperators in theplacement of the ofnasoenteral feedingtubes into thestomach or smallintestine of patientsrequiring enteralfeeding.	Delivery ofnutrition,fluids, andmedicationsto thestomach orbowel	Aids qualifiedoperators in theplacement of the ofenteral feedingtubes into thestomach or smallintestine of patientsrequiring enteralfeeding.	Identical toPredicate
Indications forUse	The ENvizion Medical ENvueSystem is designed to aidqualified operators in theplacement of the ENvizionMedical Enteral FeedingTube of 10 Fr and 12 Fr intothe stomach or smallintestine of adult patientsrequiring enteral feeding.The ENvizion Medical ENvueSystem is intended as anadjunct to currentplacement practices forassisting clinicalpractitioners who placefeeding tubes.The ENVIZION MEDICALEnteral Feeding Tube (EFT)has been specificallydesigned for use with theENvue System and isintended for placement inthe stomach or smallintestine. It is intended foruse in adult patients whorequire intermittent orcontinuous feeding via theoro/nasoenteric route. TheEFT is intended only to beused with a feeding pumpand is not compatible withgravity-based feeding bags.	The CORFLONasoentericFeeding Tube isintended for use inthose patients whorequire intermittentor continuous tubefeedings via thenasogastric ornasoenteric feedingroute.	The ENvizion Medical ENvueSystem is designed to aidqualified operators in theplacement of the ENvizionMedical Enteral FeedingTube of from 8 Fr to 12 Frinto the stomach or smallintestine of adult patientsrequiring enteral feeding.The ENvizion Medical ENvueSystem is intended as anadjunct to currentplacement practices forassisting clinicalpractitioners who placefeeding tubes.The ENVIZION MEDICALEnteral Feeding Tube (EFT)has been specificallydesigned for use with theENvue System and isintended for placement inthe stomach or smallintestine. It is intended foruse in adult patients whorequire intermittent orcontinuous feeding via theoro/nasoenteric route. TheEFT is intended only to beused with a feeding pumpand is not compatible withgravity-based feeding bags.	SubstantiallyEquivalent8 Fr EFT withstylet areequivalent to thePredicate andReferenceDevicesDifferences donot raise new ordifferentquestionsregarding safetyor effectiveness
Characteristic	ENvizion Medical™ENvue(Predicate Device)	CORPAKCORFLONasoentericFeeding Tubes(ReferenceDevice)	Modified ENvizionMedical™ ENvue(Subject Device)	Comparison toPredicate /ReferenceDevice
OperatingPrinciple anddesign	Rechargeable batterypoweredelectromagnetic (EM)system sensingtechnology to track anddisplay path of feedingtube using an EMTracking System,Computer and Display.The EM Transmitter isthe Field Generator andthe system uses multipleEM Receivers includingone integrated in thetube distal tip.A single-usepolyurethaneradiopaque tube and tip(for X-ray visualization)available with andwithout stylet. Nutritionis administered with thepolymeric tubingproviding a fluid pathbetween the nutritionalsupplement source (i.e.feeding pump) and thestomach or smallintestine of the patient.	A single-usepolyurethaneradiopaque tubeand tip (for X-rayvisualization).Nutrition isadministeredwith thepolymeric tubingproviding a fluidpath between thenutritionalsupplementsource (e.g.feeding bag orfeeding pump)and the stomachor small intestineof the patient.	Rechargeable batterypoweredelectromagnetic (EM)system sensingtechnology to track anddisplay path of feedingtube using an EMTracking System,Computer and Display.The EM Transmitter isthe Field Generator andthe system uses multipleEM Receivers includingone integrated in thetube distal tip.A single-usepolyurethaneradiopaque tube and tip(for X-ray visualization)available with andwithout stylet. Nutritionis administered with thepolymeric tubingproviding a fluid pathbetween the nutritionalsupplement source (i.e.feeding pump) and thestomach or smallintestine of the patient.	SubstantiallyequivalentDifferences donot raise new ordifferentquestionsregarding safetyor effectiveness
Tube Type	Multi Lumen withand withoutoptional stylet	Single lumenwith stylet	Multi Lumen withand withoutoptional stylet	Identical toPredicate
Characteristic	ENvizion Medical™ENvue(Predicate Device)	CORPAKCORFLONasoentericFeeding Tubes(ReferenceDevice)	Modified ENvizionMedical™ ENvue(Subject Device)	Comparison toPredicate /ReferenceDevice
Tube OuterDiameter	10 and 12Fr	8 to 12 Fr	8 to 12Fr	SubstantiallyEquivalent8 Fr EFT withstylet areequivalent to theReferenceDevicesDifferences donot raise new ordifferentquestionsregarding safetyor effectiveness
Tube UsableLength	36 to 55 in91 to 140 cm	36 to 55 in91 to 140 cm	36 to 55 in91 to 140 cm	Identical toPredicate
Patientcontactingtubing material	Polyurethane	Polyurethane	Polyurethane	Identical toPredicate
Biocompatibility	FDA application ofISO 10993	ISO 10993	FDA application ofISO 10993	Identical toPredicate
FeedingConnector	80369-3 Connector -ENFit	80369-3Connector -ENFit	80369-3 Connector -ENFit	Identical toPredicate
Sterilization	Non-sterile	Non-sterile	Non-sterile	Identical toPredicate
Characteristic	ENvizion Medical™ENvue(Predicate Device)	CORPAKCORFLONasoentericFeeding Tubes(ReferenceDevice)	Modified ENvizionMedical™ ENvue(Subject Device)	Comparison toPredicate /ReferenceDevice
Target User	Intended for use byphysicians,technicians andnutritionists.	Intended foruse byphysicians,techniciansandnutritionists.	Intended for use byphysicians,technicians andnutritionists.	Identical toPredicate
UseEnvironment	Hospitals and otherhealthcare facilities	Hospitals andotherhealthcarefacilities	Hospitals and otherhealthcare facilities	Identical toPredicate
Access /Anatomical Site	Oro / Nasoenteric	Nasoenteric	Oro / Nasoenteric	Identical toPredicate
Energy Type -For EFT Tracking	ElectromagneticField	Electromagnetic Field	ElectromagneticField	Identical toPredicate
PatientPopulation	Adults	Adults	Adults	Identical toPredicate

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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.

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.