(156 days)
No
The summary describes an electro-mechanical device with embedded software for tracking tube placement, but there is no mention of AI or ML algorithms being used for this tracking or any other function. The performance study focuses on agreement with x-ray confirmation, not on the performance of an AI/ML model.
No.
The device is used to aid in the placement of an enteral feeding tube for feeding, but it does not treat a disease or condition itself.
No
The device is used to aid in the placement of enteral feeding tubes by tracking their progression and displaying the placement pathway in real-time. It is intended as an adjunct to current practices for assisting clinical practitioners and does not diagnose disease or medical conditions.
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.
Based on the provided text, 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.
- Device Function: The ENvizion Medical ENvue System is an electro-mechanical device designed to aid in the physical placement of an enteral feeding tube within the patient's body. It tracks the tube's progress and displays its 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 the mechanical process of tube insertion and tracking.
Therefore, the ENvizion Medical ENvue System falls under the category of a medical device used for a procedural aid, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
KNT, PIF
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.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: 50 placements across 48 randomly selected patients, 100% agreement between system display and x-ray position confirmation. Device performed safely and effectively without any guidance related adverse events.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% agreement between the system display and the x-ray position confirmation.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
2
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
Name and Address | ENvizion Medical Ltd.
7 Haarad Street
Tel Aviv, 6971060
Israel
Phone +972 72-2288240 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) contact person | John Mann
Director
Evergreen Research, Inc.
433 Park Point Drive, Suite 140
Golden CO 80401
jmann@evergreenresearch.com
(720) 287-8751 |
| Date prepared | March 12, 2021 |
| DEVICE IDENTIFICATION | |
| Trade names | ENvizion Medical ENvue
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
ENvizion Medical Enteral Feeding Tube |
|---------------|-----------------------------------------------------------------|
| 510(k) number | K191387 |
4
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.
5
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)
6
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) | CORPAK
CORFLO
Nasoenteric
Feeding Tubes
(Reference
Device) | Modified ENvizion
Medical™ ENvue
(Subject Device) | Comparison to
Predicate /
Reference
Device |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K191387 | K821906 | N/A | N/A |
| Regulation
Number | 21 CFR 876.5980 | 21 CFR
876.5980 | 21 CFR 876.5980 | Identical to
Predicate |
| Classification
Name | Gastrointestinal
tube and
accessories. | Gastrointestin
al tube and
accessories. | Gastrointestinal
tube and
accessories. | Identical to
Predicate |
| Product
Classification
Code | KNT | KNT | KNT | Identical to
Predicate |
| Regulatory Class | Class II | Class II | Class II | Identical to
Predicate |
| Characteristic | ENvizion Medical™ ENvue
(Predicate Device) | CORPAK
CORFLO
Nasoenteric
Feeding Tubes
(Reference Device) | Modified ENvizion Medical™ ENvue
(Subject Device) | Comparison to
Predicate / Reference
Device |
| 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. | Delivery of
nutrition,
fluids, and
medications
to the
stomach or
bowel | Aids qualified
operators in the
placement of the of
enteral feeding
tubes into the
stomach or small
intestine of patients
requiring enteral
feeding. | Identical to
Predicate |
| 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. | The CORFLO
Nasoenteric
Feeding Tube is
intended for use in
those patients who
require intermittent
or continuous tube
feedings via the
nasogastric or
nasoenteric feeding
route. | The ENvizion Medical ENvue
System is designed to aid
qualified operators in the
placement of the ENvizion
Medical Enteral Feeding
Tube of 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. | Substantially
Equivalent
8 Fr EFT with
stylet are
equivalent to the
Predicate and
Reference
Devices
Differences do
not raise new or
different
questions
regarding safety
or effectiveness |
| Characteristic | ENvizion Medical™
ENvue
(Predicate Device) | CORPAK
CORFLO
Nasoenteric
Feeding Tubes
(Reference
Device) | Modified ENvizion
Medical™ ENvue
(Subject Device) | Comparison to
Predicate /
Reference
Device |
| 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
the Field Generator and
the system uses multiple
EM Receivers including
one integrated in the
tube distal tip.
A single-use
polyurethane
radiopaque tube and tip
(for X-ray visualization)
available with and
without stylet. 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. | 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. | 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.
A single-use
polyurethane
radiopaque tube and tip
(for X-ray visualization)
available with and
without stylet. 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. | Substantially
equivalent
Differences do
not raise new or
different
questions
regarding safety
or effectiveness |
| Tube Type | Multi Lumen with
and without
optional stylet | Single lumen
with stylet | Multi Lumen with
and without
optional stylet | Identical to
Predicate |
| Characteristic | ENvizion Medical™
ENvue
(Predicate Device) | CORPAK
CORFLO
Nasoenteric
Feeding Tubes
(Reference
Device) | Modified ENvizion
Medical™ ENvue
(Subject Device) | Comparison to
Predicate /
Reference
Device |
| Tube Outer
Diameter | 10 and 12Fr | 8 to 12 Fr | 8 to 12Fr | Substantially
Equivalent
8 Fr EFT with
stylet are
equivalent to the
Reference
Devices
Differences do
not raise new or
different
questions
regarding safety
or effectiveness |
| Tube Usable
Length | 36 to 55 in
91 to 140 cm | 36 to 55 in
91 to 140 cm | 36 to 55 in
91 to 140 cm | Identical to
Predicate |
| Patient
contacting
tubing material | Polyurethane | Polyurethane | Polyurethane | Identical to
Predicate |
| Biocompatibility | FDA application of
ISO 10993 | ISO 10993 | FDA application of
ISO 10993 | Identical to
Predicate |
| Feeding
Connector | 80369-3 Connector -
ENFit | 80369-3
Connector -
ENFit | 80369-3 Connector -
ENFit | Identical to
Predicate |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Identical to
Predicate |
| Characteristic | ENvizion Medical™
ENvue
(Predicate Device) | CORPAK
CORFLO
Nasoenteric
Feeding Tubes
(Reference
Device) | Modified ENvizion
Medical™ ENvue
(Subject Device) | Comparison to
Predicate /
Reference
Device |
| Target User | Intended for use by
physicians,
technicians and
nutritionists. | Intended for
use by
physicians,
technicians
and
nutritionists. | Intended for use by
physicians,
technicians and
nutritionists. | Identical to
Predicate |
| Use
Environment | Hospitals and other
healthcare facilities | Hospitals and
other
healthcare
facilities | Hospitals and other
healthcare facilities | Identical to
Predicate |
| Access /
Anatomical Site | Oro / Nasoenteric | Nasoenteric | Oro / Nasoenteric | Identical to
Predicate |
| Energy Type -
For EFT Tracking | Electromagnetic
Field | Electromagnet
ic Field | Electromagnetic
Field | Identical to
Predicate |
| Patient
Population | Adults | Adults | Adults | Identical to
Predicate |
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8
9
10
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.