(21 days)
No
The summary describes an electro-mechanical device with embedded software for tracking a feeding tube. There is no mention of AI, ML, image processing, or any related concepts in the intended use, device description, or performance studies. The focus is on the mechanical tracking and display of the tube's pathway.
No
This device is designed to aid in the placement of enteral feeding tubes and the tubes themselves are for delivering nutrition, not for treating a disease or condition. The "therapeutic" aspect of nutrition delivery is provided by the feeding pump and the nutrients, not by the tube placement system or the tube itself.
No
The device is designed to aid in the placement of feeding tubes and track their progression, which is a procedural aid, not a diagnostic function to identify a disease or condition.
No
The device description explicitly states it is an "electro-mechanical device with embedded software" and includes hardware components like the Enteral Feeding Tube (EFT) and a stylet. The performance studies also include hardware-specific testing like biocompatibility, dimensional inspection, and bond strength.
Based on the provided text, the ENvizion Medical ENvue System and Enteral Feeding Tube are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The ENvizion Medical ENvue System and Enteral Feeding Tube are used to place a feeding tube directly into the patient's body (stomach or small intestine) for the purpose of delivering nutrition. It aids in the physical placement of the tube and tracks its location within the body.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is entirely focused on the physical placement and tracking of the feeding tube within the patient's anatomy.
Therefore, the ENvizion Medical ENvue System and Enteral Feeding Tube fall under the category of a medical device used for a therapeutic purpose (enteral feeding) and a procedural aid (tube placement), not an in vitro diagnostic device.
N/A
Intended Use / 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.
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 Special 510(k) notification adds 4 new models of EFTs, that include a stainless-steel stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach or small intestine
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Qualified operators (physicians, technicians, nutritionists) in 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)
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 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 – Stylet and connector hub only
- Dimensional Inspection Stylet only.
- Bond strength – Stylet to connector hub
- Tubing Stiffness Comparison - Impact of Stylet on tubing stiffness
- Simulated Use - Confirm no impact of stylet on tracking
- . Shelf Life Validation – Impact of stylet on EFT shelf-life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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.
June 14, 2019
Envizion Medical Ltd. % Clay Anselmo Principal Consultant Shriner & Associates 429 Whitepine Creek Road Trout Creek, Montana 59872
Re: K191387
Trade/Device Name: ENvizion Medical ENVue SYSTEM, 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: May 24, 2019 Received: May 24, 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
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
Shani P. Haugen, Ph.D. Acting, Assistant Division 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ENvizion Medical ENvue System ENvizion Medical Enteral Feeding Tube
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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@shrinerandassociates.com
(303) 907-2955 |
| Date prepared | May 24, 2019 |
| DEVICE IDENTIFICATION | |
| Trade names | ENvizion Medical ENvue SYSTEM
ENvizion Medical Enteral Feeding Tube |
| Common name | Gastrointestinal tube and accessories |
| Classification name | Gastrointestinal Tubes And Accessories |
| Regulation Number | 21 CFR Part 876.5980 |
| Classification | Class II |
PREDICATE DEVICE
| Trade names | ENvizion Medical ENvue
ENvizion Medical Enteral Feeding Tube |
|---------------|-----------------------------------------------------------------|
| 510(k) number | K182915 |
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 (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 Special 510(k) notification adds 4 new models of EFTs, that include a stainless-steel stylet.
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 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 same 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. The only difference between the devices is the addition of 4 new EFT models incorporating a stainless-steel stylet to address some customer's preference for a stiffer tube during insertion. The stylet being added to these 4 new models is identical in technology, materials, manufacturing methods, and specifications, with the exception of length, to the stylet used in the Cediflo device cleared in K181787.
- 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.
- The stylet being added to the EFTs is equivalent to the stylet being used in the cited O reference devices and the stiffness of the ENvizion EFTs with the stylet is less than
CONFIDENTIAL
5
the CORFLO reference device, resulting in no new / significantly modified risks as a result of the modification.
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 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 – Stylet and connector hub only
- Dimensional Inspection Stylet only .
- Bond strength – Stylet to connector hub
- Tubing Stiffness Comparison - Impact of Stylet on tubing stiffness
- Simulated Use - Confirm no impact of stylet on tracking
- . Shelf Life Validation – Impact of stylet on EFT shelf-life
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)
- 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
| Characteristic | ENvizion Medical™
ENvue
(Predicate Device) | CORPAK CORFLO
Nasoenteric
Feeding Tubes
(Reference Device) | Cediflo Enteral
Feeding Tubes
(Reference Device) | Modified ENvizion
Medical™ ENvue
(Subject Device) | Comparison
to Predicate
/ Reference
Device |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182915 | K821906 | K181787 | N/A | N/A |
| Regulation
Number | 21 CFR 876.5980 | 21 CFR 876.5980 | 21 CFR 876.5980 | 21 CFR 876.5980 | Identical |
| Characteristic | ENvizion Medical™
ENvue
(Predicate Device) | CORPAK CORFLO
Nasoenteric
Feeding Tubes
(Reference Device) | Cediflo Enteral
Feeding Tubes
(Reference Device) | Modified ENvizion
Medical™ ENvue
(Subject Device) | Comparison
to Predicate
/ Reference
Device |
| Classification
Name | Gastrointestinal
Tube and
Accessories. | Gastrointestinal
Tube and
Accessories. | Gastrointestinal
Tube and
Accessories. | Gastrointestinal
Tube and
Accessories. | Identical |
| Product
Classification
Code | KNT, PIF | KNT | PIF | KNT | Identical to
Predicate |
| Regulatory Class | Class II | Class II | Class II | Class II | 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. | Delivery of
nutrition, fluids,
and medications to
the stomach or
bowel | 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 Cediflo Enteral Feeding
Tubes are intended for the
administration of enteral
nutrition, fluids, and/or
medications by the
nasoenteric route into the
stomach or small intestine.
Indicated for patients 2 years
and above which require
nutritional support, are not
able to meet their nutritional
requirements by oral intake
and have functioning and
accessible gastrointestinal
tract. Maximum duration of
use: 42 days. | 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 | Identical to
Predicate |
| Characteristic | ENvizion Medical™
ENvue
(Predicate Device) | CORPAK CORFLO
Nasoenteric
Feeding Tubes
(Reference Device) | Cediflo Enteral
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 | 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. | The Cediflo Enteral
Feeding Tubes are sterile,
single use devices
intended for use in acute
care facilities, long-term
care facilities, and home.
They are made from
radiopaque polyurethane
tubing printed with
centimeter markings and
bonded at the proximal
end to a rigid male ENFit
connector with a tethered
cap. These tubes are
supplied with or without a
guidewire. | 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 | Substantially
Equivalent.
EFT's with
stylet are
equivalent to
Reference
Devices
Differences
do not raise
new or
different
questions
regarding
safety or |
| | 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. | | | 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. | effectiveness |
| Tube Type | Multi Lumen
without stylet | Single lumen with
stylet | Single lumen with
and without stylet | Multi Lumen with
and without
optional stylet | Equivalent to
Reference
Devices |
| Tube Outer
Diameter | 10 and 12Fr | 8 to 12 Fr | 5 to 16Fr | 10 and 12Fr | Identical to
Predicate |
| Tube Usable
Length | 36 to 55 in
91 to 140 cm | 36 to 55 in
91 to 140 cm | 20 to 47in
50cm to 120cm | 36 to 55 in
91 to 140 cm | Identical to
Predicate |
| Patient
contacting tubing
material | Polyurethane | Polyurethane | Polyurethane | Polyurethane | Identical |
| Biocompatibility | FDA application of
ISO 10993 | ISO 10993 | FDA application of
ISO 10993 | FDA application of
ISO 10993 | Identical to
Predicate |
| Feeding
Connector | 80369-3 Connector
- ENFit | 80369-3 Connector
- ENFit | 80369-3 Connector
- ENFit | 80369-3 Connector
- ENFit | Identical |
| Sterilization | Non-sterile | Non-sterile | Sterile | Non-sterile | Identical to
Predicate |
| Target User | Intended for use by
physicians | Intended for use by
physicians | Intended for use by
physicians | Intended for use by
physicians | Identical |
| Characteristic | ENvizion Medical™
ENvue
(Predicate Device) | CORPAK CORFLO
Nasoenteric
Feeding Tubes
(Reference Device) | Cediflo Enteral
Feeding Tubes
(Reference Device) | Modified ENvizion
Medical™ ENvue
(Subject Device) | Comparison
to Predicate
/ Reference
Device |
| technicians and
nutritionists. | technicians and
nutritionists. | technicians and
nutritionists. | technicians and
nutritionists. | technicians and
nutritionists. | |
| Use Environment | Hospitals and other
healthcare facilities | Hospitals and other
healthcare facilities | Hospitals and other
healthcare facilities | Hospitals and other
healthcare facilities | Identical |
| Access /
Anatomical Site | Oro / Nasoenteric | Nasoenteric | Oro / Nasoenteric | Oro / Nasoenteric | Identical to
Predicate |
| Energy Type –
For EFT Tracking | Electromagnetic
Field | Electromagnetic
Field | N/A | Electromagnetic
Field | Identical to
Predicate |
| Patient
Population | Adults | Adults | Adults | Adults | Identical |
SUBSTANTIAL EQUIVALENCE COMPARISON
6
7
8
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. The addition of the stylet is addressed from a technological perspective by the specified reference device:
- Predicate: ENvizion Medical ENvue System and Enteral Feeding Tube (unmodified version)
- Reference Device: CORPAK CORFLO Nasoenteric Feeding Tubes, K821906 ●
- . Reference Device: CEDIFLO Enteral Feeding Tubes, K181787
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