(252 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a standard feeding tube, with no mention of AI or ML.
No
The device is used for feeding and administering medications, which are supportive functions and not direct therapeutic interventions to treat a disease or condition.
No
The device is described as a feeding tube, intended for hydration, feeding, and medication administration. Its description and intended use do not mention any diagnostic capabilities.
No
The device description clearly outlines physical components made of materials like PVC, ABS, and Polypropylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hydration, feeding and administration of oral medications for patients who require enteral feeding." This is a direct therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a physical tube designed for insertion into the body to deliver substances. It does not describe any components or functions related to analyzing samples from the body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (inside the body) for direct patient care.
N/A
Intended Use / Indications for Use
The Nasogastric Feeding Tubes - ENFit Port - PVC are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications.
This product is single use for no longer than 24 hours.
Product codes (comma separated list FDA assigned to the subject device)
PIF
Device Description
The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 50cm and 90cm lengths and in French sizes from 5 to 16 see Table 5-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric and Adult patients
Intended User / Care Setting
Intended Users: Physicians, nurses, and trained clinicians (by facility policy)
Environment of Use: Hospital or medical home environment
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)
Non-Clinical Tests:
Verification and validation testing was performed with the Nasogastric Feeding Tubes – ENFit Port - PVC. It was found that feeding tubes are in compliance with the design and performance requirements when tested per the standards listed below.
- Biocompatibility:
a. Cytotoxicity per ISO 10993-5:2009
b. Guinea Pig Maximization Sensitization per ISO 10993-10:2010
c. Irritation per ISO 10993-10:2010
d. Acute Systemic Toxicity per ISO 10993-11:2017
e. Material-Mediated Pyrogenicity per 10993-11:2017 - Visual Inspections
a. Visual inspection for verification of bonding - Enteral Device Performance test
a. Pressure leak testing in accordance with ISO 20695:2020
b. Tensile testing in accordance with ISO 20695:2020
c. Resistance of the tube marking to acid in accordance with internal protocol
d. Resistance of the tube marking to disinfectants in accordance with ISO 20695:2020
e. Visibility of enteral tube under x-ray in accordance with internal protocol based on ASTM F640-12
f. Flow rate testing in accordance with ISO 20695:2020 - Enteral Connector Performance Tests
a. Fluid leakage per ISO 80369-20:2019
b. Stress cracking per ISO 80369-20:2019
c. Resistance to separation from axial load per ISO 80369-20:2019
d. Resistance to separation from unscrewing per ISO 80369-20:2019
e. Resistance to overriding per ISO 80369-20:2019
f. Disconnection by unscrewing per ISO 80369-20:2019
g. ENFit dimensional verification per ISO 80369-3:2016 - Risk Analysis per ISO 14971:2019.
a. Design Failure Modes and Effects Analysis (DFMEA). - Usability Analysis per ISO 62366-1:2015.
Clinical Tests:
Clinical tests were not required to demonstrate the safety and performance of the Nasogastric Feeding Tubes – ENFit Port - PVC. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests:
Animal tests were not required to demonstrate the safety and performance the Nasogastric Feeding Tubes – ENFit Port - PVC. Product functionality has been adequately assessed by non-animal tests.
Key results: The conclusions drawn from the non-clinical tests demonstrate that the Nasogastric Feeding Tubes – ENFit Port - PVC are substantially equivalent in safety and effectiveness to the legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 9, 2022
Cair Lgl % Glenn Brunner Dir. Regulatory Affairs and Ouality Assurance Vesco Medical 1039 Kingsmill Parkway Columbus, OH 43229
Re: K213258
Trade/Device Name: Nasogastric Feeding Tubes - ENFit Port - PVC Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: May 11, 2022 Received: May 13, 2022
Dear Glenn Brunner:
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. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
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) K213258
Device Name
Nasogastric Feeding Tubes - ENFit Port - PVC
Indications for Use (Describe)
The Nasogastric Feeding Tubes - ENFit Port - PVC are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications.
This product is single use for no longer than 24 hours.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Nasogastric Feeding Tubes – ENFit Port - PVC
Tab 5A 510(k) Summary
Submitter .
| Official Contact | Name: | Glenn Brunner
Title: Dir. Regulatory Affairs and Quality Assurance
Email: gbrunner@vescomedical.com |
|---------------------|-------|-----------------------------------------------------------------------------------------------------------|
| | | Vesco Medical
Address: 1039 Kingsmill Parkway
Columbus, Ohio 43229 |
| | | Phone: 614-946-4178 (mobile)
Fax: 614-515-2800 |
| Date of Preparation | | June 6, 2022 |
II. Device
| Trade Name: | Nasogastric Feeding Tubes – ENFit Port - PVC |
|---|---|
| Common Name: | Nasogastric Tubes |
| Classification Name & | |
| Number: | Gastrointestinal Tubes and Accessories |
| 21 CFR 876.5980 | |
| Class II | |
| Product Code: PIF |
Legally Marketed Predicate Device III.
Product name: Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
510(k) Number: K150084
Manufacturer: Covidien
Product Code: PIF
Device Class: Class II
4
IV. Device Description
General Description of Nasogastric Feeding Tubes – ENFit Port - PVC
The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 50cm and 90cm lengths and in French sizes from 5 to 16 see Table 5-1.
| Nasogastric Feeding Tubes – ENFit Port - PVC | ||
|---|---|---|
| Model | Tube | |
| Size | Device Length | |
| VED-95005EO | 5 Fr | 50 cm |
| VED-99005EO | 5 Fr | 90 cm |
| VED-95006EO | 6 Fr | 50 cm |
| VED-99006EO | 6 Fr | 90 cm |
| VED-95008EO | 8 Fr | 50 cm |
| VED-99008EO | 8 Fr | 90 cm |
| VED-95010EO | 10 Fr | 50 cm |
| VED-99010EO | 10 Fr | 90 cm |
| VED-99012EO | 12 Fr | 90 cm |
| VED-99014EO | 14 Fr | 90 cm |
| VED-99016EO | 16 Fr | 90 cm |
Table 5-1: Models of Nasogastric Feeding Tubes
5
V. Intended Use
The Nasogastric Feeding Tubes – ENFit Port – PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.
VI. Substantial Equivalence Discussion
The Nasogastric Feeding Tubes – ENFit Port - PVC are substantially equivalent to the currently marketed predicate Feeding Tube. Table 5-2 is a detailed comparison of the Cair feeding tubes to the predicate devices regarding substantial equivalence.
| Table 5-2: Device comparison table for Nasogastric Feeding Tubes – ENFit Port - PVC and the |
|---|
| predicate device. |
| Design
Features/Function | Argyle Polyvinyl
Chloride Feeding
Tube, K150084
(Predicate) | Nasogastric Feeding
Tubes -ENFit Port -
PVC | Substantially
Equivalent? | Impact on Safety
and Performance |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Argyle Polyvinyl
Chloride (PVC)
Neonatal and
Pediatric Feeding
Tubes with ENFit
connectors are
intended for enteral
feeding to deliver
enteral nutrition,
liquid or medication
to patient from an
enteral feeding
syringe or feeding
set designed with a
connector for enteral
applications. | The Nasogastric
Feeding Tubes - ENFit
Port - PVC are
intended for enteral
feeding to deliver
nutrition, fluids, and
medications to the
patient from an enteral
feeding syringe or
feeding set designed
with ENFit connectors
for enteral applications.
This product is single
use for no longer than
24 hours. | Yes | Equivalent to
K150084. There are
no differences in
indications for use that
would impact the
safety and
performance of the
device. |
6
| Nasogastric Feeding Tubes – ENFit Port - PVC | |||||
|---|---|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- | -- | -- |
| Intended Use | The Argyle Polyvinyl
Chloride Feeding
Tube is intended for
pediatric patients
who require enteral
feeding.
(Warning: The
Polyvinyl Chloride
feeding tube is not
intended for use
beyond 3-5 days) | The Nasogastric
Feeding Tubes – ENFit
Port - PVC are
intended for hydration,
feeding, and
administration of oral
medications for
pediatric and adult
patients who require
enteral feeding. This
product is single use
for no longer than 24
hours. | Yes | Equivalent to
K150084. There are
no differences in
intended use that
would impact the
safety and
performance of the
device. |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use | Unspecified -
Prescription Only | Hospital or medical
home environment -
Prescription Only | Yes | Equivalent to
K150084. There are
no differences in
environment of use
that would impact the
safety and
performance of the
device. |
| Intended Users | Trained professional
clinicians or trained
pediatric caregivers. | Physicians, nurses,
and trained clinicians
(by facility policy) | Yes | Equivalent to
K150084. There are
no differences in
intended users that
would impact the
safety and
performance of the
device |
| Patient Population | Pediatric patients | Pediatric and Adult
patients | Yes | Similar to K150084.
There are no
differences in patient
population that would
impact the safety and
performance of the
device |
| Single Use | Yes | Yes | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Sterility Condition | Sterile | Sterile | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| ENFit Connector | Yes; compliant with
ISO 80369-3 | Yes; compliant with
ISO 80369-3 | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Radiopacity
Verification | Yes | Yes; compliant with
ISO 20695:2020 | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Tube Markings | Yes | Yes; compliant with
ISO 20695:2020 | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| French Sizes | 3.5, 5, 6.5, 8, 10 | 5, 6, 8, 10, 12, 14, 16 | Yes | Similar to K150084.
No impact on safety or
proper performance |
| Lengths | 41cm, 91cm, 107cm | 50cm, 90cm | Yes | Similar to K150084.
No impact on safety or
proper performance |
| Biocompatibility | Compliant with Use
of International
Standard ISO
10993-1, "Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within a
risk management
process" | Compliant with Use of
International Standard
ISO 10993-1,
"Biological evaluation
of medical devices -
Part 1: Evaluation and
testing within a risk
management process" | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Liquid Leakage
Testing | Liquid Leakage
Testing Completed
(e.g. EN 1615:2000) | Tested and met
updated standard ISO
20695:2020 Enteral
Feeding Systems -
Design and Testing | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Tensile Testing | Tensile Testing
Completed (e.g. EN
1615:2000) | Tested and met
updated standard ISO
20695:2020 Enteral
Feeding Systems –
Design and Testing | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Flow Rate Testing | Flow Rate Testing
Completed per
substantial
equivalence to
predicate device | Tested per ISO
20695:2020 Enteral
Feeding Systems –
Design and Testing | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Fluid Leakage:
Connector | Tested per ISO
80369-20 and met
the standards of
80369-3 for fluid
leakage. | Tested per ISO 80369-
20 and met the
standards of 80369-3
for fluid leakage. | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Stress Cracking:
Connector | Tested per ISO
80369-20 and met
the standards of
80369-3 for stress
cracking. | Tested per ISO 80369-
20 and met the
standards of ISO
80369-3 for stress
cracking. | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Resistance to
separation from
axial load:
connector | Tested per ISO
80369-20 and met
the standards of
80369-3 for
resistance to
separation from
axial load. | Tested per ISO 80369-
20 and met the
standards of ISO
80369-3 for resistance
to separation from axial
load. | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Resistance to
separation from
unscrewing:
connector | Tested per ISO
80369-20 and met
the standards of
80369-3 for
separation from
unscrewing. | Tested per ISO 80369-
20 and met the
standards of ISO
80369-3 for separation
from unscrewing. | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Resistance to
overriding:
connector | Tested per ISO
80369-20 and met
the standards of
80369-3 for
resistance to
overriding. | Tested per ISO 80369-
20 and met the
standards of ISO
80369-3 for resistance
to overriding. | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| Disconnection by
unscrewing:
connector | Tested per ISO
80369-20 and met
the standards of
80369-3 for
disconnection by
unscrewing. | Tested per ISO 80369-
20 and met the
standards of ISO
80369-3 for
disconnection by
unscrewing. | Yes | Equivalent to
K150084. No impact
on safety or
performance |
| ENFit Dimensional
Verification | Evaluated per ISO
80369-3 for ENFit
dimensional
verification. | Evaluated per ISO
80369-3 for ENFit
dimensional
verification. | Yes | Equivalent to
K150084. No impact
on safety or
performance |
7
8
9
VII. Discussion of Differences
There are no substantial differences between the indications for use, use conditions, and use environment of the predicate devices and the Nasogastric Feeding Tubes – ENFit Port - PVC.
VIII. Performance Testing
Non-Clinical Tests
Verification and validation testing was performed with the Nasogastric Feeding Tubes – ENFit Port - PVC. It was found that feeding tubes are in compliance with the design and performance requirements when tested per the standards listed below.
-
- Biocompatibility:
- a. Cytotoxicity per ISO 10993-5:2009
- b. Guinea Pig Maximization Sensitization per ISO 10993-10:2010
- c. Irritation per ISO 10993-10:2010
- d. Acute Systemic Toxicity per ISO 10993-11:2017
- e. Material-Mediated Pyrogenicity per 10993-11:2017
-
- Visual Inspections
- a. Visual inspection for verification of bonding
-
- Enteral Device Performance test
- a. Pressure leak testing in accordance with ISO 20695:2020
- b. Tensile testing in accordance with ISO 20695:2020
- c. Resistance of the tube marking to acid in accordance with internal protocol
10
- d. Resistance of the tube marking to disinfectants in accordance with ISO 20695:2020
- e. Visibility of enteral tube under x-ray in accordance with internal protocol based on ASTM F640-12
- Flow rate testing in accordance with ISO 20695:2020 f.
-
- Enteral Connector Performance Tests
- a. Fluid leakage per ISO 80369-20:2019
- b. Stress cracking per ISO 80369-20:2019
- C. Resistance to separation from axial load per ISO 80369-20:2019
- d. Resistance to separation from unscrewing per ISO 80369-20:2019
- e. Resistance to overriding per ISO 80369-20:2019
- Disconnection by unscrewing per ISO 80369-20:2019 f.
- g. ENFit dimensional verification per ISO 80369-3:2016
-
- Risk Analysis per ISO 14971:2019.
- a. Design Failure Modes and Effects Analysis (DFMEA).
-
- Usability Analysis per ISO 62366-1:2015.
Clinical Tests
Clinical tests were not required to demonstrate the safety and performance of the Nasogastric Feeding Tubes – ENFit Port - PVC. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests
Animal tests were not required to demonstrate the safety and performance the Nasogastric Feeding Tubes – ENFit Port - PVC. Product functionality has been adequately assessed by non-animal tests.
IX. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the Nasogastric Feeding Tubes – ENFit Port - PVC are substantially equivalent in safety and effectiveness to the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.
(End of Section)