(246 days)
Not Found
No
The summary describes a physical medical device (feeding tube) and its materials, dimensions, and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for enteral feeding to deliver nutrition, fluids, and medications, which are therapeutic interventions.
No
Explanation: The device is a feeding tube used for delivering nutrition, fluids, and medications. Its function is therapeutic/supportive rather than diagnostic.
No
The device description clearly outlines physical components made of Polyurethane, ABS, and Polypropylene, and the performance studies include testing of these physical properties. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "enteral feeding to deliver nutrition, fluids, and medications to the patient" and for "hydration, feeding and administration of oral medications." This involves direct interaction with the patient's body for therapeutic purposes (delivering substances) and supportive care (feeding and hydration).
- Device Description: The description details a physical tube designed to be inserted into the body (nasogastric) for delivering substances.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. IVDs are used to analyze samples like blood, urine, tissue, etc., to detect diseases, conditions, or physiological states.
This device falls under the category of a medical device used for patient care and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Pediatric Nasogastric Feeding Tubes - Single ENFit Port 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 29 days.
Product codes (comma separated list FDA assigned to the subject device)
PIF
Device Description
The Pediatric Nasogastric Feeding Tubes – Single ENFit Port are sterile, single use devices. The feeding tubes consist of a graduated Polyurethane tube, with radiopaque edge. The tubes have a closed tip and 2 lateral eyes. 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 40mm, 60mm and 90mm lengths and in French sizes from 4 to 12 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 patients, Neonatal and Pediatric patients
Intended User / Care Setting
Trained professional clinicians or trained pediatric caregivers.
Hospital or medical home environment - Prescription Only
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:
- 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 and Subacute Systemic Toxicity per ISO 10993-11:2017
e. Material mediated pyrogenicity per USP - 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. - Enteral Connector Performance Tests
a. Fluid leakage testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
b. Stress cracking testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
c. Resistance to separation from axial load testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
d. Resistance to separation from unscrewing testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
e. Resistance to overriding testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
f. Disconnection by unscrewing testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
g. ENFit dimensional verification testing in accordance with ISO 80369-3:2016
h. Flow rate testing in accordance ISO 20695:2020, Annex E - Risk Analysis in accordance with ISO 14971:2019. a. DFMEA in accordance with product design requirements.
- Usability Analysis in accordance with ISO 62366-1: 2015
Key results: It was found that the Pediatric Nasogastric Feeding Tubes are in compliance with all design and performance requirements based on the results of the results presented.
Clinical Tests: Not required.
Animal Tests: Not required.
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 the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 2, 2021
Cair Lgl % Glenn Brunner Dir. Regulatory Affairs and Ouality Assurance Vesco Medical 1039 Kingsmill Parkway Columbus, OH 43229
Re: K210598
Trade/Device Name: Pediatric Nasogastric Feeding Tubes - Single ENFit Port Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: September 26, 2021 Received: September 29, 2021
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) K210598
Device Name
Pediatric Nasogastric Feeding Tubes - Single ENFit Port
Indications for Use (Describe)
The Pediatric Nasogastric Feeding Tubes - Single ENFit Port 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 29 days.
| 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
510(k) Summary
Submitter 1.
CAIR LGL Parc Tertiaire De Bois Dieu 1 Allee Des Chevreuils Lissieu Rhone, FR 69380
| Official Contact | Name: Glenn Brunner |
|---|---|
| Title: Dir. Regulatory Affairs and Quality Assurance | |
| Email: gbrunner@vescomedical.com | |
| Vesco Medical | |
| Address: 1039 Kingsmill Parkway |
Address: 1039 Kingsmill Parkway Columbus, Ohio 43229
Phone: 614-946-4178 (mobile) Fax: 614-515-2800
- Date of Preparation February 17, 2021
- ll. Device
| Trade Name: | Pediatric Nasogastric Feeding Tubes - Single ENFit Port |
|---|---|
| Common Name: | Nasogastric Tubes |
| Classification Name & | |
| Number: | Gastrointestinal Tubes with Enteral Specific Connectors |
| 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
Device Description IV.
General Description of Pediatric Nasogastric Feeding Tubes – Single ENFit Port
The Pediatric Nasogastric Feeding Tubes – Single ENFit Port are sterile, single use devices. The feeding tubes consist of a graduated Polyurethane tube, with radiopaque edge. The tubes have a closed tip and 2 lateral eyes. 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 40mm, 60mm and 90mm lengths and in French sizes from 4 to 12 see Table 5.1.
| Pediatric Nasogastric Feeding Tubes – Single
| ENFit Port | ||
|---|---|---|
| Model | Tube | |
| Size | Device Length | |
| VED-84004EO | 4 Fr | 40 mm |
| VED-86004EO | 4 Fr | 60 mm |
| VED-84005EO | 5 Fr | 40 mm |
| VED-86005EO | 5 Fr | 60 mm |
| VED-86006EO | 6 Fr | 60 mm |
| VED-89006EO | 6 Fr | 90 mm |
| VED-86008EO | 8 Fr | 60 mm |
| VED-89008EO | 8 Fr | 90 mm |
| VED-86010EO | 10 Fr | 60 mm |
| VED-89010EO | 10 Fr | 90 mm |
| VED-89012EO | 12 Fr | 90 mm |
Table 5.1: Models of Pediatric Nasogastric Feeding Tubes
5
Intended Use V.
The Pediatric Nasogastric Feeding Tubes – Single ENFit Ports are intended for hydration, feeding and administration of oral medications for pediatric patients who require enteral feeding. This product is single use for no longer than 29 days.
Substantial Equivalence Discussion VI.
The Pediatric Nasogastric Feeding Tubes – Single ENFit Port 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 Comparison of Cair Feeding Tubes to the Predicate Devices Regarding Substantial | ||
|---|---|---|
| Equivalence (SE) |
| Design
Features/Functi
on | Kangaroo
Polyurethane
Feeding Tube,
K150084
(Predicate) | Pediatric Nasogastric
Feeding Tubes -
Single ENFit Port | Substantially
Equivalent? | Impact on Safety
and Performance |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Kangaroo
Polyurethane 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 Pediatric
Nasogastric Feeding
Tubes - Single ENFit
Port 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
29 days. | Yes | Equivalent to
K150084.
There are no
differences in
indications for use that
would impact the
safety and
performance of the
device. |
| Intended Use | The Kangaroo
Polyurethane Feeding
Tube is intended for
pediatric patients who
require enteral
feeding.
(Warning: The
Polyurethane feeding
tube is not intended for
use beyond 30 days) | The Pediatric
Nasogastric Feeding
Tubes – Single ENFit
Ports are intended for
hydration, feeding and
administration of oral
medications for
pediatric patients who
require enteral feeding.
This product is single
use for no longer than
29 days. | 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 | Neonatal and Pediatric
patients | Neonatal and Pediatric
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 | 4, 5, 6, 8, 10, 12 | Yes | Similar to K150084.
No impact on safety or
proper performance |
| Lengths | 31cm, 51cm, 91cm,
107cm | 40cm, 60cm, 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 |
| 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 |
6
7
8
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 Pediatric Nasogastric Feeding Tubes – Single ENFit Port.
9
VIII. Performance Testing
Non-Clinical Tests
Verification and validation testing was performed with the Pediatric Nasogastric Feeding Tubes - Single ENFit Port. It was found that the Pediatric Nasogastric Feeding Tubes are in compliance with all design and performance requirements based on the results of the results presented.
-
- 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 and Subacute Systemic Toxicity per ISO 10993-11:2017
- e. Material mediated pyrogenicity per USP
-
- Enteral Device Performance test
- a. Pressure leak testing in accordance with ISO 20695:2020.
- b. Tensile testing in accordance with ISO 20695:2020.
- Resistance of the tube marking to acid in accordance with internal protocol. C.
- 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.
-
- Enteral Connector Performance Tests
- a. Fluid leakage testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- b. Stress cracking testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- c. Resistance to separation from axial load testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- d. Resistance to separation from unscrewing testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- e. Resistance to overriding testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- Disconnection by unscrewing testing in accordance with ISO 80369-3:2016 and f. ISO 80369-20:2015.
- g. ENFit dimensional verification testing in accordance with ISO 80369-3:2016
10
- h. Flow rate testing in accordance ISO 20695:2020, Annex E
-
- Risk Analysis in accordance with ISO 14971:2019. a. DFMEA in accordance with product design requirements.
-
- Usability Analysis in accordance with ISO 62366-1: 2015
Clinical Tests
Clinical tests were not required to demonstrate performance of the Pediatric Nasoqastric Feeding Tubes – Single ENFit Port. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests
Animal tests were not required to demonstrate the performance of the Pediatric Nasogastric Feeding Tubes – Single ENFit Port. Product functionality has been adequately assessed by non-animal tests.
IX. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the Pediatric Nasogastric Feeding Tubes - Single ENFit Port are substantially equivalent, and as safe and effective as the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.