(269 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the extension sets, with no mention of AI or ML capabilities.
Yes
The device is used to deliver enteral nutrition, fluids, and medications, which are therapeutic interventions.
No
This device is designed for delivering enteral nutrition, fluids, and medications, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical tubing set with connectors and clamps, which are hardware components. There is no mention of software.
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, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications." This describes a device used for delivering substances into the body, not for examining specimens from the body to obtain diagnostic information.
- Device Description: The description details tubing sets and connectors for enteral feeding, which aligns with the intended use and not with the components of an IVD (like reagents, calibrators, controls, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for therapeutic or supportive purposes (enteral feeding), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications.
The device is single use for patients who require enteral feeding.
Product codes (comma separated list FDA assigned to the subject device)
PIF
Device Description
The ENFit to ENFit Extension Sets are sterile, single use devices. The extension sets are single and bifurcated port tubing sets with ENFit input port(s) and tethered caps, extension set tubing and clamp(s), and a single ENFit connector on the patient end. The ENFit connectors allow the extension set to be connected to other enteral devices that also have ISO 80369-3 compliant connectors. The extension sets are available in the listed lengths from 50 to 150 cm.
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
Physicians, nurses, and trained clinicians (by facility policy)
Hospital or medical home care 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 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. 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.
Key Results: It was found that extension sets are in compliance with the design and performance requirements when tested according to the listed standards.
Clinical Tests: Clinical tests were not required to demonstrate the safety and performance of the ENFit Extension Sets. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests: Animal tests were not required to demonstrate the safety and performance the ENFit to ENFit Extension Sets. Product functionality has been adequately assessed by non-animal tests.
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 shows 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.
November 2, 2023
Vesco Medical Glenn Brunner Dir. Regulatory Affairs and Quality Assurance 60 Collegeview Road, Suite 144 Westerville, Ohio 43081
Re: K230326 Trade/Device Name: ENFit to ENFit Extension Sets Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: PIF Dated: January 31, 2023 Received: February 6, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medical-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,
Sivakami Venkatachalam -S
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) K230326
Device Name ENFit to ENFit Extension Sets
Indications for Use (Describe)
The ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications.
The device is single use for patients who require enteral feeding.
| 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
Tab 5A 510(k) Summary
Submitter l.
| Official Contact | Name: Glenn Brunner
Title: Dir. Regulatory Affairs and Quality Assurance
Email: gbrunner@vescomedical.com |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| | Vesco Medical
Address: 60 Collegeview Road, Suite 144
Westerville, Ohio 43081 |
| | Phone: 614-946-4178 (mobile)
Fax: 614-515-2800 |
| Date of Preparation | October 2, 2023 |
II. Device
| Trade Name: | ENFit to ENFit Extension Sets |
|---|---|
| Common Name: | Extension Feeding Set |
| 510(k) Number: | K230326 |
| Classification Name & | |
| Number: | Gastrointestinal Tubes with Enteral Specific Connectors |
| 21 CFR 876.5980 | |
| Class II | |
| Product Code: PIF |
III. Legally Marketed Predicate Device
| Product name: | Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors |
|---|---|
| 510(k) Number: | K143018 |
| Manufacturer: | Covidien (Cardinal Health) |
| Product Code: | PIF |
| Device Class: | Class II |
4
IV. Device Description
General Description of The ENFit to ENFit Extension Sets
The ENFit to ENFit Extension Sets are sterile, single use devices. The extension sets are single and bifurcated port tubing sets with ENFit input port(s) and tethered caps, extension set tubing and clamp(s), and a single ENFit connector on the patient end. The ENFit connectors allow the extension set to be connected to other enteral devices that also have ISO 80369-3 compliant connectors. The extension sets are available in the listed lengths from 50 to 150 cm.
| ENFit to ENFit Extension Sets | |||
|---|---|---|---|
| Model | Type | Device Length | I.D. |
| VED-1020EO | Bifurcated ENFit Ports to ENFit Extension Set - Sterile | 20 in - 50 cm | 2.8 mm |
| VED-1040EO | Single ENFit Port to ENFit Extension Set - Sterile | 39 in - 100 cm | 2.8 mm |
| VED-1059EO | Co-Extruded Single ENFit Port to ENFit Extension Set - Sterile | 59 in - 150 cm | 1.35 mm |
| VED-1060EO | Bifurcated ENFit Ports to ENFit Extension Set - Sterile | 59 in - 150 cm | 2.8 mm |
Table 5-1: Models of ENFit to ENFit Extension Sets
V. Intended Use
The ENFit to ENFit Extension Sets are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition, fluids and medications from an enteral feeding syringe or set through to an ENFit feeding tube connector for enteral applications. The device is single use for patients who require enteral feeding.
5
VI. Substantial Equivalence Discussion
The ENFit to ENFit Extension Sets are substantially equivalent to the currently marketed predicate extension sets. Table 5-2 is a detailed comparison of the Vesco extension sets to the predicate devices regarding substantial equivalence.
Table 5-2: Device comparison table for ENFit to ENFit Extension Sets and the predicate device.
| Design
Features/Function | Kangaroo™
Feeding Tube
Extension Sets
with ENFit Small
Bore Connectors,
K143018
(Predicate) | ENFit to ENFit
Extension Sets | Substantially
Equivalent? | Impact on Safety
and Performance |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Kangaroo™
Feeding Tube
Extension Sets with
ENFit small bore
connectors are
intended for enteral
feeding, on the order
of a physician, to
provide a means of
delivering enteral
nutrition or
medication from an
enteral feeding
syringe through to
any feeding tube
which will accept a
connector for enteral
applications.
The device is
intended for
neonates and
infants who require
enteral feeding. | The ENFit to ENFit
Extension Sets are
intended for enteral
feeding, on the order of
a physician, to provide
a means of delivering
enteral nutrition, fluids
and medications from
an enteral feeding
syringe or set through
to an ENFit feeding
tube connector for
enteral applications.
The device is single
use for patients who
require enteral feeding. | Yes | Equivalent to
K143018. There are
no differences in
indications for use that
would impact the
safety and
performance of the
device. |
| | | | | |
| Intended Use | The Kangaroo™
Feeding Tube
Extension Sets with
ENFit small bore
connectors are
intended for enteral
feeding, on the order
of a physician, to
provide a means of
delivering enteral
nutrition or
medication from an
enteral feeding
syringe through to
any feeding tube
which will accept an
ENFit small bore
connector for enteral
applications.
The device is
intended for
neonates and
infants who require
enteral feeding. | The ENFit to ENFit
Extension Sets are
intended for enteral
feeding, on the order of
a physician, to provide
a means of delivering
enteral nutrition, fluids
and medications from
an enteral feeding
syringe or set through
to an ENFit feeding
tube connector for
enteral applications.
The device is single
use for patients who
require enteral feeding. | Yes | Equivalent to
K143018. There are
no differences in
intended use that
would impact the
safety and
performance of the
device. |
| Environment of Use | Hospital, sub-acute
care and home
settings. | Hospital or medical
home care
environment -
Prescription Only | Yes | Equivalent to
K143018. 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
K143018. There are
no differences in
intended users that
would impact the
safety and
performance of the
device |
| Patient Population | Neonatal and
pediatric patients | Pediatric and Adult
patients | Yes | Similar to K143018.
There are no
differences in patient
population that would |
| | | | | impact the safety and
performance of the
device |
| No Reuse | Single Patient Use | Single Use | Yes | Equivalent to
K143018. No impact
on safety or
performance |
| Sterility Condition | Sterile | Sterile | Yes | Equivalent to
K143018. No impact
on safety or
performance |
| ENFit Connector | Yes; compliant with
ISO 80369-3 | Yes; compliant with
ISO 80369-3 | Yes | Equivalent to
K143018. No impact
on safety or
performance |
| Lengths | 35" to 60" (90 to 150
cm) | 50cm, 100cm, 150cm | Yes | Similar to K143018.
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
K143018. 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
K143018. 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
K143018. No impact
on safety or
performance |
| Resistance to
separation from | Tested per ISO
80369-20 and met
the standards of
80369-3 for | Tested per ISO 80369-
20 and met the
standards of ISO
80369-3 for resistance | Yes | Equivalent to
K143018. No impact
on safety or
performance |
| axial load:
connector | resistance to
separation from
axial load. | to separation from axial
load. | | 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
K143018. 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
K143018. 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
K143018. 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
K143018. 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 ENFit to ENFit Extension Sets.
VIII. Performance Testing
Non-Clinical Tests
Verification and validation testing was performed with the ENFit Extension Sets. It was found that extension sets are in compliance with the design and performance requirements when tested according to the standards listed below.
9
-
- 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. 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
- Resistance to separation from axial load per ISO 80369-20:2019 C.
- 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.
- q. 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 ENFit Extension Sets. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests
Animal tests were not required to demonstrate the safety and performance the ENFit to ENFit Extension Sets. Product functionality has been adequately assessed by non-animal tests.
10
IX. Conclusion
The conclusions drawn from the non-clinical tests and other presented analyses demonstrate that the ENFit to ENFit Extension Sets are substantially equivalent to the legally marketed predicate device and do not raise new questions of safety and effectiveness.
(End of section)