(283 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of the feeding set, with no mention of AI or ML.
No
The device is described as an extension set for gastric feeding devices, primarily used for the delivery of nutrition and water, and does not directly treat a disease or condition.
No
The device is an extension set for gastric feeding devices, intended for delivering nutrition and water, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of physical components like tubes, connectors, caps, and clamps, and describes physical performance tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering nutrition and water to patients via gastric feeding devices. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a tube with connectors and a clamp, designed for physical connection and delivery of substances. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze blood, urine, tissue, or any other bodily fluid or substance to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on physical properties and functionality (flowrate, pressure leak, tensile strength, biocompatibility), not on diagnostic accuracy or clinical performance in identifying a condition.
IVD devices are specifically designed to perform tests on samples taken from the body to aid in diagnosis, monitoring, or screening. This device's function is purely for delivering substances into the body.
N/A
Intended Use / Indications for Use
The Vesco Medical Extension Feeding Sets are intended for use as an extension set to other gastric feeding devices, incorporating safety connectors which may reduce the risk of accidental connection of an IV system, or the enteral system to the IV system.
Product codes
PIF
Device Description
The Vesco Medical Extension Feeding Set product line is comprised of a group of enteral tubes that will be used by trained caregivers for the delivery of nutrition and water. The Extension Sets will be used in a hospital or home environment. The Extension Sets will be provided non-sterile and are for single patient use. The Extension Sets will incorporate a male ENFit connector which is compatible with syringes and other devices that have female ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.
The Vesco Medical Extension Feeding Sets are non-sterile, single patient use devices consisting of a polyvinylchloride tube, ABS G-button connector, ENFit connector, cap and clamp. The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. The G-button connectors are to allow compatibility to the Mic-key and Mini low profile devices. The proposed models are listed in Table 6.1.
The Vesco Medical Extension Feeding Set is substantially equivalent to the predicate device. The hollow tube and funnel are made of medical grade Polyvinylchloride (PVC). The low-profile G-button connector and the ENFit connector are made from acrylonitrile butadiene styrene. There are no changes in intension of use, product design, specification, functional performance, labels and instructions of use.
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
Patients 1 year and up
Intended User / Care Setting
trained caregivers for the delivery of nutrition and water. The Extension Sets will be used in a hospital or 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
Non-Clinical Tests:
Verification and validation testing were performed with the Vesco Medical Extension Feeding Sets. It was found that the extension sets are in compliance with all design and performance requirements based on the completed testing below
- Biocompatibility testing:
a. Cytotoxicity in accordance with ISO 10993-5:2009
b. Guinea Pig Maximization Sensitization in accordance with ISO 10993-10:2010
c. Irritation in accordance with ISO 10993-10:2010
d. Acute Systemic Toxicity in accordance with ISO 10993-11:2017
e. Subacute/Subchronic Toxicity in accordance with ISO 10993-11:2017
f. Material-Mediated Pyrogenicity in accordance with ISO 10993-11:2017 - Visual inspections/accelerated aging:
a. Visual inspection for cracks, deformation, or other visual abnormalities created during accelerated aging test per ASTM F1980-07. - Performance test:
a. Flowrate testing in accordance with Vesco Medical's design requirement.
b. Pressure leak testing in accordance with EN1615:2000 and EN1618:1997.
c. Tensile test in accordance with EN1615:2000 and EN1618:1997. - Cleaning Instructions Validation testing in accordance with CDRH's Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- Declaration of Conformance to applicable parts to ISO 80369.
- Risk Analysis in accordance with ISO 14971:2012.
- DFMEA in accordance with Vesco Medical's design requirements.
Clinical Tests: Clinical tests were not required to demonstrate performance of the Vesco Medical Extension Feeding Sets. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests: Animal tests were not required to demonstrate the performance of Vesco Medical Extension Feeding Sets. Product functionality has been adequately assessed by non-animal tests.
Key results: The conclusions drawn from the non-clinical tests demonstrate that the Vesco Medical Extension Feeding Sets are as safe, as effective and perform as well as the legally marketed devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
August 3, 2020
Vesco Medical LLC Chris O'keefe VP of Engineering 1039 Kingsmill Pkwv Columbus, OH 43229
K192991 Re:
Trade/Device Name: Vesco Medical Extension Feeding Set Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: July 6, 2020 Received: July 8, 2020
Dear Chris O'keefe:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Vesco Medical Extension Feeding Sets
Indications for Use (Describe)
The Vesco Medical Extension Feeding Sets are intended for use as an extension set to other gastric feeding devices, incorporating safety connectors which may reduce the risk of accidental connection of an IV system, or the enteral system to the IV system.
| 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 6 510(k) Summary
- Submitter l.
| Official Contact | |
|---|---|
| Name: | Chris O'Keefe |
| Title: | VP Product Development and Innovation |
| Email: | cokeefe@vescomedical.com |
Vesco Medical Address: 1039 Kingsmill Parkway Columbus, Ohio 43229
Phone: 614-914-5991 Fax: 614-902-3275
Date of Preparation July 6, 2020
ll. Device
| Trade Name: | Vesco Medical Extension Feeding Sets |
|---|---|
| Common Name: | Extension Feeding Set |
| Regulation Name: | Gastrointestinal tube and accessories |
| Regulation Number: | 21 CFR 876.5980 |
| Device Classification: | Class II |
| Device Classification/ | |
| Product Code: | Gastrointestinal Tubes with Enteral Specific Connectors/ PI |
III. Legally Marketed Predicate Devices
- Aquarius Extension Feeding Sets were cleared under notification K141631 (510k . application by Degania Silicone, Inc.)
- Product name: Aquarius Extension Feeding Set O
- 510(k) Number: K141631 O
- Manufacturer: Degania Silicone O
4
- o Product Code: KNT
- Device Class: Class II o
IV. Device Description
The Vesco Medical Extension Feeding Set product line is comprised of a group of enteral tubes that will be used by trained caregivers for the delivery of nutrition and water. The Extension Sets will be used in a hospital or home environment. The Extension Sets will be provided non-sterile and are for single patient use. The Extension Sets will incorporate a male ENFit connector which is compatible with syringes and other devices that have female ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.
The Vesco Medical Extension Feeding Sets are non-sterile, single patient use devices consisting of a polyvinylchloride tube, ABS G-button connector, ENFit connector, cap and clamp. The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. The G-button connectors are to allow compatibility to the Mic-key and Mini low profile devices. The proposed models are listed in Table 6.1.
The Vesco Medical Extension Feeding Set is substantially equivalent to the predicate device. The hollow tube and funnel are made of medical grade Polyvinylchloride (PVC). The low-profile G-button connector and the ENFit connector are made from acrylonitrile butadiene styrene. There are no changes in intension of use, product design, specification, functional performance, labels and instructions of use.
| Model # | Description |
|---|---|
| VED-1000 | 12 Inch Dual ENFit Port Right Angle Extension Feeding Set |
| VED-1001 | 24 Inch Dual ENFit Port Right Angle Extension Feeding Set |
| VED-1002 | 12 Inch Single ENFit Port Straight Extension Feeding Set |
| VED-1003 | 24 Inch Single ENFit Port Straight Extension Feeding Set |
Table 6.1 Proposed models of Vesco Medical Extension Feeding Sets
5
V. Intended Use
Vesco Medical Extension Sets are intended to be used with low profile gastrointestinal button devices to deliver enteral nutrition or water to patients.
VI. Comparison of Technological Characteristics with the Predicate Device
The proposed Vesco Medical Extension Feeding Sets are the same manufactured products as the predicate. Because of this, there are no changes in the form, function, materials, or manufacturing processes from the predicate devices currently on the market. These products also have identical uses and user profiles. Table 6.2 is a comparison summary of the proposed device with the predicate. Table 6.3 lists the comparison of the proposed device to the predicate devices regarding substantial equivalence.
| Proposed
Device
Number | Device
Description | Predicate
Device
Number | Differences
in Design | Differences
in Material | Differences
in Chemical
Composition | Differences
in Energy
Sources | Difference in
Biocompatibility | Difference in
Manufacturing |
|------------------------------|-----------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| VED-1000 | 12 Inch Dual
ENFit Port
Right Angle
Extension
Feeding Set | 1032531076VS | None-
Devices are
identical in
dimensions
and function | None -
Devices are
of the same
materials | None -
Devices are
of the same
material from
the same
source | None - Both
rely on the
same
externally
connected
devices for
fluid flow | None - Both
devices have
same material
composition and
require the same
biocompatibility
testing | None - Both
devices are
manufactured
using the same
manufacturing
processes |
| VED-1001 | 24 Inch Dual
ENFit Port
Right Angle
Extension
Feeding Set | 1032561076VS | None-
Devices are
identical in
dimensions
and function | None -
Devices are
of the same
materials | None -
Devices are
of the same
material from
the same
source | None - Both
rely on the
same
externally
connected
devices for
fluid flow | None - Both
devices have
same material
composition and
require the same
biocompatibility
testing | None - Both
devices are
manufactured
using the same
manufacturing
processes |
| VED-1002 | 12 Inch
Single ENFit
Port Straight
Extension
Feeding Set | 103290076VS | None-
Devices are
identical in
dimensions
and function | None -
Devices are
of the same
materials | None -
Devices are
of the same
material from
the same
source | None - Both
rely on the
same
externally
connected
devices for
fluid flow | None - Both
devices have
same material
composition and
require the same
biocompatibility
testing | None - Both
devices are
manufactured
using the same
manufacturing
processes |
| VED-1003 | 24 Inch
Single ENFit
Port Straight
Extension
Feeding Set | 1032960076VS | None-
Devices are
identical in
dimensions
and function | None -
Devices are
of the same
materials | None -
Devices are
of the same
material from
the same
source | None - Both
rely on the
same
externally
connected
devices for
fluid flow | None - Both
devices have
same material
composition and
require the same
biocompatibility
testing | None - Both
devices are
manufactured
using the same
manufacturing
processes |
| Table 6.2 Comparison Summary between Vesco Medical Extension Feeding Sets and the | ||
|---|---|---|
| Predicate Device |
6
Table 6.3 Comparison of Aquarius Medical Extension Feeding Sets to the Predicate Device Regarding Substantial Equivalence (SE)
| Design Features/
Function | AQUARIUS
Extension Feeding
Set K141631
(Predicate) | Vesco Medical
Extension Feeding
Sets
(Proposed) | Substantial
Equivalence |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Indications for Use | AQUARIUS Extension
Feeding Set is
intended for use as an
extension set for
AQUARIUS G-
button/or other gastric
feeding device,
incorporating safety
connectors which help
mitigate the risk of
accidental connection
of an IV system to the
enteral system, or the
enteral system to IV
system. | The Vesco Extension
Feeding Sets are
intended for use as an
extension set to other
gastric feeding
devices, incorporating
safety connectors
which may reduce the
risk of accidental
connection of an IV
system to the enteral
system, or the enteral
system to the IV
system. | Substantially
Equivalent |
| Environment of Use | Hospital or home | Hospital or home | Same |
| Patient Population | Patients 1 year and up | Patients 1 year and up | Same |
| Single Patient Use | Yes | Yes | Same |
| Sterility Condition | Sterile or Non-Sterile | Non-Sterile | Substantially
Equivalent; |
| Type of Placement | Used with enteral
feeding devices with
ENFit compliant
connector | Used with enteral
feeding devices with
ENFit compliant
connector | Same |
| ENFit Connector | Yes; compliant with
ISO 80369-3 | Yes; compliant with
ISO 80369-3 | Same |
| Connector/Clamp Materials | All connectors and
clamps are made with
Acrylonitrile Butadiene
Styrene | All connectors and
clamps are made with
Acrylonitrile Butadiene
Styrene | Same |
| Description | -single or dual port
-12 or 24 inch
-continuous or bolus
feed
-straight or 90 degree
port
-stop clamp | -single or dual port
-12 or 24 inch
-continuous or bolus
feed
-straight or 90 degree
port
-stop clamp | Same |
| Biocompatibility | Biocompatibility
testing has
demonstrated that this
device meets
guidelines presented
in 10993-1:2009 per
K141631 | Same materials,
manufacturer,
manufacturing
materials and
processes as
predicate. Same
product as predicate | Same |
| Tensile Strength Testing | Per K141631, results
demonstrated the | Same as predicate.
Compliant with EN | Same |
| | | | |
| | performance and
functionality
specification of the
device | 1615:2000 and EN
1618:1997 | |
| Flow Rate Testing | Per K141631, results
demonstrated the
compliance with the
performance and
functionality
specification of the
device | Same product as
predicate. | Substantially
Equivalent |
| Leakage Testing | Per K141631, results
demonstrated the
compliance with the
performance and
functionality
specification of the
device | Same as predicate.
Compliant with EN
1615:2000 and EN
1618:1997 | Same |
| Non IV compatible | 80369-1 Annex B,
AAMI/ANSI ID54
demonstrated non-
compatibility of the
proposed device with
female luer
connectors and
intravenous sets | Same product as
predicate. Compliant
with ISO 80369-3 | Substantially
Equivalent |
| Labeling | Sold as "Vesco
Medical Extension
Feeding Sets" | Sold as "Vesco
Medical Extension
Feeding Sets" | Same |
7
VII. Performance Data
Non-Clinical Tests
Verification and validation testing were performed with the Vesco Medical Extension Feeding Sets. It was found that the extension sets are in compliance with all design and performance requirements based on the completed testing below
-
- Biocompatibility testing
- a. Cytotoxicity in accordance with ISO 10993-5:2009
- b. Guinea Pig Maximization Sensitization in accordance with ISO 10993-10:2010
- c. Irritation in accordance with ISO 10993-10:2010
- d. Acute Systemic Toxicity in accordance with ISO 10993-11:2017
- e. Subacute/Subchronic Toxicity in accordance with ISO 10993-11:2017
- f. Material-Mediated Pyrogenicity in accordance with ISO 10993-11:2017
-
- Visual inspections/accelerated aging
8
- a. Visual inspection for cracks, deformation, or other visual abnormalities created during accelerated aging test per ASTM F1980-07.
-
- Performance test
- a. Flowrate testing in accordance with Vesco Medical's design requirement.
- b. Pressure leak testing in accordance with EN1615:2000 and EN1618:1997.
- c. Tensile test in accordance with EN1615:2000 and EN1618:1997.
-
- Cleaning Instructions Validation testing in accordance with CDRH's Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
-
- Declaration of Conformance to applicable parts to ISO 80369.
-
- Risk Analysis in accordance with ISO 14971:2012.
-
- DFMEA in accordance with Vesco Medical's design requirements.
Clinical Tests
Clinical tests were not required to demonstrate performance of the Vesco Medical Extension Feeding Sets. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests
Animal tests were not required to demonstrate the performance of Vesco Medical Extension Feeding Sets. Product functionality has been adequately assessed by non-animal tests.
VIII. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the Vesco Medical Extension Feeding Sets are as safe, as effective and perform as well as the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.
(End of Section)