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.

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.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the Vesco Medical Extension Feeding Sets. The clearance is based on proving substantial equivalence to a predicate device (Aquarius Extension Feeding Sets cleared under K141631). Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and confirmation that the proposed device meets relevant standards and internal design requirements.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states that the proposed device (Vesco Medical Extension Feeding Sets) is identical to its predicate device (Aquarius Extension Feeding Sets). Therefore, the "acceptance criteria" are implied to be the performance characteristics of the predicate device, and the "reported device performance" is that the Vesco Medical device matches these.

Acceptance Criteria (Implied from Predicate/Standards)	Reported Device Performance (Vesco Medical Extension Feeding Sets)
Biocompatibility	Complies with ISO 10993 standards: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Material-Mediated Pyrogenicity.
Visual Inspection	No cracks, deformation, or other abnormalities after accelerated aging per ASTM F1980-07.
Flowrate	Complies with Vesco Medical's internal design requirement.
Pressure Leakage	Complies with EN1615:2000 and EN1618:1997.
Tensile Strength	Complies with EN1615:2000 and EN1618:1997.
Cleaning Instructions Validation	Validated per CDRH Guidance.
Conformance to ISO 80369	Conforms to applicable parts of ISO 80369, specifically ISO 80369-3 for ENFit connectors.
Risk Analysis	Complies with ISO 14971:2012.
DFMEA	Complies with Vesco Medical's internal design requirements.
Non-IV Compatibility	Complies with ISO 80369-1 Annex B, AAMI/ANSI ID54, demonstrating non-compatibility with female luer connectors and intravenous sets.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the specific tests (e.g., how many units were tested for flow rate, tensile strength, or leakage). It lists the types of tests performed.
The data provenance is not specified in terms of country of origin or retrospective/prospective. The tests were performed by Vesco Medical, as indicated by "Vesco Medical's design requirement."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable in this context. The "ground truth" for this device, a physical extension set, is established through compliance with recognized international standards (ISO, EN, ASTM) and the manufacturer's own design specifications, rather than expert consensus on interpretive data (like medical images).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this refers to adjudication of expert interpretations for ground truth, which is not relevant for this type of device submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical component, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this device is not an algorithm or AI system. Its performance is evaluated through physical and chemical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of the Vesco Medical Extension Feeding Sets is primarily established by:
* International Standards: Compliance with standards like ISO 10993 (biocompatibility), EN 1615, EN 1618 (tensile, leakage), ISO 80369 (connector compatibility), ASTM F1980 (accelerated aging).
* Manufacturer Design Requirements: Internal specifications set by Vesco Medical for flow rate and DFMEA.
* Predicate Device Performance: The primary claim of substantial equivalence is based on the new device being identical in form, function, and materials to the already cleared predicate device, which itself met similar standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K192991

Device Name Vesco Medical Extension Feeding Sets

Indications for Use (Describe)

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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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

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o Product Code: KNT
Device Class: Class II o

IV. Device Description

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

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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.

ProposedDeviceNumber	DeviceDescription	PredicateDeviceNumber	Differencesin Design	Differencesin Material	Differencesin ChemicalComposition	Differencesin EnergySources	Difference inBiocompatibility	Difference inManufacturing
VED-1000	12 Inch DualENFit PortRight AngleExtensionFeeding Set	1032531076VS	None-Devices areidentical indimensionsand function	None -Devices areof the samematerials	None -Devices areof the samematerial fromthe samesource	None - Bothrely on thesameexternallyconnecteddevices forfluid flow	None - Bothdevices havesame materialcomposition andrequire the samebiocompatibilitytesting	None - Bothdevices aremanufacturedusing the samemanufacturingprocesses
VED-1001	24 Inch DualENFit PortRight AngleExtensionFeeding Set	1032561076VS	None-Devices areidentical indimensionsand function	None -Devices areof the samematerials	None -Devices areof the samematerial fromthe samesource	None - Bothrely on thesameexternallyconnecteddevices forfluid flow	None - Bothdevices havesame materialcomposition andrequire the samebiocompatibilitytesting	None - Bothdevices aremanufacturedusing the samemanufacturingprocesses
VED-1002	12 InchSingle ENFitPort StraightExtensionFeeding Set	103290076VS	None-Devices areidentical indimensionsand function	None -Devices areof the samematerials	None -Devices areof the samematerial fromthe samesource	None - Bothrely on thesameexternallyconnecteddevices forfluid flow	None - Bothdevices havesame materialcomposition andrequire the samebiocompatibilitytesting	None - Bothdevices aremanufacturedusing the samemanufacturingprocesses
VED-1003	24 InchSingle ENFitPort StraightExtensionFeeding Set	1032960076VS	None-Devices areidentical indimensionsand function	None -Devices areof the samematerials	None -Devices areof the samematerial fromthe samesource	None - Bothrely on thesameexternallyconnecteddevices forfluid flow	None - Bothdevices havesame materialcomposition andrequire the samebiocompatibilitytesting	None - Bothdevices aremanufacturedusing the samemanufacturingprocesses

Table 6.2 Comparison Summary between Vesco Medical Extension Feeding Sets and the
	Predicate Device

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Table 6.3 Comparison of Aquarius Medical Extension Feeding Sets to the Predicate Device Regarding Substantial Equivalence (SE)

Design Features/Function	AQUARIUSExtension FeedingSet K141631(Predicate)	Vesco MedicalExtension FeedingSets(Proposed)	SubstantialEquivalence
Indications for Use	AQUARIUS ExtensionFeeding Set isintended for use as anextension set forAQUARIUS G-button/or other gastricfeeding device,incorporating safetyconnectors which helpmitigate the risk ofaccidental connectionof an IV system to theenteral system, or theenteral system to IVsystem.	The Vesco ExtensionFeeding Sets areintended for use as anextension set to othergastric feedingdevices, incorporatingsafety connectorswhich may reduce therisk of accidentalconnection of an IVsystem to the enteralsystem, or the enteralsystem to the IVsystem.	SubstantiallyEquivalent
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	SubstantiallyEquivalent;
Type of Placement	Used with enteralfeeding devices withENFit compliantconnector	Used with enteralfeeding devices withENFit compliantconnector	Same
ENFit Connector	Yes; compliant withISO 80369-3	Yes; compliant withISO 80369-3	Same
Connector/Clamp Materials	All connectors andclamps are made withAcrylonitrile ButadieneStyrene	All connectors andclamps are made withAcrylonitrile ButadieneStyrene	Same
Description	-single or dual port-12 or 24 inch-continuous or bolusfeed-straight or 90 degreeport-stop clamp	-single or dual port-12 or 24 inch-continuous or bolusfeed-straight or 90 degreeport-stop clamp	Same
Biocompatibility	Biocompatibilitytesting hasdemonstrated that thisdevice meetsguidelines presentedin 10993-1:2009 perK141631	Same materials,manufacturer,manufacturingmaterials andprocesses aspredicate. Sameproduct as predicate	Same
Tensile Strength Testing	Per K141631, resultsdemonstrated the	Same as predicate.Compliant with EN	Same

	performance andfunctionalityspecification of thedevice	1615:2000 and EN1618:1997
Flow Rate Testing	Per K141631, resultsdemonstrated thecompliance with theperformance andfunctionalityspecification of thedevice	Same product aspredicate.	SubstantiallyEquivalent
Leakage Testing	Per K141631, resultsdemonstrated thecompliance with theperformance andfunctionalityspecification of thedevice	Same as predicate.Compliant with EN1615:2000 and EN1618:1997	Same
Non IV compatible	80369-1 Annex B,AAMI/ANSI ID54demonstrated non-compatibility of theproposed device withfemale luerconnectors andintravenous sets	Same product aspredicate. Compliantwith ISO 80369-3	SubstantiallyEquivalent
Labeling	Sold as "VescoMedical ExtensionFeeding Sets"	Sold as "VescoMedical ExtensionFeeding Sets"	Same

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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

1. 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
1. Visual inspections/accelerated aging

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a. Visual inspection for cracks, deformation, or other visual abnormalities created during accelerated aging test per ASTM F1980-07.
1. 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.
1. Cleaning Instructions Validation testing in accordance with CDRH's Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
1. Declaration of Conformance to applicable parts to ISO 80369.
1. Risk Analysis in accordance with ISO 14971:2012.
1. 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)

Regulation Number and Section

§ 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.