The Vesco Medical Nasoenteric Feeding Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (<30 days).

Device Description

The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes) are non-sterile, single use devices consisting of flexible, radiopaque, polyurethane tubing adhered to a plastic male ENFit single-port connector with a tethered, twist-on cap. The plastic ENFit port allows for connection to enteral feeding sets and enteral-specific syringes while reducing the likelihood of misconnections to non-enteral devices. The cap allows for port coverage when enteral devices are not in use. The distal tip of the tubing is open and has four (4) evenly spaced, alternating eyelet openings to allow for first three inches of the distal tip are coated with a hydrophilic lubricant to aid in friction reduction during tube insertion. The tubing is printed with graduated markings in centimeters, the length from the distal tip in order to provide users with approximate insertion depth information. Certain models of the Vesco Medical Nasoenteric Feeding tube are provided with a stylet wire attached to a flow-through, ENFit hub. The stylet wire is intended to stiffen the tube during insertion and be removed after insertion is complete. The proposed device will be offered in sizes ranging between 8 French and 14 French.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Vesco Medical Nasoenteric Feeding Tubes. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving an AI/ML device or its performance criteria in the way requested.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML device from this document. The document pertains to a traditional medical device (nasoenteric feeding tubes) and its regulatory clearance based on substantial equivalence and non-clinical performance testing.

However, I can extract information about the non-clinical performance testing that was done for this specific device, which serves as its "acceptance criteria" and "study" for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria (Test/Standard)	Reported Device Performance (Compliance)
Biocompatibility Testing:
a. Cytotoxicity (ISO-10993-5)	Compliant.
b. Cytotoxicity, intracutaneous, maximization sensitization	Compliant (leveraged from Cedic for component materials).
c. ENFit connector material and colorant biocompatibility	Compliant (leveraged from Cedic's K140581).
d. Stylet wire, tubing, ink, lubricant, adhesive biocompatibility	Compliant (leveraged from K992494 due to material and manufacturing equivalence).
Visual and Physical Inspections:
a. Visual inspection for bleeding of tube ink markings	Compliant per Vesco Medical Design Requirement.
b. Visual inspection for legibility of tube ink markings	Compliant per Vesco Medical Design Requirement.
c. Visual inspection for cracks or delamination of lubricous coating	Compliant per Vesco Medical Design Requirement.
d. Physical inspection for water activation of lubricious coating	Compliant per Vesco Medical Design Requirement.
e. Visual Inspection for adhesion between NE Tube and ENFit connector	Compliant per Vesco Medical Design Requirement.
f. Patency of stylet	Compliant per Vesco Medical Design Requirement.
g. Stylet removal force	Compliant per Vesco Medical Design Requirement.
Functional/Mechanical Testing:
a. Patency of NE Tubes/flow rate testing (using water)	Compliant (compared against predicate).
b. Patency of NE Tubes/flow rate testing (using nutritional fluid)	Compliant (compared against predicate).
c. Leakage Testing (EN1615:2000 & EN1618:1997)	Compliant.
d. Tensile Testing (EN1615:2000 & EN1618:1997)	Compliant.
e. Resistance to Kinking (EN1615:2000 & EN 13868:2002)	Compliant (against predicate).
f. Fluid Leakage (ISO 80369-3:2016)	Compliant (performed by Cedic).
g. Stress Cracking (ISO 80369-3:2016)	Compliant (performed by Cedic).
h. Resistance to separation from axial load (ISO 80369-3:2016)	Compliant (performed by Cedic).
i. Resistance to separation from unscrewing (ISO 80369-3:2016)	Compliant (performed by Cedic).
j. Resistance to overriding (ISO 80369-3:2016)	Compliant (performed by Cedic).
k. Disconnection by unscrewing (ISO 80369-3:2016)	Compliant (performed by Cedic).
l. ENFit dimensional verification (ISO 80369-3:2016)	Compliant (performed by Cedic).
Other:
a. Accelerated aging (18-month shelf life)	Substantiated an eighteen (18) month shelf life.
b. Risk Analysis (ISO 14971:2012)	Performed (Result: The conclusions drawn from the nonclinical tests demonstrate that the Vesco Medical Nasoenteric Feeding tubes are as safe, as effective, and perform as well as or better than the legally marketed devices).
c. Design Failure Modes and Effects Analysis (DFMEA)	Performed (Result: The conclusions drawn from the nonclinical tests demonstrate that the Vesco Medical Nasoenteric Feeding tubes are as safe, as effective, and perform as well as or better than the legally marketed devices).

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

This document describes non-clinical laboratory testing of physical samples of the device. It does not refer to a "test set" in the context of an AI/ML algorithm or patient data. The provenance of the testing data is not explicitly stated in terms of country of origin, but it is implied to be laboratory testing conducted for regulatory submission in the U.S. There is no concept of "retrospective or prospective" testing for these types of physical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to the non-clinical physical device testing described. Ground truth for the performance of a physical device against a standard is established by the specifications of the standard itself and measurable physical properties, not expert consensus.

4. Adjudication method for the test set

Not applicable to non-clinical physical device testing. The "adjudication method" for these tests is whether the device passed or failed the specified criteria of the international standards and Vesco Medical's design requirements.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" for the non-clinical tests described is defined by:

International Standards: ISO 80369-3, EN1615:2000, EN1618:1997, EN 13868:2002, ISO 10993-1, ISO 10993-5, ISO 14971:2012.
Vesco Medical Design Requirements: For visual inspections, patency, and stylet removal force.
Predicate Device Performance: Used as a benchmark for patency/flow rate and resistance to kinking, demonstrating "as well as or better than" performance.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2017

Vesco Medical, LLC Rachel Kunzweiler Product Development Engineer 692 N. High Street, Suite 205 Columbus. OH 43215

Re: K170162

Trade/Device Name: Vesco Medical Nasoenteric Feeding Tubes Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF Dated: August 31, 2017 Received: August 31, 2017

Dear Rachel Kunzweiler:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Charles Viviano -S

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K170162

Device Name Vesco Medical Nasoenteric Feeding Tubes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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TAB 5 510(k) Summary

Submitter I.

Official Contact	Name: Chris O'KeefeTitle: VP Product Development and InnovationEmail: cokeefe@vescomedical.com
	Vesco MedicalAddress: 692 N. High Street, Suite 205efColumbus, Ohio 43215
	Phone: 614-914-5991Fax: 614-902-3275
Date of Preparation	September 24, 2017

II. Device

Name of Device:	Vesco Medical Nasoenteric Feeding Tubes
Common/Usual Name:	Gastrointestinal Tubes
Device Classification:	Class II
Classification Name/Product Code:	Gastrointestinal Tubes and Accessories (21 CFR 876.5980) / PIF

Legally Marketed Predicate Devices III.

Covidien Dobbhoff™ Dual Port Feeding Tubes were most recently cleared under notification K112511.
Ross Product Division Abbott Laboratories Flexiflo Enteral Feeding Tubes were most recently cleared under notification K992494.

Device Description IV.

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are coated with a hydrophilic lubricant to aid in friction reduction during tube insertion. The tubing is printed with graduated markings in centimeters, the length from the distal tip in order to provide users with approximate insertion depth information. Certain models of the Vesco Medical Nasoenteric Feeding tube are provided with a stylet wire attached to a flow-through, ENFit hub. The stylet wire is intended to stiffen the tube during insertion and be removed after insertion is complete. The proposed

V. Intended Use

The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (<30 days).

device will be offered in sizes ranging between 8 French and 14 French.

Comparison of Technological Characteristics with the Predicate VI. Device

The proposed Vesco Medical Nasoenteric Feeding Tubes and the predicate devices are all intended for administering nutrition, fluids, and medications through the nastoenteric route to the stomach or small bowel of patients unable to manage nutritional intake through normal mastication and deducts have similar intended uses, technological characteristics, manufacturing methods, and operating principles. There are no significant differences that would affect the performance of the Vesco Medical Nasoenteric Feeding Tubes as compared to the predicate devices. Table 5.1 lists the comparisons of the proposed device to the predicate devices.

Design Features/Function ofProposed Device	Proposed Device Compared toCovidien Dobbhoff Dual PortFeeding Tubes K112511(Predicate)	Proposed Device Compared toRoss Products Division AbbottFlexiflo Enteral Feeding TubesK992494 (Predicate)
Intended Use	Similar and SE	Similar and SE
Environment of Use	Similar and SE	Similar and SE
Intended Users	Similar and SE	Similar and SE
Patient Population	Similar	Same
Single Use	Same	Same
Nonsterile	Same	Same
Stomach and Small BowelPlacement	Same	Same
ENFit Connector	Different (predicate has catheterslip-tip connector); no decreasein performance of proposeddevice	Different (predicate has catheterslip-tip connector)
Single Port	Different (predicate has dual port)	Different (predicate has dual port)
Flow-through Stylet Hub	Unknown	Different (predicate's hub is non-ENFit and of different material)
No Bolus Weight	Unknown	Similar (with or without bolus)
Radiopaque Tube Material	Similar and SE	Same
Hydrophilic Coating	Similar and SE	Same
Markings on Tube for MeasuringInserted Length	Similar and SE	Same

Table 5.1: Comparison of Vesco Medical Nasoenteric Feeding Tubes to predicate devices reqarding substantial equivalence (SE), similarities, and differences.

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Traditional 510(k)		Vesco Medical Nasoenteric Feeding Tubes
Used With or Without Stylet	Similar and SE	Same
French Sizes	Same	Same
Lengths	Similar and SE	Same

Performance Data: VII.

Non-Clinical Tests

Verification and validation Testing was performed with the Vesco Medical Nasoenteric Feeding Tubes. It was found that Vesco Medical Nasoenteric Feeding Tubes are in compliance with design and performance requirements according to ISO 80369 "Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications," and EN1615:2000 "Enteral feeding catheters and enteral giving sets for single use and their connectors: Design and Testing." Additionally, Vesco Medical Nasoenteric Feeding Tubes that underwent accelerated aging conditioning were tested in order to substantiate an eighteen (18) month shelf life.

The following testing was conducted on the Vesco Medical Nasoenteric Feeding Tubes:

1. Biocompatibility Testing per ISO-10993-1 and ISO 10993-5
- Cytotoxicity performed per ISO-10993-5 on Vesco Medical Nasoenteric Feeding Tubes a.
- Cytotoxicity, intracutaneous, and maximization sensitization testing reports provided b. by Cedic for component with same materials, manufacturer, and manufacturing process as stylet hub.
- C. Additional biocompatibility testing for the ENFit connector material and colorant leveraged from Cedic's previously cleared K140581.
- d. Remaining biocompatibility testing leveraged from K992494 due to material and manufacturing equivalence (stylet wire, tubing, ink, lubricant, and adhesive).
1. Visual and Physical Inspections
- a. Visual inspection for bleeding of tube ink markings per Vesco Medical Design Requirement
- Visual inspection for legibility of tube ink markings per Vesco Medical Design ﻘ Requirement
- Visual inspection for cracks or delamination of the lubricous coating per Vesco Medical C. Design Requirement
- Physical inspection for water activation of lubricious coating per Vesco MedicalDesign d. Requirement
- Visual Inspection for adequate adhesion between extruded NE Tube and ENFit e. connector per Vesco Medical Design Requirement
- Patency of stylet per Vesco Medical Design Requirement f.
- q. Stylet removal force per Vesco Medical Design Requirement
1. Patency of NE Tubes/flow rate testing (compared against predicate)
- a. Using water
- Using nutritional fluid b.
1. Leakage Testing per EN1615:2000 & EN1618:1997
1. Tensile Testing per EN1615:2000 & EN1618:1997
1. Resistance to Kinking per EN1615:2000 & EN 13868:2002, against predicate
1. Fluid Leakage per ISO 80369-3:2016, performed by Cedic
1. Stress Cracking per ISO 80369-3:2016, performed by Cedic
Resistance to separation from axial load ISO 80369-3:2016, performed by Cedic 9.
1. Resistance to separation from unscrewing per ISO 80369-3:2016, performed by Cedic
1. Resistance to overriding per ISO 80369-3:2016, performed by Cedic
1. Disconnection by unscrewing per ISO 80369-3:2016, performed by Cedic
1. ENFit dimensional verification per ISO 80369-3:2016, performed by Cedic

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1. Risk Analysis per ISO 14971:2012
1. Design Failure Modes and Effects Analysis (DFMEA)

Clinical Tests

Clinical tests were not required to demonstrate performance of Vesco Medical Nasoenteric Feeding Tubes. Product functionality has been adequately assessed by non-clinical tests.

Animal Tests

Animal tests were not required to demonstrate the performance of Vesco Medcical Nasoenteric Feeding Tubes. Product functionality has been adequately assessed by non-animal tests.

VIII. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Vesco Medical Nasoenteric Feeding tubes are as safe, as effective, and perform as well as or better than the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this 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.