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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called "ENFit to ENFit Extension Sets." It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a physical medical device (extension sets for enteral feeding), not a software or AI-driven diagnostic tool. Therefore, the questions regarding acceptance criteria for a "study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training data) are not applicable to this type of device submission.

The "acceptance criteria" for this device are related to its physical performance, safety, and functional equivalence to a legally marketed predicate device, as demonstrated through non-clinical testing and comparison. The "study that proves the device meets the acceptance criteria" refers to the verification and validation testing performed.

Here's the information as requested, adapted to the context of a physical medical device:

Acceptance Criteria and Device Performance (adapted for a physical medical device)

The acceptance criteria for this device are established by demonstrating compliance with recognized international standards for medical devices and particularly for enteral feeding connectors, and by showing substantial equivalence to a predicate device in terms of design, intended use, and performance.

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

The document primarily demonstrates acceptance by adherence to specific ISO standards and by direct comparison to a predicate device. The "reported device performance" is the confirmation that the device met the requirements of these standards.

Acceptance Criteria (based on ISO Standards & Predicate Comparison)	Reported Device Performance
Biocompatibility: - Cytotoxicity per ISO 10993-5:2009 - Guinea Pig Maximization Sensitization per ISO 10993-10:2010 - Irritation per ISO 10993-10:2010 - Acute Systemic Toxicity per ISO 10993-11:2017 - Material-mediated Pyrogenicity per 10993-11:2017	Compliant with Use of International Standard ISO 10993-1: "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process."
Visual Inspections: - Verification of bonding.	Visual inspection for verification of bonding was performed and met requirements.
Enteral Device Performance (per ISO 20695:2020): - Pressure leak testing - Tensile testing - Flow rate testing	Found to be in compliance with design and performance requirements when tested according to ISO 20695:2020.
ENFit Connector Performance (per ISO 80369-20:2019 & ISO 80369-3:2016): - Fluid leakage - Stress cracking - Resistance to separation from axial load - Resistance to separation from unscrewing - Resistance to overriding - Disconnection by unscrewing - ENFit dimensional verification	Tested per ISO 80369-20 and met the standards of 80369-3 for all specified connector performance aspects. Evaluated per ISO 80369-3 for ENFit dimensional verification and met requirements. Device is compliant with ISO 80369-3.
Risk Analysis (per ISO 14971:2019): - Design Failure Modes and Effects Analysis (DFMEA).	Risk analysis per ISO 14971:2019 was performed, including DFMEA.
Usability Analysis (per ISO 62366-1:2015):	Usability analysis per ISO 62366-1:2015 was performed.
Substantial Equivalence to Predicate Device (K143018) for: - Indications for Use - Intended Use - Environment of Use - Intended Users - Patient Population (differences acknowledged but deemed acceptable) - No Reuse - Sterility Condition - ENFit Connector - Lengths (differences acknowledged but deemed acceptable)	All aspects were deemed "Substantially Equivalent?", with "Yes" indicated for each. Differences in patient population (pediatric and adult vs. neonates and pediatric) and lengths were justified as not impacting safety or performance.

2. Sample size used for the test set and the data provenance:

For this type of device, "sample size" is typically not referred to in the context of data points for an algorithm's performance, but rather the number of physical devices or batches tested in laboratory settings. The document states "Verification and validation testing was performed with the ENFit Extension Sets" but does not specify the exact number of units tested for each non-clinical test. The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Vesco Medical, to assess the device's compliance with ISO standards. This is prospective testing carried out specifically for regulatory submission. The country of origin of the data is implicitly the country where Vesco Medical conducted its testing (Westerville, Ohio, USA).

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

This concept is not applicable. For physical medical devices, "ground truth" is established by adherence to recognized international standards and performance specifications, not through expert consensus on diagnostic images or similar. The "experts" would be the engineers and quality assurance professionals performing and evaluating the non-clinical tests according to the established protocols. Their qualifications would involve expertise in materials science, mechanical engineering, and quality systems for medical devices.

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

This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. For physical device testing, results are typically quantitative and compared against predefined pass/fail criteria from international standards.

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:

This is not applicable. MRMC studies are used for evaluating diagnostic performance of AI or imaging systems. This submission is for a physical enteral feeding extension set, not a diagnostic imaging device or AI software. There are no "human readers" interpreting data with or without AI assistance.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device is based on objective performance measurements against established international standards (e.g., ISO 80369-3, ISO 80369-20, ISO 20695, ISO 10993, ISO 14971, ISO 62366-1) and demonstrated functional equivalence to a legally marketed predicate device. There is no "pathology" or "outcomes data" in the typical sense used for diagnostic devices; rather, the device is tested for physical and material integrity, fluid dynamics, and biocompatibility.

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are iterative and informed by industry standards and best practices, but there isn't a "training set" of data in the AI sense.

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

This is not applicable. Since there is no training set for an AI model, there is no "ground truth" established for it. The design specifications and performance requirements are informed by engineering principles, regulatory standards, and the performance of existing predicate devices.

Summary

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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).

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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

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Indications for Use

510(k) Number (if known) K230326

Device Name ENFit to ENFit Extension Sets

Indications for Use (Describe)

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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Tab 5A 510(k) Summary

Submitter l.

Official Contact	Name: Glenn BrunnerTitle: Dir. Regulatory Affairs and Quality AssuranceEmail: gbrunner@vescomedical.com
	Vesco MedicalAddress: 60 Collegeview Road, Suite 144Westerville, 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 Connectors21 CFR 876.5980Class IIProduct 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

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IV. Device Description

General Description of The ENFit to ENFit Extension Sets

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

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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.

DesignFeatures/Function	Kangaroo™Feeding TubeExtension Setswith ENFit SmallBore Connectors,K143018(Predicate)	ENFit to ENFitExtension Sets	SubstantiallyEquivalent?	Impact on Safetyand Performance
Indications for Use	The Kangaroo™Feeding TubeExtension Sets withENFit small boreconnectors areintended for enteralfeeding, on the orderof a physician, toprovide a means ofdelivering enteralnutrition ormedication from anenteral feedingsyringe through toany feeding tubewhich will accept aconnector for enteralapplications.The device isintended forneonates andinfants who requireenteral feeding.	The ENFit to ENFitExtension Sets areintended for enteralfeeding, on the order ofa physician, to providea means of deliveringenteral nutrition, fluidsand medications froman enteral feedingsyringe or set throughto an ENFit feedingtube connector forenteral applications.The device is singleuse for patients whorequire enteral feeding.	Yes	Equivalent toK143018. There areno differences inindications for use thatwould impact thesafety andperformance of thedevice.

Intended Use	The Kangaroo™Feeding TubeExtension Sets withENFit small boreconnectors areintended for enteralfeeding, on the orderof a physician, toprovide a means ofdelivering enteralnutrition ormedication from anenteral feedingsyringe through toany feeding tubewhich will accept anENFit small boreconnector for enteralapplications.The device isintended forneonates andinfants who requireenteral feeding.	The ENFit to ENFitExtension Sets areintended for enteralfeeding, on the order ofa physician, to providea means of deliveringenteral nutrition, fluidsand medications froman enteral feedingsyringe or set throughto an ENFit feedingtube connector forenteral applications.The device is singleuse for patients whorequire enteral feeding.	Yes	Equivalent toK143018. There areno differences inintended use thatwould impact thesafety andperformance of thedevice.
Environment of Use	Hospital, sub-acutecare and homesettings.	Hospital or medicalhome careenvironment -Prescription Only	Yes	Equivalent toK143018. There areno differences inenvironment of usethat would impact thesafety andperformance of thedevice.
Intended Users	Trained professionalclinicians or trainedpediatric caregivers.	Physicians, nurses,and trained clinicians(by facility policy)	Yes	Equivalent toK143018. There areno differences inintended users thatwould impact thesafety andperformance of thedevice
Patient Population	Neonatal andpediatric patients	Pediatric and Adultpatients	Yes	Similar to K143018.There are nodifferences in patientpopulation that would
				impact the safety andperformance of thedevice
No Reuse	Single Patient Use	Single Use	Yes	Equivalent toK143018. No impacton safety orperformance
Sterility Condition	Sterile	Sterile	Yes	Equivalent toK143018. No impacton safety orperformance
ENFit Connector	Yes; compliant withISO 80369-3	Yes; compliant withISO 80369-3	Yes	Equivalent toK143018. No impacton safety orperformance
Lengths	35" to 60" (90 to 150cm)	50cm, 100cm, 150cm	Yes	Similar to K143018.No impact on safety orproper performance
Biocompatibility	Compliant with Useof InternationalStandard ISO10993-1, "Biologicalevaluation ofmedical devices –Part 1: Evaluationand testing within arisk managementprocess"	Compliant with Use ofInternational StandardISO 10993-1,"Biological evaluationof medical devices –Part 1: Evaluation andtesting within a riskmanagement process"	Yes	Equivalent toK143018. No impacton safety orperformance
Fluid Leakage:Connector	Tested per ISO80369-20 and metthe standards of80369-3 for fluidleakage.	Tested per ISO 80369-20 and met thestandards of 80369-3for fluid leakage.	Yes	Equivalent toK143018. No impacton safety orperformance
Stress Cracking:Connector	Tested per ISO80369-20 and metthe standards of80369-3 for stresscracking.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for stresscracking.	Yes	Equivalent toK143018. No impacton safety orperformance
Resistance toseparation from	Tested per ISO80369-20 and metthe standards of80369-3 for	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for resistance	Yes	Equivalent toK143018. No impacton safety orperformance
axial load:connector	resistance toseparation fromaxial load.	to separation from axialload.		on safety orperformance
Resistance toseparation fromunscrewing:connector	Tested per ISO80369-20 and metthe standards of80369-3 forseparation fromunscrewing.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for separationfrom unscrewing.	Yes	Equivalent toK143018. No impacton safety orperformance
Resistance tooverriding:connector	Tested per ISO80369-20 and metthe standards of80369-3 forresistance tooverriding.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for resistanceto overriding.	Yes	Equivalent toK143018. No impacton safety orperformance
Disconnection byunscrewing:connector	Tested per ISO80369-20 and metthe standards of80369-3 fordisconnection byunscrewing.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 fordisconnection byunscrewing.	Yes	Equivalent toK143018. No impacton safety orperformance
ENFit DimensionalVerification	Evaluated per ISO80369-3 for ENFitdimensionalverification.	Evaluated per ISO80369-3 for ENFitdimensionalverification.	Yes	Equivalent toK143018. No impacton safety orperformance

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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.

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1. 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
1. Visual Inspections
- a. Visual inspection for verification of bonding
1. 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
1. 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
1. Risk Analysis per ISO 14971:2019.
- a. Design Failure Modes and Effects Analysis (DFMEA).
1. 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.

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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)

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.