The Pediatric Nasogastric Feeding Tubes - Single ENFit Port are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications. This product is single use for no longer than 29 days.

The Pediatric Nasogastric Feeding Tubes – Single ENFit Ports are intended for hydration, feeding and administration of oral medications for pediatric patients who require enteral feeding. This product is single use for no longer than 29 days.

Device Description

The Pediatric Nasogastric Feeding Tubes – Single ENFit Port are sterile, single use devices. The feeding tubes consist of a graduated Polyurethane tube, with radiopaque edge. The tubes have a closed tip and 2 lateral eyes. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 40mm, 60mm and 90mm lengths and in French sizes from 4 to 12.

AI/ML Overview

The provided text is a 510(k) summary for the Pediatric Nasogastric Feeding Tubes - Single ENFit Port. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of an AI-powered diagnostic device.

Therefore, the information required to answer the questions about acceptance criteria and the study that proves the device meets the acceptance criteria for an AI diagnostic device is not present in the provided text. The document details performance testing for a physical medical device (nasogastric feeding tubes), not an AI algorithm.

Specifically:

There is no AI device described.
There are no acceptance criteria for AI performance (e.g., accuracy, sensitivity, specificity).
There is no mention of a test set, training set, ground truth acquisition involving experts, MRMC studies, or standalone algorithm performance.

The "Performance Testing" section (pages 9-10) describes non-clinical tests performed on the physical feeding tubes, such as biocompatibility, pressure leak testing, tensile testing, and connector performance tests against various ISO standards. It explicitly states, "Clinical tests were not required to demonstrate performance... Product functionality has been adequately assessed by non-clinical tests." and "Animal tests were not required... Product functionality has been adequately assessed by non-animal tests."

Summary

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November 2, 2021

Cair Lgl % Glenn Brunner Dir. Regulatory Affairs and Ouality Assurance Vesco Medical 1039 Kingsmill Parkway Columbus, OH 43229

Re: K210598

Trade/Device Name: Pediatric Nasogastric Feeding Tubes - Single ENFit Port Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: September 26, 2021 Received: September 29, 2021

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 (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

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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 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 (OS) 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 mediation-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,

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) K210598

Device Name

Pediatric Nasogastric Feeding Tubes - Single ENFit Port

Indications for Use (Describe)

This product is single use for no longer than 29 days.

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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510(k) Summary

Submitter 1.

CAIR LGL Parc Tertiaire De Bois Dieu 1 Allee Des Chevreuils Lissieu Rhone, FR 69380

Official Contact	Name: Glenn Brunner
	Title: Dir. Regulatory Affairs and Quality Assurance
	Email: gbrunner@vescomedical.com
	Vesco Medical
	Address: 1039 Kingsmill Parkway

Address: 1039 Kingsmill Parkway Columbus, Ohio 43229

Phone: 614-946-4178 (mobile) Fax: 614-515-2800

Date of Preparation February 17, 2021
ll. Device

Trade Name:	Pediatric Nasogastric Feeding Tubes - Single ENFit Port
Common Name:	Nasogastric Tubes
Classification Name &Number:	Gastrointestinal Tubes with Enteral Specific Connectors21 CFR 876.5980
	Class II
	Product Code: PIF

Legally Marketed Predicate Device III.

Product name: Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector 510(k) Number: K150084 Manufacturer: Covidien Product Code: PIF Device Class: Class II

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Device Description IV.

General Description of Pediatric Nasogastric Feeding Tubes – Single ENFit Port

Pediatric Nasogastric Feeding Tubes – SingleENFit Port
Model	TubeSize	Device Length
VED-84004EO	4 Fr	40 mm
VED-86004EO	4 Fr	60 mm
VED-84005EO	5 Fr	40 mm
VED-86005EO	5 Fr	60 mm
VED-86006EO	6 Fr	60 mm
VED-89006EO	6 Fr	90 mm
VED-86008EO	8 Fr	60 mm
VED-89008EO	8 Fr	90 mm
VED-86010EO	10 Fr	60 mm
VED-89010EO	10 Fr	90 mm
VED-89012EO	12 Fr	90 mm

Table 5.1: Models of Pediatric Nasogastric Feeding Tubes

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Intended Use V.

Substantial Equivalence Discussion VI.

The Pediatric Nasogastric Feeding Tubes – Single ENFit Port are substantially equivalent to the currently marketed predicate Feeding Tube. Table 5.2 is a detailed comparison of the Cair feeding tubes to the predicate devices regarding substantial equivalence.

Table 5.2 Comparison of Cair Feeding Tubes to the Predicate Devices Regarding Substantial
Equivalence (SE)

DesignFeatures/Function	KangarooPolyurethaneFeeding Tube,K150084(Predicate)	Pediatric NasogastricFeeding Tubes -Single ENFit Port	SubstantiallyEquivalent?	Impact on Safetyand Performance
Indications forUse	The KangarooPolyurethane Neonataland Pediatric FeedingTubes with ENFitconnectors areintended for enteralfeeding to deliverenteral nutrition, liquidor medication topatient from an enteralfeeding syringe orfeeding set designedwith a connector forenteral applications.	The PediatricNasogastric FeedingTubes - Single ENFitPort are intended forenteral feeding todeliver nutrition, fluids,and medications to thepatient from an enteralfeeding syringe orfeeding set designedwith ENFit connectorsfor enteral applications.This product is singleuse for no longer than29 days.	Yes	Equivalent toK150084.There are nodifferences inindications for use thatwould impact thesafety andperformance of thedevice.
Intended Use	The KangarooPolyurethane FeedingTube is intended forpediatric patients whorequire enteralfeeding.(Warning: ThePolyurethane feedingtube is not intended foruse beyond 30 days)	The PediatricNasogastric FeedingTubes – Single ENFitPorts are intended forhydration, feeding andadministration of oralmedications forpediatric patients whorequire enteral feeding.This product is singleuse for no longer than29 days.	Yes	Equivalent toK150084. There areno differences inintended use thatwould impact thesafety andperformance of thedevice.
Environment ofUse	Unspecified -Prescription Only	Hospital or medicalhome environment -Prescription Only	Yes	Equivalent toK150084. There areno differences inenvironment of usethat would impact thesafety andperformance of thedevice.
Intended Users	Trained professionalclinicians or trainedpediatric caregivers.	Physicians, nurses, andtrained clinicians (byfacility policy)	Yes	Equivalent toK150084. There areno differences inintended users thatwould impact thesafety andperformance of thedevice
PatientPopulation	Neonatal and Pediatricpatients	Neonatal and Pediatricpatients	Yes	Similar to K150084.There are nodifferences in patientpopulation that wouldimpact the safety andperformance of thedevice
Single Use	Yes	Yes	Yes	Equivalent toK150084. No impacton safety orperformance
Sterility Condition	Sterile	Sterile	Yes	Equivalent toK150084. No impacton safety orperformance
ENFit Connector	Yes; compliant withISO 80369-3	Yes; compliant withISO 80369-3	Yes	Equivalent toK150084. No impacton safety orperformance
RadiopacityVerification	Yes	Yes; compliant withISO 20695:2020	Yes	Equivalent toK150084. No impacton safety orperformance
Tube Markings	Yes	Yes; compliant withISO 20695:2020	Yes	Equivalent toK150084. No impacton safety orperformance
French Sizes	3.5, 5, 6.5, 8, 10	4, 5, 6, 8, 10, 12	Yes	Similar to K150084.No impact on safety orproper performance
Lengths	31cm, 51cm, 91cm,107cm	40cm, 60cm, 90cm	Yes	Similar to K150084.No impact on safety orproper performance
Biocompatibility	Compliant with Use ofInternational StandardISO 10993-1,"Biological evaluationof medical devices -Part 1: Evaluation andtesting within a riskmanagement process"	Compliant with Use ofInternational StandardISO 10993-1,"Biological evaluationof medical devices -Part 1: Evaluation andtesting within a riskmanagement process"	Yes	Equivalent toK150084. No impacton safety orperformance
Liquid LeakageTesting	Liquid LeakageTesting Completed(e.g. EN 1615:2000)	Tested and metupdated standard ISO20695:2020 EnteralFeeding Systems -Design and Testing	Yes	Equivalent toK150084. No impacton safety orperformance
Tensile Testing	Tensile TestingCompleted (e.g. EN1615:2000)	Tested and metupdated standard ISO20695:2020 EnteralFeeding Systems -Design and Testing	Yes	Equivalent toK150084. No impacton safety orperformance
Fluid Leakage:Connector	Tested per ISO 80369-20 and met thestandards of 80369-3for fluid leakage.	Tested per ISO 80369-20 and met thestandards of 80369-3for fluid leakage.	Yes	Equivalent toK150084. No impacton safety orperformance

Stress Cracking:Connector	Tested per ISO 80369-20 and met thestandards of 80369-3for stress cracking.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for stresscracking.	Yes	Equivalent toK150084. No impacton safety orperformance
Resistance toseparation fromaxial load:connector	Tested per ISO 80369-20 and met thestandards of 80369-3for resistance toseparation from axialload.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for resistanceto separation from axialload.	Yes	Equivalent toK150084. No impacton safety orperformance
Resistance toseparation fromunscrewing:connector	Tested per ISO 80369-20 and met thestandards of 80369-3for separation fromunscrewing.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for separationfrom unscrewing.	Yes	Equivalent toK150084. No impacton safety orperformance
Resistance tooverriding:connector	Tested per ISO 80369-20 and met thestandards of 80369-3for resistance tooverriding.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 for resistanceto overriding.	Yes	Equivalent toK150084. No impacton safety orperformance
Disconnection byunscrewing:connector	Tested per ISO 80369-20 and met thestandards of 80369-3for disconnection byunscrewing.	Tested per ISO 80369-20 and met thestandards of ISO80369-3 fordisconnection byunscrewing.	Yes	Equivalent toK150084. No impacton safety orperformance
ENFitDimensionalVerification	Evaluated per ISO80369-3 for ENFitdimensionalverification.	Evaluated per ISO80369-3 for ENFitdimensionalverification.	Yes	Equivalent toK150084. 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 Pediatric Nasogastric Feeding Tubes – Single ENFit Port.

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VIII. Performance Testing

Non-Clinical Tests

Verification and validation testing was performed with the Pediatric Nasogastric Feeding Tubes - Single ENFit Port. It was found that the Pediatric Nasogastric Feeding Tubes are in compliance with all design and performance requirements based on the results of the results presented.

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 and Subacute Systemic Toxicity per ISO 10993-11:2017
- e. Material mediated pyrogenicity per USP<151>
1. Enteral Device Performance test
- a. Pressure leak testing in accordance with ISO 20695:2020.
- b. Tensile testing in accordance with ISO 20695:2020.
- Resistance of the tube marking to acid in accordance with internal protocol. C.
- d. Resistance of the tube marking to disinfectants in accordance with ISO 20695:2020.
- e. Visibility of enteral tube under x-ray in accordance with internal protocol based on ASTM F640-12.
1. Enteral Connector Performance Tests
- a. Fluid leakage testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- b. Stress cracking testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- c. Resistance to separation from axial load testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- d. Resistance to separation from unscrewing testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- e. Resistance to overriding testing in accordance with ISO 80369-3:2016 and ISO 80369-20:2015.
- Disconnection by unscrewing testing in accordance with ISO 80369-3:2016 and f. ISO 80369-20:2015.
- g. ENFit dimensional verification testing in accordance with ISO 80369-3:2016

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h. Flow rate testing in accordance ISO 20695:2020, Annex E
1. Risk Analysis in accordance with ISO 14971:2019. a. DFMEA in accordance with product design requirements.
1. Usability Analysis in accordance with ISO 62366-1: 2015

Clinical Tests

Clinical tests were not required to demonstrate performance of the Pediatric Nasoqastric Feeding Tubes – Single ENFit Port. Product functionality has been adequately assessed by non-clinical tests.

Animal Tests

Animal tests were not required to demonstrate the performance of the Pediatric Nasogastric Feeding Tubes – Single ENFit Port. Product functionality has been adequately assessed by non-animal tests.

IX. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the Pediatric Nasogastric Feeding Tubes - Single ENFit Port are substantially equivalent, and as safe and effective as 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.