Pediatric Nasogastric Feeding Tubes - Single ENFit Port

K210598 · Cair Lgl · PIF · Nov 2, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K210598
• Device Name: Pediatric Nasogastric Feeding Tubes - Single ENFit Port
• Applicant: Cair Lgl
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Nov 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Sterile, single-use nasogastric feeding tube; consists of graduated polyurethane tube with radiopaque edge, closed tip, and two lateral eyes. Features male ENFit connector (ABS) with polypropylene cap and thermoplastic polyurethane tether. Available in French sizes 4-12 and lengths 40-90mm. Used in hospital or medical home environments by physicians, nurses, or trained clinicians. Device connects to female enteral devices (ISO 80369-3 compliant) to deliver nutrition, fluids, or medications. Facilitates enteral access for pediatric patients; radiopaque material allows for placement verification via X-ray.

Clinical Evidence

No clinical data. Performance demonstrated via bench testing, including biocompatibility (ISO 10993), enteral device performance (ISO 20695:2020), and connector performance (ISO 80369-3/20).

Technological Characteristics

Materials: Polyurethane tube, ABS connector, polypropylene cap, thermoplastic polyurethane tether. Radiopaque edge. Dimensions: 4-12 Fr, 40-90mm lengths. Connectivity: ISO 80369-3 compliant ENFit male connector. Sterilization: Sterile. Standards: ISO 10993-1 (biocompatibility), ISO 20695:2020 (enteral feeding systems), ISO 80369-3/20 (connectors), ASTM F640-12 (radiopacity).

Indications for Use

Indicated for neonatal and pediatric patients requiring enteral feeding for the delivery of nutrition, fluids, and medications via an enteral feeding syringe or feeding set with ENFit connectors. Single use, maximum duration 29 days.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Argyle™ Polyvinyl Chloride (PVC) and Kangaroo™ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector (K150084)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|--|
| <span style="text-decoration: underline;"></span> 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: <a href="mailto:[e-mail]">[e-mail]</a> |
| | Vesco Medical |
| | Address: 1039 Kingsmill Parkway |

Address: 1039 Kingsmill Parkway Columbus, Ohio 43229

Phone: [phone] (mobile) Fax: [phone]

- Date of Preparation February 17, 2021
- ll. Device

| Trade Name: | Pediatric Nasogastric Feeding Tubes - Single ENFit Port |
|----------------------------------|----------------------------------------------------------------------------|
| Common Name: | Nasogastric Tubes |
| Classification Name &<br>Number: | Gastrointestinal Tubes with Enteral Specific Connectors<br>21 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

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 see Table 5.1.

| Pediatric Nasogastric Feeding Tubes – Single<br>ENFit Port | | |
|------------------------------------------------------------|--------------|---------------|
| Model | Tube<br>Size | 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.

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.

#### 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) | | |

| Design<br>Features/Functi<br>on | Kangaroo<br>Polyurethane<br>Feeding Tube,<br>K150084<br>(Predicate) | Pediatric Nasogastric<br>Feeding Tubes -<br>Single ENFit Port | Substantially<br>Equivalent? | Impact on Safety<br>and Performance |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Kangaroo<br>Polyurethane Neonatal<br>and Pediatric Feeding<br>Tubes with ENFit<br>connectors are<br>intended for enteral<br>feeding to deliver<br>enteral nutrition, liquid<br>or medication to<br>patient from an enteral<br>feeding syringe or<br>feeding set designed<br>with a connector for<br>enteral applications. | The Pediatric<br>Nasogastric Feeding<br>Tubes - Single ENFit<br>Port are intended for<br>enteral feeding to<br>deliver nutrition, fluids,<br>and medications to the<br>patient from an enteral<br>feeding syringe or<br>feeding set designed<br>with ENFit connectors<br>for enteral applications.<br>This product is single<br>use for no longer than<br>29 days. | Yes | Equivalent to<br>K150084.<br>There are no<br>differences in<br>indications for use that<br>would impact the<br>safety and<br>performance of the<br>device. |
| Intended Use | The Kangaroo<br>Polyurethane Feeding<br>Tube is intended for<br>pediatric patients who<br>require enteral<br>feeding.<br>(Warning: The<br>Polyurethane feeding<br>tube is not intended for<br>use beyond 30 days) | The Pediatric<br>Nasogastric Feeding<br>Tubes – Single ENFit<br>Ports are intended for<br>hydration, feeding and<br>administration of oral<br>medications for<br>pediatric patients who<br>require enteral feeding.<br>This product is single<br>use for no longer than<br>29 days. | Yes | Equivalent to<br>K150084. There are<br>no differences in<br>intended use that<br>would impact the<br>safety and<br>performance of the<br>device. |
| Environment of<br>Use | Unspecified -<br>Prescription Only | Hospital or medical<br>home environment -<br>Prescription Only | Yes | Equivalent to<br>K150084. There are<br>no differences in<br>environment of use<br>that would impact the<br>safety and<br>performance of the<br>device. |
| Intended Users | Trained professional<br>clinicians or trained<br>pediatric caregivers. | Physicians, nurses, and<br>trained clinicians (by<br>facility policy) | Yes | Equivalent to<br>K150084. There are<br>no differences in<br>intended users that<br>would impact the<br>safety and<br>performance of the<br>device |
| Patient<br>Population | Neonatal and Pediatric<br>patients | Neonatal and Pediatric<br>patients | Yes | Similar to K150084.<br>There are no<br>differences in patient<br>population that would<br>impact the safety and<br>performance of the<br>device |
| Single Use | Yes | Yes | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Sterility Condition | Sterile | Sterile | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| ENFit Connector | Yes; compliant with<br>ISO 80369-3 | Yes; compliant with<br>ISO 80369-3 | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Radiopacity<br>Verification | Yes | Yes; compliant with<br>ISO 20695:2020 | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Tube Markings | Yes | Yes; compliant with<br>ISO 20695:2020 | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| French Sizes | 3.5, 5, 6.5, 8, 10 | 4, 5, 6, 8, 10, 12 | Yes | Similar to K150084.<br>No impact on safety or<br>proper performance |
| Lengths | 31cm, 51cm, 91cm,<br>107cm | 40cm, 60cm, 90cm | Yes | Similar to K150084.<br>No impact on safety or<br>proper performance |
| Biocompatibility | Compliant with Use of<br>International Standard<br>ISO 10993-1,<br>"Biological evaluation<br>of medical devices -<br>Part 1: Evaluation and<br>testing within a risk<br>management process" | Compliant with Use of<br>International Standard<br>ISO 10993-1,<br>"Biological evaluation<br>of medical devices -<br>Part 1: Evaluation and<br>testing within a risk<br>management process" | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Liquid Leakage<br>Testing | Liquid Leakage<br>Testing Completed<br>(e.g. EN 1615:2000) | Tested and met<br>updated standard ISO<br>20695:2020 Enteral<br>Feeding Systems -<br>Design and Testing | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Tensile Testing | Tensile Testing<br>Completed (e.g. EN<br>1615:2000) | Tested and met<br>updated standard ISO<br>20695:2020 Enteral<br>Feeding Systems -<br>Design and Testing | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Fluid Leakage:<br>Connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for fluid leakage. | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for fluid leakage. | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| | | | | |
| Stress Cracking:<br>Connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for stress cracking. | Tested per ISO 80369-<br>20 and met the<br>standards of ISO<br>80369-3 for stress<br>cracking. | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Resistance to<br>separation from<br>axial load:<br>connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for resistance to<br>separation from axial<br>load. | Tested per ISO 80369-<br>20 and met the<br>standards of ISO<br>80369-3 for resistance<br>to separation from axial<br>load. | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Resistance to<br>separation from<br>unscrewing:<br>connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for separation from<br>unscrewing. | Tested per ISO 80369-<br>20 and met the<br>standards of ISO<br>80369-3 for separation<br>from unscrewing. | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Resistance to<br>overriding:<br>connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for resistance to<br>overriding. | Tested per ISO 80369-<br>20 and met the<br>standards of ISO<br>80369-3 for resistance<br>to overriding. | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| Disconnection by<br>unscrewing:<br>connector | Tested per ISO 80369-<br>20 and met the<br>standards of 80369-3<br>for disconnection by<br>unscrewing. | Tested per ISO 80369-<br>20 and met the<br>standards of ISO<br>80369-3 for<br>disconnection by<br>unscrewing. | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |
| ENFit<br>Dimensional<br>Verification | Evaluated per ISO<br>80369-3 for ENFit<br>dimensional<br>verification. | Evaluated per ISO<br>80369-3 for ENFit<br>dimensional<br>verification. | Yes | Equivalent to<br>K150084. No impact<br>on safety or<br>performance |

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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>
- 2. 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.
- 3. 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
- 4. Risk Analysis in accordance with ISO 14971:2019. a. DFMEA in accordance with product design requirements.
- 5. 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.