Nasogastric Feeding Tubes - ENFit Port - PVC

K213258 · Cair Lgl · PIF · Jun 9, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K213258
• Device Name: Nasogastric Feeding Tubes - ENFit Port - PVC
• Applicant: Cair Lgl
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Jun 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Nasogastric Feeding Tubes – ENFit Port – PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.

Device Story

Nasogastric feeding tube for delivery of nutrition, fluids, and medications; consists of graduated polyvinyl chloride (PVC) tube with radiopaque edge; features closed tip with lateral eyes (2 eyes for 5-10 Fr; 3 eyes for 12-16 Fr); includes ABS ENFit male connector with polypropylene cap and thermoplastic polyurethane tether. Used in hospital or medical home environments by physicians, nurses, or trained clinicians. Device connects to ISO 80369-3 compliant female enteral devices. Single-use, sterile, 24-hour duration. Provides secure enteral access; prevents misconnections via ENFit standard.

Clinical Evidence

No clinical data. Safety and performance established through bench testing, including biocompatibility (ISO 10993), pressure leak, tensile strength, flow rate, and connector performance (ISO 80369-3/20, ISO 20695:2020).

Technological Characteristics

Materials: Polyvinyl chloride (tube), ABS (connector), polypropylene (cap), thermoplastic polyurethane (tether). Radiopaque edge. Sizes: 5-16 Fr; Lengths: 50cm, 90cm. Connectivity: ISO 80369-3 compliant ENFit connector. Sterilization: Sterile. Standards: ISO 10993 (biocompatibility), ISO 20695:2020 (enteral feeding systems), ISO 80369-3/20 (connectors), ASTM F640-12 (radiopacity).

Indications for Use

Indicated for pediatric and adult patients requiring enteral feeding for the delivery of nutrition, fluids, and medications via an enteral feeding syringe or feeding set with ENFit connectors.

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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 9, 2022

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

Re: K213258

> Trade/Device Name: Nasogastric Feeding Tubes - ENFit Port - PVC Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: May 11, 2022 Received: May 13, 2022

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) K213258

Device Name

Nasogastric Feeding Tubes - ENFit Port - PVC

### Indications for Use (Describe)

The Nasogastric Feeding Tubes - ENFit Port - PVC 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 24 hours.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Nasogastric Feeding Tubes – ENFit Port - PVC

# Tab 5A 510(k) Summary

#### Submitter .

| Official Contact | Name: | Glenn Brunner<br>Title: Dir. Regulatory Affairs and Quality Assurance<br>Email: [e-mail] |
|---------------------|-------|-----------------------------------------------------------------------------------------------------------|
| | | Vesco Medical<br>Address: 1039 Kingsmill Parkway<br>Columbus, Ohio 43229 |
| | | Phone: [phone] (mobile)<br>Fax: [phone] |
| Date of Preparation | | June 6, 2022 |

#### II. Device

| Trade Name: | Nasogastric Feeding Tubes – ENFit Port - PVC |
|----------------------------------|-----------------------------------------------------------|
| Common Name: | Nasogastric Tubes |
| Classification Name &<br>Number: | Gastrointestinal Tubes and Accessories<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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#### IV. Device Description

### General Description of Nasogastric Feeding Tubes – ENFit Port - PVC

The Nasogastric Feeding Tubes – ENFit Port - PVC are sterile, single use devices. The feeding tubes consist of a graduated polyvinyl chloride tube, with radiopaque edge. The tubes have a closed tip and two lateral eyes for Fr sizes 5 to 10 and three lateral eyes for Fr sizes 12 to 16. 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 50cm and 90cm lengths and in French sizes from 5 to 16 see Table 5-1.

| Nasogastric Feeding Tubes – ENFit Port - PVC | | |
|----------------------------------------------|--------------|---------------|
| Model | Tube<br>Size | Device Length |
| VED-95005EO | 5 Fr | 50 cm |
| VED-99005EO | 5 Fr | 90 cm |
| VED-95006EO | 6 Fr | 50 cm |
| VED-99006EO | 6 Fr | 90 cm |
| VED-95008EO | 8 Fr | 50 cm |
| VED-99008EO | 8 Fr | 90 cm |
| VED-95010EO | 10 Fr | 50 cm |
| VED-99010EO | 10 Fr | 90 cm |
| VED-99012EO | 12 Fr | 90 cm |
| VED-99014EO | 14 Fr | 90 cm |
| VED-99016EO | 16 Fr | 90 cm |

## Table 5-1: Models of Nasogastric Feeding Tubes

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#### V. Intended Use

The Nasogastric Feeding Tubes – ENFit Port – PVC are intended for hydration, feeding and administration of oral medications for patients who require enteral feeding. This product is single use for no longer than 24 hours.

#### VI. Substantial Equivalence Discussion

The Nasogastric Feeding Tubes – ENFit Port - PVC 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: Device comparison table for Nasogastric Feeding Tubes – ENFit Port - PVC and the |
|---------------------------------------------------------------------------------------------|
| predicate device. |

| Design<br>Features/Function | Argyle Polyvinyl<br>Chloride Feeding<br>Tube, K150084<br>(Predicate) | Nasogastric Feeding<br>Tubes -ENFit Port -<br>PVC | Substantially<br>Equivalent? | Impact on Safety<br>and Performance |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Argyle Polyvinyl<br>Chloride (PVC)<br>Neonatal and<br>Pediatric Feeding<br>Tubes with ENFit<br>connectors are<br>intended for enteral<br>feeding to deliver<br>enteral nutrition,<br>liquid or medication<br>to patient from an<br>enteral feeding<br>syringe or feeding<br>set designed with a<br>connector for enteral<br>applications. | The Nasogastric<br>Feeding Tubes - ENFit<br>Port - PVC are<br>intended for enteral<br>feeding to deliver<br>nutrition, fluids, and<br>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>24 hours. | Yes | Equivalent to<br>K150084. There are<br>no differences in<br>indications for use that<br>would impact the<br>safety and<br>performance of the<br>device. |

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| Nasogastric Feeding Tubes – ENFit Port - PVC | | | | | |
|----------------------------------------------|--|--|--|--|--|
|----------------------------------------------|--|--|--|--|--|

| Intended Use | The Argyle Polyvinyl<br>Chloride Feeding<br>Tube is intended for<br>pediatric patients<br>who require enteral<br>feeding.<br>(Warning: The<br>Polyvinyl Chloride<br>feeding tube is not<br>intended for use<br>beyond 3-5 days) | The Nasogastric<br>Feeding Tubes – ENFit<br>Port - PVC are<br>intended for hydration,<br>feeding, and<br>administration of oral<br>medications for<br>pediatric and adult<br>patients who require<br>enteral feeding. This<br>product is single use<br>for no longer than 24<br>hours. | 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 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,<br>and trained clinicians<br>(by 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 Population | Pediatric patients | Pediatric and Adult<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 | 5, 6, 8, 10, 12, 14, 16 | Yes | Similar to K150084.<br>No impact on safety or<br>proper performance |
| Lengths | 41cm, 91cm, 107cm | 50cm, 90cm | Yes | Similar to K150084.<br>No impact on safety or<br>proper performance |
| Biocompatibility | Compliant with Use<br>of International<br>Standard ISO<br>10993-1, "Biological<br>evaluation of<br>medical devices -<br>Part 1: Evaluation<br>and testing within a<br>risk management<br>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 |
| Flow Rate Testing | Flow Rate Testing<br>Completed per<br>substantial<br>equivalence to<br>predicate device | Tested per 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<br>80369-20 and met<br>the standards of<br>80369-3 for fluid<br>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<br>80369-20 and met<br>the standards of<br>80369-3 for stress<br>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<br>80369-20 and met<br>the standards of<br>80369-3 for<br>resistance to<br>separation from<br>axial 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<br>80369-20 and met<br>the standards of<br>80369-3 for<br>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<br>80369-20 and met<br>the standards of<br>80369-3 for<br>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<br>80369-20 and met<br>the standards of<br>80369-3 for<br>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 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 Nasogastric Feeding Tubes – ENFit Port - PVC.

# VIII. Performance Testing

## Non-Clinical Tests

Verification and validation testing was performed with the Nasogastric Feeding Tubes – ENFit Port - PVC. It was found that feeding tubes are in compliance with the design and performance requirements when tested per the standards listed below.

- 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
- 2. Visual Inspections
- a. Visual inspection for verification of bonding
- 3. Enteral Device Performance test
- a. Pressure leak testing in accordance with ISO 20695:2020
- b. Tensile testing in accordance with ISO 20695:2020
- c. Resistance of the tube marking to acid in accordance with internal protocol

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- 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
- Flow rate testing in accordance with ISO 20695:2020 f.
- 4. Enteral Connector Performance Tests
- a. Fluid leakage per ISO 80369-20:2019
- b. Stress cracking per ISO 80369-20:2019
- C. Resistance to separation from axial load per ISO 80369-20:2019
- 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.
- g. ENFit dimensional verification per ISO 80369-3:2016
- 5. Risk Analysis per ISO 14971:2019.
- a. Design Failure Modes and Effects Analysis (DFMEA).
- 6. Usability Analysis per ISO 62366-1:2015.

### Clinical Tests

Clinical tests were not required to demonstrate the safety and performance of the Nasogastric Feeding Tubes – ENFit Port - PVC. Product functionality has been adequately assessed by non-clinical tests.

## Animal Tests

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

#### IX. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the Nasogastric Feeding Tubes – ENFit Port - PVC are substantially equivalent in safety and effectiveness to the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.

(End of Section)