ENFit to ENFit Extension Sets

K230326 · Vesco Medical · PIF · Nov 2, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230326
• Device Name: ENFit to ENFit Extension Sets
• Applicant: Vesco Medical
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Nov 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Sterile, single-use extension tubing sets for enteral feeding; includes single or bifurcated input ports with tethered caps, tubing, clamps, and patient-end ENFit connector. Connects enteral feeding syringes or sets to ISO 80369-3 compliant feeding tubes. Used in hospital or home care settings by physicians, nurses, or trained clinicians. Facilitates delivery of nutrition, fluids, and medications to patients requiring enteral access. Benefits include standardized, secure connection to prevent misconnections.

Clinical Evidence

No clinical data. Safety and performance demonstrated via non-clinical bench testing, including biocompatibility (ISO 10993), enteral device performance (ISO 20695), and connector performance (ISO 80369-20).

Technological Characteristics

Sterile, single-use tubing sets; lengths 50-150 cm; I.D. 1.35-2.8 mm. Features ISO 80369-3 compliant ENFit connectors. Biocompatibility per ISO 10993-1. Mechanical performance tested per ISO 20695 and ISO 80369-20. No software or electronic components.

Indications for Use

Indicated for pediatric and adult patients requiring enteral feeding, nutrition, fluids, or medication delivery via enteral feeding tubes.

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

• Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors (K143018)

Submission Summary (Full Text)

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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## Tab 5A 510(k) Summary

#### Submitter l.

| Official Contact | Name: Glenn Brunner<br>Title: Dir. Regulatory Affairs and Quality Assurance<br>Email: [e-mail] |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| | Vesco Medical<br>Address: 60 Collegeview Road, Suite 144<br>Westerville, Ohio 43081 |
| | Phone: [phone] (mobile)<br>Fax: [phone] |
| 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 &<br>Number: | Gastrointestinal Tubes with Enteral Specific Connectors<br>21 CFR 876.5980<br>Class II<br>Product 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

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.

| 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

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.

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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.

| Design<br>Features/Function | Kangaroo™<br>Feeding Tube<br>Extension Sets<br>with ENFit Small<br>Bore Connectors,<br>K143018<br>(Predicate) | ENFit to ENFit<br>Extension Sets | Substantially<br>Equivalent? | Impact on Safety<br>and Performance |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Kangaroo™<br>Feeding Tube<br>Extension Sets with<br>ENFit small bore<br>connectors are<br>intended for enteral<br>feeding, on the order<br>of a physician, to<br>provide a means of<br>delivering enteral<br>nutrition or<br>medication from an<br>enteral feeding<br>syringe through to<br>any feeding tube<br>which will accept a<br>connector for enteral<br>applications.<br>The device is<br>intended for<br>neonates and<br>infants who require<br>enteral feeding. | The ENFit to ENFit<br>Extension Sets are<br>intended for enteral<br>feeding, on the order of<br>a physician, to provide<br>a means of delivering<br>enteral nutrition, fluids<br>and medications from<br>an enteral feeding<br>syringe or set through<br>to an ENFit feeding<br>tube connector for<br>enteral applications.<br>The device is single<br>use for patients who<br>require enteral feeding. | Yes | Equivalent to<br>K143018. There are<br>no 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>Feeding Tube<br>Extension Sets with<br>ENFit small bore<br>connectors are<br>intended for enteral<br>feeding, on the order<br>of a physician, to<br>provide a means of<br>delivering enteral<br>nutrition or<br>medication from an<br>enteral feeding<br>syringe through to<br>any feeding tube<br>which will accept an<br>ENFit small bore<br>connector for enteral<br>applications.<br>The device is<br>intended for<br>neonates and<br>infants who require<br>enteral feeding. | The ENFit to ENFit<br>Extension Sets are<br>intended for enteral<br>feeding, on the order of<br>a physician, to provide<br>a means of delivering<br>enteral nutrition, fluids<br>and medications from<br>an enteral feeding<br>syringe or set through<br>to an ENFit feeding<br>tube connector for<br>enteral applications.<br>The device is single<br>use for patients who<br>require enteral feeding. | Yes | Equivalent to<br>K143018. 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 | Hospital, sub-acute<br>care and home<br>settings. | Hospital or medical<br>home care<br>environment -<br>Prescription Only | Yes | Equivalent to<br>K143018. 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>K143018. 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 | Neonatal and<br>pediatric patients | Pediatric and Adult<br>patients | Yes | Similar to K143018.<br>There are no<br>differences in patient<br>population that would |
| | | | | impact the safety and<br>performance of the<br>device |
| No Reuse | Single Patient Use | Single Use | Yes | Equivalent to<br>K143018. No impact<br>on safety or<br>performance |
| Sterility Condition | Sterile | Sterile | Yes | Equivalent to<br>K143018. 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>K143018. No impact<br>on safety or<br>performance |
| Lengths | 35" to 60" (90 to 150<br>cm) | 50cm, 100cm, 150cm | Yes | Similar to K143018.<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>K143018. 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>K143018. 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>K143018. No impact<br>on safety or<br>performance |
| Resistance to<br>separation from | Tested per ISO<br>80369-20 and met<br>the standards of<br>80369-3 for | Tested per ISO 80369-<br>20 and met the<br>standards of ISO<br>80369-3 for resistance | Yes | Equivalent to<br>K143018. No impact<br>on safety or<br>performance |
| axial load:<br>connector | resistance to<br>separation from<br>axial load. | to separation from axial<br>load. | | 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>K143018. 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>K143018. 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>K143018. 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>K143018. 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 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
- 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. Flow rate testing in accordance with ISO 20695:2020
- 4. 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
- 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 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)