Vesco Medical Extension Feeding Set

K192991 · Vesco Medical, LLC · PIF · Aug 3, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K192991
• Device Name: Vesco Medical Extension Feeding Set
• Applicant: Vesco Medical, LLC
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Aug 3, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Vesco Medical Extension Feeding Sets are intended for use as an extension set to other gastric feeding devices, incorporating safety connectors which may reduce the risk of accidental connection of an IV system, or the enteral system to the IV system.

Device Story

Extension feeding sets facilitate delivery of enteral nutrition or water from feeding source to gastric feeding device; used in hospital or home by trained caregivers. Device consists of PVC tube, ABS G-button connector, and ENFit connector. ENFit connector (ISO 80369-3 compliant) prevents misconnection with non-enteral (e.g., IV) systems. Device connects to low-profile gastric buttons (e.g., Mic-key, Mini). Single patient use; non-sterile. No active components; passive fluid delivery.

Clinical Evidence

No clinical data. Performance demonstrated via bench testing, including biocompatibility (ISO 10993), visual inspection/accelerated aging (ASTM F1980-07), flow rate, pressure leak, and tensile testing (EN 1615:2000, EN 1618:1997).

Technological Characteristics

Materials: Medical grade Polyvinylchloride (PVC) for tubes/funnels; Acrylonitrile Butadiene Styrene (ABS) for connectors/clamps. Design: Single/dual port, 12/24 inch lengths, straight/right-angle configurations. Connectivity: ENFit (ISO 80369-3) compliant. Passive fluid flow. Non-sterile.

Indications for Use

Indicated for patients 1 year and older requiring enteral nutrition or water delivery via gastric feeding devices. Used in hospital or home settings by trained caregivers.

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

• Aquarius Extension Feeding Sets (K141631)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 3, 2020

Vesco Medical LLC Chris O'keefe VP of Engineering 1039 Kingsmill Pkwv Columbus, OH 43229

K192991 Re:

Trade/Device Name: Vesco Medical Extension Feeding Set Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: July 6, 2020 Received: July 8, 2020

Dear Chris O'keefe:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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 (QS) 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 medical devices and radiation-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,

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K192991

Device Name Vesco Medical Extension Feeding Sets

Indications for Use (Describe)

The Vesco Medical Extension Feeding Sets are intended for use as an extension set to other gastric feeding devices, incorporating safety connectors which may reduce the risk of accidental connection of an IV system, or the enteral system to the IV system.

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## Tab 6 510(k) Summary

- Submitter l.

| Official Contact | |
|------------------|---------------------------------------|
| Name: | Chris O'Keefe |
| Title: | VP Product Development and Innovation |
| Email: | [e-mail] |

Vesco Medical Address: 1039 Kingsmill Parkway Columbus, Ohio 43229

Phone: [phone] Fax: [phone]

### Date of Preparation July 6, 2020

#### ll. Device

| Trade Name: | Vesco Medical Extension Feeding Sets |
|-----------------------------------------|-------------------------------------------------------------|
| Common Name: | Extension Feeding Set |
| Regulation Name: | Gastrointestinal tube and accessories |
| Regulation Number: | 21 CFR 876.5980 |
| Device Classification: | Class II |
| Device Classification/<br>Product Code: | Gastrointestinal Tubes with Enteral Specific Connectors/ PI |

#### III. Legally Marketed Predicate Devices

- Aquarius Extension Feeding Sets were cleared under notification K141631 (510k . application by Degania Silicone, Inc.)
- Product name: Aquarius Extension Feeding Set O
- 510(k) Number: K141631 O
- Manufacturer: Degania Silicone O

{4}------------------------------------------------

- o Product Code: KNT
- Device Class: Class II o

#### IV. Device Description

The Vesco Medical Extension Feeding Set product line is comprised of a group of enteral tubes that will be used by trained caregivers for the delivery of nutrition and water. The Extension Sets will be used in a hospital or home environment. The Extension Sets will be provided non-sterile and are for single patient use. The Extension Sets will incorporate a male ENFit connector which is compatible with syringes and other devices that have female ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices.

The Vesco Medical Extension Feeding Sets are non-sterile, single patient use devices consisting of a polyvinylchloride tube, ABS G-button connector, ENFit connector, cap and clamp. The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. The G-button connectors are to allow compatibility to the Mic-key and Mini low profile devices. The proposed models are listed in Table 6.1.

The Vesco Medical Extension Feeding Set is substantially equivalent to the predicate device. The hollow tube and funnel are made of medical grade Polyvinylchloride (PVC). The low-profile G-button connector and the ENFit connector are made from acrylonitrile butadiene styrene. There are no changes in intension of use, product design, specification, functional performance, labels and instructions of use.

| Model # | Description |
|----------|-----------------------------------------------------------|
| VED-1000 | 12 Inch Dual ENFit Port Right Angle Extension Feeding Set |
| VED-1001 | 24 Inch Dual ENFit Port Right Angle Extension Feeding Set |
| VED-1002 | 12 Inch Single ENFit Port Straight Extension Feeding Set |
| VED-1003 | 24 Inch Single ENFit Port Straight Extension Feeding Set |

Table 6.1 Proposed models of Vesco Medical Extension Feeding Sets

{5}------------------------------------------------

#### V. Intended Use

Vesco Medical Extension Sets are intended to be used with low profile gastrointestinal button devices to deliver enteral nutrition or water to patients.

### VI. Comparison of Technological Characteristics with the Predicate Device

The proposed Vesco Medical Extension Feeding Sets are the same manufactured products as the predicate. Because of this, there are no changes in the form, function, materials, or manufacturing processes from the predicate devices currently on the market. These products also have identical uses and user profiles. Table 6.2 is a comparison summary of the proposed device with the predicate. Table 6.3 lists the comparison of the proposed device to the predicate devices regarding substantial equivalence.

| Proposed<br>Device<br>Number | Device<br>Description | Predicate<br>Device<br>Number | Differences<br>in Design | Differences<br>in Material | Differences<br>in Chemical<br>Composition | Differences<br>in Energy<br>Sources | Difference in<br>Biocompatibility | Difference in<br>Manufacturing |
|------------------------------|-----------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| VED-1000 | 12 Inch Dual<br>ENFit Port<br>Right Angle<br>Extension<br>Feeding Set | 1032531076VS | None-<br>Devices are<br>identical in<br>dimensions<br>and function | None -<br>Devices are<br>of the same<br>materials | None -<br>Devices are<br>of the same<br>material from<br>the same<br>source | None - Both<br>rely on the<br>same<br>externally<br>connected<br>devices for<br>fluid flow | None - Both<br>devices have<br>same material<br>composition and<br>require the same<br>biocompatibility<br>testing | None - Both<br>devices are<br>manufactured<br>using the same<br>manufacturing<br>processes |
| VED-1001 | 24 Inch Dual<br>ENFit Port<br>Right Angle<br>Extension<br>Feeding Set | 1032561076VS | None-<br>Devices are<br>identical in<br>dimensions<br>and function | None -<br>Devices are<br>of the same<br>materials | None -<br>Devices are<br>of the same<br>material from<br>the same<br>source | None - Both<br>rely on the<br>same<br>externally<br>connected<br>devices for<br>fluid flow | None - Both<br>devices have<br>same material<br>composition and<br>require the same<br>biocompatibility<br>testing | None - Both<br>devices are<br>manufactured<br>using the same<br>manufacturing<br>processes |
| VED-1002 | 12 Inch<br>Single ENFit<br>Port Straight<br>Extension<br>Feeding Set | 103290076VS | None-<br>Devices are<br>identical in<br>dimensions<br>and function | None -<br>Devices are<br>of the same<br>materials | None -<br>Devices are<br>of the same<br>material from<br>the same<br>source | None - Both<br>rely on the<br>same<br>externally<br>connected<br>devices for<br>fluid flow | None - Both<br>devices have<br>same material<br>composition and<br>require the same<br>biocompatibility<br>testing | None - Both<br>devices are<br>manufactured<br>using the same<br>manufacturing<br>processes |
| VED-1003 | 24 Inch<br>Single ENFit<br>Port Straight<br>Extension<br>Feeding Set | 1032960076VS | None-<br>Devices are<br>identical in<br>dimensions<br>and function | None -<br>Devices are<br>of the same<br>materials | None -<br>Devices are<br>of the same<br>material from<br>the same<br>source | None - Both<br>rely on the<br>same<br>externally<br>connected<br>devices for<br>fluid flow | None - Both<br>devices have<br>same material<br>composition and<br>require the same<br>biocompatibility<br>testing | None - Both<br>devices are<br>manufactured<br>using the same<br>manufacturing<br>processes |

| Table 6.2 Comparison Summary between Vesco Medical Extension Feeding Sets and the | | |
|-----------------------------------------------------------------------------------|------------------|--|
| | Predicate Device | |

{6}------------------------------------------------

Table 6.3 Comparison of Aquarius Medical Extension Feeding Sets to the Predicate Device Regarding Substantial Equivalence (SE)

| Design Features/<br>Function | AQUARIUS<br>Extension Feeding<br>Set K141631<br>(Predicate) | Vesco Medical<br>Extension Feeding<br>Sets<br>(Proposed) | Substantial<br>Equivalence |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Indications for Use | AQUARIUS Extension<br>Feeding Set is<br>intended for use as an<br>extension set for<br>AQUARIUS G-<br>button/or other gastric<br>feeding device,<br>incorporating safety<br>connectors which help<br>mitigate the risk of<br>accidental connection<br>of an IV system to the<br>enteral system, or the<br>enteral system to IV<br>system. | The Vesco Extension<br>Feeding Sets are<br>intended for use as an<br>extension set to other<br>gastric feeding<br>devices, incorporating<br>safety connectors<br>which may reduce the<br>risk of accidental<br>connection of an IV<br>system to the enteral<br>system, or the enteral<br>system to the IV<br>system. | Substantially<br>Equivalent |
| Environment of Use | Hospital or home | Hospital or home | Same |
| Patient Population | Patients 1 year and up | Patients 1 year and up | Same |
| Single Patient Use | Yes | Yes | Same |
| Sterility Condition | Sterile or Non-Sterile | Non-Sterile | Substantially<br>Equivalent; |
| Type of Placement | Used with enteral<br>feeding devices with<br>ENFit compliant<br>connector | Used with enteral<br>feeding devices with<br>ENFit compliant<br>connector | Same |
| ENFit Connector | Yes; compliant with<br>ISO 80369-3 | Yes; compliant with<br>ISO 80369-3 | Same |
| Connector/Clamp Materials | All connectors and<br>clamps are made with<br>Acrylonitrile Butadiene<br>Styrene | All connectors and<br>clamps are made with<br>Acrylonitrile Butadiene<br>Styrene | Same |
| Description | -single or dual port<br>-12 or 24 inch<br>-continuous or bolus<br>feed<br>-straight or 90 degree<br>port<br>-stop clamp | -single or dual port<br>-12 or 24 inch<br>-continuous or bolus<br>feed<br>-straight or 90 degree<br>port<br>-stop clamp | Same |
| Biocompatibility | Biocompatibility<br>testing has<br>demonstrated that this<br>device meets<br>guidelines presented<br>in 10993-1:2009 per<br>K141631 | Same materials,<br>manufacturer,<br>manufacturing<br>materials and<br>processes as<br>predicate. Same<br>product as predicate | Same |
| Tensile Strength Testing | Per K141631, results<br>demonstrated the | Same as predicate.<br>Compliant with EN | Same |
| | | | |
| | performance and<br>functionality<br>specification of the<br>device | 1615:2000 and EN<br>1618:1997 | |
| Flow Rate Testing | Per K141631, results<br>demonstrated the<br>compliance with the<br>performance and<br>functionality<br>specification of the<br>device | Same product as<br>predicate. | Substantially<br>Equivalent |
| Leakage Testing | Per K141631, results<br>demonstrated the<br>compliance with the<br>performance and<br>functionality<br>specification of the<br>device | Same as predicate.<br>Compliant with EN<br>1615:2000 and EN<br>1618:1997 | Same |
| Non IV compatible | 80369-1 Annex B,<br>AAMI/ANSI ID54<br>demonstrated non-<br>compatibility of the<br>proposed device with<br>female luer<br>connectors and<br>intravenous sets | Same product as<br>predicate. Compliant<br>with ISO 80369-3 | Substantially<br>Equivalent |
| Labeling | Sold as "Vesco<br>Medical Extension<br>Feeding Sets" | Sold as "Vesco<br>Medical Extension<br>Feeding Sets" | Same |

{7}------------------------------------------------

# VII. Performance Data

## Non-Clinical Tests

Verification and validation testing were performed with the Vesco Medical Extension Feeding Sets. It was found that the extension sets are in compliance with all design and performance requirements based on the completed testing below

- 1. Biocompatibility testing
- a. Cytotoxicity in accordance with ISO 10993-5:2009
- b. Guinea Pig Maximization Sensitization in accordance with ISO 10993-10:2010
- c. Irritation in accordance with ISO 10993-10:2010
- d. Acute Systemic Toxicity in accordance with ISO 10993-11:2017
- e. Subacute/Subchronic Toxicity in accordance with ISO 10993-11:2017
- f. Material-Mediated Pyrogenicity in accordance with ISO 10993-11:2017
- 2. Visual inspections/accelerated aging

{8}------------------------------------------------

- a. Visual inspection for cracks, deformation, or other visual abnormalities created during accelerated aging test per ASTM F1980-07.
- 3. Performance test
- a. Flowrate testing in accordance with Vesco Medical's design requirement.
- b. Pressure leak testing in accordance with EN1615:2000 and EN1618:1997.
- c. Tensile test in accordance with EN1615:2000 and EN1618:1997.
- 4. Cleaning Instructions Validation testing in accordance with CDRH's Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- 5. Declaration of Conformance to applicable parts to ISO 80369.
- 6. Risk Analysis in accordance with ISO 14971:2012.
- 7. DFMEA in accordance with Vesco Medical's design requirements.

## Clinical Tests

Clinical tests were not required to demonstrate performance of the Vesco Medical Extension Feeding Sets. Product functionality has been adequately assessed by non-clinical tests.

### Animal Tests

Animal tests were not required to demonstrate the performance of Vesco Medical Extension Feeding Sets. Product functionality has been adequately assessed by non-animal tests.

# VIII. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the Vesco Medical Extension Feeding Sets are as safe, as effective and perform as well as the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.

(End of Section)