EnteraLoc Flow

K223683 · Vonco Products · PIF · Jul 10, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K223683
• Device Name: EnteraLoc Flow
• Applicant: Vonco Products
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Jul 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.

Device Story

EnteraLoc Flow is a single-use, non-sterile foil pouch with an integrated female ENFit® connector; designed for pre-filling with liquid nutrition formula. Used in clinical or home settings by clinicians, laypersons, or patients. Operation involves connecting the pouch directly to a male ENFit® feeding tube or extension set; nutrition is delivered via gravity feeding (hanging) or bolus feeding (manual squeezing). Eliminates need for separate syringes or feeding bags; reduces risk of spills and contamination during transfer. Benefits include simplified enteral feeding process and improved hygiene.

Clinical Evidence

Bench testing only. Performance data includes flow rate analysis, biocompatibility (cytotoxicity, irritation, sensitization per ISO 10993-1:2019), and mechanical performance testing per ISO 80369-3:2016 (dimensioning, leakage, stress cracking, axial load, unscrewing, overriding). Also includes ISO 80369-1:2018 misconnection analysis, spouted pouch functional testing, retort suitability, stability testing, and risk analysis for OTC suitability.

Technological Characteristics

Materials: Laminated foil film pouch, polypropylene cap and spout. Connectivity: Female ENFit® connector (ISO 80369-3). Form factor: Single-use spouted pouch. Energy source: Manual (gravity or squeeze). Sterilization: Non-sterile.

Indications for Use

Indicated for enteral nutrition delivery via direct connection to feeding tube or extension set for patients of all age groups in clinical or home settings.

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

• EnteraLoc Flow (K210971)
• U Deliver Bolink ENFit Enteral Feeding Sets (K190310)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".

July 10, 2023

Vonco Products Christie Marr Sr. Director of Quality & Regulatory 10826 250th Avenue Trevor, WI 53179

Re: K223683 Trade/Device Name: EnteraLoc Flow Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: June 6, 2023 Received: June 6, 2023

#### Dear Christie Marr:

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

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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 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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-devices/device-advicecomprehensive-regulatory-assistance/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 -S

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) K223683

Device Name Vonco Products EnteraLoc Flow

#### Indications for Use (Describe)

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.

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

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K223683 Page 1 of 5

Image /page/3/Picture/1 description: The image shows the logo for Vonco Products. The logo consists of a blue circle with the word "Vonco" in white letters. To the right of the circle is the word "Products" in gray letters. Below the word "Products" is the phrase "Performance That Delivers" in a smaller gray font.

#### Traditional 510(k)

#### 5.1 Administrative Information

| Date of Summary<br>Preparation: | 12/07/2022 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vonco Products, LLC<br>10826 250th Avenue<br>Trevor, WI 53179<br>Phone: [phone]<br>Fax: [phone] |
| Primary Contact<br>Information: | Christie Marr<br>Senior Director of Quality & Regulatory<br>10826 250th Avenue<br>Trevor, WI 53179<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Information: | Brian Young<br>Vice President of Technical Engineering<br>10826 250th Avenue<br>Trevor, WI 53179<br>Phone: [phone]<br>Email: [e-mail] |
| 2 Device Information | |
| Trade Name: | EnteraLoc Flow |
| Common Name: | Gastrointestinal Tubes with Enteral Specific Connectors |
| Classification Name: | Gastrointestinal Tubes and Accessories |
| Regulation Number: | 21 CFR 876.5980 |
| Regulatory Class: | II |
| Product Code: | PIF |
| Panel: | Gastroenterology and Urology |
| Prior Submissions Related to | K210971 |

Subject Device:

5.2

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K223683 Page 2 of 5

Image /page/4/Picture/1 description: The image shows the logo for Vonco Products. The logo features a blue circle on the left side with the word "Vonco" in white letters. To the right of the circle, the word "Products" is written in a gray sans-serif font. Below "Products" is the tagline "Performance That Delivers" in a smaller, gray font.

Traditional 510(k)

#### 5.3 Predicate Device

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is substantially equivalent to the following devices:

- . K210971 - EnteraLoc Flow
- K190310 - U Deliver Bolink ENFit Enteral Feeding Sets

#### 5.4 Device Description

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end. The EnteraLoc Flow pouch is provided with a tamper evident cap. The pouch is designed to be pre-filled with liquid nutrition formula for tube feeding. EnteraLoc Flow is a single use device.

EnteraLoc Flow spouted pouch with ENFit® Connector is designed as a single use, over-the-counter device. The pouches will be available in a range of sizes, with a range of nutritional values (based upon the formula which the pouch is filled). Based upon the required nutritional intake requirements, the user will select the proper size pouch and quantity for feeding.

#### 5.5 Indications for Use

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is indicated for use as a dispenser of enteral nutrition by way of direct connection to a feeding tube or extension set. It is intended to deliver nutrition into the gastrointestinal system of a patient. The pouch, once filled, is intended to be used in clinical or home care settings by users ranging from laypersons to clinicians, in all age groups.

#### 5.6 Intended Use

The EnteraLoc Flow spouted pouch with ENFit® Connector is intended to deliver liquid nutrition feeding to an enteral access device.

#### 5.7 Comparison of Technological Characteristics

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector is intended to connect to male ENFit® connectors, including temporary transition sets and feeding tube administration sets. The disposable pouch is for single use and is designed such that the user can connect the pouch directly to a feeding tube.

The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector will be pre-filled with liquid nutrition formula, so the need for a syringe or feeding bag is not required. Having the liquid nutrition contained in the EnteraLoc Flow pouch eliminates the frequency of spills during transfer to these syringes or feeding bags. Liquid nutrition can be administered by hanging the pouch for gravity feeding or by gently squeezing the pouch to perform a bolus feeding.

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Image /page/5/Picture/0 description: The image shows the logo for Vonco Products. The logo features a blue circle on the left side with the word "Vonco" in white letters. To the right of the circle, the word "Products" is written in gray letters, and below that, the phrase "Performance That Delivers" is also written in gray letters.

Traditional 510(k)

A comparison of the proposed and predicate devices can be found in Table 5-1.

## Table 5-1

| Device<br>Characteristics | Vonco Products<br>Subject Device | Vonco Products<br>Subject Device<br>(K210971) | U Deliver Predicate<br>(K190310) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | PIF | PIF | PIF |
| Regulation | 876.5980 | 876.5980 | 876.5980 |
| Indications for Use | Indicated for use as a<br>dispenser of enteral<br>nutrition by way of<br>direct connection to a<br>feeding tube or extension<br>set. It is intended to<br>deliver nutrition into the<br>gastrointestinal system<br>of a patient. The pouch,<br>once filled, is intended to<br>be used in clinical or<br>home care settings by<br>users ranging from<br>laypersons to clinicians,<br>in all age groups. | Indicated for use as a<br>dispenser of enteral<br>nutrition by way of direct<br>connection to a feeding<br>tube or extension set. It<br>is intended to deliver<br>nutrition into the<br>gastrointestinal system of<br>a patient. The pouch,<br>once filled, is intended to<br>be used in clinical or<br>home care settings by<br>users ranging from<br>laypersons to clinicians,<br>in all age groups. | Intended for over-the-<br>counter use to deliver<br>liquid nutritional<br>formulas or water to a<br>patient's enteral access<br>device (feeding tube). |
| Intended Use | Is intended to deliver<br>liquid nutrition formula<br>to an enteral access<br>device. | Is intended to deliver<br>liquid nutrition formula<br>to an enteral access<br>device. | Intended for over-the-<br>counter use to deliver<br>liquid nutritional<br>formulas or water to a<br>patient's enteral access<br>device (feeding tube). |
| User Population | Patients with enteral<br>access devices, their<br>clinicians, and<br>caregivers. | Patients with enteral<br>access devices, their<br>clinicians, and<br>caregivers. | They can be used for<br>adults, children,<br>infants, and neonates. |
| Type of Feeding | Gravity or Bolus | Gravity or Bolus | Gravity or Bolus |
| Design<br>Characteristics | Foil Pouch with<br>integrated female<br>ENFit® Connector | Foil Pouch with<br>integrated female<br>ENFit® Connector | Cap with tube and<br>integrated female<br>ENFit® Connector<br>designed to be<br>interconnected to a<br>reservoir for water or<br>liquid nutrition<br>formulas. |
| Device Materials | Laminated foil film<br>Pouch, Polypropylene<br>Cap and Spout | Laminated foil film<br>Pouch, Polypropylene<br>Cap and Spout | Not Available |
| Female ENFit®<br>Connector | Meets ISO 80369-3 | Meets ISO 80369-3 | Meets ISO 80369-3 |
| Biocompatibility | Meets ISO 10993-1 | Meets ISO 10993-1 | Meets ISO 10993-1 |
| Sterilization | Non-Sterile | Non-Sterile | Sterile and Non-Sterile |
| Single-Use | Yes | Yes | Yes |
| Latex Free | Yes | Yes | Yes |

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Image /page/6/Picture/1 description: The image shows the logo for Vonco Products. The logo features a blue circle on the left side with the word "Vonco" in white letters. To the right of the circle, the word "Products" is written in gray letters, and below that, the phrase "Performance That Delivers" is also written in gray letters.

Traditional 510(k)

The intended use of the subject device and predicate devices are similar in that they each are single use, disposable devices intended to provide liquid nutrition to a patient via a feeding tube. The subject device is provided non-sterile just as the Vonco predicate device (K210971) and the U Deliver predicate device (K190310). The principles of operation are the same. Each device employs a female ENFit® connector to connect directly to a male ENFit® connector on a feeding tube or extension set. The Vonco Products EnteraLoc Flow spouted pouch with ENFit® Connector and the Vonco predicate device (K210971) are the same in that they both eliminate the need to pre-fill the device prior to feeding, reducing the risk of spills and food contamination. The U Deliver predicate (K190310) connects to a reservoir similar to the EnteraLoc pouch to allow for direct feeding.

#### 5.8 Performance Data

Vonco Products has conducted the following performance testing on the EnteraLoc Flow spouted pouch with ENFit® Connector:

- Flow Rate Analysis
- Biocompatibility Testing per ISO 10993-1:2019 ●
- o Cytotoxicity
- O Irritation/Intracutaneous Reactivity
- Sensitization o
- Performance Testing per ISO 80369-3:2016 ●
- Dimensioning O
- Falling Drop Positive Pressure Liquid Leakage O
- Stress Cracking O
- Resistance to Separation from Axial Load o
- Resistance to Separation from Unscrewing o
- Resistance to Overriding o
- Disconnection by Unscrewing O
- ISO 80369-1:2018 Misconnection Analysis ●
- Spouted Pouch Functional Testing ●
- Retort Suitability ●
- Stability Testing ●
- Risk Analysis for OTC suitability .

#### Conclusion 5.9

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K223683 Page 5 of 5

Image /page/7/Picture/1 description: The image shows the logo for Vonco Products. The logo consists of a blue circle on the left, with the word "Vonco" in white letters inside the circle. To the right of the circle is the word "Products" in gray letters. Below the word "Products" is the phrase "Performance That Delivers" in smaller, gray letters.

Traditional 510(k)

In accordance with 21 CFR Part 807 and based on a comparison of 'Indications for Use', technological characteristics and performance data, Vonco Products, LLC concludes that the proposed EnteraLoc Flow spouted pouch with ENFit® Connector is substantially equivalent to the predicate devices, EnteraLoc Flow (K210971) and U Deliver Bolink ENFit Enteral Feeding Sets (K190310).