EnteraLoc Flow

K210971 · Vonco Products · PIF · Aug 18, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K210971
• Device Name: EnteraLoc Flow
• Applicant: Vonco Products
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Aug 18, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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

Device Story

EnteraLoc Flow is a foil pouch with an integrated female ENFit connector designed for enteral nutrition delivery. The pouch is pre-filled with liquid nutrition formula, eliminating the need for separate syringes or feeding bags during transfer. It is used in clinical or home care settings by clinicians or laypersons. Operation involves connecting the pouch directly to a feeding tube or extension set; nutrition is administered via gravity feeding (hanging the pouch) or bolus feeding (manually squeezing the pouch). The device reduces the risk of spills and food contamination by containing the nutrition within the pouch until delivery. It is a single-patient, disposable device.

Clinical Evidence

Bench testing only. Testing included flow rate analysis, biocompatibility (cytotoxicity, irritation, sensitization per ISO 10993-1:2019), and performance testing per ISO 80369-3:2016 (dimensioning, leakage, stress cracking, axial load, unscrewing, overriding, and disconnection). Misconnection analysis per ISO 80369-1:2018, spouted pouch functional testing, and retort suitability were also performed.

Technological Characteristics

Foil pouch with integrated female ENFit connector. Sizes range from 30mL to 1500mL. Single-patient use. Complies with ISO 80369-3:2016 for small-bore connectors and ISO 10993-1:2019 for biocompatibility. Non-sterile. Manual operation (gravity or squeeze).

Indications for Use

Indicated for use as a dispenser of enteral nutrition by direct connection to a feeding tube or extension set for patients of all age groups in clinical or home care 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

• Trovita Health Science Safe-T Feed Ready-To-Feed Pouch with ENFit Connector (K163586)
• NeoMed Oral/Enteral Syringes with ENFit Connector (K183540)

Submission Summary (Full Text)

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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 18, 2021

Vonco Products Christie Marr Quality Manager 10826 250th Avenue Trevor, WI 53179

Re:

K210971 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: March 31, 2021 Received: March 31, 2021

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

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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

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# Indications for Use

510(k) Number (if known) K210971

Device Name EnteraLoc Flow

Indications for Use (Describe)

The 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 style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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K210971 Page 1 of 4

Image /page/3/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)

# 510K Summary

# 5.1 Administrative Information

Date of Summary

Preparation:

| 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>Director of Quality & Regulatory<br>10826 250th Avenue<br>Trevor, WI 53179<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Information: | Keith Smith<br>President<br>10826 250th Avenue<br>Trevor, WI 53179<br>Phone: [phone]<br>Email: [e-mail] |
| 5.2 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<br>Subject Device: | None |

08/11/2021

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

- K163586 - Trovita Health Science Safe-T Feed Ready-To-Feed Pouch with ENFit Connector
- K183540 - NeoMed Oral/Enteral Syringes with ENFit Connector

### 5.4 Device Description

The Vonco Products EnteraLoc Flow pouch with ENFit Connector is a Rx only device.

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.

The EnteraLoc Flow spouted pouch with ENFit Connector will be available in sizes ranging from 30mL - 1500mL dependent upon market and customer need.

### 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 (feeding tube).

### 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-patient 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

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K210971 Page 3 of 4

Image /page/5/Picture/1 description: The image shows the logo for Vonco Products. The logo consists of a blue circle on the left side with the word "Vonco" in white letters inside the circle. To the right of the circle, the word "Products" is written in gray letters. Below the word "Products", the phrase "Performance That Delivers" is written in smaller gray letters.

Traditional 510(k)

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.

The intended use of the subject device and predicate devices are similar in that they each are singleuse, disposable devices intended to provide liquid nutrition to a patient via a feeding tube. The subject device is provided non-sterile just as the Trovita predicate (K163586) while the NeoMed predicate (K183540) are provided sterile and non-sterile. 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 differs in that the need to pre-fill the device prior to feeding is eliminated, reducing the risk of spills and food contamination.

# 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 ●
- Cytotoxicity O
- Irritation/Intracutaneous Reactivity O
- 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 ●

#### 5.9 Substantial Equivalence

The results of the performance testing listed above show that the subject device meets its specifications. Similar performance testing was conducted on the predicate devices. The subject device and predicate devices have similar intended use, technological characteristics, principles of operation, and treat a similar target population. This information along with the supporting documentation provided in this submission indicates that the subject device is substantially equivalent to the predicate devices.

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K210971 Page 4 of 4

Image /page/6/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 a smaller, gray font. Below "Products" is the tagline "Performance That Delivers" in a smaller, gray font.

Traditional 510(k)

# 5.10 Conclusion

Based upon the 510(k) Summaries and information provided within this 510(k) submission, Vonco Products concludes that the subject device is substantially equivalent to the predicate devices listed in Section 5.3.