(140 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a pouch for delivering enteral nutrition, with no mention of AI or ML.
No.
The device is described as a dispenser of enteral nutrition, not a device that directly treats a disease or condition. Its function is to hold and deliver nutrition, which is supportive care rather than therapeutic.
No
Explanation: The device is described as a dispenser of enteral nutrition, intended to deliver nutrition into the gastrointestinal system. It does not perform any diagnostic function.
No
The device description clearly states it is a physical pouch with an integrated connector and cap, which are hardware components. The performance studies also focus on physical properties like flow rate and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to dispense enteral nutrition directly into a patient's gastrointestinal system via a feeding tube. This is a direct therapeutic or supportive intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a pouch designed to hold and deliver liquid nutrition. It does not contain reagents, test strips, or other components typically associated with in vitro diagnostic tests.
- Performance Studies: The performance studies listed focus on the physical and functional characteristics of the pouch and its connection (flow rate, biocompatibility, connection standards, functional testing, retort suitability). These are relevant to a device used for delivering nutrition, not for diagnosing a condition.
In vitro diagnostics are tests performed on samples (like blood, urine, tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such tests.
N/A
Intended Use / Indications for Use
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.
Product codes
PIF
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.
The EnteraLoc Flow spouted pouch with ENFit Connector will be available in sizes ranging from 30mL - 1500mL dependent upon market and customer need.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal system
Indicated Patient Age Range
all age groups
Intended User / Care Setting
users ranging from laypersons to clinicians, in all age groups, in clinical or home care settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Unscrewing o
- Resistance to Overriding O
- Disconnection by Unscrewing O
- ISO 80369-1:2018 Misconnection Analysis
- Spouted Pouch Functional Testing
- Retort Suitability
Key results: The results of the performance testing listed above show that the subject device meets its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
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).(b)
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.
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 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
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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
10826 250th Avenue
Trevor, WI 53179
Phone: (800)323-9077
Fax: (262)298-7242 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact
Information: | Christie Marr
Director of Quality & Regulatory
10826 250th Avenue
Trevor, WI 53179
Phone: (262)298-7203
Email: christie@vonco.com |
| Secondary Contact
Information: | Keith Smith
President
10826 250th Avenue
Trevor, WI 53179
Phone: (262)298-7220
Email: keith@vonco.com |
| 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
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
5
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.