(214 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a pouch for enteral nutrition delivery, with no mention of AI or ML.
No
This device is a dispenser for enteral nutrition, delivering it to the gastrointestinal system, but it does not directly treat or cure a disease or condition itself.
No
The device is described as a dispenser of enteral nutrition, designed to deliver nutrition into the gastrointestinal system, not to diagnose medical conditions.
No
The device description clearly indicates a physical pouch with an integrated connector, which is a hardware component. The performance studies also focus on physical properties and testing of the pouch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "dispenser of enteral nutrition" intended to "deliver nutrition into the gastrointestinal system of a patient." This is a delivery mechanism for substances into the body, not a test performed on samples from the body.
- Intended Use: The intended use is for delivering nutrition, not for diagnosing or monitoring a medical condition through analysis of biological samples.
The device is a medical device, specifically an enteral feeding device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
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. 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.
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
used in clinical or home care settings by users ranging from laypersons to clinicians
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
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 .
Key Metrics
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 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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 PRAStaff(@fda.hhs.gov
"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
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
| Preparation: | 12/07/2022 |
|---|---|
| Submitter: | Vonco Products, LLC |
| 10826 250th Avenue | |
| Trevor, WI 53179 | |
| Phone: (800)323-9077 | |
| Fax: (262)298-7242 | |
| Primary Contact | |
| Information: | Christie Marr |
| Senior Director of Quality & Regulatory | |
| 10826 250th Avenue | |
| Trevor, WI 53179 | |
| Phone: (262)298-7203 | |
| Email: christie@vonco.com | |
| Secondary Contact | |
| Information: | Brian Young |
| Vice President of Technical Engineering | |
| 10826 250th Avenue | |
| Trevor, WI 53179 | |
| Phone: (262)298-7236 | |
| Email: brian.young@vonco.com | |
| 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
4
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:
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.
5
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
Characteristics | Vonco Products
Subject Device | Vonco Products
Subject Device
(K210971) | U Deliver Predicate
(K190310) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | PIF | PIF | PIF |
| Regulation | 876.5980 | 876.5980 | 876.5980 |
| Indications for Use | 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. | 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. | Intended for over-the-
counter use to deliver
liquid nutritional
formulas or water to a
patient's enteral access
device (feeding tube). |
| Intended Use | Is intended to deliver
liquid nutrition formula
to an enteral access
device. | Is intended to deliver
liquid nutrition formula
to an enteral access
device. | Intended for over-the-
counter use to deliver
liquid nutritional
formulas or water to a
patient's enteral access
device (feeding tube). |
| User Population | Patients with enteral
access devices, their
clinicians, and
caregivers. | Patients with enteral
access devices, their
clinicians, and
caregivers. | They can be used for
adults, children,
infants, and neonates. |
| Type of Feeding | Gravity or Bolus | Gravity or Bolus | Gravity or Bolus |
| Design
Characteristics | Foil Pouch with
integrated female
ENFit® Connector | Foil Pouch with
integrated female
ENFit® Connector | Cap with tube and
integrated female
ENFit® Connector
designed to be
interconnected to a
reservoir for water or
liquid nutrition
formulas. |
| Device Materials | Laminated foil film
Pouch, Polypropylene
Cap and Spout | Laminated foil film
Pouch, Polypropylene
Cap and Spout | Not Available |
| Female ENFit®
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 |
6
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
7
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).