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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the "EnteraLoc Flow" device, which is an enteral nutrition dispensing pouch. The document details the device's indications for use, comparison to predicate devices, and a list of performance tests conducted.

However, the document does not contain the level of detail requested for the acceptance criteria and study that proves the device meets those criteria, particularly within the context of an AI/ML-based medical device. Specifically, it lacks information on:

A table of acceptance criteria and reported device performance with specific quantitative metrics. The document lists types of tests (e.g., Flow Rate Analysis, Biocompatibility Testing, Performance Testing per ISO standards) but does not provide the pass/fail criteria or the actual results obtained.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance. This is explicitly an AI/ML-specific question, and the device described is a physical medical device, not an AI/ML diagnostic tool.
Whether a standalone performance study was done (algorithm only without human-in-the-loop performance). Again, this is an AI/ML-specific question.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and various physical and biological performance tests relevant to a non-AI/ML medical device.

Therefore, it is impossible to extract the requested information from the provided text as it pertains to an AI/ML product's acceptance criteria and study details. The device in question, the "EnteraLoc Flow" spouted pouch with ENFit® Connector, is a physical device for dispensing enteral nutrition, not an AI/ML diagnostic or assistive tool. The questions are tailored for evaluating an AI/ML-based medical device.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K223683

Device Name Vonco Products EnteraLoc Flow

Indications for Use (Describe)

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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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 SummaryPreparation:	12/07/2022
Submitter:	Vonco Products, LLC10826 250th AvenueTrevor, WI 53179Phone: (800)323-9077Fax: (262)298-7242
Primary ContactInformation:	Christie MarrSenior Director of Quality & Regulatory10826 250th AvenueTrevor, WI 53179Phone: (262)298-7203Email: christie@vonco.com
Secondary ContactInformation:	Brian YoungVice President of Technical Engineering10826 250th AvenueTrevor, WI 53179Phone: (262)298-7236Email: 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

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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

5.5 Indications for Use

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

DeviceCharacteristics	Vonco ProductsSubject Device	Vonco ProductsSubject 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 adispenser of enteralnutrition by way ofdirect connection to afeeding tube or extensionset. It is intended todeliver nutrition into thegastrointestinal systemof a patient. The pouch,once filled, is intended tobe used in clinical orhome care settings byusers ranging fromlaypersons to clinicians,in all age groups.	Indicated for use as adispenser of enteralnutrition by way of directconnection to a feedingtube or extension set. Itis intended to delivernutrition into thegastrointestinal system ofa patient. The pouch,once filled, is intended tobe used in clinical orhome care settings byusers ranging fromlaypersons to clinicians,in all age groups.	Intended for over-the-counter use to deliverliquid nutritionalformulas or water to apatient's enteral accessdevice (feeding tube).
Intended Use	Is intended to deliverliquid nutrition formulato an enteral accessdevice.	Is intended to deliverliquid nutrition formulato an enteral accessdevice.	Intended for over-the-counter use to deliverliquid nutritionalformulas or water to apatient's enteral accessdevice (feeding tube).
User Population	Patients with enteralaccess devices, theirclinicians, andcaregivers.	Patients with enteralaccess devices, theirclinicians, andcaregivers.	They can be used foradults, children,infants, and neonates.
Type of Feeding	Gravity or Bolus	Gravity or Bolus	Gravity or Bolus
DesignCharacteristics	Foil Pouch withintegrated femaleENFit® Connector	Foil Pouch withintegrated femaleENFit® Connector	Cap with tube andintegrated femaleENFit® Connectordesigned to beinterconnected to areservoir for water orliquid nutritionformulas.
Device Materials	Laminated foil filmPouch, PolypropyleneCap and Spout	Laminated foil filmPouch, PolypropyleneCap 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

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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).

Regulation Number and Section

§ 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.