(108 days)
No
The device description and performance studies focus on the mechanical aspects of gravity feeding sets and usability testing, with no mention of AI or ML.
No.
The device is used to deliver nutritional formulas or water, which supports life but does not actively treat a disease or condition.
No
The device is an enteral feeding set, used to deliver nutritional formulas or water to a patient's feeding tube. It does not perform any diagnostic function.
No
The device description clearly outlines physical components made of PVC and other medical-grade materials, and the intended use involves the physical delivery of liquids. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube)." This is a delivery mechanism for substances into the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a physical set of tubes and connectors for gravity feeding. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or analytical methods
The device is clearly designed for the administration of nutrition and hydration, which falls under the category of medical devices used for treatment or support, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
Product codes
PIF
Device Description
The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:
- U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. BK-2085) .
- U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-2405)
The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO18250-3, "Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
U Deliver Bolink ENFit Enteral Feeding Sets are not intended for a specific patient population: they can be used for adults, children, infants and neonates.
Intended User / Care Setting
Over-The-Counter Use
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
The testing necessary for this submission was usability testing to demonstrate that both laypersons with no prior tube feeding experience and caregivers/tubefeeders were able to perform the essential tasks using only the proposed instructions for use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were carried out on samples of the U Deliver Bolink ENFit Enteral Feeding Sets and were submitted with the predicate device (K170555). No new device testing was necessary as no changes have been made to the device design, materials or packaging. The testing necessary for this submission was usability testing to demonstrate that both laypersons with no prior tube feeding experience and caregivers/tubefeeders were able to perform the essential tasks using only the proposed instructions for use. The results of usability testing demonstrate that the subject device(s) are appropriate for over-the-counter use.
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 & 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.
May 31, 2019
U Deliver Medical, LLC % Thomas Dold President/ Principal Consultant Vista Regulatory Solutions, LLC 18205 E. Sioux Vista Dr. Jordan, MN 55352
Re: K190310/S001
Trade/Device Name: U Deliver Bolink ENFit Enteral Feeding Sets Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: February 7, 2019 Received: February 12, 2019
Dear Thomas Dold:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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. Acting Assistant Division 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
U Deliver Bolink ENFit Enteral Feeding Sets
Indications for Use (Describe)
The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Trade Name: | U Deliver Bolink ENFit Enteral Feeding Sets |
|---|---|
| Type of 510(k) submission: | Traditional |
| Date of Submission: | 05 May 2019 |
| 510(k) Owner and Submitter: | U Deliver Medical, LLC |
| 7900 Excelsior Blvd, Suite 108 | |
| Hopkins, MN 55343 | |
| USA | |
| Phone: | 952-200-0270 |
| FDA Registration Number: | 3014016859 |
| Owner/Operator Number: | 10055940 |
| 510(k) Application Correspondent: | Mr. Thomas Dold |
| President / Principal Consultant | |
| Vista Regulatory Solutions, LLC | |
| Jordan, MN 55352 | |
| Phone: | (612) 965-6057 |
| Email: | tdold@vistareg.com |
| FDA Product Code: | PIF |
| FDA Regulation Number: | 21 CFR 876.5980 |
| FDA Classification Name: | Gastrointestinal tube and accessories |
| Classification Panel: | Gastroenterology and Urology |
| Common Name: | Enteral Feeding Sets |
| FDA Device Class: | Class II |
| FDA Identification: | The connector is attached to an enteral tube and is intended to |
| facilitate the administration of hydration, medication, and feed | |
| to a patient. |
Device Description:
The U Deliver Bolink ENFit Enteral Feeding Sets consist of two configurations:
- U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector (ref. BK-2085) .
- U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector (ref: BK-2405)
The U Deliver Bolink Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a safety screw connection meeting the requirements of clauses 4 "General requirement" and 5 "Dimensional requirements for enteral feed reservoir connectors" of ISO18250-3, "Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications', to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3, 'Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications'.
4
The U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector uses the free flow of gravity to dispense enteral feeding solutions from a distal reservoir (not supplied) which connects via a screw cap with a 40 mm thread, to a PVC tube with external clamp, to a distal ENFit connector, meeting the requirements of ISO 80369-3
Both sets are constructed from medical grade, biocompatible materials, and are supplied non-sterile for single patient use only.
Indications for Use/Intended Use
The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use to deliver liquid nutritional formulas or water to a patient's enteral access device (feeding tube).
Principle of operation, mechanism of action, and interaction with the patient
The U Deliver Bolink ENFit Enteral Feeding Sets operate by providing a means of interconnecting enteral feeding solution reservoirs to a patient's enteral access device (feeding tube), so that patient enteral feeding can take place when 'new generation' enteral end fittings in accordance with ISO 80369-3 ('ENFit' connections) are present on the feeding tube. A clamp is provided on the tubes to allow feeding to be turned on or off. Although contact of components of the Enteral Feeding Sets may accidentally occur with patient's intact skin during use, the Enteral Feeding Sets have a central fluid path through which feeding solutions flow into the patient during the feeding process.
The U Deliver Bolink ENFit Enteral Feeding Sets are intended for over-the-counter use.
U Deliver Bolink ENFit Enteral Feeding Sets are not intended for a specific patient population: they can be used for adults, children, infants and neonates.
Device Specification
The ENFit connectors on the Enteral Feeding Sets are designed in compliance with FDA-recognized standard ISO 80369-3 "Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications" and tested in accordance with FDA-recognized standard ISO 80369-20 "Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods".
The safety screw connector on the U Bolink ENFit Deliver Enteral Set with Safety Screw Connector is designed in accordance with ISO/DIS 18250-3.
The screw cap on the U Deliver Bolink Large Cap Gravity Feeding Set with ENFit Connector is designed with identical major dimensions to the predicate device, U Deliver Bolink ENFit Enteral Feeding Sets (K170555).
Manufacture
The U Deliver Bolink ENFit Enteral Feeding Sets are assembled from components manufactured by subcontractors/suppliers to Cedic, the contract manufacturer, in environmentally controlled areas (clean room Class 8 according to ISO 14644), together with tubing and adhesive sourced 'off-the-shelf' by Cedic from other suppliers.
Performance Data
Bench tests were carried out on samples of the U Deliver Bolink ENFit Enteral Feeding Sets and were submitted with the predicate device (K170555). No new device testing was necessary as no changes have been made to the device design, materials or packaging. The testing necessary for this submission was usability testing to demonstrate that both laypersons with no prior tube feeding experience and caregivers/tubefeeders were able to perform the essential tasks using only the proposed instructions for use. The results of usability testing demonstrate that the subject device(s) are appropriate for over-the-counter use.
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Image /page/5/Picture/1 description: The image shows the text "U Deliver Medical LLC" in blue font. The words "U Deliver" are on the top line and are a darker shade of blue. The words "Medical LLC" are on the second line and are a lighter shade of blue.
Predicate device
The Predicate Device selected for comparison with the U Deliver Bolink ENFit Enteral Feeding Sets:
| Predicate Device: | U Deliver Bolink ENFit Enteral Feeding Sets |
|---|---|
| Sponsor: | U Deliver Medical, LLC |
| 510(k) Number: | K170555 |
| Clearance Date: | 17 August 2017 |
| FDA Product Code: | PIF |
| FDA Classification Name: | Gastrointestinal Tubes and Accessories |
| FDA Regulation No: | 21-CFR-876.5980 |
The Subject Device and the Predicate Device have identical properties and features. The only difference that exists is:
- The indications for use and intended use have changed from Prescription-Use-Only to ● Over-the-Counter Use.
Conclusion:
Based on the information contained within this submission, it is concluded that the U Deliver Bolink ENFit Enteral Feeding Sets intended for over-the-counter use, are substantially equivalent and are as safe and effective as the identified predicate device already in interstate commerce within the USA.