(251 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a feeding tube, with no mention of AI or ML technologies.
Yes
Explanation: The device is used for "administration of nutrition, fluids, and medications" to patients who cannot orally manage nutritional intake, which constitutes a therapeutic intervention.
No
This device is designed for the administration of nutrition, fluids, and medications, not for the purpose of diagnosing a medical condition.
No
The device description clearly outlines physical components like tubing, connectors, and a stylet, indicating it is a hardware device, not software-only.
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 Vesco Medical Nasoenteric Feeding Tubes are used for the administration of nutrition, fluids, and medications directly into the gastrointestinal tract. They are a delivery system, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states the purpose is for administering substances, not for analyzing biological samples to diagnose or monitor a condition.
- Device Description: The description details the physical components of a tube designed for insertion and delivery, not for collecting or analyzing samples.
- Performance Studies: The performance studies focus on the physical and functional aspects of the tube (compliance with standards, shelf life), not on the accuracy or reliability of a diagnostic test.
In summary, the Vesco Medical Nasoenteric Feeding Tube is a medical device used for therapeutic purposes (delivering nutrition and medication), not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (
§ 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.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three profiles facing right, representing health and well-being. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2017
Vesco Medical, LLC Rachel Kunzweiler Product Development Engineer 692 N. High Street, Suite 205 Columbus. OH 43215
Re: K170162
Trade/Device Name: Vesco Medical Nasoenteric Feeding Tubes Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF Dated: August 31, 2017 Received: August 31, 2017
Dear Rachel Kunzweiler:
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. 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.
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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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K170162
Device Name Vesco Medical Nasoenteric Feeding Tubes
Indications for Use (Describe)
The Vesco Medical Nasoenteric Feeding Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use ( 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."
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TAB 5 510(k) Summary
Submitter I.
| Official Contact | Name: Chris O'Keefe
Title: VP Product Development and Innovation
Email: cokeefe@vescomedical.com |
|---------------------|--------------------------------------------------------------------------------------------------------|
| | Vesco Medical
Address: 692 N. High Street, Suite 205ef
Columbus, Ohio 43215 |
| | Phone: 614-914-5991
Fax: 614-902-3275 |
| Date of Preparation | September 24, 2017 |
II. Device
| Name of Device: | Vesco Medical Nasoenteric Feeding Tubes |
|---|---|
| Common/Usual Name: | Gastrointestinal Tubes |
| Device Classification: | Class II |
| Classification Name/ | |
| Product Code: | Gastrointestinal Tubes and Accessories (21 CFR 876.5980) / PIF |
Legally Marketed Predicate Devices III.
- Covidien Dobbhoff™ Dual Port Feeding Tubes were most recently cleared under notification K112511.
- Ross Product Division Abbott Laboratories Flexiflo Enteral Feeding Tubes were most recently cleared under notification K992494.
Device Description IV.
The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes) are non-sterile, single use devices consisting of flexible, radiopaque, polyurethane tubing adhered to a plastic male ENFit single-port connector with a tethered, twist-on cap. The plastic ENFit port allows for connection to enteral feeding sets and enteralspecific syringes while reducing the likelihood of misconnections to non-enteral devices. The cap allows for port coverage when enteral devices are not in use. The distal tip of the tubing is open and has four (4) evenly spaced, alternating eyelet openings to allow for first three inches of the distal tip
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are coated with a hydrophilic lubricant to aid in friction reduction during tube insertion. The tubing is printed with graduated markings in centimeters, the length from the distal tip in order to provide users with approximate insertion depth information. Certain models of the Vesco Medical Nasoenteric Feeding tube are provided with a stylet wire attached to a flow-through, ENFit hub. The stylet wire is intended to stiffen the tube during insertion and be removed after insertion is complete. The proposed
V. Intended Use
The Vesco Medical Nasoenteric Feeding Tubes (NE Tubes), with and without flow-through stylet, are for the administration of nutrition, fluids, and medications to the stomach or small bowel by the nasoenteric route in pediatric, adult or elderly patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Vesco Medical Nasoenteric Feeding Tubes have not been tested for use longer than short-term use (