(301 days)
The Veritract Enteral Feeding Tube System is intended for use in those patients who require intermittent or continuous tube feeding via the nasogastric route. The vision and steering provided by the Veritract System is intended as an adjunct to current practices to aid qualified clinicians with experience in placing naso-enteric feeding tubes into the stomach or small bowel of patients requiring enteral feeding. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required prior to commencing administration. The Veritract Enteral Feeding Tube has not been tested for use longer than shortterm use (<30 days).
Not Found
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "Veritract Enteral Feeding Tube System," which indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The letter discusses:
- The device name, regulation number, and product code.
- The FDA's determination of substantial equivalence.
- General controls provisions and other regulations applicable to the device.
- Contact information for various FDA offices.
- The Indications for Use Statement (Section 4), which describes how the device is intended to be used, but not performance metrics or acceptance criteria from a study.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth establishment, MRMC studies, or standalone performance, as these details are not present in the provided document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2014
Veritract, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K133334
Trade/Device Name: Veritract Enteral Feeding Tube System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: August 20, 2014 Received: August 21, 2014
Dear Mark Job,
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Herbert P. Lerner -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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SECTION 4. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K133334
Device Name: Veritract Enteral Feeding Tube System
Indications for Use:
The Veritract Enteral Feeding Tube System is intended for use in those patients who require intermittent or continuous tube feeding via the nasogastric route. The vision and steering provided by the Veritract System is intended as an adjunct to current practices to aid qualified clinicians with experience in placing naso-enteric feeding tubes into the stomach or small bowel of patients requiring enteral feeding. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required prior to commencing administration. The Veritract Enteral Feeding Tube has not been tested for use longer than shortterm use (<30 days).
Prescription Use ____x (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use _ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.