(273 days)
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminate the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system.
Nutrisafe® Enteral Feeding Tube
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Vygon Nutrisafe Enteral Feeding Tube". This type of document primarily confirms that a device is substantially equivalent to a predicate device already on the market and can be legally marketed. It does not typically contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the way described in your request (e.g., performance metrics like sensitivity, specificity, or AUC, and details about study design).
Therefore, I cannot extract the requested information from the provided text because it is not present. The letter focuses on regulatory clearance, not a performance study report.
To answer your questions, I would need a document that presents the results of a performance study for the device, including:
- A table of acceptance criteria and the reported device performance: This would typically list metrics like tensile strength, flow rate, biocompatibility testing results, etc. against predefined acceptance limits.
- Sample size used for the test set and the data provenance: Details on how many tubes were tested, where the materials came from, and if the testing was prospective (designed for the device) or retrospective (using existing data).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): This is highly relevant for AI/imaging devices but unlikely for a physical medical device like an enteral feeding tube. For physical devices, ground truth is usually established through validated measurement methods or established standards.
- Adjudication method: Again, more relevant to diagnostic interpretations than physical device performance.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a physical feeding tube. This is for AI-powered diagnostic tools comparing human performance with and without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical feeding tube.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a feeding tube, this would likely be physical measurements, chemical analyses, or biocompatibility tests.
- The sample size for the training set: Not applicable for a non-AI physical device.
- How the ground truth for the training set was established: Not applicable for a non-AI physical device.
In summary, the provided document is a regulatory clearance letter and does not contain the detailed performance study information you are asking for.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1999 FEB
Anne Marie Cesario, R.A. C. Director of Regulatory Affairs Schiff & Company® 1129 Bloomfield Avenue West Caldwell, NJ 07006
Re: K981629
Vygon Nutrisafe Enteral Feeding Tube Dated: November 10, 1998 Received: November 12, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 FPD
Dear Ms. Cesario:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | Not assigned yet |
|---|---|
| Device Name: | Nutrisafe® Enteral Feeding Tube |
| Indications for Use: | |
| For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminate the risk of accidental connection of an I.V. system to the enteral system, or the enteral system to an I.V. system. | |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Prescription Use(Per 21 CFR 801.109) | or Over-The-Counter Use(Optional Format 1-2-96) |
| (Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices | |
| 510(k) Number | K981629/5001 |
§ 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.