(90 days)
Not Found
Not Found
No
The summary describes a mechanical device for aspiration and collection, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as a collection and aspirate measuring device for aspiration of stomach contents, which serves a diagnostic or monitoring function rather than directly treating a disease or condition.
No
The device is described as a "collection and aspirate measuring device" for the "aspiration of stomach contents," which are functions related to treatment or monitoring rather than diagnosis.
No
The device description and intended use clearly describe a physical collection and aspirate measuring device, not a software-only product.
Based on the provided information, the Vygon Neo-Sump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed for the aspiration of stomach contents and measuring them. This is a procedure performed on the patient (in vivo) to collect a sample and quantify it.
- IVD Definition: In vitro diagnostics are tests performed outside the body (in vitro) on biological samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions.
- Lack of Diagnostic Testing: The description doesn't mention any analysis or testing of the collected stomach contents to diagnose a condition. It's purely for collection and measurement.
Therefore, the Vygon Neo-Sump is a medical device used for a clinical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Vygon Neo-Sump is a collection and aspirate measuring device designed for the aspiration of the stomach contents in the newborn using wall line suction.
Product codes
78 KNT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
Indicated Patient Age Range
newborn
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/2 description: The image shows a logo for the Department of Health. The logo features a stylized human figure with three heads, stacked on top of each other. The figure is black and white. The text "DEPARTMENT OF HEALTH" is written in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1998
Mr. John A. Leaity Vice President, Vygon Corp. c/o Ms. Ann Marie Cesario, R.A.C. Director, Regulatory Affairs Schiff & Company 1129 Bloomfield Avenue West Caldwell, NJ 07006
Re: K974806 Vygon Neo-Sump (Collection and aspirate measuring device) Dated: December 19, 1997 Received: December 23, 1997 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT
Dear Mr. Leaity:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 (OS) 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification submission does not affect any obligation you might have under sections 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.gow/cdr/dsmaldsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known):
Device Name:
Vygon NEO-SUMP
Indications for Use:
The Vygon Neo-Sump is a collection and aspirate measuring device designed for the aspiration of the stomach contents in the newborn using wall line suction.
(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)
Roler R. Ratting/
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 74806 ડી 510(k) Number.