(325 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI/ML. It describes a simple catheter for fluid delivery.
Yes
The device delivers therapy, drugs, or fluids to neonates, which are therapeutic interventions.
No
Explanation: The device is a catheter intended for delivering therapy, drugs, or fluids to neonates, which is a therapeutic function, not diagnostic.
No
The summary describes a physical catheter, which is a hardware medical device, not a software-only device.
Based on the provided information, the Vygon 2 FR Epicutaneo PUR Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for administering therapy, drugs, or fluids intravenously to neonates. This is a direct medical intervention on a patient, not a test performed on a sample taken from a patient.
- Device Description: While the description is "Not Found," the name and intended use strongly suggest a catheter, which is a medical device used for accessing the bloodstream.
- 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 assays
Therefore, the Vygon 2 FR Epicutaneo PUR Catheter is a medical device used for patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vygon 2 FR Epicutaneo PUR Catheter is intended for use in neonates who require form from therapy, drugs for pain management or intravenous fluids.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
Not Found
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
neonates
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2000 AUG
Mr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
K993052 Re: Vygon 2 FR Epicutaneo PUR-Catheter Trade Name: Requlatory Class: II Product Code: LJS May 26, 2000 Dated: "May 30, 2000 Received:
Dear Mr. Schiff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the actrantially equivalent (for the indications for use stated in the enclosure) to legally marketed pređicate use stated in the chorobate, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che enacement awe been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the rouseds 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 II (Special Controls) or 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. ਜ 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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 .
1
Page 2 - Mr. Schiff
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, płease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
510(k) PREMARKET NOTIFIC VYGON, EAST RUTHERFORD, NJ 2 FR EPICUTANEO PUR CATHETER
INDICATIONS FOR USE STATEMENT
K99 305-2
510(k) Number (if known): Device Name:
Not assigned yet Vygon 2 FR Epicutaneo PUR Catheter.
Indications for Use:
The Vygon 2 FR Epicutaneo PUR Catheter is intended for use in neonates who The Vygon 2 1 t t = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = require form from therapy, drugs for pain management or intravenous fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation {OBE}
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFER 801.109)
(Optional Format 1-2-96)
Patricia Cosciente
(Division Sign-Off Division of Dental. Info and General Hos 510(k) Number