(296 days)
Not Found
Not Found
No
The summary describes a standard PICC catheter and does not mention any AI or ML components or functionalities.
Yes
The device is described as "intended for use in patients who require mid-long term I.V. therapy" to "administer hyperalimentation, chemotherapy, pain management or intravenous fluids," which are all forms of therapy.
No
The device is a catheter for administering therapies and fluids, not for diagnosing medical conditions.
No
The device description clearly identifies it as a physical catheter, which is a hardware component.
Based on the provided information, the Vygon LIFECATH-PICC (PUR) Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for administering substances directly into a patient's bloodstream (I.V. therapy). This is an in vivo (within a living organism) application.
- Device Description: The description details a catheter, which is a medical device used for accessing the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are devices used to perform tests on samples taken from the body, not devices inserted into the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Vygon LIFECATH-PICC (PUR) Catheter is intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, chemotherapy, management or intravenous fluids.
Product codes
LJS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a symbol that resembles three stylized human figures or abstract shapes, stacked on top of each other.
AUG 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re : K993442 Vygon Lifecath-PICC (PUR) Catheters & Single Trade Name: and Double Lumen, 3 FR, 4 FR, 4.5 FR, and 5 FR) Regulatory Class: II Product Code: LJS May 23, 2000 Dated: May 24, 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 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 reqistration, 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. 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 requlation (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 described in your sia ... mur alence of your device to a legally Finding or bubbeanstal organisation a classification for your marketta predicate are ts 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 regulacion (stic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che promotion and (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance
obcarned 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
othy A. Ulatowski Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) PREMARKET NOTIFICATION VYGON, EAST RUTHERFORD, NJ LIFECATH-PICC (PUR) CATHETER
INDICATIONS FOR USE STATEMENT
12993442
510(k) Number (if known): Device Name:
Not assigned yet Vygon LIFECATH-PICC (PUR) Catheter.
Indications for Use:
The Vygon LIFECATH-PICC (PUR) Catheter is intended for use in patients who The Vygon Life Corrern I.V. therapy. It may be used to administer hyperalimentation, require mid-long term f.V. thorapy - remay a management or intravenous fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFER 801.109)
(Optional Format 1-2-96)
Patricio Escobete
(Division Sign-Off) Division of Dental, Infection Control, - General Hospital Devices 499 (k) Number ___________________________________________________________________________________________________________________________________________________________________
SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ
10/8/99 kl D:\Vygon\1294,1295\510k.doc