(96 days)
Not Found
Not Found
No
The summary describes a standard medical device (PICC catheter) and explicitly states that AI, DNN, or ML were "Not Found".
Yes
The device is described as a PICC catheter used for administering various therapies (hyperalimentation, antibiotics, chemotherapy, pain management, intravenous fluids), indicating its role in treatment.
No
Explanation: The device is a PICC catheter intended for mid-long term IV therapy, administering various substances. Its description does not mention any diagnostic capabilities.
No
The device description clearly identifies it as a physical catheter, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Vygon LIFEVAC Dual Lumen PICC Catheters are used for administering substances directly into the patient's bloodstream (I.V. therapy). This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) diagnostic test.
The device is a catheter used for delivering treatments, not for analyzing samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The Vygon LIFEVAC Dual Lumen PICC Catheters (4.0 Fr. and 5.0 Fr.) are intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids.
Product codes
LJS
Device Description
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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
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): 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
§ 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1999
Vygon Corproation C/O Ms. Anne Marie Cesario Director of Regulatory Affairs, R.A.C. Schiff & Company® 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re : K983544 Trade Name: Vygon Double Lumen PICC Catheter 4.0 Fr. & 5.0 Fr. Unclassified Regulatory Class: Product Code: LJS Dated: December 29, 1998 Received: December 30, 1998
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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ 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 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
1
Page 2 - Ms. Cesario
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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, 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 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
Tim othy A. Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Not assigned yet K9r3544
Device Name:
LIFEVAC Dual Lumen PICC Catheter 4.0 Fr. LIFEVAC Dual Lumen PICC Catheter 5.0 Fr.
Indications for Use:
The Vygon LIFEVAC Dual Lumen PICC Catheters (4.0 Fr. and 5.0 Fr.) are intended for use in patients who require mid-long term I.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain 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 (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Patricia Cincenti
(Division Sign-G
Division of Deat. Infentice Control,
and General Hospital Depes
K98.354
510(k) Number