(147 days)
Not Found
Not Found
No
The summary describes a physical medical device (a catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device description and intended use indicate it is for access, infusion, monitoring, and sampling, not for treating a disease or condition.
No
Explanation: The device is described as a "Double Lumen Umbilical Catheter" used for "Venous/arterial umbilical access in infants for infusion... and monitoring/blood sampling". Its primary function is therapeutic and monitoring, not diagnosing a medical condition. While it can be used for "blood sampling," this is a method for obtaining samples that might later be used for diagnosis, but the catheter itself is not performing the diagnostic analysis.
No
The device description explicitly states "Double Lumen Umbilical Catheter," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for direct access to the venous/arterial system in infants for infusion, monitoring, and blood sampling. This is a therapeutic and diagnostic procedure performed directly on the patient, not a test performed on a sample outside the body.
- Device Description: A double lumen umbilical catheter is a medical device used for accessing blood vessels, not for performing tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like reagents, test strips, analyzers, etc.).
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used for direct patient intervention and access.
N/A
Intended Use / Indications for Use
Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.
Product codes
FOS
Device Description
Double Lumen Umbilical Catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
umbilical
Indicated Patient Age Range
infants
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol consisting of three stylized human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1998
Anne Marie Cesario, R.A.C. Director of Requlatory Affairs Schiff & Company® 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re : K981630 Trade Name: Vygon Double Lumen Umbilical Catheter Requlatory Class: II Product Code: FOS Dated: August 11, 1998 Received: August 14-1998 ..
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 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 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 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 regulation (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 works of 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,
Susan Runne
Timothy A. Ulatowski Director 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):
12981630 Not assigned yet
Device Name:
Double Lumen Umbilical Catheter
Indications for Use:
Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.
(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)
Susa Russer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prepared by Schiff & Company, West Caldwell, NJ ۰۰ - ۱۰۰۰ - ۱۰۰ Page 10