(390 days)
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No
The summary describes a physical medical device (catheter insertion tray) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.
No
The device is described as an umbilical catheter insertion tray for venous and arterial access in infants. While catheters can be used therapeutically, the device itself is for "access" and "insertion," implying it's a tool for a procedure rather than actively delivering therapy or measuring a therapeutic result. Therefore, it's a procedural device rather than a therapeutic device in its own right.
No
This device is an umbilical catheter insertion tray, designed for venous and arterial access in infants. It is a tool used for medical procedures, not for diagnosing conditions.
No
The device description explicitly states "Vygon Umbilical Catheter Insertion Tray (2.5 Fr. & 3.5 Fr.)", indicating a physical medical device (catheter and tray) and not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Venous arterial umbilical access in infants." This describes a procedure performed directly on a patient for therapeutic or diagnostic purposes, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The device is an "Umbilical Catheter Insertion Tray." Catheters are used for accessing blood vessels within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVDs are devices used to examine specimens derived from the human body to provide information for clinical purposes. This device is used for direct access to the body's vascular system.
N/A
Intended Use / Indications for Use
Venous arterial umbilical access in infants.
Product codes
FOZ
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
umbilical
Indicated Patient Age Range
infants
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 1997
Ms. Anne Marie Cesario Director, Regulatory Affairs Vygon Corporation One Madison Street 07073 East Rutherford, New Jersey
Re : K963196 Vygon Umbilical Catheter Insertion Tray Trade Name: (2.5 Fr., 3.5 Fr.) Requlatory Class: II Product Code: FOZ Dated: June 12, 1997 Received: June 17, 1977
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 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, Druq, and Cosmetic Act (the Act). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that the of Act. medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510 (k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your tray. 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 additional controls. Existing major requlations 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
1
Paqe 2 - Ms. Cesario
Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Reqister. 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.
FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:
-
- The labeling, packaging and method of sterilization of the suture cannot be chanqed without prior notification, review and clearance by FDA.
- The supplier of the sutures used in your device cannot be 2. changed without prior notification, review and clearance by FDA.
In addition, we have determined that your device kit contains betadine swabsticks which are subject to requlation as a drugs .
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this druq, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Druq Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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Page 3 - Ms. Cesario
This letter will allow you to beqin 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 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 requlation 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo y A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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K963196-Vygon Umbilical Catheter Insertion Tray (2.5 Fr., 3.5 Fr.) Response to FDA Questions Dated November 19, 1996
510(k) Number (if known): K963196
Device Name:
e
Vygon Umbilical Catheter Insertion Tray (2.5 Fr. & 3.5 Fr.)
Indications for Use:
Venous arterial umbilical access in infants.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Palinella Cacceniti
(Division Sign-Off
Division of Dentat, Infection Control,
and General Hospital Dantess
510(k) NumberK963196
Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Over-The-Counter Use