VYGON 2 FR EPICUTANEO PUR-CATHETER by VYGON CORP.

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.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification document for a medical device, the Vygon 2 FR Epicutaneo PUR Catheter. This type of document is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria.

Therefore, this document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document primarily states:

Device Name: Vygon 2 FR Epicutaneo PUR Catheter
Intended Use: For neonates who require long-term therapy, drugs for pain management, or intravenous fluids.
Regulatory Class: Class II
Product Code: LJS
Date: May 26, 2000
Outcome: The FDA determined the device to be substantially equivalent to a legally marketed predicate device, allowing it to proceed to market.

To summarize, the request cannot be fulfilled because the provided text is a regulatory submission for market clearance based on substantial equivalence, not a study evaluating device performance against pre-defined acceptance criteria.

Summary

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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 .

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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

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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.

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Concurrence of CDRH, Office of Device Evaluation {OBE}

Prescription Use

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

Regulation Number and Section

§ 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.”