VYGON UMBILICAL CATHETHER INSERTION TRAY by VYGON CORP.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a Vygon Umbilical Catheter Insertion Tray, indicating substantial equivalence to a predicate device.

This type of document does not typically contain detailed information about:

Specific acceptance criteria (performance metrics and thresholds) that Vygon established for their device.
The design or results of performance studies conducted by Vygon to demonstrate that their device meets those criteria.
Details about test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics.

The FDA 510(k) clearance process primarily evaluates substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with predefined acceptance criteria in the same way a PMA (Premarket Approval) would. While manufacturers do conduct testing to support their 510(k) submission, the specifics of that testing and the predefined acceptance criteria are not usually detailed in the public-facing clearance letter.

Therefore, without additional information from Vygon's 510(k) submission or dedicated performance studies, I cannot answer your request.

Summary

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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

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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:

1. 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:

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)

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

Regulation Number and Section

§ 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).