EXEL AVF SINGLE NEEDLE by EXEL INTL.

I am sorry, but the provided text, which appears to be an FDA 510(k) clearance letter for the "Excel AVF Single Needle for Blood Pheresis" device, does not contain the information required to answer your request.

The document is a regulatory communication establishing substantial equivalence for the device. It focuses on:

Device Name: Excel AVF Single Needle for Blood Pheresis
Manufacturer: Exel International, Inc.
Regulatory Class: II (21 CFR 876.5540)
Indications for Use: "THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALYSIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINGLE USE DEVICE."
Date of Clearance: May 5, 1998

This type of document does not typically include detailed information about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related aspects (like MRMC studies, standalone algorithm performance, or training set details). These details would usually be found in the manufacturer's 510(k) submission itself, not in the FDA's clearance letter.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH &" are written vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 5 1008

Mr. Armand Hamid Exel International, Inc. P.O. Box 3194 Culver City, CA 90231-3194 Re: K963658

Excel AVF Single Needle for Blood Pheresis Dated: March 9, 1998 Received: March 23, 1998 Regulatory Class: II 21 CFR & 876.5540/Procode: 78 LBW

Dear Mr. Hamid:

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, 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 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. 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 vou might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4613. 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" (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.gov/cdrh/dsmaldsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

Director. Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page J

510(k) Number (if known): x963658

Device Name: EXEL SINGLE NEEDLE AVF

Indications For Use:

THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALISIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINCLE USE DEVICE.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter R. Salling
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K963658

Prescription Use U (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).