EXEL AVF SINGLE NEEDLE

K963658 · Exel Intl. · FMI · May 5, 1998 · General Hospital

Device Facts

• Record ID: K963658
• Device Name: EXEL AVF SINGLE NEEDLE
• Applicant: Exel Intl.
• Product Code: FMI · General Hospital
• Decision Date: May 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Exel Single Needle AVF is a sterile, single-use needle assembly designed for blood pheresis procedures. It functions as a vascular access component when connected to a hemo-dialysis machine. Operated by trained clinical staff in a dialysis or clinical setting, the device facilitates the extracorporeal circulation of blood. It provides a physical conduit for blood withdrawal and return, enabling the therapeutic separation of blood components. The device is intended to assist in the management of patients requiring dialysis-related blood processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, single-use needle assembly for vascular access. Designed for integration with hemo-dialysis equipment. No electronic, software, or complex sensing components.

Indications for Use

Indicated for patients requiring blood pheresis procedures using a hemo-dialysis machine. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 5 1998

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

Re: K963658
Excel AVF Single Needle for Blood Phoresis
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 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. 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 through 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,


Enclosure

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Page 1 of 1

510(k) Number (if known): K963658

Device Name: EXEL SINGLE NEEDLE AVF

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.


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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dale R Nalbry
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K963658

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)