FLOW-EZE BLUNT CANNULA (1999BC)

K972538 · Acacia, Inc. · FMI · Jul 15, 1998 · General Hospital

Device Facts

• Record ID: K972538
• Device Name: FLOW-EZE BLUNT CANNULA (1999BC)
• Applicant: Acacia, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jul 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Indications for Use

ACACIA'S Flow Eze Blunt Cannula for use with a sterile Acacia 3 riow mac bean medication into a Baxter's Interlink ) Injece meaze Blunt Cannula is single-use only. Split Septum.

Device Story

Flow-Eze Blunt Cannula is a single-use accessory device designed for the delivery of sterile medication into a Baxter Interlink Split Septum. The device functions as a fluid pathway interface between a medication source and the split septum access point. It is intended for use by healthcare professionals in clinical settings. By providing a blunt interface, it facilitates needle-free access to the medication delivery system, reducing the risk of accidental needle sticks while maintaining the integrity of the split septum.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Blunt cannula design for interface with split septum systems. Single-use, sterile, disposable device.

Indications for Use

Indicated for use with a sterile medication into a Baxter's Interlink Split Septum. Single-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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 1998

Mr. James Sullivan ·President ACACIA, Incorporated P.O. Box 1799 Ojai, California 93023

K972538 Re : Flow-Eze Blunt Cannula Trade Name: Requlatory Class: II Product Code: FMI Dated: May 18, 1998 Received: May 21, 1998

Dear Mr. Sullivan:

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 legally marketed predicate 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 reqistration, 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 Requlations, 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 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

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Page 2 - Mr. Sullivan

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"(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 [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Susan Pearson

Timothy A. Ulatowski 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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Page of of

114

510(k) Number (if known) : _ K972538 FLOW-EZE BLUNT CANNULA Device Name:

Indications For Use:

14

ACACIA'S Flow Eze Blunt Cannula for use with a sterile Acacia 3 riow mac bean medication into a Baxter's Interlink ) Injece meaze Blunt Cannula is single-use only. Split Septum.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cisceritz
(Division Sign-Off)

Division of Demal, Infection Control, and General Hospital Devices

510(k) Number K9722538

Prescription Use L (Per 21 CFR 801.109

OR

Over the Counter Use