VACUETTE HOLDEX

K980768 · Greiner Meditech, Inc. · FMI · Apr 9, 1998 · General Hospital

Device Facts

• Record ID: K980768
• Device Name: VACUETTE HOLDEX
• Applicant: Greiner Meditech, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Apr 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

To be used in routine venipuncture procedures using butterfly needles and/or hypodermic luer needles.

Device Story

VACUETTE® Holdex® is a single-use disposable plastic holder for routine venipuncture; facilitates connection between butterfly or luer needles and blood collection tubes. Sterile version manufactured from polystyrene; non-sterile version manufactured from polycarbonate. Used in clinical settings by healthcare professionals. Device functions as a mechanical interface to secure needles during blood draw procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Polystyrene (sterile version) or polycarbonate (non-sterile version). Form factor: Single-use disposable holder. Sterilization: Electronic beam (sterile version); autoclavable (non-sterile version).

Indications for Use

Indicated for use in routine venipuncture procedures requiring butterfly or hypodermic luer needles.

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.

Predicate Devices

• Becton Dickinson VACUTAINER® Brand Direct Draw Adapter - Multiple sample luer adapter with pre-attached needle holder (K921520)

Submission Summary (Full Text)

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## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

APR - 9 1998

9807

Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for it's Greiner VACUETTE® Holder. The VACUETTE® Holdex® Holder is a single-use disposable plastic device to be used in routine venipuncture procedures Sterile and non-sterile versions are available. The using butterfly needles or luer needles. sterile version of VACUETTE® Holdex® is manufactured from polystyrene plastic and is sterilized by electronic beam. The non-sterile version is autoclavable and is manufactured from polycarbonate plastic.

Greiner is claiming substantial equivalence to Becton Dickinson's preamendment VACUTAINER® Brand holder in combination with Becton Dickinson VACUTAINER® Brand luer adapter (K921520). The Becton Dickinson product is sold as a sterile combination set as VACUTAINER® Brand Direct Draw Adapter - Multiple sample luer adapter with pre-attached needle holder (catalog no. 364894). Both devices have the same intended use and both are manufactured from plastic.

Greiner's 510(k) has been submitted on February 26th, 1998 by Doug Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland 21014 (T: 410-836-8228).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 1998

Mr. Douglas L. Harris Managing Director Greiner Meditech, Incorporated 260 Gateway Drive, Suite 17A Bel Air, Maryland 21014

K980768 Re : Vacuette Holdex Trade Name: Regulatory Class: II Product Code: FMI Dated: February 27, 1998 February 27, 1998 Received:

Dear Mr. Harris:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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

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Page 2 - Mr. Harris

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 aciding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predication wour 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 che Dffice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaration choused, (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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

.

510(k) Number (if known)

Device Name: VACUETTE® Holdex®

Indications for Use: To be used in routine venipuncture procedures using butterfly needles and/or hypodermic luer needles.

Prescription ___ X

Over-the-Counter __

Patacia Cucenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

11 980 510(k) Number_

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