VACUETTE MULTIPLE SAMPLE LUER ADAPTER

K981619 · Greiner Meditech, Inc. · FMI · Jul 15, 1998 · General Hospital

Device Facts

• Record ID: K981619
• Device Name: VACUETTE MULTIPLE SAMPLE LUER ADAPTER
• Applicant: Greiner Meditech, 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

Intended Use

For use in venous blood collection with attached butterfly needle or luer needle.

Device Story

Device is a sterile, single-use, disposable multiple sample luer adapter. Consists of a plastic male luer adapter on one end and a sharpened stainless steel needle on the other. Needle is epoxy-bonded to a plastic hub and protected by a rubber sheath. Used by clinicians in venous blood collection procedures; the adapter is threaded into a needle holder to facilitate attachment of a butterfly needle or luer needle. Device enables secure connection between the blood collection system and the patient's venous access point.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: plastic hub, stainless steel needle, epoxy adhesive, rubber sheath. Form factor: male luer adapter with integrated needle. Sterilization: sterile, single-use disposable. Connectivity: none. Energy source: none.

Indications for Use

Indicated for venous blood collection in patients requiring blood sampling via butterfly needle or luer needle.

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

• SURESHARP® Luer Adapter (K950159)

Submission Summary (Full Text)

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K98/619

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

Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for it's Greiner Vacuette® Multiple Sample Luer Adapter. The Greiner Vacuette® Multiple Sample Luer Adapter is a device of which one end is a plastic male luer adapter and the other end is a sharpened stainless steel needle. The needle end of the luer adapter is epoxy bonded to the plastic upper end (hub) and is covered by a rubber sheath. The luer adapter is threaded into a needle holder for the purposes of attaching a butterfly needle for use in venous blood collection. The luer adapter is a sterile, single-use disposable device.

claiming substantial equivalence to Greiner is Gainor Medical's SURESHARP® Luer Adapter (K950159). Both luer adapters have the same intended use and contain the same material. The equivalency of the luer adapters is certified by a statement that the luer adapters are the same and purchased from the same supplier in Japan.

Greiner's 510(k) has been submitted on Wednesday, April 30, 1998 by Douglas L. Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland, 21014 (410-836-8228).

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its head facing left and its wings represented by three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 1998

Mr. Douglas L. Harris Managing Director Greiner Meditech, Incorporated P.O. Box 943 Bel Air, Maryland 21014

K981619 Re : VACUETTE® Multiple Sample Luer Adapter Trade Name: Requlatory Class: II Product Code: FMI May 6, 1998 Dated: May 6, 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 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 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 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. Harris

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (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 requlation 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 Russer

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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known) ___K981619

Device Name: VACUETTE® Multiple Sample Luer Adapter

Indications for Use: For use in venous blood collection with attached butterfly needle or luer needle.

Pabricio Crescente
(Division Sign. OSD

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K 9810 510(k) Number _

Prescription Use X

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________