VACUETTE MULTI-SAMPLE NEEDLE

K973620 · Greiner Meditech, Inc. · FMI · Dec 17, 1997 · General Hospital

Device Facts

• Record ID: K973620
• Device Name: VACUETTE MULTI-SAMPLE NEEDLE
• Applicant: Greiner Meditech, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

For use in venous blood collection

Device Story

Vacuette Multi-sample needle is a tubular stainless steel device sharpened at both ends; one end withdraws blood, other end threads into needle holder to guide needle into evacuated blood collection tube. Device used by clinicians for venous blood collection. Hub made of polypropylene; sleeve covering short end made of rubber; needle shield made of polypropylene.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Tubular stainless steel needle; polypropylene hub and shield; rubber sleeve. Manual operation. Non-electronic, non-software device.

Indications for Use

Indicated for venous blood collection in patients requiring blood sampling.

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 needles (K950159)

Submission Summary (Full Text)

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K973620

DEC 17 1997

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

Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for it's Greiner Vacuette® Multi- sample needle. The Vacuette® Multi- sample needle is a tubular stainless steel device sharpened at both ends, one end to withdraw blood, and the other end to be threaded into a needle holder which is used to guide the needle into an evacuated blood collection tube..

Greiner is claiming substantial equivalence to Gainor Medical's Suresharp® needles (K950159). Both multi-sample needles have the same intended use and contain the same material. The material of the Greiner needle is stainless steel and is the same material used for the Gainor needle. The material of the hub for both needles is made from polypropylene. The sleeve covering the short end of the needle is made from rubber. The needle shield is made from polypropylene. The equivalency of the needles is certified by a statement that the needles are the same and purchased from the same supplier in Japan.

Greiner's 510(k) has been submitted on Monday, September 22, 1997, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Douq Harris Manaqinq Director Greiner Meditech, Incorporated 260 Gateway Drive, Suite 17A Bel Air, Maryland 21014

DEC 17 1997

Re : K973620 Vacuette Multi-Sample Needle Trade Name: II Requlatory Class: Product Code: FMI Dated: September 18, 1997 September 23, 1997 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, Druq, 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, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 regulation entitled, "Misbranding by reference to ons regaration theation" (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

Timo 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) _ K 9 7 34 20

Device Name: VACUETTE® Multi-sample Needle

Indications for Use: For use in venous blood collection

Labaux Cucinol

(Division Sign-Off) Division of Dental, Info and General Hospi 510(k) Number

Prescription Use _X_

18:00

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________