VACUETTE SAFETY BLOOD COLLECTION SET

K011786 · Greiner Vacuette North America, Inc. · FMI · Jul 12, 2001 · General Hospital

Device Facts

• Record ID: K011786
• Device Name: VACUETTE SAFETY BLOOD COLLECTION SET
• Applicant: Greiner Vacuette North America, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jul 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is used in routine venipuncture procedures which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

Device Story

Device is a sterile, single-use winged blood collection needle attached to flexible tubing with a female luer adapter. Used by healthcare professionals during routine venipuncture. Features a manual safety shield mechanism activated after needle withdrawal to cover the needle, preventing accidental needlestick injuries. Available in various needle gauges, needle lengths, and tubing lengths. Device is disposable; no cleaning or reuse intended.

Clinical Evidence

Bench testing only. Biocompatibility data provided, including sterility, pyrogenicity, and systemic injection testing.

Technological Characteristics

Winged needle with flexible tubing and female luer adapter. Safety shield mechanism with latch. Sterile, single-use. Materials support biocompatibility requirements. No electronic components or software.

Indications for Use

Indicated for use by trained healthcare professionals for routine venipuncture procedures to collect blood samples while providing a safety mechanism to protect against accidental needlestick injuries.

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

• Sherwood Medical Angel Wing™ Safety Blood Collection Set (K912563)

Submission Summary (Full Text)

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# JUL 1 2 2001

July 11, 2001

## 510(k) SUMMARY

CONTACT:

Douglas L. Harris Greiner Vacuette North America, Inc. P.O Box 1026 Monroe, NC 28111

NAME OF DEVICES:

Trade Name: Common Names/Descriptions: Classification Name:

Vacuette® Safety Blood Collection Set Intravascular Catheter Catheter, Intravascular, Short-Term

### PREDICATE DEVICE:

Sherwood Medical Angel Wing™ Safety Blood Collection Set (K912563)

# DEVICE DESCRIPTION:

VICE DESCRIPTION.
INTENDED USE: The VACUETTE® Safety Blood Collection Set is a single-use, steries, winged blood collection needle bonded to a flexible tubing with a female luer adapter.

PRODUCT DESCRIPTION: The VACUETTE® Safety Blood Collection Set is used in PRODUCT DESCRIPTION. The Winged needle is designed with a safety shield, which routine vehipuncture proobuation. It inmediately following venipuncture to aid in the can be activated to cover the noodle in houleve in the product is to be used by appropriately protection against accreental in accordance with these instructions.

The safety feature is easily operated through the release of a latch mechanism whereby the The Salely leature is easily operator and it is removed from the patient. Once the user slides a wingsu ocatety cover locks in place. This mechanism is substantially needie is covered, the oulony ject® Angel Wing Blood Collection Set.

The VACUETTE® Safety Blood Collection Set will be available in 80 configurations to include needle gauge (10 gauge sizes), needle length (2 lengths) and tubing length (4 lengths).

The devices are packaged as sterile and are labeled for single use only. There is no ability The devices are pookegoe as ses. The results of biocompatibility data support the to clean and rease theose and include sterility, pyrogenicity and systemic injection testing.

#### SUBSTANTIAL EQUIVALENCE:

The VACUETTE® Safety Blood Collection Set is substantially equivalent to the Monoject® The VACOLTTE® Gallery Blood Collection Set in interials, biocompatibility, and overall performance characteristics.

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Public Health Service

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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Greiner Vacuette North America, Incorporated C/O Ms. Judi Smith Sienna Partners, L.L.C P.O. Box 103 Baldwin, Maryland 21013

JUL 1 2 2001

K011786 Re : Vacuette® Safety Blood Collection Trade/Device Name: Set 880.5570 Requlation Number: Regulatory Class: II Product Code: FMI Dated: June 8, 2001 June 8, 2001 Received:

Dear Ms. Smith:

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 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.

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Page 2 - Ms. Smith

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ent affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enrough Siz on 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 marice 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 ritro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at [phone]. 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,

SRoy THN
Palina Cucentffer

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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510(k) Number (if known):

Device Name: VACUETTE® Safety Blood Collection Set

Indications For Use: The VACUETTE® Safety Blood Collection Set is a single-use, sterile, The VACUETTE Salety Blood Collection to a flexible tubing with a
winged blood collection needle bonded to a flexible for is winged blood Collection necale Bonees of the Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is used in Toutine vehipanskars which can be activated to cover the needle immediately following venipuncture to aid in the protection heedle Immediately longwing vompanetics injury. The product is to be used by against accidental neediestion injury. The ps only in accordance with these instructions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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OR

Over-The-Counter Use _

(Optional Format 1-2-9G)

Antina Crescenti

vision Sian-Off Division of Dental, Infectio and General Hospital I - 8- O'k) Number