SAFETY INFUSION SET

K080235 · Greiner Bio-One Vacuette North America · FMI · Apr 24, 2008 · General Hospital

Device Facts

• Record ID: K080235
• Device Name: SAFETY INFUSION SET
• Applicant: Greiner Bio-One Vacuette North America
• Product Code: FMI · General Hospital
• Decision Date: Apr 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

Device Story

VACUETTE® Safety Infusion Set consists of a winged needle bonded to flexible tubing with a luer connector; features integrated safety shield to prevent needlestick injuries. Device used by clinicians for blood collection or short-term IV fluid infusion. Safety mechanism activated by user via latch release, sliding winged cover over needle post-venipuncture; cover locks in place. Available in 21G and 23G needle gauges with 7.5-inch tubing. Sterile, single-use device.

Clinical Evidence

Bench testing only. Device tested for sterility, pyrogenicity, and systemic injection; found to be biocompatible.

Technological Characteristics

Winged needle with safety shield, flexible tubing, luer connector. Available in 21G and 23G gauges. Sterile, single-use. Biocompatible materials.

Indications for Use

Indicated for patients requiring blood collection or short-term intravenous fluid infusion. Single-use device for professional use.

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

• Nipro® SafeTouch Safety Scalp Vein Set (K011297)
• Greiner VACUETTE® Safety Blood Collection Set (K011786)

Submission Summary (Full Text)

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K080235

April 24, 2008

# 510(k) SUMMARY

#### CONTACT

Douglas L. Harris Greiner Bio-One North America, Inc. 4238 Capital Drive Monroe, NC 28110

APR 2 4 2008

# NAME OF DEVICE

Trade Name: Regulation Number: Classification Name:

VACUETTE® Safety Infusion Set 880.5440 IV Fluid Transfer Set

# PREDICATE DEVICE

Intended Use: Nipro® SafeTouch Safety Scalp Vein Set (K011297) Description: Greiner VACUETTE® Safety Blood Collection Set (K011786)

# DEVICE DESCRIPTION

INTENDED USE: The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

PRODUCT DESCRIPTION: The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is identical to that of the Greiner VACUETTE® Safety Blood Collection Set (K011786).

The VACUETTE® Safety Infusion Set will be available in 2 configurations of needle gauge (21G and 23G) and one tubing length (7.5 inches).

The devices are packaged as sterile and are labeled for single use only. There is no The devices were tested for sterility, ability to clean and reuse these devices. pyrogenicity and systemic injection testing and were found to be biocompatible.

# SUBSTANTIAL EQUIVALENCE

The VACUETTE® Safety Infusion Set is substantially equivalent to the Nipro® SafeTouch Safety Scalp Vein Set in intended use. Since the VACUETTE® Safety Infusion Set represents a new intended use for the VACUETTE® Safety Blood Collection Set, its design, safety feature, raw materials, biocompatibility, and performance are identical to the previously FDA-cleared Greiner VACUETTE® Safety Blood Collection Set. n addition, both devices are manufactured in the same plant - Nipro (Thailand) Corp. Ltd.

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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Greiner Bio-One North America, Incorporated C/O Ms. Judith Smith Director-IVD/Medical Devices Beaufort Advisors, L.L.C. 13801 Eck Road Hydes, Maryland 21082

APR 2 4 2008

Re: K080235

Trade/Device Name: VACUETTE® Safety Infusion Set Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 29, 2008 Received: January 30, 2008

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Swete Y. Michael Omd

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K080235

Device Name: VACUETTE® Safety Infusion Set

Indications For Use:

The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the shortterm infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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