VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER

K102774 · Greiner Bio-One North America, Inc. · FMI · Oct 15, 2010 · General Hospital

Device Facts

• Record ID: K102774
• Device Name: VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
• Applicant: Greiner Bio-One North America, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Oct 15, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.

Device Story

The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is a non-sterile, single-use plastic device used during routine venipuncture. It functions as a housing for VACUETTE® blood collection tubes and is used in conjunction with the VACUETTE® VISIO PLUS Blood Collection Needle. The device features an integrated safety shield that can be activated by the user (including a thumb-activation option) immediately following venipuncture to cover the needle, thereby reducing the risk of accidental needlestick injuries. The device is operated by trained healthcare professionals in clinical settings. By securing the collection tube and providing a protective shield, the device facilitates safe blood collection and protects the clinician from sharps-related injuries.

Clinical Evidence

Bench testing only. A total of 500 devices were tested for failure using the thumb activation option in simulated blood drawing scenarios; no failures occurred.

Technological Characteristics

Non-sterile, single-use plastic tube holder. Features an integrated safety shield with manual or thumb-activation capability. Designed for use with VACUETTE® VISIO PLUS needles and VACUETTE® blood collection tubes.

Indications for Use

Indicated for use by trained healthcare professionals for routine venipuncture procedures to secure blood collection tubes and provide a safety shield to cover the needle post-venipuncture to prevent accidental needlestick injury.

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

• Greiner VACUETTE® QUICKSHIELD Safety Tube Holder (K033478)

Submission Summary (Full Text)

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K102774

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OCT 1 5 2010

September 20, 2010

Special 510(k)

Device Modification of Greiner VACUETTE® QUICKSHIELD Safety Tube Holder (K033478)

#### 3 510(k) SUMMARY

CONTACT:

Manfred Abel Greiner Bio-One North America, Inc. P.O Box 1026 Monroe, NC 28111

NAME OF DEVICES:

Trade Name:

Common Names/Descriptions:

Classification Name:

VACUETTE® QUICKSHIELD with SNAPPY Tube Holder

Evacuated Blood Collection Tube Holder Needle, Hypodermic, Single Lumen

PREDICATE DEVICE:

Greiner VACUETTE® QUICKSHIELD Safety Tube Holder - K033478

### DEVICE DESCRIPTION:

Intended Use: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is to be used together only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window and VACUETTE® Blood Collection Tubes as a svstem in routine venipuncture procedures. This device 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 iniurv.

Product Description: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is a non-sterile single-use plastic tube holder. It 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. VACUETTE® QUICKSHIELD with SNAPPY Tube Holder helps secure VACUETTE® tubes in place during collection. Note: Always follow tube manufacturer's specimen collection instructions for holding tube in place to ensure a complete vacuum draw. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.

### SUBSTANTIAL EQUIVALENCE:

The Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is substantially equivalent to the Greiner VACUETTE® QUICKSHIELD Safety Tube Holder (K033478) in intended use and materials.

This Special 510(k) is submitted for a device modification to the Greiner VACUETTE® QUICKSHIELD Safety Tube Holder to:

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#### Special 510(k)

Device Modification of Greiner VACUETTE® QUICKSHIELD Safety Tube Holder (K033478)

- substitute the SNAPPY Tube Holder (Class I) in place of the standard . tube holder,
- change the recommended needle from the VACUETTE® Multi-. Sample Needles to VACUETTE® VISIO PLUS Blood Collection Needle with View Window; and
- to add the option of thumb activation of the QUICKSHIELD safety . shield.

A total of 500 devices were tested for failure with multiple users employing the thumb activation option in simulated blood drawing. No failures occurred.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Greiner Bio-One North America, Incoroporated C/O Ms. Judi Smith P.O. Box 103 Baldwin, Maryland 21013

OCT 15 2010

Re: K102774

Trade/Device Name: VACUETTE® QUICKSHIELD with SNAPPY Tube Holder Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 20, 2010 Received: September 24, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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

K102774

OCT 1 5 2010

510(k) Number (if known):

Device Name: Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder

Indication For Use:

Intended Use: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of Device Evaluation

510(k)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ KLO2774 Page 1 of 1