VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER

K113505 · Greiner Bio-One North America, Inc. · FMI · Feb 17, 2012 · General Hospital

Device Facts

• Record ID: K113505
• Device Name: VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
• Applicant: Greiner Bio-One North America, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Feb 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is to be used together only with VACUETTE® Blood Collection Needles 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

Non-sterile, single-use plastic tube holder; designed for use with VACUETTE blood collection needles and tubes; features integrated safety shield to cover needle post-venipuncture; reduces risk of accidental needlestick injury; operated by trained healthcare professionals in clinical settings; secures tubes during collection to ensure vacuum draw; device modification adds compatibility with VACUETTE Multi-Sample Needles.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Polypropylene; non-sterile; single-use; manual safety shield activation (stable surface or thumb); compatible with various gauge (18G-22G) and length (25mm-38mm) VACUETTE needles.

Indications for Use

Indicated for use by trained healthcare professionals for routine venipuncture procedures to secure blood collection needles and tubes.

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 with SNAPPY Tube Holder (K102774)

Reference Devices

• VACUETTE® VISIO PLUS Blood Collection Needle with View Window (K061483)
• VACUETTE® Multi-Sample Needles (K973620)

Submission Summary (Full Text)

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FEB 1 7 2012

## K113505

### 510(k) SUMMARY

February 7, 2012

CONTACT:

Manfred Abel Greiner Bio-One North America, Inc. P.O Box 1026 Monroe, NC 28111 [phone] [e-mail]

NAME OF DEVICES:

| Trade Name: | VACUETTE® QUICKSHIELD with SNAPPY Tube Holder |
|----------------------|-----------------------------------------------|
| Common Name: | Evacuated Blood Collection Tube Holder |
| Classification Name: | Needle, Hypodermic, Single Lumen |
| CFR Reference No.: | 21 CFR 880.5570 |
| Product Code: | FMI |

PREDICATE DEVICE: Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder - K102774

## DEVICE DESCRIPTION:

Intended Use: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is to be used together only with VACUETTE® Blood Collection Needles 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.

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.

The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder can be used with any size VACUETTE® Multi-Sample Needle:

- Needle gauge = 18G: Front needle length = 38 mm [1 inch] .
- Needle gauge = 18G; Front needle length = 38 mm [1 ½ inch] .
- Needle gauge = 20G; Front needle length = 38 mm [1 inch] .

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- Needle gauge = 20G; Front needle length = 38 mm [1 ½ inch] .
- Needle gauge = 21G; Front needle length = 25 mm [1 inch] .
- . Needle gauge = 21G; Front needle length = 38 mm [1 ½ inch]
- Needle gauge = 22G; Front needle length = 25 mm [1 inch] .
- Needle qauqe = 22G; Front needle length = 38 mm [1 ½ inch] .

The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder can be used with the following size VACUETTE® VISIO Blood Collection Needles:

- Needle gauge = 21G; Front needle length = 25 mm [1 inch] .
- Needle gauge = 22G; Front needle length = 25 mm [1 inch] .
- Needle gauge = 21G; Front needle length = 38 mm [1 ½ inch] .
- Needle gauge = 22G; Front needle length = 38 mm [1 ½ inch] .

### SUBSTANTIAL EQUIVALENCE:

The Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is substantially equivalent to the predicate device in fundamental scientific technology and materials.

This Traditional 510(k) is submitted for a device modification to the Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder (K102774, FDA cleared 10/15/2010) to include VACUETTE® Multi-Sample Needles as an additional recommended needle type.

| | VACUETTE® QUICKSHIELD with<br>SNAPPY Tube Holder | VACUETTE® QUICKSHIELD with<br>SNAPPY Tube Holder (K102774) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (subject of this Traditional 510(k)) | (predicate device) |
| Intended Use | The VACUETTE® QUICKSHIELD<br>with SNAPPY Tube Holder is to be<br>used together only with VACUETTE®<br>Blood Collection Needles and<br>VACUETTE® Blood Collection Tubes<br>as a system in routine venipuncture<br>procedures. These devices are to be<br>used by properly trained healthcare<br>professionals only in accordance with<br>these instructions. | The VACUETTE® QUICKSHIELD<br>with SNAPPY Tube Holder is to be<br>used together only with VACUETTE®<br>VISIO PLUS Blood Collection Needle<br>with View Window and VACUETTE®<br>Blood Collection Tubes as a system<br>in routine venipuncture procedures.<br>These devices are to be used by<br>properly trained healthcare<br>professionals only in accordance with<br>these instructions. |
| Holder | SNAPPY Tube Holder<br>(21CFR880.5570, Product Code FMI) | Same |
| Holder<br>Material | Polypropylene, with tabs | Same |
| Sharp Safety<br>Feature | Polypropylene holder with<br>polypropylene needle locking shield | Same |
| Safety Feature<br>Activation | Stable surface or thumb | Same |

#### Table 1: Substantial Equivalence Comparison Table

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| | VACUETTE® QUICKSHIELD with<br>SNAPPY Tube Holder<br>(subject of this Traditional 510(k)) | VACUETTE® QUICKSHIELD with<br>SNAPPY Tube Holder (K102774)<br>(predicate device) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Sterilization | Non-sterile | Same |
| Needle<br>Recommendation | VACUETTE® VISIO PLUS Blood<br>Collection Needle with View Window<br>(K061483, FDA cleared 8/14/06)<br><br>VACUETTE® Multi-Sample Needles<br>(K973620, FDA cleared 12/17/97) | VACUETTE® VISIO PLUS Blood<br>Collection Needle with View Window<br>(K061483, FDA cleared 8/14/06) |

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three birds in flight, arranged in a diagonal line from the upper right to the lower left.

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

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

FEB 1 7 2012

Re: K113505

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: January 18, 2012 Received: January 19, 2012

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 relerenced above and have atternalosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 the Federal Food, Drag, and Ooshway, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirements for annual registerity of 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 (1 will the 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 (20 Percents 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.

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 Compilations if increation" (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 I ou may obtain other ground and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G. Sir Anthony S. Watson

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

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 to be used together only with VACUETTE® Blood Collection Needles 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 × (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 Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation

510(k) K113505

Page 1 of 1

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

K113505

510(k) Number: _______________________________________________________________________________________________________________________________________________________________