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 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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Greiner VACUETTE® QUICKSHIELD with SNAPPY Tube Holder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
No failures during simulated blood drawing with thumb activation option.	No failures occurred (0 failures out of 500 tests).

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: 500 devices were tested.
Data Provenance: The text does not specify the country of origin. It indicates it was a "simulated blood drawing" test, which implies a prospective, internal validation study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The text states "multiple users employing the thumb activation option." It does not specify the exact number of users or their qualifications (e.g., healthcare professionals, engineers, etc.). The "ground truth" here is the functionality of the device during simulated use.

4. Adjudication Method for the Test Set:

The text does not explicitly detail an adjudication method. It simply states "No failures occurred," implying a direct observation of device function rather than a need for multiple expert opinions to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This device is a medical instrument (blood collection tube holder), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI or human readers is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth was based on direct observation of device functionality (absence of failure) during simulated venipuncture procedures.

8. The Sample Size for the Training Set:

The document describes a modification to an existing device (predicate device K033478) and a test of the modified device. There is no mention of a separate "training set" in the context of machine learning or algorithm development, as this device's performance is not based on such models. The 500 devices tested were for verification of the modification.

9. How the Ground Truth for the Training Set Was Established:

As this is not an AI-based device, the concept of a "training set" and its associated ground truth establishment is not applicable. The study described is a performance verification test.

Summary

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K102774

ﺮ

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:

ﻬﻮﺗ

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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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).