The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and VACUETTE® Blood Collection Tubes as a system 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 injury.

Device Description

AI/ML Overview

The provided text describes a 510(k) summary for the VACUETTE® QUICKSHIELD Safety Tube Holder. It focuses on demonstrating substantial equivalence to a predicate device and includes a very limited study.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Assumed)	Reported Device Performance
No failures of the safety shield during simulated venipuncture	0 failures in 500 uses
Substantial equivalence to predicate device in intended use, materials, and overall performance characteristics	Reported as substantially equivalent

Note: The document implies "no failures" as the acceptance criterion for the safety shield's functionality. The "substantial equivalence" is a regulatory finding rather than a quantifiable performance metric in the same way.

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

Sample Size: 500 VACUETTE® QUICKSHIELD Safety Tube Holders.
Data Provenance: The document states "In a study of 50 users, 500 VACUETTE® QUICKSHIELD Safety Tube Holders were used in simulated venipuncture." This indicates a prospective study involving human users. The country of origin is not explicitly stated.

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

Not applicable. The study described is a performance test of a mechanical safety feature, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for the safety shield was its physical activation and function.

4. Adjudication Method for the Test Set

Not applicable. There was no need for adjudication as the task involved observing a simple pass/fail outcome of the safety shield activation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is typically for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The VACUETTE® QUICKSHIELD Safety Tube Holder is a medical device for blood collection with a safety mechanism.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence. The described study evaluates the device's inherent mechanical function (safety shield activation) without human interpretation affecting its performance outcome. While "users" were involved, their role was to operate the device, not to make a diagnostic judgment. The device's performance was measured directly.

7. The Type of Ground Truth Used

The ground truth was essentially the physical functionality of the safety shield – whether it successfully activated and covered the needle. This is an objective observation of the device's mechanical design.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical safety device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this device does not involve a training set.

Summary

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ERE #2 Ko.

DEC 2 9 2003

510(K) SUMMARY

December 15, 2003

CONTACT:

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

NAME OF DEVICE:

Trade Name:

Common Names/Descriptions:

Classification Name:

VACUETTE® QUICKSHIELD Safety Tube Holder Evacuated Blood Collection Tube Holder Needle, Hypodermic, Single Lumen

PREDICATE DEVICE:

Becton Dickinson VACUTAINER® Brand ECLIPSE™ Blood Collection Needle (K982541)

DEVICE DESCRIPTION:

SUBSTANTIAL EQUIVALENCE:

The VACUETTE® QUICKSHIELD Safety Tube Holder is substantially equivalent to the Becton Dickinson VACUTAINER® Brand ECLIPSE™ Blood Collection Needle in intended use, materials, and overall performance characteristics.

In a study of 50 users, 500 VACUETTE® QUICKSHIELD Safety Tube Holders were used in simulated venipuncture. No failures of the safety shield were encountered.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2003

Greiner Bio-One Vacuette North America, Incorporated C/O Ms. Judi Smith Principal Sienna partners, L.L.C. P.O. Box 103 Baldwin, Maryland 21013

Re: K033478

Trade/Device Name: Vacuette Quickshield Safety Tube holder Regulation Number: 880.5570 Regulation Name: Hypodermic Single lumen Needle Regulatory Class: II Product Code: FMI Dated: October 31, 2003 Received: November 3, 2003

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 vour 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 (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.

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qre

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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Enclosure #

Ko33478

Page 1 of 1

510(k) Number (if known): K033478

Device Name: VACUETTE® QUICKSHIELD Safety Tube Holder

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Patric Accardi

Division Sign-Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: 4033478

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter Use _

(Optional Formal 1-2-96)

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).