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 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (VACUETTE® QUICKSHIELD with SNAPPY Tube Holder) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and performance of an AI/algorithm-based device. Therefore, most of the requested information cannot be extracted from this document.

However, I can extract the general acceptance criteria for showing substantial equivalence and the "device performance" in terms of its characteristics compared to the predicate.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device K102774. This means the device must be shown to have the same intended use, fundamental scientific technology, and materials, and any differences do not raise new questions of safety or effectiveness.

Reported Device Performance: The document doesn't present a quantitative performance metric in the way you might expect for an AI algorithm (e.g., sensitivity, specificity). Instead, it compares the characteristics of the modified device to the predicate.

Acceptance Criteria / Characteristic	Reported Device Performance (Subject Device)	Predicate Device (K102774) Performance/Characteristics
Substantial Equivalence	The device is deemed substantially equivalent to the predicate. This is the overarching "acceptance criterion" of the 510(k) process.	N/A (The predicate device itself was cleared as substantially equivalent previously).
Intended Use	To be used together only with VACUETTE® Blood Collection Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures by properly trained healthcare professionals.	To be used together only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures by properly trained healthcare professionals. (Note: The change* in intended use to broadened needle type is the subject of this 510(k), but the fundamental use is the same)*
Holder	SNAPPY Tube Holder (21CFR880.5570, Product Code FMI)	Same
Holder Material	Polypropylene, with tabs	Same
Sharp Safety Feature	Polypropylene holder with polypropylene needle locking shield	Same
Safety Feature Activation	Stable surface or thumb	Same
Sterilization	Non-sterile	Same
Needle Recommendation	VACUETTE® VISIO PLUS Blood Collection Needle with View Window (K061483) and VACUETTE® Multi-Sample Needles (K973620)	VACUETTE® VISIO PLUS Blood Collection Needle with View Window (K061483)
Technological Characteristics	The device is "substantially equivalent to the predicate device in fundamental scientific technology and materials." The modification is specifically to include an additional recommended needle type (VACUETTE® Multi-Sample Needles). The overall design and safety mechanism (QUICKSHIELD with SNAPPY Tube Holder) are maintained from the predicate.	The predicate device shares the same fundamental scientific technology and materials for the holder and safety features. The difference is the original predicate was only cleared with VACUETTE® VISIO PLUS Blood Collection Needle.

Missing Information (Not applicable to this document as it's not an AI/algorithm study):

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
If a standalone (algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The sample size for the training set
How the ground truth for the training set was established

Reason for Missing Information:

This document is a 510(k) summary for a physical medical device (blood collection tube holder), not an AI or algorithm-based device. Therefore, the concepts of "test set," "training set," "ground truth," "experts," "adjudication," and "MRMC studies" as they relate to AI performance are not applicable and are not discussed in this type of submission. The "study" here is primarily a comparison of device specifications and intended use against a legally marketed predicate device to demonstrate substantial equivalence, rather than a performance study with clinical outcomes or accuracy metrics.

Summary

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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 (704) 261-7800 manfred.abel@gbo.com

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 withSNAPPY Tube Holder	VACUETTE® QUICKSHIELD withSNAPPY Tube Holder (K102774)
	(subject of this Traditional 510(k))	(predicate device)
Intended Use	The VACUETTE® QUICKSHIELDwith SNAPPY Tube Holder is to beused together only with VACUETTE®Blood Collection Needles andVACUETTE® Blood Collection Tubesas a system in routine venipunctureprocedures. These devices are to beused by properly trained healthcareprofessionals only in accordance withthese instructions.	The VACUETTE® QUICKSHIELDwith SNAPPY Tube Holder is to beused together only with VACUETTE®VISIO PLUS Blood Collection Needlewith View Window and VACUETTE®Blood Collection Tubes as a systemin routine venipuncture procedures.These devices are to be used byproperly trained healthcareprofessionals only in accordance withthese instructions.
Holder	SNAPPY Tube Holder(21CFR880.5570, Product Code FMI)	Same
HolderMaterial	Polypropylene, with tabs	Same
Sharp SafetyFeature	Polypropylene holder withpolypropylene needle locking shield	Same
Safety FeatureActivation	Stable surface or thumb	Same

Table 1: Substantial Equivalence Comparison Table

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	VACUETTE® QUICKSHIELD withSNAPPY Tube Holder(subject of this Traditional 510(k))	VACUETTE® QUICKSHIELD withSNAPPY Tube Holder (K102774)(predicate device)
Sterilization	Non-sterile	Same
NeedleRecommendation	VACUETTE® VISIO PLUS BloodCollection Needle with View Window(K061483, FDA cleared 8/14/06)VACUETTE® Multi-Sample Needles(K973620, FDA cleared 12/17/97)	VACUETTE® VISIO PLUS BloodCollection Needle with View Window(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 (800) 638-2041 or (301) 796-7100 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:

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: _______________________________________________________________________________________________________________________________________________________________

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).