(21 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and functionality, with no mention of AI or ML.
No
This device is a tube holder designed for blood collection procedures, specifically to aid in safety against needlestick injuries and secure tubes, not to treat or diagnose a disease or condition.
No
The device description states that the VACUETTE QUICKSHIELD with SNAPPY Tube Holder is a non-sterile single-use plastic tube holder designed with a safety shield to protect against accidental needlestick injury during routine venipuncture procedures. Its function is to secure blood collection tubes, not to diagnose a condition or disease.
No
The device description explicitly states it is a "non-sterile single-use plastic tube holder," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for routine venipuncture procedures to collect blood. This is a procedure for obtaining a sample, not for performing a diagnostic test on the sample itself.
- Device Description: The device is a tube holder with a safety shield. Its function is to facilitate blood collection and protect against needlestick injury. It does not perform any analysis or testing of the blood.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood components, detect markers, or provide any diagnostic information.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to diagnose diseases or conditions. This device's purpose is solely for the collection of the sample.
N/A
Intended Use / Indications 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.
Product codes
FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
properly trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A total of 500 devices were tested for failure with multiple users employing the thumb activation option in simulated blood drawing. No failures occurred.
Summary of Performance Studies
A total of 500 devices were tested for failure with multiple users employing the thumb activation option in simulated blood drawing. No failures occurred.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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:
ﻬﻮﺗ
1
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.
2
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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3
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
4
INDICATIONS FOR USE
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