(81 days)
No
The device description and intended use focus on mechanical components for blood collection and safety, with no mention of AI or ML terms or functionalities.
No.
This device is a blood collection accessory designed to aid in venipuncture procedures and protect against needlestick injury, not to provide therapy.
No
The device is a tube holder designed to facilitate blood collection, not to interpret or analyze collected specimens for diagnostic purposes.
No
The device description explicitly states it is a "non-sterile single-use plastic tube holder," indicating it is a physical hardware device.
Based on the provided text, the VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for routine venipuncture procedures, specifically for holding blood collection tubes and providing a safety shield for the needle. This is a procedure for collecting a sample, not for performing a diagnostic test on the sample itself.
- Device Description: The description focuses on the physical characteristics of the device (plastic tube holder, safety shield) and its function in the blood collection process. It does not mention any components or functions related to analyzing or testing a biological sample.
- Lack of Diagnostic Function: The device's purpose is to facilitate the safe collection of a blood sample. It does not perform any analysis, measurement, or interpretation of the blood sample to provide diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is a tool used during the collection of the specimen, not for the diagnostic testing of the specimen.
N/A
Intended Use / Indications for Use
Indication For 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 codes (comma separated list FDA assigned to the subject device)
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.
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] .
- 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] .
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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] .
1
- 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
SNAPPY Tube Holder | VACUETTE® QUICKSHIELD with
SNAPPY Tube Holder (K102774) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (subject of this Traditional 510(k)) | (predicate device) |
| 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. | 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 system
in routine venipuncture procedures.
These devices are to be used by
properly trained healthcare
professionals only in accordance with
these instructions. |
| 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 |
Table 1: Substantial Equivalence Comparison Table
2
| | VACUETTE® QUICKSHIELD with
SNAPPY Tube Holder
(subject of this Traditional 510(k)) | VACUETTE® QUICKSHIELD with
SNAPPY Tube Holder (K102774)
(predicate device) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Sterilization | Non-sterile | Same |
| Needle
Recommendation | VACUETTE® VISIO PLUS Blood
Collection Needle with View Window
(K061483, FDA cleared 8/14/06)
VACUETTE® Multi-Sample Needles
(K973620, FDA cleared 12/17/97) | VACUETTE® VISIO PLUS Blood
Collection Needle with View Window
(K061483, FDA cleared 8/14/06) |
3
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.
4
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
5
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
510(k) Number: _______________________________________________________________________________________________________________________________________________________________