(56 days)
Not Found
No
The description focuses on a mechanical safety mechanism for a blood collection tube holder and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is a safety tube holder for venipuncture procedures, designed to protect against needlestick injury. It does not treat or diagnose a disease or condition.
No
Justification: The device's intended use is for routine venipuncture procedures to collect blood, and its primary function is to protect against accidental needlestick injury. It does not analyze, diagnose, or provide information about a patient's medical condition. It is a tool for safe blood collection, not for diagnosis.
No
The device description clearly indicates a physical device ("safety shield") designed to cover a needle, which is a hardware component. The performance study also focuses on the functionality of this physical shield.
Based on the provided text, the VACUETTE® QUICKSHIELD Safety Tube Holder is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for routine venipuncture procedures and protection against accidental needlestick injury. This is a procedure for collecting a sample, not for performing a diagnostic test on the sample itself.
- Device Description: The description focuses on its function in blood collection and safety features, not on analyzing or testing a sample.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or any other biological sample to provide diagnostic information.
- Predicate Device: The predicate device is a blood collection needle, which is also not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VACUETTE® QUICKSHIELD Safety Tube Holder is a tool used in the process of collecting the specimen, not for the diagnostic analysis of the specimen.
N/A
Intended Use / Indications for Use
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.
Product codes
FMI
Device Description
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.
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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:
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.
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.
2
1
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.
2
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
3
Enclosure #
Ko33478
Page 1 of 1
510(k) Number (if known): K033478
Device Name: VACUETTE® QUICKSHIELD Safety Tube Holder
Indications For Use:
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.
(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)