(25 days)
Not Found
No
The description focuses on mechanical safety features and visual indicators for venipuncture, with no mention of AI or ML.
No
The device is described for use in routine venipuncture procedures for blood collection and safety, not for treating any medical condition.
No
The device is a blood collection needle and safety holder system for routine venipuncture procedures. Its purpose is to collect blood, not to diagnose.
No
The device description clearly describes physical components like a safety shield, needle, cannula hub, and flashback window, indicating it is a hardware device used in venipuncture procedures. There is no mention of software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for routine venipuncture procedures and blood collection. It focuses on the physical act of drawing blood and protecting against needlestick injury.
- Device Description: The description reinforces the function of the device as a blood collection system with a safety feature.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro for the purpose of providing information for diagnosis, monitoring, or treatment. The device's function is solely related to the collection of the specimen.
Therefore, the QUICKSHIELD Complete and VACUETTE® VISIO PLUS Blood Collection Needles, as described, are medical devices used for specimen collection, not IVDs.
N/A
Intended Use / Indications for Use
The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. 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. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
Product codes
FMI
Device Description
Intended Use: The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. 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. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel 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 only, adequately trained healthcare personnel
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)
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
510(K) SUMMARY
CONTACT:
Douglas L. Harris Greiner Bio-One North America, Inc. P.O Box 1026 Monroe, NC 28111
SEP 1 4 2007
August 17, 2007
NAME OF DEVICES:
Trade Name:
Common Names/Descriptions:
Classification Name:
VACUETTE® QUICKSHIELD Complete Evacuated Blood Collection Tube Holder Needle, Hypodermic, Single Lumen
1072320
PREDICATE DEVICE:
Greiner VACUETTE® QUICKSHIELD safety holder - K033478; VACUETTE® Multi-Sample Needles - K973620: VACUETTE® VISIO PLUS Needles - K061483
DEVICE DESCRIPTION:
Intended Use: The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. 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. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
SUBSTANTIAL EQUIVALENCE:
The Greiner VACUETTE® QUICKSHIELD Complete is substantially equivalent to the Greiner VACUETTE® QUICKSHIELD safety holder (K033478), the VACUETTE® Multi-Sample Needles (K973620), and the VACUETTE® VISIO PLUS Needles (K061483) in intended use, materials, and sterilization process.
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 stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
SEP 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Greiner Bio-One North America, Incorporated C/O Ms. Judi Smith Director, IVD/Medical Devices Beaufort Advisors Limited Liability Company 500 East Main Street, Suite 1301 Norfolk, Virginia 23510
Re: K072320
:
Trade/Device Name: Greiner VACUETTE® QUICKSHIELD Complete Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 17, 2007 Received: August 20, 2007
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 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.
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 (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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
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
INDICATIONS FOR USE 1.2.
Indication for Use
510(k) Number (if known):
Device Name: Greiner VACUETTE® QUICKSHIELD Complete
Indication For Use:
The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. 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. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
Prescription Use × (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE: CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
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
Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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