(34 days)
No
The device description and intended use focus on a mechanical safety mechanism for a blood collection set and do not mention any computational or data-driven features.
No
The device is a blood collection set for venipuncture procedures, designed to collect blood samples, not to treat a disease or health condition.
No
This device is a blood collection set used in venipuncture procedures. It is designed to collect blood, not to analyze or interpret any biological samples or patient data for diagnostic purposes.
No
The device description clearly outlines a physical medical device consisting of a needle, tubing, and luer adapter with a safety shield mechanism. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "used in routine venipuncture procedures." This describes a procedure for collecting a sample from the body, not for performing a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description focuses on the physical components and safety features of a blood collection needle and tubing. It does not mention any reagents, assays, or analytical components that would be used to test a sample.
- Lack of Diagnostic Information: There is no mention of analyzing blood, detecting substances, or providing diagnostic information based on the collected sample.
An IVD device is specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a tool for collecting the sample, not for testing it.
N/A
Intended Use / Indications for Use
The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle 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. The product is to be used by appropriately trained medical personnel only in accordance with these instructions.
Product codes
FMI
Device Description
The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter.
PRODUCT DESCRIPTION: The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle 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. The product is to be used by appropriately trained medical personnel only in accordance with these instructions.
The safety feature is easily operated through the release of a latch mechanism whereby the user slides a safety cover over the needle and it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially similar to the Monoject® Angel Wing Blood Collection Set.
The VACUETTE® Safety Blood Collection Set will be available in 80 configurations to include needle gauge (10 gauge sizes), needle length (2 lengths) and tubing length (4 lengths).
The devices are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices. The results of biocompatibility data support the safety of the device and include sterility, pyrogenicity and systemic injection testing.
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
appropriately trained medical 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
JUL 1 2 2001
July 11, 2001
510(k) SUMMARY
CONTACT:
Douglas L. Harris Greiner Vacuette North America, Inc. P.O Box 1026 Monroe, NC 28111
NAME OF DEVICES:
Trade Name: Common Names/Descriptions: Classification Name:
Vacuette® Safety Blood Collection Set Intravascular Catheter Catheter, Intravascular, Short-Term
PREDICATE DEVICE:
Sherwood Medical Angel Wing™ Safety Blood Collection Set (K912563)
DEVICE DESCRIPTION:
VICE DESCRIPTION.
INTENDED USE: The VACUETTE® Safety Blood Collection Set is a single-use, steries, winged blood collection needle bonded to a flexible tubing with a female luer adapter.
PRODUCT DESCRIPTION: The VACUETTE® Safety Blood Collection Set is used in PRODUCT DESCRIPTION. The Winged needle is designed with a safety shield, which routine vehipuncture proobuation. It inmediately following venipuncture to aid in the can be activated to cover the noodle in houleve in the product is to be used by appropriately protection against accreental in accordance with these instructions.
The safety feature is easily operated through the release of a latch mechanism whereby the The Salely leature is easily operator and it is removed from the patient. Once the user slides a wingsu ocatety cover locks in place. This mechanism is substantially needie is covered, the oulony ject® Angel Wing Blood Collection Set.
The VACUETTE® Safety Blood Collection Set will be available in 80 configurations to include needle gauge (10 gauge sizes), needle length (2 lengths) and tubing length (4 lengths).
The devices are packaged as sterile and are labeled for single use only. There is no ability The devices are pookegoe as ses. The results of biocompatibility data support the to clean and rease theose and include sterility, pyrogenicity and systemic injection testing.
SUBSTANTIAL EQUIVALENCE:
The VACUETTE® Safety Blood Collection Set is substantially equivalent to the Monoject® The VACOLTTE® Gallery Blood Collection Set in interials, biocompatibility, and overall performance characteristics.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Greiner Vacuette North America, Incorporated C/O Ms. Judi Smith Sienna Partners, L.L.C P.O. Box 103 Baldwin, Maryland 21013
JUL 1 2 2001
K011786 Re : Vacuette® Safety Blood Collection Trade/Device Name: Set 880.5570 Requlation Number: Regulatory Class: II Product Code: FMI Dated: June 8, 2001 June 8, 2001 Received:
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
2
Page 2 - Ms. Smith
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ent affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enrough Siz on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 marice 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 and additionally 809.10 for in ritro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at (301) 594-4692. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
SRoy THN
Palina Cucentffer
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: VACUETTE® Safety Blood Collection Set
Indications For Use: The VACUETTE® Safety Blood Collection Set is a single-use, sterile, The VACUETTE Salety Blood Collection to a flexible tubing with a
winged blood collection needle bonded to a flexible for is winged blood Collection necale Bonees of the Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is used in Toutine vehipanskars which can be activated to cover the needle immediately following venipuncture to aid in the protection heedle Immediately longwing vompanetics injury. The product is to be used by against accidental neediestion injury. The ps only in accordance with these instructions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
.........................................................................................................................................................................
OR
Over-The-Counter Use _
(Optional Format 1-2-9G)
Antina Crescenti
vision Sian-Off Division of Dental, Infectio and General Hospital I - 8- O'k) Number