(76 days)
No
The device description details a physical blood collection needle with a flashback window and safety valve. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
This device is designed for blood collection, which is a diagnostic procedure, not a therapeutic one. It facilitates the drawing of blood samples but does not treat or cure any condition.
No
This device is a blood collection needle used to draw blood, which is a tool for collecting samples but does not perform diagnostic analysis itself.
No
The device description clearly states it is a physical blood collection needle made of stainless steel with a safety valve and flashback window, indicating it is a hardware device.
Based on the provided information, the VACUETTE® VISIO PLUS Blood Collection Needles are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "use in the daily blood collection routine". This describes a device used to collect a sample from the body.
- Device Description: The description details a needle designed for venipuncture (drawing blood). It focuses on features related to the collection process (flashback window, safety valve).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis or testing of the blood sample itself. It is solely a tool for obtaining the sample.
Therefore, the VACUETTE® VISIO PLUS Blood Collection Needles are a medical device used for blood collection, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner.
Product codes
FMI
Device Description
VACUETTE® VISIO PLUS Blood Collection Needles are manufactured from stainless steel and are fitted with a safety valve at one end. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. The perforated label not only serves to simplify identification, but also acts as a seal of integrity. VACUETTE® VISIO PLUS Blood collection needles are a sterile single-use product. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
The VACUETTE® VISIO PLUS Blood Collection Needles will be available in four configurations to include two needle gauge sizes (21G and 22G) and two corresponding needle lengths (25 mm [1 inch] and 38 mm [ 1 ½ inches]):
- 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] .
The needles are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices.
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
daily blood collection routine when delegated by a qualified practitioner.
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 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
July 11, 2006
510(k) SUMMARY
CONTACT
Douglas L. Harris Greiner Bio-One North America, Inc. P.O Box 1026 Monroe, NC 28111
AUG 1 4 2006
| NAME OF DEVICE: | |
|---|---|
| Trade Name: | VACUETTE® VISIO PLUS Blood Collection Needles |
| Common Names/Descriptions: | Blood Collection Needles |
| Classification Name: | Needle, Hypodermic, Single Lumen |
PREDICATE DEVICE.
Greiner VACUETTE® Multi-Sample Needle (K973620)
DEVICE DESCRIPTION:
INTENDED USE: VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner.
PRODUCT_DESCRIPTION: VACUETTE® VISIO PLUS Blood Collection Needles are manufactured from stainless steel and are fitted with a safety valve at one end. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. The perforated label not only serves to simplify identification, but also acts as a seal of integrity. VACUETTE® VISIO PLUS Blood collection needles are a sterile single-use product. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
The VACUETTE® VISIO PLUS Blood Collection Needles will be available in four configurations to include two needle gauge sizes (21G and 22G) and two corresponding needle lengths (25 mm [1 inch] and 38 mm [ 1 ½ inches]):
- 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] .
The needles are packaged as sterile and are labeled for single use only. There is no ability to clean and reuse these devices.
SUBSTANTIAL EQUIVALENCE:
The Greiner VACUETTE® VISIO PLUS Blood Collection Needles are substantially equivalent to the Greiner VACUETTE® Multi-Sample Needle (K973620) in intended use, materials, and general design.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.
AUG 1 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Greiner Bio-One North America, Incorporated C/O Ms. Judith J. Smith Principal Sienna Partners, L.L.C. P.O. Box 103 Baldwin, Maryland 21013
Re: K061483
Trade/Device Name: Greiner VACUETTE® VISIO PLUS Blood Collection Needles Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 11, 2006 Received: July 12, 2006
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave to re would be 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to are rood Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval applied.ion (the Act. The general controls provisions of the Act include eonerols provisions of 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 IT your device is classified (See h additional controls. Existing major regulations affecting (1 wrt), it nay of backed to back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roulish 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. or the Fet of any a vith 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 and insting (21 CF North 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) I mis leter notification. The FDA finding of substantial equivalence of your device to a promainter notified 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), nlease 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Soulette y. Michael Davis
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
| INTENDED USE STATEMENT | Page 1 of 1 | ||
|---|---|---|---|
| 10(k) Number (if known): K061483 | |||
| Device Name: Greiner VACUETTE® VISIO PLUS Blood Collection Needles | |||
| Indications For Use: | |||
| VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily | |||
| blood collection routine when delegated by a qualified practitioner. | |||
| Prescription Use X | OR | Over-The-Counter Use | |
| (Per 21 CFR 801.109) | |||
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF | NEEDED) | ||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
| ா Sign-Off) | of Anesthesiology, General Hospital, | ||
| Jon Control, Dental Devices | |||
| Number . _ 15 461983 | |||
| ﺎﺭ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | (Optional Format 1-2-96) | ||