VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES

K061483 · Greiner Bio-One North America, Inc. · FMI · Aug 14, 2006 · General Hospital

Device Facts

• Record ID: K061483
• Device Name: VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
• Applicant: Greiner Bio-One North America, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Aug 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner.

Device Story

VACUETTE® VISIO PLUS Blood Collection Needles are sterile, single-use stainless steel needles used for blood collection. Device features a safety valve and a transparent flashback window in the cannula hub to provide visual confirmation of successful vein penetration. Available in 21G and 22G gauges with 25mm or 38mm lengths. Operated by trained healthcare personnel in clinical settings. Flashback window assists user in verifying needle placement during venipuncture; facilitates successful blood draw; minimizes risk of failed attempts.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel construction; single-use; sterile; includes safety valve and transparent flashback window in cannula hub; available in 21G/22G gauges and 25mm/38mm lengths.

Indications for Use

Indicated for use in daily blood collection routines by trained healthcare personnel when delegated by a qualified practitioner.

Regulatory Classification

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.

Predicate Devices

• Greiner VACUETTE® Multi-Sample Needle (K973620)

Submission Summary (Full Text)

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K061483

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.

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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.

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### 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 [phone]. 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 [phone] or [phone] 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

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| | 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<br>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,<br>Jon Control, Dental Devices | | |
| Number . _ 15 461983 | | | |
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