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.

AI/ML Overview

This document, K061483, is a 510(k) summary for a blood collection needle and does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the way envisioned by the prompt for AI/diagnostic devices.

Instead, it's a submission for a medical device (a blood collection needle) seeking clearance based on substantial equivalence to a predicate device. For such devices, the "acceptance criteria" are related to safety, effectiveness, and substantial equivalence, often demonstrated through comparison to a legally marketed predicate device and adherence to recognized standards, rather than numerical performance metrics from a dedicated study.

Therefore, many of the requested categories related to AI/diagnostic device performance studies (sample sizes, ground truth, expert opinions, MRMC studies) are not applicable or extractable from this type of regulatory document.

Here's a breakdown of what can be extracted and explanations for what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary "acceptance criteria" for K061483 is demonstrating substantial equivalence in intended use, materials, and general design to the predicate device, Greiner VACUETTE® Multi-Sample Needle (K973620), and compliance with general controls for Class II devices. Specific numerical performance metrics for the device itself (like sensitivity/specificity for a diagnostic) are not detailed as this is a physical medical device.
Reported Device Performance: This document does not contain a study with reported performance metrics for the VACUETTE® VISIO PLUS Blood Collection Needles beyond stating its design features. The clearance is based on its similarity to an already approved device.

Table (Not Applicable for detailed numerical performance results in this context):

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent in intended use to predicate device.	Intended use is identical to predicate: "designed for use in the daily blood collection routine when delegated by a qualified practitioner."
Substantially equivalent in materials to predicate device.	Manufactured from stainless steel, similar to predicate.
Substantially equivalent in general design to predicate device.	Fitted with a safety valve, similar to predicate. Includes a flashback window, which is a design feature.
Compliance with general controls (e.g., sterilization, single-use).	Stated as sterile and for single-use only.

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission does not describe a "test set" or a performance study with a sample size in the context of diagnostic accuracy or AI model evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not Applicable. This document pertains to regulatory clearance of a physical medical device, not a diagnostic or AI algorithm requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is a physical blood collection needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical blood collection needle, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. The "ground truth" for this device would be its physical properties, sterility, and functionality as a blood collection needle, which are assessed through engineering and biocompatibility testing, manufacturing controls, and comparison to existing standards/devices, not expert consensus on diagnostic images or pathology.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device; there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. There is no training set for this type of device.

Summary

{0}------------------------------------------------

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.

{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 dailyblood 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)

Regulation Number and Section

§ 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).