The BD VACUTAINER™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.

Device Description

The BD VACUTAINER™ Push Button Blood Collection Set is for venous blood collection. The wing set contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks. The retraction of the needle occurs when the user depresses the button.

AI/ML Overview

This 510(k) premarket notification is for the BD VACUTAINER™ Push Button Blood Collection Set.

1. Table of acceptance criteria and the reported device performance:

The document describes the performance evaluation in general terms, stating that "Mechanical and Simulated Use testing was performed to confirm the robustness of the design and reliability of the safety feature function. Clinical use testing was performed to evaluate the function of the safety feature in a blood drawing environment."

Specific quantitative acceptance criteria and corresponding reported device performance values are not explicitly provided in this summary. The document does not detail pass/fail rates, specific metrics, or thresholds for the mechanical, simulated use, or clinical testing. It generally states that the device was found to be "substantially equivalent" to predicate devices, implying that its performance met the necessary criteria for safety and effectiveness.

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

The document does not specify the exact sample size for the test set in either the mechanical, simulated use, or clinical testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study involved "Clinical use testing... in a blood drawing environment," implying evaluation by healthcare professionals, but the number or qualifications of these individuals, acting as "experts" for ground truth establishment, are not detailed.

4. Adjudication method for the test set:

The document does not describe any specific adjudication method for the test set (e.g., 2+1, 3+1).

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:

This device is a blood collection set with a safety mechanism, not an AI-powered diagnostic imaging device or a system requiring "human readers" in the sense of image interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not performed or described for this device.

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

This is a physical medical device, not a software algorithm. Therefore, "standalone" algorithm-only performance is not applicable and was not performed or described. The device's safety feature (needle retraction) is an integral mechanical function intended for user activation during a blood collection procedure (human-in-the-loop).

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

For the mechanical and simulated use testing, the "ground truth" would likely be based on engineering specifications and functional requirements (e.g., successful needle retraction, structural integrity). For the clinical use testing, the "ground truth" would be the observed successful activation of the safety feature and prevention of needlestick injury in a real-world scenario, as assessed by the clinicians performing the venipuncture. However, the specific methodology for defining and confirming this ground truth is not explicitly detailed.

8. The sample size for the training set:

This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require a "training set."

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

This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models.

Summary

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AUG 2 9 2001

Koll 984

I. 510(k) Summary of Safety and Effectiveness

510(k) Summary Of Safety and Effectiveness

I. General Information
Caonofal Information accordance with the requirements of the SMDA of 1990 and 21 § 807.92

Establishment:

•	Address:	Becton Dickinson VACUTAINERSystems1 Becton DriveFranklin Lakes, NJ 07417-1885
•	Registration Number:	2243072
•	Contact Person:	M. Wendy BosshardtRegulatory Affairs SpecialistTelephone no.: 201-847-6280Fax No. 201-847-4858
•	Date of Summary:	June 25, 2001
Device
•	Trade Name:	BD VACUTAINER™ Push Button BloodCollection Set
•	Classification Name:	Tubes, Vials, Systems, SerumSeparators, Blood Collection
•	Classification:	Class II

None Established under 514 of the Performance Standards: . Food, Drug and Cosmetic Act

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

Substantial Equivalence Declaration:

The term "Substantial Equivalence" as used in this 510(k) Premarket Notification is limited to the definition of Substantial Equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR § 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

· Device Description
The BD VACUTAINER™ Push Button Blood Collection Set is for venous blood collection. The wing set contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks. The retraction of the needle occurs when the user depresses the button.
· Intended Use
The BD VACUTAINER™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.
· Synopsis of Performance Study Results
Mechanical and Simulated Use testing was performed to confirm the robustness of the design and reliability of the safety feature function. Clinical use testing was performed to evaluate the function of the safety feature in a blood drawing environment.

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III. Predicate Device Summary Table

· Substantial Equivalence

Based on comparison of the device features, materials, intended use and performance, the BD VACUTAINER™ Push Button Blood Collection Set be shown to be substantially equivalent to the commercially available predicate devices indicated in the table below. The predicate devices, K number, and clearance date are also identified in the table below.

Manufacturer	Predicate Device	K-Number	Clearance Date
Becton Dickinson	BD VACUTAINER™Brand Safety-Lok™Blood Collection Set	K921636 K931367 K965202 K980414	April 29, 1992May 18, 1993February 10, 1997March 3, 1998

. Wendy Boxshersat

August 17, 2001
Date

M. Wendy Bosshardt Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems Becton Dickinson and Company

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2001

Ms. M. Wendy Bosshardt Regulatory Affairs Specialist Becton Dickinson & Company 1 Becton Drive 07417-1880 Franklin Lakes, New Jersey

K011984 Re:

Trade/Device Name: BD Vacutainer™ Push Button Blood Collection Set Regulation Number: 880.5570 and 862.1675 Regulatory Class: II Product Code: FMI and JKA Dated: June 25, 2001 Received: June 26, 2001

Dear Ms. Bosshardt:

We have reviewed your Section 510(k) notification of intent to we have reviewed referenced above and we have determined the merice 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 The general controls controls provisions of the Act. 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 (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. ਉ 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 action. In addition, FDA may publish further announcements

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Page 2 – Ms. Bosshardt

concerning your device in the Eederal Register. Please note: concerning your device in the Lacks in submission does this response to your premarked the have under sections 531 not arrect any obligation you mages under the Electronic through 542 of the Act for acvices and 1 and 1 and 1 and or requlations.

This letter will allow you to begin marketing your device as This letter will allow your be results notification. The FDA described in your 510(K) premaince of your device to a legally
finding of substantial equivalence of your device for your finding of substancial equivalence of yolassification for your marketed predicate device rebared in a canada to the market.

If you desire specific advice for your device on our labeling If you desire specific advice for for for for any office of regulacion (21 cm Fare 80% are contact the Office of vitro diagnostic devices), proad otionally, for questions on Compilance at (301) 554 issing of your device, please contact the promotion and advertising of Jour dones. The office of the Office of Complia the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). _ Other general premarked notification - (arch Joies under the Act may be Informacion on your respon of Small Manufacturers
obtained from the Division of Small Manufacturers toll obtained from the Bivibron on image at its toll-free number International and Combamer its internet address
(800) 638-2041 or (301) 443-6597 or at its internet address (800) 850 2041 -52 - 30 - 30 - 30 - 30 - 30 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Sincerely Yours,

Timothy A. Ulatowski Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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B. INDICATIONS FOR USE

510(K) NUMBER (IFKNOWN): K 011984

K 011984

DEVICE NAME: BD VACUTAINER™ PUSH BUTTON BLOOD COLLECTION SET

INDICATIONS FOR USE:

(Please do not Write below this line-continue on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PRESCRIPTION USE

OR Over-The-Counter Use_

(PER 21 CFR § 801.109)

(OPTIONAL FORMAT 1-2-96)

Paltace Cucente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).