The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiple-sample, 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

The provided text describes the 510(k) summary for the BD Vacutainer™ Push Button Blood Collection Set. However, it does not include detailed information regarding specific acceptance criteria, a detailed study report demonstrating performance against those criteria, or the methodology (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) typically associated with such studies for AI/ML-based devices.

The submission is for a medical device (blood collection set) that is not an AI/ML-based device. Therefore, many of the requested categories (like "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Training set sample size", and "How the ground truth for the training set was established") are not applicable to this type of device and are not present in the provided document.

Here's an attempt to answer the questions based only on the provided text, flagging where information is not available or not applicable:

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

The document states: "Extensive mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness." However, specific numerical acceptance criteria (e.g., "95% of needle retractions must be successful") and their corresponding reported performance values are not provided in this summary. The summary focuses on establishing substantial equivalence to a predicate device.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document	Extensive mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Extensive mechanical, simulated use and clinical testing were performed," but does not provide details on the sample sizes used for these tests, nor the data provenance (country of origin, retrospective/prospective nature).

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)

This question is not applicable as this is a physical medical device (blood collection set), not an AI/ML device requiring expert-established ground truth for algorithm evaluation. The document does not mention any expert review or ground truth establishment in this context.

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

This question is not applicable as this is a physical medical device, not an AI/ML device relying on human adjudication for performance evaluation. The document does not mention any adjudication method.

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 question is not applicable as this is a physical medical device, not an AI-assisted diagnostic tool for human readers. The document does not mention an MRMC study.

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

This question is not applicable as this is a physical medical device, not an algorithm. The document does not describe standalone algorithm performance. The device itself operates "standalone" in mechanical function, but this refers to its physical operation, not an algorithm's performance.

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

This question is not applicable in the context of typical AI/ML device evaluation. For this physical device, "ground truth" would relate to successful mechanical function, sterility, and injury prevention, which would be assessed through standard engineering and clinical validation methodologies, not expert consensus on data interpretation. The document does not specify the "ground truth" methodology.

8. The sample size for the training set

This question is not applicable as this is a physical medical device, not an AI/ML device that requires a training set. The document does not mention a training set.

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

This question is not applicable as this is a physical medical device, not an AI/ML device that requires a training set and its associated ground truth. The document does not mention how ground truth for a training set was established.

Summary

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SEP 1 1 2002

Attachment 4

510(k) Summary Of Safety and Effectiveness

I. General Information
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92

Establishment:

●	Address:	Becton Dickinson Vacutainer Systems,Preanalytical Solutions1 Becton DriveFranklin Lakes, NJ 07417-1885
●	Registration Number:● Contact Person:	2243072M. Wendy BosshardtRegulatory Affairs SpecialistTelephone no.: 201-847-6280Fax No. 201-847-4858
●	Date of Summary:	August 29, 2002
Device●	Trade Name:	BD Vacutainer™ Push Button Blood CollectionSet
●	Classification Name:● Classification:● Performance Standards:	Blood Specimen Collection DevicesClass IINone Established under 514 of the Food, Drugand Cosmetic Act

BD Vacutainer™ Push Button Blood Collection Set

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

· Device Description

• 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
Extensive mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness.

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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 device indicated in the table below. The predicate device, K number, and clearance date are also identified in the table below.

Manufacturer	Predicate Device	K-Number	Clearance Date
Becton	BD Vacutainer™	K011984	August 29, 2001
Dickinson	Push Button BloodCollection Set

.windu Boppshardt

August 29, 2002
Date

M. Wendy Bosshardt Regulatory Affairs Specialist Becton Dickinson Vacutainer Systems, PreAnalytical Solutions Becton Dickinson and Company

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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2002

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

Re: K022875

Trade/Device Name: BD VACUTAINERTM Push Button Blood Collection Set Regulation Number: 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA Dated: August 29, 2002 Received: August 30, 2002

Dear Ms. Bosshardt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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.

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Page 2 – Ms. Bosshardt

You must comply with 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 requirements as set forth 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Jlatowski 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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Attachment 2

B. INDICATIONS FOR USE

22875

510(K) Number (IF Known):

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 Ов Over-The-Counter Use

(Per 21 CFR § 801.109)

(OPTIONAL FORMAT 1-2-96)

Patricia Cuscenti

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022875

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.