MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

K022875 · Becton, Dickinson & CO · JKA · Sep 11, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022875
• Device Name: MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Applicant: Becton, Dickinson & CO
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

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 Story

Sterile, single-use, winged blood collection set for venipuncture; needle retracts into device body upon button depression; activation occurs prior to removal from venipuncture site; aids in prevention of accidental needlestick injuries; used by healthcare professionals for blood specimen collection.

Clinical Evidence

Extensive mechanical, simulated use, and clinical testing performed to demonstrate safety and effectiveness.

Technological Characteristics

Sterile, single-use, winged blood collection set; features integrated push-button needle retraction mechanism; multiple-sample capability.

Indications for Use

Indicated for venipuncture to obtain blood specimens from patients. Single-use, sterile, winged blood collection set.

Regulatory Classification

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.

Predicate Devices

• BD Vacutainer™ Push Button Blood Collection Set (K011984)

Submission Summary (Full Text)

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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,<br>Preanalytical Solutions<br>1 Becton Drive<br>Franklin Lakes, NJ 07417-1885 |
|-------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| ● | Registration Number:<br>● Contact Person: | 2243072<br>M. Wendy Bosshardt<br>Regulatory Affairs Specialist<br>Telephone no.: 201-847-6280<br>Fax No. 201-847-4858 |
| ● | Date of Summary: | August 29, 2002 |
| Device<br>● | Trade Name: | BD Vacutainer™ Push Button Blood Collection<br>Set |
| ● | Classification Name:<br>● Classification:<br>● Performance Standards: | Blood Specimen Collection Devices<br>Class II<br>None Established under 514 of the Food, Drug<br>and Cosmetic Act |

BD Vacutainer™ Push Button Blood Collection Set

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#### II. Safety and Effectiveness Information Supporting Substantial Equivalence

#### · 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
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 Blood<br>Collection 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

(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