BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341

K030573 · Bd Vacutainer Systems Preanalyical Solutions · JKA · May 8, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030573
• Device Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
• Applicant: Bd Vacutainer Systems Preanalyical Solutions
• Product Code: JKA · Clinical Chemistry
• Decision Date: May 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

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 BD Vacutainer™ Push Button Blood Collection Set is also indicated for the intravenous administration of fluids as indicated in 21 CFR §880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy. 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 accidental needlestick injury.

Device Story

Sterile, single-use, winged blood collection set; used for venipuncture and IV fluid administration. Features integrated needle retraction mechanism activated by button press prior to removal from venipuncture site. Designed to prevent accidental needlestick injuries. Operated by healthcare professionals in clinical settings. Output is successful blood specimen collection or IV fluid delivery. Benefits include enhanced safety for clinicians via needle retraction.

Clinical Evidence

Bench testing only; biocompatibility testing performed to demonstrate safety and performance.

Technological Characteristics

Sterile, single-use, winged blood collection set with integrated push-button needle retraction mechanism. Materials are biocompatible. No energy source required. Mechanical operation.

Indications for Use

Indicated for venipuncture to obtain blood specimens and for intravenous administration of fluids in any patient population, considering patient size, solution appropriateness, and therapy duration.

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™ Brand Safety-Lok™ Blood Collection Set (K980414)
• BD Vacutainer™ Push Button Blood Collection Set (K022875)

Submission Summary (Full Text)

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# I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 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: | BD Vacutainer Systems, Preanalytical<br>Solutions<br>1 Becton Drive<br>Franklin Lakes, NJ 07417-1885 |
|---|------------------------|--------------------------------------------------------------------------------------------------------------|
| • | Registration Number: | 2243072 |
| • | Contact Person: | M. Wendy Ballesteros<br>Regulatory Affairs Specialist<br>Telephone no.: 201-847-6280<br>Fax No. 201-847-4858 |
| • | Date of Summary: | February 21, 2003 |
| | Device | |
| • | Trade Name: | BD VacutainerTM Push Button Blood<br>Collection Set |
| • | Classification Name: | Tubes, Vials, Systems, Serum<br>Separators, Blood Collection |
| • | Classification: | Class II |
| • | Performance Standards: | None Established under 514 of the<br>Food Drug and Cosmetic Act |

KO35573

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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 and IV administration. It contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks.

- · 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 BD Vacutainer™ Push Button Blood Collection Set is also indicated for the intravenous administration of fluids as indicated in 21 CFR §880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.

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 accidental needlestick injury.

- · Synopsis of Performance Study Results
Based upon previously demonstrated performance and successful completion of biocompatibility testing, Push Button Blood Collection Set will perform as intended.

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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 is 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 |
|---------------------------------------------------------|-------------------------------------------------------------|----------|--------------------|
| BD Vacutainer<br>Systems,<br>Preanalytical<br>Solutions | BD VACUTAINER™<br>Brand Safety-Lok™<br>Blood Collection Set | K980414 | March 3, 1998 |
| BD Vacutainer<br>Systems,<br>Preanalytical<br>Solutions | BD Vacutainer™ Push<br>Button Blood<br>Collection Set | K022875 | September 11, 2002 |

M. Wendy Ballesta

2/21/03
Date

Date

M. Wendy Ballesteros Regulatory Affairs Specialist BD Vacutainer Systems, Preanalytical Solutions Becton Dickinson and Company

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2003

BD Vacutainer Systems, Preanalytical Solutions Ms. M. Wendy Ballesteros Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

Re: K030573

Trade/Device Name: BD Vacutainer™ Push Button Blood Collection Set Regulation Number: 21 CFR 862.1675, 21 CFR 880.5440 Regulation Name: Blood Specimen Collection Device, Intravascular Administration Set Regulatory Class: II Product Code: 75 JKA. 80 FPA Dated: February 21, 2003 Received: February 24, 2003

Dear Ms. Ballesteros:

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 may, 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.

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Page 2 - Ms. Ballesteros

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. 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 (OS) 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), please 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/dsma/dsmamain.html

Sincerely yours,

Susan Dunner

Susan Runner, DDS, MA Interim 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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# B. INDICATIONS FOR USE

| 510(k) Number (if known): | K030543 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: BD Vacutainer™ Push Button Blood Collection Set

Indications for 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 BD Vacutainer™ Push Button Blood Collection Set is also indicated for intravenous administration of fluids as indicated in 21 CFR §880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.

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 accidental 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 | <span style="text-decoration: overline;">✓</span> |
|------------------|------------------------------------------------------------------------|
| Or | Over-the-Counter Use <span style="text-decoration: underline;"></span> |

(Per 21 CFR § 801.109)

| (Division Sign-Off) | |
|---------------------------------------------------------------------------------|--------------------------|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | (Optional format 1-2-96) |

| 510(k) Number: | <span style="text-decoration: underline;">K030575</span> |
|----------------|----------------------------------------------------------|
|----------------|----------------------------------------------------------|

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