BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538

K022426 · Becton, Dickinson & CO · JKA · Aug 8, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022426
• Device Name: BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538
• Applicant: Becton, Dickinson & CO
• Product Code: JKA · Clinical Chemistry
• Decision Date: Aug 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The BD Preset™ and BD A-Line™ Blood Collection Syringes are intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry, and other tests.

Device Story

BD Preset™ and BD A-Line™ are sterile, single-use blood collection syringes. BD A-Line™ is designed for arterial line blood aspiration. BD Preset™ features a volume-preset mechanism and a self-venting membrane to expel residual air during filling. Used by clinicians in clinical settings to collect whole blood for diagnostic analysis (pH, gases, electrolytes, metabolites, co-oximetry). The device facilitates rapid, controlled blood sampling, ensuring specimen integrity for laboratory testing. Benefits include improved sampling efficiency and reduced air contamination in arterial blood specimens.

Clinical Evidence

Bench testing only. Performance studies compared the subject devices to the predicate to demonstrate equivalence in blood collection functionality.

Technological Characteristics

Sterile, single-use blood collection syringes. Features include a self-venting membrane for air expulsion and a preset volume mechanism. Materials and design are consistent with established blood collection standards.

Indications for Use

Indicated for the collection of whole blood specimens for diagnostic testing, including pH, blood gases, electrolytes, metabolites, and co-oximetry. Intended for prescription use.

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

• VACUTAINER™ Brand Blood Collection Syringes (K982922)

Submission Summary (Full Text)

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AUG 0 8 2002

1022426

## 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: | BD Vacutainer Systems, 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 |
| Device | Date of Summary: | July 22, 2002 |
| | Trade Name: | BD Preset™ and BD A-Line™ Blood<br>Collection Syringes |
| | Classification Name: | Tubes, Vials, Systems, Serum<br>Separators, Blood Collection |
| | Classification:<br>Performance Standards: | Class II<br>None Established under 514 of the<br>Food, Drug and Cosmetic Act |

Special 510(k): Device Modification
BD Preset™ and BD A-Line™

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- II. Safety and Effectiveness Information Supporting Substantial Equivalence
- · Device Description

The BD Preset™ and BD A-Line™ Blood Collection Syringes are sterile, single use devices designed to collect whole blood specimens for diagnostic testing.

> BD A-Line™ Blood Collection Syringe is specifically designed for aspiration of blood samples from arterial lines.

> BD Preset™ Blood Collection Syringe is a specifically designed (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the selfventing membrane (as blood fills the syringe), which ensures rapid filling.

- Intended Use
The BD Preset™ and BD A-Line™ Blood Collection Syringes are intended to collect whole blood specimens for diagnostic testing which may include: pH. blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry, and other tests.

- · Synopsis of Performance Study Results
Performance studies were done the performance and equivalence of the principal devices to the predicate devices currently marketed in the United States.

All results from the studies show equivalence between the principal devices and the predicate devices. Therefore, the BD Preset™ and BD A-Line™ Blood Collection Syringes are substantially equivalent to the predicate devices.

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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 Preset™ and BD A-Line™ Blood Collection Syringes are 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<br>Dickinson | VACUTAINER™ | K982922 | Sept. 22, 1998 |
| | Brand Blood<br>Collection Syringes | | |

M. Wendy Booshardt

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

July 22, 2002
Date

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. M. Wendy Bosshardt Regulatory Affairs Specialist Becton, Dickinson and Co. 1 Becton Drive Franklin Lakes, NJ 07417

Re: k022426

> Trade/Device Name: BD Preset™ and BD A-Line™ Blood Collection Syringe Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code:. JKA Dated: July 22, 2002 Received: July 25, 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 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. Iisting 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. 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.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 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 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.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment 2

Indications for Use Statement

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# 510(k) Number (if known)

:

| Device Name | BD Preset™ and BD A-Line™ Blood Collection Syringe |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | BD Preset™ and BD A-Line™ Blood Collection Syringe<br>are intended to collect whole blood specimens for<br>diagnostic testing which may include: pH, blood gases,<br>electrolytes (including ionized calcium), metabolytes,<br>co-oximetry, and other tests |

#### PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Sean Cooper |
|-----------------------------------------|---------------------|
| | (Division Sign-Off) |
| Division of Clinical Laboratory Device. | |
| 510(k) Number | K0224266 |

| Prescription Use<br>(per 21 CFR 801.109) | OR | Over-The Counter Use |
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