BD Preset Syringe & BD A-Line Syringe

K202446 · Becton, Dickinson and Company · JKA · Sep 25, 2020 · Clinical Chemistry

Device Facts

• Record ID: K202446
• Device Name: BD Preset Syringe & BD A-Line Syringe
• Applicant: Becton, Dickinson and Company
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 25, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

The BD Preset™ Syringe & BD A-Line™ Syringe are sterile, single use medical devices specifically intended to be used for the collection of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry. The device is intended to be used by trained healthcare professionals.

Device Story

Sterile, single-use syringes for whole blood collection; used by trained healthcare professionals for in vitro diagnostic testing (pH, blood gases, electrolytes, metabolites, co-oximetry). BD A-Line™ variant designed for arterial line aspiration; BD Preset™ variant features self-venting membrane to expel residual air and ensure rapid filling. Syringes contain calcium-balanced Lithium Heparin anticoagulant. Device operation involves manual aspiration or preset volume collection. Output is a blood sample in a syringe for laboratory analysis. Benefits include standardized, rapid, and safe blood collection for critical care diagnostics.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via bench testing (tip cap leak, shield activation/force, plunger force, needle pull-out, heparin activity) and biocompatibility/sterilization validation per ISO 10993 and ISO 11137 standards.

Technological Characteristics

Materials: Radiation grade polypropylene (barrel/plunger), synthetic elastomer (stopper). Features: Self-venting membrane, calcium-balanced Lithium Heparin. Sterilization: Gamma (SAL 10-6). Standards: ISO 10993-1/4/5/10/11/18, ISO 11137-1/2/3, ISO 11737-1/2, ASTM F2148-18, ASTM D4169-16, USP <87>/<88>/<151>.

Indications for Use

Indicated for trained healthcare professionals to collect whole blood specimens for in vitro diagnostic testing, including pH, blood gases, electrolytes (including ionized calcium), metabolites, and co-oximetry.

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 Preset™ and BD A-Line™ Blood Collection Syringes (K022426)

Submission Summary (Full Text)

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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K202446

B Applicant

Becton, Dickinson, and Company

C Proprietary and Established Names

BD Preset™ Syringe &amp; BD A-Line™ Syringe

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JKA | Class II | 21 CFR 862.1675 - Blood Specimen Collection Device | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device BD Preset™ and BD A-Line™ Blood Collection Syringes, k022426.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the following:

- Material changes to the resin of the syringe, the tip cap of the BD Preset™ Hemogard® and the primary packaging material.
- A new product configuration offering that includes a BD Eclipse™ Needle.
- Revisions to the labeling to improve readability and updates to safety precautions per current medical practice recommendations.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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