BD BACTEC™ Plus Aerobic/F Culture Vials

K222591 · Becton, Dickinson and Company · MDB · Mar 24, 2023 · Microbiology

Device Facts

• Record ID: K222591
• Device Name: BD BACTEC™ Plus Aerobic/F Culture Vials
• Applicant: Becton, Dickinson and Company
• Product Code: MDB · Microbiology
• Decision Date: Mar 24, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Indications for Use

BD BACTEC™ Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC™ fluorescent series instruments. Additional information The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC™ fluorescent series instruments.

Device Story

BD BACTEC™ Plus Aerobic/F Culture Vials are plastic vials containing enriched Soybean-Casein Digest Broth; used for aerobic culture and recovery of bacteria and yeast from 3-10 mL blood samples. Vials are placed in BD BACTEC™ fluorescent series instruments (FX, FX40, 9240, 9050). Principle of operation: microorganisms metabolize substrates in the medium, producing CO2; CO2 increases fluorescence of a vial sensor; instrument monitors fluorescence to detect positive vials. Healthcare providers use instrument output to determine presence of viable organisms, aiding diagnosis of infectious disease. Modified device differs from predicate only in vitamin concentration.

Clinical Evidence

No clinical studies performed. Substantial equivalence established via bench-only analytical testing. Studies included Time to Detection (TTD), Percent Recovery (sensitivity), False Negative/Positive rates, and Resin Performance (antimicrobial neutralization) using 44 organisms across various inoculum levels (0-1, 1-10, 10-100 CFU/vial) and blood volumes (3 mL, 10 mL). Results showed no statistically relevant differences in TTD or recovery between modified and predicate devices.

Technological Characteristics

Plastic culture vials containing 30 mL enriched Soybean-Casein Digest Broth. Sensing principle: fluorescent CO2 sensor. Energy source: BD BACTEC™ fluorescent series instruments. Connectivity: instrument-based monitoring. Sterilization: nonsterile. Software: instrument-specific firmware versions (e.g., FX 6.40A, FX40 3.40A, 9240 4.95A, 9050 2.01A2).

Indications for Use

Indicated for the aerobic culture and recovery of bacteria and yeast from blood samples (3-10 mL) to aid in the diagnosis of disease caused by pathogenic microorganisms. For prescription use only.

Regulatory Classification

Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Predicate Devices

• BD BACTEC™ Plus Aerobic/F Culture Vials (K113558)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K222591

B Applicant

Becton, Dickinson and Company

C Proprietary and Established Names

BD BACTEC Plus Aerobic/F Culture Vials

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| MDB | Class I, reserved | 21 CFR 866.2560 - Microbial Growth Monitor | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS I 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.
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 and package labeling.
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 demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
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:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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 modifications 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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