(156 days)
The BD BACTEC™ Plus Anaerobic/F medium is used in a qualitative procedure for the anaerobic culture and recovery of microorganisms (bacteria) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.
The sample to be tested is inoculated into one or more vials which are inserted into the BD BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.
The provided text describes a 510(k) premarket notification for a medical device called the "BD BACTEC Plus Anaerobic/F (plastic)" medium. This device is an anaerobic blood culture medium used with BD BACTEC fluorescent series instruments for the qualitative culture and recovery of microorganisms from blood. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the "BD BACTEC Plus Anaerobic/F" medium (glass bottle).
The acceptance criteria for this type of device are primarily tied to demonstrating equivalent performance to a legally marketed predicate device across several analytical performance metrics. The study described is a series of analytical studies comparing the new plastic bottle device to the predicate glass bottle device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are not explicitly stated as numerical targets in a table format within the document. Instead, the studies aim to demonstrate "equivalent performance" or that differences are "minimal" or "detectable but favoring the new device" compared to the predicate. The performance is reported in terms of comparison to the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (BD BACTEC Plus Anaerobic/F (plastic) vs. Predicate) |
|---|---|---|
| Instrument Time to Detection (TTD) | Minimal difference in median TTD compared to predicate. | Median TTD difference of 4.62 minutes, favoring the new device. Minimal effect of differences. |
| Percent Recovery | Equivalent or improved recovery compared to predicate. | Significant difference favoring the new device, detecting 12 more vials than the predicate. |
| False Positive Rate | No false positives within recommended usage range of blood volumes. | No false positive bottles observed within the recommended usage range (3 to 10 mL). |
| False Negative Rate | Equivalent or improved false negative rate compared to predicate. | 2 false negative results observed in the new device vs. 14 in the predicate device. |
| Antimicrobial Neutralization Capability | Equivalent positive detection rate in the presence of antimicrobials compared to predicate. | New device detected positive 86 times (95.56%) vs. predicate 87 times (96.67%). Demonstrated equivalent performance. |
| Reproducibility | Acceptable reproducibility across lots in TTD and recovery. | Statistical difference in TTD observed between lots, but marginal (mean/median difference |
§ 866.2560 Microbial growth monitor.
(a)
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.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.