(106 days)
BACTEC FX, BACTEC 9240, BACTEC 9050
No
The description focuses on chemical sensors and fluorescence detection, with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies are based on traditional statistical comparisons of recovery rates and time to detection.
No.
The device is used to detect the presence of microorganisms in blood through culture, which is a diagnostic procedure, not a therapeutic one.
Yes
The device qualitatively detects microorganisms from blood, and its output (presumptive presence of viable microorganisms) provides information used to aid in the diagnosis.
No
The device description clearly describes a physical vial containing a chemical sensor and medium, which is used in conjunction with a BACTEC instrument. This involves hardware components and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the medium is used in a "qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood." This describes a test performed in vitro (outside the body) on a biological sample (blood) to provide information about a patient's health status (presence of microorganisms).
- Device Description: The description details how the device works by detecting CO2 produced by microbial growth in the medium. This is a diagnostic process performed on a sample.
- Anatomical Site: The sample is taken from "blood," which is a biological specimen used for diagnostic testing.
- Performance Studies: The document includes analytical studies evaluating the performance of the device in terms of recovery of microorganisms, false positive/negative rates, and compatibility with instruments. These are typical performance metrics for IVD devices.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description as it is a medium used in a system (with the BACTEC instruments) to detect microorganisms in blood, which is a diagnostic process.
N/A
Intended Use / Indications for Use
The BD BACTEC Plus Aerobic/F medium is 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.
Product codes
MDB
Device Description
The sample to be tested is inoculated into one or more vials which are inserted into the 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.
Resins have been described for the treatment of blood specimens both prior to and after their inoculation into culture media. Resins have been incorporated into BACTEC culture media to enhance recovery of organisms without a need for special processing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Analytical Studies:
Instrument Time to Detection: A total of 726 paired sets were positive in both the new and predicate devices. There was no significant difference in recovery between the BD BACTEC Plus Aerobic/F blood culture medium contained in plastic bottles and the predicate device contained in glass bottles. The Wilcoxon estimated median TTD difference for the 726 positive sets is 0.083 hours (5 minutes). The data indicate that the effect of differences between the new and predicate devices on TTD under these test conditions was minimal and that the new device performs equivalently to the predicate device.
Percent Recovery: A total of 738 paired sets were evaluated in the Percent Recovery comparison. Of those, 726 paired sets were positive in both the new and predicate devices (98.4%). The McNemar p-value for this data set equals 1. The data indicate that the effect of differences between the new and predicate devices on percent recovery under these test conditions was not statistically detectable and that the new device performs equivalently to the predicate device.
False Positive Rate: A total of 240 paired sets were used to execute this study. The 240 paired sets were comprised of 80 bottles from each of 3 lots. There were no false positive bottles of the new device observed within the recommended usage range of blood volumes (3 to 10 mL). Two false positive bottles were observed when inoculated with a blood volume outside of the recommended usage range for the device (
§ 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.
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510(k) SUMMARY
MAR 1 6 2012
SUBMITTED BY:
BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE SPARKS, MD 21152 Phone: 410-316-4905 410-316-4499 Fax:
CONTACT NAME: DATE PREPARED: Paul Swift, Regulatory Affairs Specialist March 7, 2012
BD BACTEC Plus Aerobic/F (plastic) DEVICE TRADE NAME:
DEVICE COMMON NAME: Aerobic blood culture medium
DEVICE CLASSIFICATION: 21 CFR §866.2560, Class I
PREDICATE DEVICE: BD BACTEC PLUS Aerobic/F medium (K921133)
INTENDED USE:
The BD BACTEC Plus Aerobic/F medium is 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.
DEVICE DESCRIPTION:
The sample to be tested is inoculated into one or more vials which are inserted into the 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.
Resins have been described for the treatment of blood specimens both prior to and after their inoculation into culture media. Resins have been incorporated into BACTEC culture media to enhance recovery of organisms without a need for special processing. 12-3,4
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1 Wallis, C. et al. 1980. Rapid isolation of bacteria from septicents by use of an antimicrobial agent removal device. J. Clin.Microbiol. 11:462-464.
2 Applebaum, P.C. et al. 1983. Enhanced detection of bacteremia with a new BACTEC resin blood culture medium. J. Clin. Microbiol. 17:48-51.
3 Pohlman, J.K. et al. 1995. Controlled clinical comparison of Isolator and BACTEC 9240 Aerobic/F resin bottle for detection of bloodstream infections. J. Clin. Microbiol. 33:2525-2529.
4 Flayhart, D. et al. 2007. Comparison of BACTEC Plus blood culture media to BacT/Alert FA blood culture media for detection of bacterial pathogens in samples containing therapeutic levels of antibiotics. J. Clin. Microbiol. 45:816-821.
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DEVICE COMPARISON:
The BD BACTEC Plus Aerobic/F (plastic) differs from the BD BACTEC Plus Aerobic/F (K921133) in the following ways:
- The medium in the new device is contained in a plastic bottle; whereas, the . medium in the predicate device is contained in a glass bottle.
- : The new device's sensor has been adjusted to obtain equivalent performance to that of the predicate device.
- . The sugar concentration of the growth medium in the new device has been increased by 0.2%.
- The new device weighs approximately 60% less than predicate device. .
- The new device measures 5.0 inches high compared to the predicate device height . of 5.6 inches.
The BD BACTEC Plus Aerobic/F (plastic) is similar to the BD BACTEC Plus Aerobic/F (K921133) in the following ways:
- Both the new and predicate devices are used for the qualitative aerobic culture . and recovery of microorganisms from human blood.
- Both devices are intended to be used with the BD BACTEC fluorescent-series of . blood culture instruments.
- The BD BACTEC fluorescent-series of blood culture instruments apply the same . incubation and agitation parameters to both devices.
- The BD BACTEC fluorescent-series of blood culture instruments apply the same . growth and detection algorithms to both devices.
- Both devices are incubated at 35° C (± 1.5° C) for a period of up to 120 hours. .
- Both devices incorporate resins for the adsorption of antimicrobials that may be . present in clinical samples.
- Both devices incorporate a sensor that detects increases in CO2 within the bottle . as a result of organism growth. Both devices require a sample volume of 3 - 10 mL of blood.
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- Both devices utilize 30 mL of enriched soybean casein digest broth as the growth ● medium.
- Both devices have a maximum blood to broth ratio of 1:4. ●
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SUMMARY OF PERFORMANCE DATA
Analytical Studies:
Instrument Time to Detection
A total of 726 paired sets were positive in both the new and predicate devices. There was no significant difference in recovery between the BD BACTEC Plus Aerobic/F blood culture medium contained in plastic bottles and the predicate device contained in glass bottles. The Wilcoxon estimated median TTD difference for the 726 positive sets is 0.083 hours (5 minutes).
The following organisms exhibited TTD differences of greater than 1 hour (plastic vials minus glass vials): Candida glabrata (-2.83), Cryptococcus neoformans (-1.67), Haemophilus parainfluenzae biotype I (1.33). Micrococcus luteus (2.83), Leuconostoc spp. (8.00) (i.e., Candida glabruta and Cryptococcus neoformans recovered faster in the new device; whereas Haemophilus parainfluenzae biotype I, Micrococcus luteus and Leuconostoc spp. recovered faster in the predicate device). Micrococcus luteus is rarely implicated as a cause of human infections and is usually considered a contaminant of clinical specimens. Leuconostoc spp. is very rarely isolated in blood culture specimens and when it is, it is often not clinically significant.
The data indicate that the effect of differences between the new and predicate devices on TTD under these test conditions was minimal and that the new device performs equivalently to the predicate device.
Percent Recovery
A total of 738 paired sets were evaluated in the Percent Recovery comparison. Of those, 726 paired sets were positive in both the new and predicate devices (98.4%). The McNemar p-value for this data set equals 1. The data indicate that the effect of differences between the new and predicate devices on percent recovery under these test conditions was not statistically detectable and that the new device performs equivalently to the predicate device.
Leuconostoc spp. was recovered in nearly all replicates of the new device (17 of 18) and the predicate device (16 of 18). This organism is rarely associated with human disease and is usually considered a probable contaminant.
False Positive Rate
A total of 240 paired sets were used to execute this study. The 240 paired sets were comprised of 80 bottles from each of 3 lots. The paired sets were inoculated with fresh human blood at varving levels as specified by the test protocol and entered into the BACTEC blood culture instrument. It was expected that each bottle would be instrumentnegative following the complete protocol (120 hours). There were no false positive bottles of the new device observed within the recommended usage range of blood
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volumes (3 to 10 mL). Two false positive bottles were observed when inoculated with a blood volume outside of the recommended usage range for the device (