(127 days)
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No
The description focuses on chemical sensors and fluorescence detection, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is used to detect microorganisms in blood cultures, not to treat a condition or disease.
Yes
The device detects the presumptive presence of viable microorganisms in blood samples by monitoring CO2 production, which directly aids in diagnosing infections.
No
The device description clearly outlines a physical culture medium vial containing a chemical sensor and its interaction with a BACTEC fluorescent series instrument for incubation and reading. This involves hardware components (vials, sensor, instrument) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "aerobic culture and recovery of microorganisms (bacteria and yeast) from blood." This is a diagnostic procedure performed in vitro (outside the body) on a biological sample (blood) to identify the presence of microorganisms.
- Device Description: The description details how the device works by detecting CO2 produced by microbial growth in a culture medium. This process is a standard method for diagnosing infections by identifying the causative agent in a patient sample.
- Anatomical Site: The sample is blood, which is a biological specimen used for diagnostic testing.
- Performance Studies: The provided performance studies (Time to Detection, Percent Recovery, False Positive Rate, False Negative Rate, Antimicrobial Neutralization Capability) are typical evaluations for an IVD device used in microbiology to assess its accuracy and reliability in detecting microorganisms.
- Predicate Device: The predicate device listed (BD BACTEC PLUS Aerobic/F medium) is also an IVD used for blood culture.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD BACTEC Plus PRIME 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 affer 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Studies:
- Instrument Time to Detection: A total of 333 paired sets were positive in both the new and predicate devices. The estimated median TTD difference for the 333 positive sets is 0.92 hours (55 minutes). At the 10 to 100 CFU inoculum level, approximately 80% of 244 paired sets had a time to detection difference of less than 10%. 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 246 paired sets were evaluated. 244 paired sets were positive in both the new and predicate devices (99.2%). The data indicate that the effect of differences between the new and predicate devices on percent recovery under these test conditions was not statistically significant and that the new device performs equivalently to the predicate device.
- False Positive Rate: A total of 120 paired sets (40 bottles from each of 3 lots) were used. All 120 paired sets completed the protocol with no positive results observed in either the new or predicate devices.
- False Negative Rate: A total of 93 paired sets were evaluated. There were two false negative results with the new device (Kingella kingae). Subsequent testing of five isolates of K. kingae demonstrated growth and recovery as expected.
- Antimicrobial Neutralization Capability:
- Eleven drugs representing their classes were evaluated at the MIC level of selected strains. Both devices demonstrated complete recovery (100%) in 10 out of 11 drug classes. With aztreonam, observed recovery rates were 55.6% for the new device and 66.7% for the predicate device. There was no statistically significant difference in recovery between the new and predicate devices observed during this evaluation (McNemar's test p-value = 0.5637).
- A total of 150 paired sets were evaluated at the peak serum level. The P-value for the peak serum level drug-bug challenge was less than (
§ 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.
0
7 2012
AUG
510(k) SUMMARY SUBMITTED BY: BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE
SPARKS, MD 21152 Phone: 410-316-4905 Fax: 410-316-4499
Paul Swift, Regulatory Affairs Specialist CONTACT NAME: DATE PREPARED: August 7. 2012 DEVICE TRADE NAME: BD BACTEC Plus PRIME Aerobic/F
DEVICE COMMON NAME: Aerobic blood culture medium
DEVICE CLASSIFICATION: 21 CFR§866.2560, Class I
PREDICATE DEVICE: BD BACTEC PLUS Aerobic/F medium (K083572)
INTENDED USE:
The BD BACTEC Plus PRME 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 affer 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
BD Diagnostic Systems Becton, Dickinson and company Page 1
1 Wallis, C. et al. 1980. Rapid isolation of bacteria from septicemic patients 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 PRIME Acrobic/F medium differs from the BD BACTEC Plus Aerobic/F (K083572) medium in the following ways:
- The resin blend in the modified device consists of two hydrophobic adsorbing . resins and one cationic exchange resin; whereas, the current legally marketed device contains one hydrophobic adsorbing resin and one cationic exchange resin.
- The percent of total resin blend per weight volume is lower in the modified device . compared to the current legally marketed device.
- The concentration of sodium polyanetholsulfonate (SPS) is 0.085% per weight . volume in the modified device; whereas, the current legally marketed device contains 0.05% SPS per weight volume.
The BD BACTEC Plus PRIME Aerobic/F medium is similar to the BD BACTEC Plus Acrobic/F (K083572) medium 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. o
- . 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.
- 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.
- Both devices are contained in glass vials. .
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SUMMARY OF PERFORMANCE DATA
Analytical Studies:
Instrument Time to Detection
A total of 333 paired sets were positive in both the new and predicate devices. There was no clinically relevant difference in recovery hours between the BD BACTEC Plus PRIME Aerobic/F blood culture medium and the predicate device. The estimated median TTD difference for the 333 positive sets is 0.92 hours (55 minutes). At the 10 to 100 CFU inoculum level, approximately 80% of 244 paired sets had a time to detection difference of less than 10%: 18% of the paired sets that had time to detection increases, and approximately 2% had time to detection decreases with the BD BACTEC Plus PRIME Aerobic/F medium when comparing to the predicate device.
The following organisms had a mean TTD difference that was more rapid in the predicate device: Abiotrophia defectiva (2.39 h), Acinetobacter Iwoffii (0.97), Cardiobacterium hominis (3.11 h), Haemophilus influenzae (3.70 h), Streptococcus sanguinis (8.12 h), Candida albicans (0.75 h), Enterococcus faecalis (0.62 h), Granulicatella spp. (1 h), Kingella kingae (4.38 h), Micrococcus luteus (1.06 h), Pediococcus acidilactici (1.08 h) and Streptococcus pneumoniae (0.81 h). Leuconostoc spp. exhibited a mean TTD difference increase of 10.00 h compared to the predicate device (mean TTD of 69.21 h), an increase of 14.45% in the new device.
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 246 paired sets were evaluated in the Percent Recovery comparison. There was no significant difference in recovery between the BD BACTEC Plus PRIME Aerobic/F blood culture medium and the predicate device. Of those, 244 paired sets were positive in both the new and predicate devices (99.2%). The McNemar p-value for this data set equals 0.1573. The data indicate that the effect of differences between the new and predicate devices on percent recovery under these test conditions was not statistically significant and that the new device performs equivalently to the predicate device.
False Positive Rate
A total of 120 paired sets were used to execute this study. The 120 paired sets were comprised of 40 bottles from each of 3 lots. The paired sets were inoculated with fresh human blood at varying levels as specified by the test protocol and entered into the the BACTEC blood culture instrument. It was expected that each bottle would be instrumentnegative following the complete protocol (120 hours). All 120 paired sets completed the protocol with no positive results observed in either the new or predicate devices.
BD Diagnostic Systems Becton, Dickinson and company Page 3
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False Negative Rate
A total of 93 paired sets were evaluated for the determination of the False Negative Rate of the new device. There were two false negative results with the new device: Kingella kingae with 3 mL of blood (plate count 31 CFU). The K. kingae replicates that failed to recover in the new device were determined to be false negative based on the expected test results. Terminal subcultures of both replicates resulted in no growth. Subsequent testing of five isolates of K. kingae, including the false negative isolate noted above, under the same test conditions and over three lots all demonstrated growth and recovery as expected.
Antimicrobial Neutralization Capability
Both the new and predicate devices incorporate resins to enhance the recovery of microorganisms by adsorption of antibiotics in the blood sample. The new device incorporates a third resin for additional antimicrobial neutralization capability. Eleven drugs representative of their classes were evaluated at the MIC level of selected strains to demonstrate equivalent performance of the new device to the predicate device. At the MIC level, both devices demonstrated complete recovery (100%) in 10 out of 11 drug classes. With aztreonam, observed recovery rates were 55.6% and 66.7% for the BD BACTEC Plus PRIME Aerobic/F medium and the BD BACTEC Plus Aerobic/F medium, respectively. There was no statistically significant difference in recovery between the new and predicate devices observed during this evaluation (McNemar's test p-value = 0.5637).
A total of 150 paired sets were evaluated at the peak serum level. Concentrations of antimicrobials in test vials were at an average of 20x the MIC of the test organisms. The P-value for the peak serum level drug-bug challenge as calculated with the McNemar's test was less than (