(59 days)
BACTEC® 9240 System
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No
The description mentions "Positivity Algorithms by Media Type" but provides no indication that these algorithms utilize AI or ML. The performance studies focus on equivalence to a predicate device based on recovery rates and time to detection, not on the performance of any AI/ML component. There is no mention of AI, DNN, or ML in the provided text.
No.
The device is an automated blood culturing system designed for the detection of microorganisms in blood, not for treating or diagnosing a disease.
Yes
The device is described as a "blood culturing system which is designed for the monitoring and detection of clinical cultures of blood for the presence of microorganisms." This function directly supports the diagnosis of infections by identifying the presence of microorganisms in blood samples.
No
The device description clearly outlines hardware components such as a Florescence Detector (LED), agitation mechanism, incubator, power supplies, and physical dimensions, indicating it is a physical system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring and detection of clinical cultures of blood for the presence of microorganisms." This is a diagnostic purpose performed on a biological sample (blood) in vitro (outside the body).
- Device Description: The description details a system that analyzes blood cultures using a fluorescence detector to detect microbial growth. This process is a classic example of an in vitro diagnostic test.
- Anatomical Site: The anatomical site is listed as "blood," which is a biological specimen used for in vitro testing.
The information provided clearly indicates that this device is designed to perform a diagnostic test on a biological sample outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A non-radiometric automated blood culturing system which is designed for the monitoring and detection of clinical cultures of blood for the presence of microorganisms.
Product codes
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Device Description
BACTEC 9050 System is an automated blood culturing system that monitors and detects the presence of microorganisms in clinical blood cultures. It processes 50 specimens, uses positivity algorithms by media type for culture analysis, and has an agitation state "On" during testing. Detection optics use a Fluorescence Detector (LED) and incubation temperature is 35°C +/- 1.5°C. Protocol length is 4 to 7 days, and it uses Fluorescent Series Media. Specimen testing frequency is every 10 minutes, and it uses low voltage DC power supplies. The display screen shows 1 rack (Rotor). Its dimensions are 24"W x 28.5"H x 25.5"D.
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
Nonclinical tests were conducted to determine the substantial equivalence of the BACTEC 9050 to the BACTEC 9240. A total of 485 paired seeded vials were detected in both systems using 23 organisms that were chosen for their clinical relevency and are representative of the organisms for which the various media types are designed to support growth. The current available media was used in the tests along with the recommended minimum and maximum blood volumes.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were conducted to determine the substantial equivalence of the BACTEC 9050 to the BACTEC 9240. A total of 485 paired seeded vials were detected in both systems using 23 organisms. The difference in recovery between the BACTEC 9240 and the BACTEC 9050 systems was 0.2% with a mean time to detection for microorganisms being equal (
§ 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
AUG - 8 1996
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
- SUBMITTED BY: BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIRCLE SPARKS, MD 21152
CONTACT: Robert E. James, Director International Regulatory and Quality Development TELEPHONE: (410) 584-7116 FAX: (410) 584-8121
PREPARED: June 6, 1996
- DEVICE NAME: BACTEC® 9050 System
- COMMON NAME: Blood Culture Instrument
CLASSIFICATION
NAME: Monitor, Microbial Growth
PREDICATE
DEVICE: BACTEC® 9240 System
- INTENDED USE: A non-radiometric automated blood culturing system which is designed for the monitoring and detection of clinical cultures of blood for the presence of microorganisms.
- SUMMARY: Table 1 summarizes the similarities and differences between the BACTEC 9050 and the BACTEC 9240/9120.
Nonclinical tests were conducted to determine the substantial equivalence of the BACTEC 9050 to the BACTEC 9240. A total of 485 paired seeded vials were detected in both systems using 23 organisms that were chosen for their clinical relevency and are representative of the organisms for which the various media types are designed to support growth. The current available media was used in the tests along with the recommended minimum and maximum blood volumes. The difference in recovery between the BACTEC 9240 and the BACTEC 9050 systems was 0.2% with a mean time to detection for microorganisms being equal (