(59 days)
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.
BACTEC® 9050 System is a non-radiometric automated blood culturing system. It has a capacity of 50 specimens, uses Positivity Algorithms by Media Type for culture analysis, has agitation on during testing, uses a Florescence Detector (LED) for detection optics, incubates at 35°C ± 1.5°C, has a protocol length of 4 to 7 Days, uses Florescent Series Media, tests specimens every 10 Minutes, uses Low Voltage DC power supplies, and displays 1 rack (Rotor). Its dimensions are 24"W x 28.5"H x 25.5"D.
Here's an analysis of the provided text, focusing on the acceptance criteria and study details:
Acceptance Criteria and Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device rather than defining specific numerical acceptance criteria for a novel performance threshold. The core acceptance criterion appears to be that the BACTEC 9050 performs "equivalent" to the BACTEC 9240.
| Acceptance Criteria | Reported Device Performance (BACTEC 9050 vs. BACTEC 9240) |
|---|---|
| Recovery rate of microorganisms for clinically relevant organisms using available media and recommended blood volumes. | Difference in recovery: 0.2% |
| Mean time to detection of microorganisms. | Mean time to detection: Equal (<0.01 hours difference) |
| Overall performance compared to predicate device (BACTEC 9240). | Performed "equivalent" to the BACTEC 9240. |
Study Details
- Sample Size for Test Set: 485 paired seeded vials.
- Data Provenance: Not explicitly stated, but given it's a non-clinical test using "seeded vials" (likely laboratory-prepared cultures), it's a controlled laboratory setting rather than patient-derived data. The country of origin is not mentioned. It is a prospective, non-clinical test.
- Number of Experts Used to Establish Ground Truth for Test Set and Qualifications: Not applicable. The "ground truth" for these non-clinical tests would have been the known quantity and type of microorganisms seeded into the vials. There's no mention of expert consensus or interpretation required for this.
- Adjudication Method: Not applicable. As the ground truth is based on known seeded organisms, no expert adjudication process is described or needed.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This study is a technical performance comparison between two automated blood culture instruments in a non-clinical setting, not an evaluation of human reader performance with or without AI assistance.
- Standalone Performance (Algorithm Only): Yes, this study evaluates the standalone performance of the BACTEC 9050 system's ability to detect microbial growth compared to the BACTEC 9240. There isn't a human-in-the-loop component described.
- Type of Ground Truth Used: "Known seeded organisms." The study involved using 23 specific organisms chosen for clinical relevance, implying that the presence and identity of these organisms in the seeded vials constituted the ground truth.
- Sample Size for Training Set: Not applicable. This document describes a non-clinical validation study comparing a new device to a predicate, not the development or training of an AI algorithm.
- How Ground Truth for Training Set was Established: Not applicable. (See above).
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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 (<0.01 hours). The BACTEC 9050 performed equivalent to the BACTEC 9240.
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Table 1
Comparison of BACTEC 9240/9120 and BACTEC 9050
| BACTEC 9240/9120 | BACTEC 9050 | |
|---|---|---|
| Number of Specimens | 240/120 | 50 |
| Intended Use | Growth and detection of clinical cultures ofblood for the presence of microorganisms | Same |
| Sample Type | Blood | Same |
| Culture Analysis | Positivity Algorithms by Media Type | Same |
| Agitation State During Testing | Off | On |
| Detection Optics | Florescence Detector (LED) | Same |
| Incubation Temperature | 35°C ± 1.5°C | Same |
| Protocol Length | 1 to 30 Days | 4 to 7 Days |
| Reagents | Florescent Series Media | Same |
| Specimen Testing Frequency | Every 10 Minutes | Same |
| Power Supplies | Low Voltage DC | Same |
| Display Screen | Displays 6 racks/3 racks | Displays 1 rack ( Rotor) |
| Dimensions | 52"W x 38"H x 22.5"D/52"W x 24"H x 22.5"D | 24"W x 28.5"H x 25.5"D |
§ 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.