(515 days)
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No
The description focuses on a fluorescence-based detection system for oxygen consumption, which is a standard biological assay method, not AI/ML. There are no mentions of AI, ML, image processing, or data-driven algorithms for analysis or interpretation.
No
The device is used for the detection of mycobacteria, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is used for the "Detection of mycobacteria in clinical respiratory specimens," which directly supports diagnosing an infection.
No
The device description clearly outlines hardware components including a fluorescence sensor, silicon rubber base, and an on-board incubator, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Detection of mycobacteria in clinical respiratory specimens." This clearly indicates the device is used to examine specimens taken from the human body (in vitro) to provide information for diagnostic purposes (detecting mycobacteria).
- Device Description: The description details a system that analyzes a biological sample (respiratory specimens) using a broth and a fluorescence sensor to detect biological activity (mycobacterial growth). This is a typical setup for an in vitro diagnostic test.
- Predicate Device: The mention of predicate devices like "BACTEC® 460TB" and "CONVENTIONAL MEDIA" further supports its classification as an IVD. These are known IVD devices used for similar purposes.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
N/A
Intended Use / Indications for Use
Detection of mycobacteria in clinical respiratory specimens
Product codes
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Device Description
Fluorescence sensor in silicon rubber base
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)
The BACTEC® 9000MB system was compared to the BACTEC® 460TB system and Conventional Media (Lowenstein-Jensen agar slants) for the detection of mycobacteria.
BACTEC® 9000MB versus BACTEC® 460TB:
- Intended Use: Detection of mycobacteria in clinical respiratory specimens (BACTEC® 9000MB) vs. Detection of mycobacteria in clinical specimens (BACTEC® 460TB).
- Sample type: Primary sample type - respiratory for both. Other body fluids (including blood) acceptable for BACTEC® 460TB.
- Sample volume: 0.5 mL for BACTEC® 9000MB vs. 0.5 to 1.0 mL for BACTEC® 460TB.
- Growth medium: 7H9 Middlebrook broth base with nutrient additives for BACTEC® 9000MB vs. 7H12 Middlebrook broth base with nutrient additives for BACTEC® 460TB.
- Detector: Fluorescence sensor in silicon rubber base for BACTEC® 9000MB vs. ¹⁴C labeled fatty acid present in the media for BACTEC® 460TB.
- Antimicrobial supplement: Polymixin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin (PANTA) for both.
- Growth detection: Fluorescent detection of O₂ consumption by mycobacterial growth for BACTEC® 9000MB vs. Radiometric detection of CO₂ liberated by mycobacterial growth for BACTEC® 460TB.
- Time to detection (TTD): Eleven to fifteen days for BACTEC® 9000MB vs. Seven to twelve days for BACTEC® 460TB.
- Incubation temp. mixing: On-board incubation at 37°C ± 1.5°C; internal instrument agitation every 10 minutes for BACTEC® 9000MB vs. External incubation at 37° C ± 1.0° C. No agitation in instrument for BACTEC® 460TB.
BACTEC® 9000MB versus CONVENTIONAL MEDIA:
- Intended Use: Detection of mycobacteria in clinical respiratory specimens (BACTEC® 9000MB) vs. Used for the cultivation of Mycobacterium tuberculosis and other mycobacterial species (Conventional Media).
- Sample type: Primary sample type - respiratory for both. Other body fluids (including blood) acceptable for Conventional Media.
- Sample volume: 0.5 mL for BACTEC® 9000MB vs. 0.1 to 0.5 mL for Conventional Media.
- Growth medium: 7H9 Middlebrook broth base with nutrient additives for BACTEC® 9000MB vs. Lowenstein-Jensen medium: Egg enriched agar base with nutrient additives for Conventional Media.
- Detector: Fluorescence sensor in silicon rubber base for BACTEC® 9000MB vs. None for Conventional Media.
- Antimicrobial supplement: Polymixin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin (PANTA) for BACTEC® 9000MB vs. None for Conventional Media.
- Growth detection: Fluorescent detection of O₂ consumption by mycobacterial growth for BACTEC® 9000MB vs. Macroscopic observance of growth on media surface for Conventional Media.
- Time to detection (TTD): Eleven to fifteen days for BACTEC® 9000MB vs. Twenty-one to forty-nine days for Conventional Media.
- Incubation temp. Mixing: On-board incubation at 37° ± 1.5°C; internal instrument agitation every 10 minutes for BACTEC® 9000MB vs. 35° C to 38° C⁺; Manual manipulation of media for Conventional Media.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
MAY 21 1996
SUMMARY OF SAFETY & EFFICACY
BACTEC® 9000MB versus BACTEC® 460TB Table 1:
| Intended Use | Detection of mycobacteria in clinical
respiratory specimens | Detection of mycobacteria in clinical
specimens |
|-----------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Primary sample type - respiratory | Primary sample type - respiratory;
other body fluids (including blood)
acceptable |
| Sample volume | 0.5 mL | 0.5 to 1.0 mL |
| Growth medium | 7H9 Middlebrook broth base with
nutrient additives | 7H12 Middlebrook broth base with
nutrient additives |
| Detector | Fluorescence sensor in silicon rubber
base | ¹⁴C labeled fatty acid present in the
media |
| Antimicrobial
supplement | Polymixin B, amphotericin B,
nalidixic acid, trimethoprim &
azlocillin (PANTA) | Polymixin B, amphotericin B,
nalidixic acid, trimethoprim &
azlocillin (PANTA) |
| Growth detection | Fluorescent detection of O₂
consumption by mycobacterial
growth | Radiometric detection of CO₂
liberated by mycobacterial growth |
| Time to detection
(TTD) | Eleven to fifteen days | Seven to twelve days |
| Incubation temp.
mixing | On-board incubation at 37°C ±
1.5°C; internal instrument agitation
every 10 minutes. | External incubation at 37° C ± 1.0°
C. No agitation in instrument. |
1
SUMMARY OF SAFETY & EFFICACY
BACTEC® 9000MB versus CONVENTIONAL MEDIA Table 2:
| Intended Use | Detection of mycobacteria in clinical
respiratory specimens | Used for the cultivation of
Mycobacterium tuberculosis and othe
mycobacterial species. |
|-----------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Sample type | Primary sample type - respiratory | Primary sample type - respiratory;
other body fluids (including blood)
acceptable |
| Sample volume | 0.5 mL | 0.1 to 0.5 mL |
| Growth medium | 7H9 Middlebrook broth base with
nutrient additives | Lowenstein-Jensen medium:
Egg
enriched agar base with nutrient
additives |
| Detector | Fluorescence sensor in silicon rubber
base | None |
| Antimicrobial
supplement | Polymixin B, amphotericin B,
nalidixic acid, trimethoprim &
azlocillin (PANTA) | None |
| Growth detection | Fluorescent detection of O₂
consumption by mycobacterial
growth | Macroscopic observance of growth
on media surface |
| Time to detection
(TTD) | Eleven to fifteen days | Twenty-one to forty-nine days |
| Incubation temp.
Mixing | On-board incubation at 37° ± 1.5°C;
internal instrument agitation every 10
minutes. | 35° C to 38° C⁺
Manual manipulation of media. |
CONVENTIONAL MEDIA -Lowenstein-Jensen agar slants tCDC recommendations