(300 days)
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BACTEC 460 TB, BACTEC 460
No
The summary describes an automated system for detecting mycobacteria growth based on established methods (growth promotion, comparison to predicate devices). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on growth detection and recovery rates, not on algorithmic performance metrics like AUC or standalone performance of an AI model.
No
Explanation: Therapeutic devices are used for treatment, prevention, or mitigation of disease. This device is for detection of mycobacteria, which is a diagnostic purpose, not a therapeutic one.
Yes
The device detects mycobacteria in clinical specimens, which is a qualitative procedure for diagnosing the presence of an infection.
No
The device description explicitly states it is an "Automated system for growth and detection of mycobacteria organisms," which implies hardware components for incubation, detection, and processing of the process bottles. The performance studies also describe growth promotion and comparison to other systems involving physical media and detection methods.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative procedures for recovery and detection of mycobacteria in clinical specimens other than blood." This describes a test performed on a sample taken from the human body to provide information about a person's health.
- Device Description: The device is described as an "Automated system for growth and detection of mycobacteria organisms in clinical specimens other than blood." This further reinforces its use in analyzing clinical samples.
- Clinical Specimens: The device is used with "clinical specimens," which are samples taken from a patient for diagnostic purposes.
- Detection of Mycobacteria: The purpose is to detect the presence of mycobacteria, which is a diagnostic activity.
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
MB/BacT Process bottles are used with the MB/BacT Mycobacteria Detection System in qualitative procedures for recovery and detection of mycobacteria in clinical specimens other than blood.
Product codes
Not Found
Device Description
Automated system for growth and detection of mycobacteria organisms in clinical specimens other than blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Growth promotion studies were performed on the MB/BacT Process System which consists of the media bottle, antibiotic supplement, and reconstitution fluid along with the MB/BacT instrument. These data were generated to demonstrate that the media was capable of growing several strains of mycobacteria in vitro. ATCC strains were used and clinical strains not commonly encountered were obtained from CDC for testing. These data demonstrate the MB/BacT Process System is capable of supporting growth of a variety of mycobacteria organisms. Colony counts were performed on select strains to determination the level of growth to trigger a positive reading by the instrument. These counts ranged from 100 to 10° CFU/ml. Data was generated on select strains of mycobacteria at different concentrations comparing MB/BacT to Bactec 460. Times to detection ranged from 7.9 to 17.1 days for MB/BacT and from 5 to 14 days for Bactec 460 (when a G.I. of 50 was considered positive).
Comparison Studies were conducted at 4 clinical sites to evaluate the performance of the MB/BacT Mycobacteria Detection System compared to conventional solid media for growth and detection of mycobacteria. One of the sites also used the BACTEC 460 in addition to conventional solid media. The comparative methods used at the sites were as follows:
- Site A Lowenstein-Jensen Slants Middlebrook 7H11 bi-plates containing selective and non-selective media
- Site B Lowenstein-Jensen Slants Middlebrook 7H11 selective agar slants
- Site C Lowenstein-Jensen Slants Middlebrook 7H11 bi-plates containing selective and non-selective media
- Lowenstein-Jensen Slants Site D Middlebrook 7H11 bi-plates containing selective and non-selective media BACTEC 460 TB
- Site E Lowenstein-Jensen Slants ВАСТЕС 460ТВ
Summary of Performance Studies
Nonclinical tests: Growth promotion studies were performed on the MB/BacT Process System. These data demonstrated that the media was capable of growing several strains of mycobacteria in vitro, including ATCC strains and clinical strains from CDC. Colony counts were performed on select strains to determine the level of growth to trigger a positive reading by the instrument, ranging from 100 to 10 CFU/ml. Comparison data for select mycobacteria strains at different concentrations showed MB/BacT detection times ranged from 7.9 to 17.1 days, and Bactec 460 from 5 to 14 days.
Clinical tests: Comparison studies were conducted at 4 clinical sites, evaluating MB/BacT against conventional solid media. One site also used BACTEC 460. The tables provided show the recovery of various Mycobacteria species. For MB/BacT vs BACTEC, out of 179 total isolates, MB/BacT was positive for 151, MB/BacT positive only for 22, Bactec positive for 150, and Bactec positive only for 18. For MB/BacT vs Solid Media, out of 395 total isolates, MB/BacT was positive for 335, MB/BacT positive only for 88, Solid positive for 307, and Solid positive only for 60.
Key results: The performance characteristics of the new device are comparable to those of the predicate devices. The data demonstrates that the new device performs substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Manual Methods including Lowenstein Jensen (LJ) slants, Middlebrook 7H11 solid media and Bactec 460
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
JUL 22 1996
510(k) Summary
BacT/Alert MB/BacT Mycobacteria Detection System
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and the final rule under 21 CFR 807.92 published December 14, 1994.
The submitter's name, address, telephone number, a contact person, and the date (A)(1) the summary was prepared:
Submitter's Name: Organon Teknika Corporation
Submitter's Address: 100 Akzo Avenue, Durham, NC, 27712
Submitter's Telephone: (919) 620-2634
Submitter's Contact: Ann M. Quinn
Date 510(k) Summary Prepared: July 11, 1996
(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known.
Trade or Proprietary Name: MB/BacT Mycobacteria Detection System
Common or Usual Name: Microbial Growth Monitor
Classification Name: Microbial Growth Monitor
(a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence.
Device Equivalent to: Manual Methods including Lowenstein Jensen (LJ) slants, Middlebrook 7H11 solid media and Bactec 460, all of which are pre amendment devices.
(a)(4) A description of the device
Device description: Automated system for growth and detection of mycobacteria organisms in clinical specimens other than blood.
(a)(5) A statement of the intended use of the device
Device Intended Use: MB/BacT Process bottles are used with the MB/BacT Mycobacteria Detection System in qualitative procedures for recovery and detection of mycobacteria in clinical specimens other than blood.
1
(a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device.
MB/BacT Mycobacteria Detection System detects the growth of mycobacteria in a broth culture bottle by colorimetric measurement of CO2 production. Bactec 460 detects the orowth of mycobacteria in a broth culture bottle by radiometric measurement of CO2 production. Manual solid media methods such as Lowenstein Jensen slants or Middlebrook 7H11 plates, growth is detected by visual examination. MB/BacT cultures are continuously monitored while the other methods are monitored periodically. MB/BacT is a closed monitoring system once the specimen is inoculated into the bottle. This limits the technologist's exposure to potentially infectious organisms. This safety feature is not present in the other systems.
(b)(1) A brief discussion of the nonclinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalency.
Growth promotion studies were performed on the MB/BacT Process System which consists of the media bottle, antibiotic supplement, and reconstitution fluid along with the MB/BacT instrument. These data were generated to demonstrate that the media was capable of growing several strains of mycobacteria in vitro. ATCC strains were used and clinical strains not commonly encountered were obtained from CDC for testing. These data demonstrate the MB/BacT Process System is capable of supporting growth of a variety of mycobacteria organisms. Colony counts were performed on select strains to determination the level of growth to trigger a positive reading by the instrument. These counts ranged from 100 to 10° CFU/ml. Data was generated on select strains of mycobacteria at different concentrations comparing MB/BacT to Bactec 460. Times to detection ranged from 7.9 to 17.1 days for MB/BacT and from 5 to 14 days for Bactec 460 (when a G.I. of 50 was considered positive)
(b)(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalency.
Comparison Studies were conducted at 4 clinical sites to evaluate the performance of the MB/BacT Mycobacteria Detection System compared to conventional solid media for growth and detection of mycobacteria. One of the sites also used the BACTEC 460 in addition to conventional solid media. The comparative methods used at the sites were as follows:
- Site Comparative Method
- Site A Lowenstein-Jensen Slants Middlebrook 7H11 bi-plates containing selective and non-selective media
- Site B Lowenstein-Jensen Slants Middlebrook 7H11 selective agar slants
- Site C Lowenstein-Jensen Slants Middlebrook 7H11 bi-plates containing selective and non-selective media
2
Lowenstein-Jensen Slants Site D Middlebrook 7H11 bi-plates containing selective and non-selective media BACTEC 460 TB
- Site E Lowenstein-Jensen Slants ВАСТЕС 460ТВ
A summary of the organisms recovered and comparison to the predicate devices is provided in the following tables.
| Mycobacteria species
only | Total
recovered | MB/BacT
pos | MB/BacT
pos only | Bactec
pos | Bactec
pos only | Solid
pos | Solid
pos |
|------------------------------|--------------------|----------------|---------------------|---------------|--------------------|--------------|--------------|
| M. avium | 67 | 52 | 4 | 61 | 10 | 43 | 0 |
| M. chelonae | 6 | 4 | 0 | 6 | 2 | 2 | 0 |
| M. gordonae | 21 | 17 | 14 | 7 | 2 | 3 | 0 |
| M. intracellulare | 1 | 1 | 0 | 0 | 0 | 1 | 0 |
| M. kansasii | 2 | 2 | 0 | 2 | 0 | 2 | 0 |
| M. simiae | 1 | 1 | 0 | 1 | 0 | 1 | 0 |
| M. tuberculosis | 79 | 74 | 4 | 71 | 2 | 65 | 0 |
| M. xenopi | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Atypical mycobacteria | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Total isolates | 179 | 151 | 22 | 150 | 18 | 117 | 0 |
Recovery of Mycobacteria species - MB/BacT vs BACTEC
Recovery of Mycobacteria species - MB/BacT vs Solid Media
| Mycobacteria species | Total
recovered | MB/BacT
pos | MB/BacT
pos only | Solid
pos | Solid
pos only |
|------------------------|--------------------|----------------|---------------------|--------------|-------------------|
| M. avium | 132 | 111 | 38 | 94 | 21 |
| M. chelonae | 6 | 5 | 3 | 3 | 1 |
| M. fortuitum | 7 | 6 | 3 | 4 | 1 |
| M. gordonae | 31 | 30 | 24 | 7 | 1 |
| M. kansasii | 12 | 9 | 2 | 10 | 3 |
| M. terrae | 1 | 0 | 0 | 1 | 1 |
| M. tuberculosis | 205 | 173 | 18 | 187 | 32 |
| M. xenopi | 1 | 1 | 0 | 1 | 0 |
| Total isolates | 395 | 335 | 88 | 307 | 60 |
3
The conclusions drawn from the nonclinical and clinical tests that demonstrate (b)(3) that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
The performance characteristics of the new device are comparable to those of the predicate devices and typical of methods used for detection of mycobacteria. The data presented in the premarket notification demonstrate that the new device performs substantially equivalent to the predicate devices.