(240 days)
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Yes
The summary explicitly states that the device uses an algorithm based on "supervised machine learning known as the 'Advanced Spectrum Classifier'".
No.
The device is an in vitro diagnostic mass spectrometer system used to identify Gram-negative bacterial colonies to aid in the diagnosis of Gram-negative bacterial infections. It does not directly treat or prevent a disease.
Yes
The intended use explicitly states that the system is "indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections." This clearly positions it as a tool for diagnosis.
No
The device is described as a "mass spectrometer system" and the performance studies include testing of hardware components like the Bacterial Test Standard (BTS) and HCCA portioned (Matrix), indicating it is a hardware system with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the system is a "qualitative in vitro diagnostic mass spectrometer system" and is "indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details how the system analyzes bacterial samples (cultured from human specimens) to identify organisms based on their protein patterns. This process is performed in vitro (outside the body).
- Anatomical Site: The input is from "human specimens," which is a key characteristic of IVDs.
- Performance Studies: The extensive performance studies described (Precision/Repeatability, Specificity, Method Comparison, etc.) are typical evaluations required for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a predicate device (K124067; Vitek® MS MALDI-TOF mass spectrometer system) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
The presence of machine learning ("Advanced Spectrum Classifier") within the device's algorithm does not change its classification as an IVD. It is a component of the diagnostic process performed in vitro.
No
The input document does not contain explicit language stating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is marked "Not Found".
Intended Use / Indications for Use
The Bruker Daltonics, Inc MALDI Biotyper CA System is a qualitative in vitro diagnostic mass spectrometer system for the identification of Gram-negative bacterial colonies cultured from human specimens using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) mass spectrometry technology.
The MALDI Biotyper CA System is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections.
Product codes (comma separated list FDA assigned to the subject device)
PEX
Device Description
The MBT-CA System uses a different methodology for organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ge 2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and =2.0 and 0/16 "no ID" and 0/16 (0%) "false ID" for both targets.
Proficiency/Familiarity:
Prior to method comparison study initiation, each intended study operator from the four (4) US Study sites underwent a proficiency/familiarity period to ensure that each operator was familiar with all aspects of instrument operation. Each intended operator was asked to test five (5) QC organisms using both the Direct Transfer (DT) and Extraction (Ext) method following product instructions for use. All operators across 4 sites showed high rates of samples passed (mostly 25/25, 29/30, 30/30, 32/32, 30/35) for both DT and Ext methods, confirming reproducibility.
Reproducibility:
The reproducibility study was conducted to confirm day-to-day reproducibility and precision of the MALDI Biotyper CA System on different clinical study was conducted for five (5) days with two (2) runs each day/each clinical site. The sources of variability tested were: Two (2) operators/each clinical study site, Four (4) clinical study sites, Four (4) Target plates each clinical study sites, Four (4) microflex LT/SH instruments. Ten (10) well-characterized organisms were chosen for this study and tested in duplicate via direct transfer method.
100% of all blinded test organisms (80/80) were correctly identified on the species level at each clinical test site when both DT and Ext methods were used.
Challenge Panel:
A panel of 100 organisms was tested at five (5) study sites. Eighty (80) of the Organisms included in the panel were selected from stored organisms tested during the clinical study. Twenty (20) were selected from strain collections. The study reference laboratory, prepared the panel. Organism identifications were blinded to test sites. Each site tested the challenge panel member via direct transfer method in accordance with product instructions. If DT result yielded a log(score) =2.0), 48 showed Positive Organism ID (Low Confidence, log(score) >=1.7, =2.0, and 9 (Positive Organism (Low Discrimination)). Total Positive was 497.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for details on Correct Identification rates, False Identifications, No Identifications, and log(score) thresholds.
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.
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
Not Found
§ 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
(a)
Identification. A mass spectrometer system for clinical use for the identification of microorganisms is a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a spectral database. The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software.
(2) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols.
(3) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(4) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(5) Premarket notification submissions must include details on the appropriate end user device training program that will be offered while marketing the device.
0
510(k) SUMMARY
| Date of Summary: | October 28, 2013 |
|---|---|
| Product Name | MBT-CA System |
| Sponsor: | Bruker Daltonics, Inc |
| 40 Manning Road, | |
| Billerica, MA 01821 | |
| Correspondent | MDC Associates, LLC |
| Fran White, Regulatory Consultant | |
| 180 Cabot Street | |
| Beverly, MA 01915 | |
| Device Identification | |
| Trade or Proprietary Name: | MALDI Biotyper CA System |
| Common or Usual Name: | Mass spectrometer for clinical multiplex test systems |
| Product Code: | PEX |
| Regulation Section: | 21 CFR 862.3361 Instrumentation for clinical multiplex test sys |
21 CFR 862.3361 Instrumentation for clinical multiplex test systems Class II (special controls) Microbiology
Substantial Equivalency
Device Class:
Panel:
The Bruker Daltonics, Inc MBT-CA System is substantially equivalent to the Vitek® MS MALDI-TOF mass spectrometer system (K124067). Table 1 compares the characteristics of the MBT-CA System (New Device) and the Vitek® MS (predicate device).
1
Comparison of New Device with Predicate Device
TABLE 1: Substantial Equivalency Table
| Similarities | ||
|---|---|---|
| Characteristic | NEW DEVICE | |
| Bruker Daltonics, Inc MBT-CA System | ||
| (K130831) | PREDICATE DEVICE | |
| Vitek® MS | ||
| (K124067) | ||
| Product Codes | PEX | PEX |
| Intended use | The Bruker Daltonics, Inc MALDI Biotyper | |
| CA System is a qualitative in vitro | ||
| diagnostic mass spectrometer system for | ||
| the identification of Gram-negative | ||
| bacterial colonies cultured from human | ||
| specimens using matrix-assisted laser | ||
| desorption/ ionization - time of flight | ||
| (MALDI-TOF) mass spectrometry | ||
| technology. |
The MALDI Biotyper CA System is
indicated for use in conjunction with
other clinical and laboratory findings to
aid in the diagnosis of Gram negative
bacterial infections. | The Vitek® MS is a mass spectrometer
system using matrix-assisted laser
desorption/ionization-time to flight
(MALDI-TOF) for the identification of
microorganisms cultured from human
specimen.
The VITEK MS is a qualitative in vitro
diagnostic device indicated for use in
conjunction with other clinical and
laboratory findings to aid in the diagnosis
of bacterial and yeast infections. |
| Sample type | Isolated colony from any patient sample
source.
Acceptable media:
• Columbia blood agar with 5% sheep
blood
• Trypticase soy agar with 5% sheep
Blood
• Chocolate agar
• MacConkey Agar | Isolated colony from any patient sample
source.
Acceptable media:
• Columbia blood agar with 5% sheep
blood
• Trypticase soy agar with 5% sheep
Blood
• Chocolate polyvitex agar
• Campylosel agar
• MacConkey Agar
• Modified Sabouraud dextrose Agar
• ChromID CPS |
| Type of Test | Automated Mass Spectrometry System | Automated Mass Spectrometry System |
| Matrix | α-Cyano-4-hydroxycinnamic acid | α-Cyano-4-hydroxycinnamic acid |
| Method of
Testing | Bacteria: Direct testing
If after initial analysis the log(score) is
reported at Similarities | | |
| Characteristic | NEW DEVICE
Bruker Daltonics, Inc MBT-CA System
(K130831) | PREDICATE DEVICE
Vitek® MS
(K124067) |
| Result
Reporting | Organism identification is reported with
high confidence if the log(score) is $\ge$ 2.00.
An organism identification is reported with low confidence if the log(score) is
between 1.70 and