FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper System (CA, sirius CA, or sirius one CA) for the qualitative identification of microorganisms using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens.

The BD Kiestra IdentifA is indicated for use in the clinical laboratory with the BD Kiestra ReadA Compact and Bruker MALDI Biotyper System (CA, sirius one CA) to aid in the diagnosis of bacterial and fungal infections.

Device Description

The BD Kiestra™ IdentifA automates preparation of MALDI targets for the Bruker MALDI Biotyper® CA System, sirius CA system, and/or sirius one CA System that are used in clinical laboratories for identification and differentiation of organisms grown on plated media by Matrix-Assisted Laser Desorption/lonization Time-of-Flight Mass Spectrometry (MALDI-TOF MS). The system comprises of the BD Kiestra™ IdentifA module (including the associated software and onboard nephelometers and pipetting system), formic acid and automation-compatible transfer vials (for HCCA matrix and Bacterial Test Standard (BTS), which are obtained directly from Bruker and manually transferred to the vials for use on the instrument), consumables (pipette tips and cuvette arrays for preparation of organism suspensions and fluid movement), and nephelometer calibration standards (McFarland standard vials for measuring turbidity of microbial suspensions).

When identification of an organism growing on a culture medium plate is required, a technologist designates specific colonies for picking by the BD Kiestra™ IdentifA module using a digital image of the plate obtained using the BD Kiestra™ ReadA Compact module. The BD Kiestra™ IdentifA automatically suspends the designated colonized water and uses an onboard nephelometer to determine the resulting turbidity. The organism concentration is adjusted automatically by picking additional designated colonies or by appropriate dilution of the suspension to achieve a turbidity within a targeted range of McFarland values. Based on the final organism concentration, the BD Kiestra™ IdentifA pipets one or more aliquots of the microbial suspension onto a MALDI target (either reusable 48-spot or disposable 96-spot targets) and dries the spots at elevated temperature.

The BD Kiestra™ IdentifA performs the extended Direct Transfer (eDT) Sample Preparation Procedure from Bruker whereby the instrument overlays the dried sample spot on the MALDI target with formic acid and matrix. The BD Kiestra™ IdentifA also spots the BTS used for quality control of MALDI-TOF MS organism identification. Once spots are dry, the technologist manually removes the target from the BD Kiestra™ IdentifA and loads it into the Bruker MALDI Biotyper® System for analysis. Information regarding the location of each sample and BTS on the targets and the associated MALDI-TOF MS results are transmitted between the BD Kiestra™ IdentifA and Bruker MALDI Biotyper® System via the Synapsys Informatics, the main software interface, and the BD Kiestra™ BeA, the data interface hub module that communicates with all the other modules including the BD Kiestra™ IdentifA. In addition to preparing the MALDI target, if requested, the BD Kiestra™ IdentifA will also dilute the organism suspension to a standardized turbidity of 0.5 McFarland.

Modules of the BD Kiestra™ System each have their own operating software that communicates via the central BeA data interface hub module with the Synapsys user interface which in turn sends and receives information to/from the Laboratory Information System (LIS).

The BD KiestraTM ReadA or ReadA Compact module is required for use in conjunction with the BD Kiestra™ IdentifA module for image capture. Culture plate incubation may be done offline and then moved to the BD Kiestra™ ReadA or ReadA Compact module for imaging, or incubation can be done in the ReadA and then remain in the ReadA for imaging. Additional software modules (BD Synapsys Informatics and BD Kiestra™ BeA) are also required for the function of the BD Kiestra™ IdentifA, and these modules reside on the BD Kiestra™ Laboratory Automation Solution. The digital image is used by the BD Kiestra™ IdentifA for image analysis and colony designation by the operator.

AI/ML Overview

The provided text outlines the performance characteristics and acceptance criteria for the BD Kiestra IdentifA device. This device is an automated in vitro diagnostic specimen preparation system for MALDI-TOF MS analysis of microorganisms. The submission focuses on demonstrating substantial equivalence to a predicate device (K191964) with the addition of the BD Kiestra ReadA camera system and the Bruker MALDI Biotyper sirius CA and sirius one CA systems.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful outcomes of the studies demonstrating equivalency or accuracy. The performance is reported as meeting these criteria.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Supporting Performance
Colony Picking Accuracy: 100% of colonies picked successfully by BD Kiestra IdentifA, and 100% of MALDI target spots provide expected identification with High Confidence Log(score) values ≥ 2.00.	All (100%) 1230 colonies were picked successfully. All (100%) of 408 MALDI target spots provided the expected identification, with High Confidence Log(score) values ≥ 2.00.	Study 1
Camera Equivalency (BD Kiestra ReadA 25MP vs. ReadA Compact 5MP): Overall Minimal Morphological Identification (MMI) percent agreement between BD Kiestra ReadA (25MP) and ReadA Compact (5MP) plate images should demonstrate equivalency.	Overall MMI percent agreement was 99% for TSA II media and 100% for MAC media. Two of three BD Kiestra ReadA (25MP) systems had 100% agreement. One reader on the third system had 1 discrepancy with a low dilution, deemed not significant.	Study 2
Identification Accuracy (Bruker MALDI Biotyper sirius CA System vs. CA System): Two spots' log(score) values must be in the same log(score) range for 100% of tested organisms, and no isolates should have more than one log(score) value range difference.	The two spots' log(score) values were in the same log(score) value range for 100% (111/111) of the tested organisms. No isolates had more than one log(score) value range difference.	Study 3
Modified BTS Workflow Equivalency: Modified BTS workflow for BTS spots prepared using the BD Kiestra IdentifA performs equivalently to the standard workflow, with ≥ 98% spots yielding Log(score) values ≥ 2.00 and no statistical difference (paired chi square P value > 0.05).	423 (98.4%) spots yielded Log(score) values ≥ 2.00. Paired chi square P value = 0.368, indicating no statistical difference.	Quality Control section (previous submission K191964, results accepted for current submission)

Study Details:

2. Sample Size and Data Provenance:

Study 1 (Colony Picking Accuracy):
- Sample Size: 205 mixed cultures (Escherichia coli and Streptococcus pyogenes). 1230 colonies were picked, and 408 isolate MALDI ID results were analyzed.
- Data Provenance: Not explicitly stated regarding country of origin, but generally, clinical device studies for FDA submissions are conducted in the US or in countries with comparable regulatory and quality standards. The data provenance is prospective as it involves experimental setup and data collection for the purpose of the study.
Study 2 (Camera Equivalency):
- Sample Size: 15 microorganisms, 3 dilutions (10^3, 10^4, 10^5 CFU/mL), 2 solid media types (MAC, TSA II).
  - BD Kiestra ReadA (25MP): 270 plate images (15 organisms x 3 dilutions x 2 media types x 3 systems).
  - BD Kiestra ReadA Compact (5MP): 90 plate images (15 organisms x 3 dilutions x 2 media types x 1 system).
- Data Provenance: Not explicitly stated regarding country of origin. Prospective.
Study 3 (Identification Accuracy - Bruker MALDI Biotyper systems):
- Sample Size: 37 Gram-positive bacteria, Gram-negative bacteria, and yeast organisms. Two spots per suspension, tested for three days for repeatability.
- Data Provenance: Not explicitly stated regarding country of origin. Prospective.
Quality Control (BTS Workflow):
- Sample Size: 102 spots (standard workflow) and 430 spots (modified workflow).
- Data Provenance: Not explicitly stated regarding country of origin. Prospective.

3. Number of Experts Used and Qualifications:

Study 2 (Camera Equivalency): "Three operators representative of the intended user interpreted the culture plate images and assigned a minimal morphological identification (MMI) code."
Other Studies: The document does not specify the number or qualifications of experts (e.g., microbiologists, lab technologists) involved in establishing ground truth or performing manual inspections (like in Study 1 for visual confirmation of picking). However, for a device in microbiology, it is standard that trained laboratory personnel or microbiologists perform these tasks.

4. Adjudication Method for the Test Set:

The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the test set results.
For Study 2, the "Minimal Morphological Identification (MMI) code" was assigned by "three operators," and agreement was measured. It implies independent assessment rather than a consensus/adjudication process.
For other studies, the "expected identification" or "Bruker interpretive criteria" served as the reference standard, rather than an adjudicated human consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done to show how human readers improve with AI vs. without AI assistance. This device is an automated preparation system, aiding in sample processing for subsequent human evaluation via MALDI-TOF MS results, rather than an AI diagnostic interpretation tool for images. Study 2 did involve multiple readers evaluating images from different camera systems, but it focused on camera equivalency for MMI interpretation, not on AI assistance for readers.

6. Standalone Performance:

The device (BD Kiestra IdentifA) is an automated system for sample preparation. Its "standalone performance" is implicitly demonstrated through the accuracy of its automated functions (colony picking, suspension preparation, spotting) and the subsequent successful identification by the Bruker MALDI Biotyper systems, which are separate components. The studies confirm the accuracy of the BD Kiestra IdentifA's automated steps in preparing samples suitable for the MALDI-TOF MS system. The MALDI-TOF MS system itself has its own performance characteristics.

7. Type of Ground Truth Used:

Study 1 (Colony Picking Accuracy):
- Initial confirmation of picking: Visual inspection of plates and comparison to original digital images.
- Confirmation of identification success: Bruker MALDI identification using established interpretive criteria (Log(score) values).
Study 2 (Camera Equivalency): Minimal Morphological Identification (MMI) codes assigned by trained operators. This is a form of expert interpretation/consensus (though agreement was measured, not a formal consensus process).
Study 3 (Identification Accuracy - Bruker MALDI Biotyper systems): Bruker interpretive criteria for species identification (Log(score) values). This relies on the established performance of the MALDI-TOF MS system and comparison of results between different versions of the system.
Quality Control (BTS Workflow): Bruker interpretive criteria for species identification (Log(score) values) for the Bacterial Test Standard (BTS).

In summary, the ground truth for microorganism identification is based on the established MALDI-TOF MS interpretive criteria (log scores for identification confidence), as the device's role is to prepare samples for this established identification method. For colony picking and image interpretation, the ground truth is based on visual inspection, comparison to expected outcomes, and expert human interpretation (for MMI).

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of an AI/ML model for the BD Kiestra IdentifA. This device is described as an automated specimen preparation system utilizing robotics, nephelometry, and image processing, rather than a system based on machine learning that requires a separate training phase. The studies described are performance validation studies.

9. How the Ground Truth for the Training Set was Established:

As the document does not describe an AI/ML model with a distinct training set, this question is not applicable. The device's functionality is based on predefined algorithms and hardware performance, validated against established laboratory methods and interpretive criteria, as detailed in point 7.

Summary

Regulation Number and Section

§ 866.3378 Clinical mass spectrometry microorganism identification and differentiation system.

(a)
Identification. A clinical mass spectrometry microorganism identification and differentiation system is a qualitative in vitro diagnostic device intended for the identification and differentiation of microorganisms from processed human specimens. The system acquires, processes, and analyzes spectra to generate data specific to a microorganism(s). The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infection.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use statement must include a detailed description of what the device detects, the type of results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended, when applicable.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt with an indication for in vitro diagnostic use.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including all device components, control elements incorporated into the test procedure, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology and all pre-analytical methods for processing of specimens, and algorithm used to generate a final result. This must include a description of validated inactivation procedure(s) that are confirmed through a viability testing protocol, as applicable.
(ii) Performance characteristics for all claimed sample types from clinical studies with clinical specimens that include prospective samples and/or, if appropriate, characterized samples.
(iii) Performance characteristics of the device for all claimed sample types based on analytical studies, including limit of detection, inclusivity, reproducibility, interference, cross-reactivity, interfering substances, carryover/cross-contamination, sample stability, and additional studies regarding processed specimen type and intended use claims, as applicable.
(iv) A detailed explanation of the interpretation of test results for clinical specimens and acceptance criteria for any quality control testing.
(4) The device's labeling must include a prominent hyperlink to the manufacturer's website where the manufacturer must make available their most recent version of the device's labeling required under § 809.10(b) of this chapter, which must reflect any changes in the performance characteristics of the device. FDA must have unrestricted access to this website, or manufacturers must provide this information to FDA through an alternative method that is considered and determined by FDA to be acceptable and appropriate.
(5) Design verification and validation must include:
(i) Any clinical studies must be performed with samples representative of the intended use population and compare the device performance to results obtained from an FDA-accepted reference method and/or FDA-accepted comparator method, as appropriate. Documentation from the clinical studies must include the clinical study protocol (including predefined statistical analysis plan, if applicable), clinical study report, and results of all statistical analyses.
(ii) Performance characteristics for analytical and clinical studies for specific identification processes for the following, as appropriate:
(A) Bacteria,
(B) Yeasts,
(C) Molds,
(D) Mycobacteria,
(E) Nocardia,
(F) Direct sample testing (
e.g., blood culture),(G) Antibiotic resistance markers, and
(H) Select agents (
e.g., pathogens of high consequence).(iii) Documentation that the manufacturer's risk mitigation strategy ensures that their device does not prevent any device(s) with which it is indicated for use, including incorporated device(s), from achieving their intended use (
e.g., safety and effectiveness of the functions of the indicated device(s) remain unaffected).(iv) A detailed device description, including the following:
(A) Overall device design, including all device components and all control elements incorporated into the testing procedure.
(B) Algorithm used to generate a final result from raw data (
e.g., how raw signals are converted into a reported result).(C) A detailed description of device software, including validation activities and outcomes.
(D) Acquisition parameters (
e.g., mass range, laser power, laser profile and number of laser shots per profile, raster scan, signal-to-noise threshold) used to generate data specific to a microorganism.(E) Implementation methodology, construction parameters, and quality assurance protocols, including the standard operating protocol for generation of reference entries for the device.
(F) For each claimed microorganism characteristic, a minimum of five reference entries for each organism (including the type strain for microorganism identification), or, if there are fewer reference entries, a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, for why five reference entries are not needed.
(G) DNA sequence analysis characterizing all type strains and at least 20 percent of the non-type strains of a species detected by the device, or, if there are fewer strain sequences, then a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, must be provided for the reduced number of strains sequenced.
(H) As part of the risk management activities, an appropriate end user device training program, which must be offered as an effort to mitigate the risk of failure from user error.