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

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August 31, 2023

Becton, Dickinson and Company Laura Stewart Senior Manager, Regulatory Affairs 7 Loveton Circle Mail Code 694 Sparks, Maryland 21152

Re: K222563

Trade/Device Name: BD Kiestra IdentifA Regulation Number: 21 CFR 866.3378 Regulation Name: Clinical Mass Spectrometry Microorganism Identification And Differentiation System Regulatory Class: Class II Product Code: QQV, QBN Dated: June 2, 2023 Received: June 5, 2023

Dear Laura Stewart:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ribhi Shawar -S

Ribhi Shawar, Ph.D. (ABMM) Branch Chief. General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K222563

Device Name BD Kiestra IdentifA

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary BD Kiestra™ IdentifA

Summary Preparation Date: 8/24/2023

I Background Information

A 510(k) Number

K222563

B Applicant

BD Integrated Diagnostic Solutions Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 Establishment Registration Number: 1119779 Contact: Laura Stewart Telephone: 410-316-4000

C Proprietary and Established Name

BD Kiestra™ IdentifA

D Regulatory Information

ProductCode(s)	Classification	Regulation Section	Panel
QQV	Class II	21 CFR 866.3378 - ClinicalMass SpectrometryMicroorganism IdentificationAnd Differentiation System	MI – Microbiology
QBN	Class II	21 CFR 866.3378 – ClinicalMass SpectrometryMicroorganism IdentificationAnd Differentiation System	MI – Microbiology

II Submission/Device Overview:

A Purpose for Submission:

To obtain substantial equivalence determination for the BD Kiestra™ IdentifA instrument with the addition of the BD Kiestra ReadA camera system as well as the Bruker MALDI Biotyper sirius CA and sirius one CA systems.

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B Type of Test:

Qualitative in vitro diagnostic device for identification of microorganisms cultured from human specimens by automation of target preparation for mass spectrometry analysis.

III Intended Use/Indications for Use:

Intended Use(s): A

See Indication(s) for Use

B Indication(s) for Use:

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 and differentiation 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 or ReadA Compact and Bruker MALDI Biotyper® System (CA, sirius CA, or sirius one CA) to aid in the diagnosis of bacterial and fungal infections.

C Special Conditions for Use Statement(s):

Rx For Prescription Use Only .
IVD For In Vitro Diagnostic Use Only ●

D Special Instrument Requirements:

1. BD Kiestra™ ReadA and ReadA Compact

The BD KiestraTM ReadA or ReadA Compact module is required for use in conjunction with the BD Kiestra™ IdentifA to obtain the digital image the IdentifA uses for colony selection and target preparation. The ReadA or ReadA Compact is an essential component to the performance of the IdentifA and, together with the IdentifA and the Bruker MALDI Biotyper® System (CA, sirius CA, or sirius one CA), comprises a test system for the qualitative identification and differentiation of microorganisms. Any change to the ReadA Compact will be assessed and appropriate verification and validation will be performed as applicable to assure proper function of the BD Kiestra™ IdentifA.

Bruker MALDI Biotyper® for Clinical Applications (MBT-CA)

When using the BD Kiestra™ IdentifA, refer to the most recent version of the Bruker MALDI Biotyper® System labeling (CA, sirius CA, or sirius one CA).

Performance of the BD Kiestra IdentifA was evaluated with the following culture media that are validated as compatible with the Bruker MALDI Biotyper® System (CA, sirius CA, or sirius one CA):

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Trypticase Soy Agar with 5% Sheep Blood MacConkev Agar Columbia CNA Agar with 5% Sheep Blood Chocolate Agar Sabouraud-Dextrose Agar CDC Anaerobe Agar 5% Sheep Blood Campylobacter Agar with 5 Antimicrobics and 10% Sheep Blood

Performance of the BD Kiestra IdentifA has not been established with the following culture media that are validated as compatible on the Bruker MALDI Biotyper® System (CA, sirius CA, or sirius one CA):

Bacteroides Bile Esculin Agar with Amikacin Bordet Gengou Agar with 15% Sheep Blood Clostridium Difficile Agar with 7% Sheep Blood Buffered Charcoal Yeast Extract Agar Buffered Charcoal Yeast Extract Agar with Polymixin, Anisomycin and Vancomycin Brucella Agar with 5% Horse Blood CDC Anaerobe 5% Sheep Blood Agar with Phenylethyl Alcohol CDC Anaerobe Laked Sheep Blood Agar with Kanamycin and Vancomycin Modified Thayer-Martin Agar

IV Device/System Characteristics:

A Device Description:

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

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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.

Image /page/6/Figure/5 description: This image shows a block diagram of the BD Kiestra system. At the top of the diagram is the Laboratory Information System (LIS), which connects to the BD Kiestra™ Synapsys Informatics block. The Bruker MALDI Biotyper® System also connects to the BD Kiestra™ Synapsys Informatics block. The BD Kiestra™ Synapsys Informatics block connects to the BD Kiestra™ BeA block, which connects to the BD Kiestra™ ReadA or ReadA Compact, BD Kiestra™ IdentifA, and Additional BD Kiestra™ Modules blocks.

Figure 1: Overview of software interfaces for the BD Kiestra™ Laboratory Automation System

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B Instrument Description Information:

1. Instrument Name:
  BD Kiestra™ IdentifA

2. Specimen Sampling and Handling:

The BD Kiestra™ ReadA or ReadA Compact has default parameters for image capture as well as user-defined settings. Images taken under the default parameters are always captured in addition to any further images taken under conditions of illumination and background that are specified by the user. Each of the images is presented to the user via the Synapsis interface.

Culture plates for processing by the BD Kiestra™ IdentifA are loaded manually or via an automated conveyor, depending on the instrument configuration. Plates are identified by the BD Kiestra™ IdentifA by scanning a linear barcode on the side of the bottom half of each plate. The BD Kiestra™ IdentifA then queries the Synapsys software via the BeA data interface to obtain patient information and details of the testing to be performed. Colonies are identified by a technologist from a digital image of each culture plate obtained from the ReadA or ReadA Compact and designated for picking via the BD Kiestra™ IdentifA. Specific colonies' locations are identified by polar coordinates that are calculated relative to the position of the barcode label. The BD Kiestra™ IdentifA automatically orientates each plate based on the location of the barcode, picks the designated colonies and prepares a suspension in deionized water. Mucoid colonies are detected automatically and processed using a modified procedure to reduce the potential for contamination and ensure homogeneity of the suspension. The turbidity of the final suspension is measured and adjusted as necessary to within a target range of McFarland values. One or more aliquots of the suspension is used to prepare a MALDI target, which is dried at elevated temperature and manually transferred to the Bruker MALDI Biotyper® System for analysis. The location into which each microbial suspension is spotted on the MALDI target together with other relevant tracking parameters for the microbial suspension prepared by the BD Kiestra™ IdentifA are posted to the Synapsis interface via the BeA module.

1. Specimen Identification:
  MALDI targets are manually transferred to the Bruker MALDI Biotyper® System, which performs microbial differentiation and species identification of microorganisms via matrixassisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis. Two-way communication between the BD Kiestra™ IdentifA and Bruker MALDI Biotyper® System is mediated by the Synapsys interface to enable transfer of the MALDI target map to the MALDI Biotyper® System and subsequent receipt of microbial identification results that are displayed to the user.
1. Calibration:

Camera Calibration

Calibration of the BD Kiestra™ ReadA or ReadA Compact camera must be performed each time the camera is cleaned or when the position of the camera is changed. Calibration and reference plates containing a plastic disk with red/green/blue print and a barcode label are provided with the system for use with the built-in software calibration wizard, OPTIS, to verify the accuracy of barcode reading, image dimensions and quality. Imaging area detection first selects the appropriate area of the image that contains the plate. Black calibration determines the average grey value and signal-to-noise ratio (SNR) in black images (all lights off). Plate

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holder detection uses various inputs to determine the position of the plate holder. Lights calibration adjusts lighting power to ensure homogenous illumination. Linearity calibration ensures that increased exposure of an object results increased signal intensity in each channel of the Bayer filter. SNR calibration determines the SNR as a function of input grey value. White balance and light references calibration normalize RGB channel intensities so that a white object appears white when imaged by the camera system. Pixel calibration accounts for chromatic aberrations and geometrical distortions. When acquiring an image, multiple images of the same scene are evaluated to reduce potential noise and runtime checks are performed to ensure consistency with calibration. Additionally, Petri dishes are imaged with top, side, and bottom illumination utilizing black or white contrasting backgrounds to maximize information and allow reading of plates by microbiologists. After successful image capture, images are normalized and adjusted according to calibrated metrics to improve image quality and reduce variability across each instrument.

Nephelometer Calibration

Calibration of the BD Kiestra™ IdentifA nephelometers must be performed once a month using the provided calibration cuvette array standards (0.2, 0.5, 1.0 and 3.0 McFarland). Additional verification of the nephelometers must be performed daily using the 0.5 McFarland cuvette array. MALDI target preparation will not resume until daily verification passes.

5. Quality Control:

Use of the Bruker US IVD Bacterial Test Standard (BTS) is required to obtain valid identification results with the Bruker MALDI Biotyper® System. The BD Kiestra™ IdentifA uses a modified workflow for preparation and spotting of the BTS solution whereby the volume of solvent is increased to improve the precision of automated pipetting. The modified BTS workflow was verified by conducting a study to validate equivalency of using a double volume of BTS solution (2 uL) compared to the standard volume (1 uL). BTS was prepared per the manufacturer's instructions for use (diluted in 50 µL solvent), and 1 µL was dispensed onto 48and 96-spot MALDI targets for 102 spots. BTS was then prepared using twice the amount (100 uL) of solvent, and 2 uL was dispensed onto MALDI targets for a total of 430 spots. The modified BTS workflow for BTS spots prepared using the BD Kiestra™ IdentifA performs equivalently to the standard workflow with 423 (98.4%) spots yielding Log(score) values ≥ 2.00 (high-confidence identification) and no statistical difference in performance (paired chi square P value = 0.368) compared to the standard workflow. The results from K191964 are acceptable. No changes were made to Quality Control for this submission.

V Substantial Equivalence Information:

A Predicate Device Name(s):

BD Kiestra™ IdentifA

B Predicate 510(k) Number(s):

K191964

C Comparison with Predicate(s):

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Device & PredicateDevice:	Device:K222563	Predicate:K191964
Device Trade Name	Same	BD Kiestra™ IdentifA
General Device Characteristic Differences
IntendedUse/Indications ForUse	The BD Kiestra™ IdentifA module isan automated in vitro diagnosticspecimen preparation system for usewith the BD Kiestra™ LaboratoryAutomation Solution to prepareMALDI targets for the Bruker MALDIBiotyper® System (CA, sirius CA, orsirius one CA) for the qualitativeidentification and differentiation ofmicroorganisms using matrix-assistedlaser desorption/ionization-time offlight mass spectrometry (MALDI-TOF MS) analysis of colonies grownon plated culture media from humanspecimens.The BD Kiestra™ IdentifA is indicatedfor use in the clinical laboratory withthe BD Kiestra™ ReadA or ReadACompact and Bruker MALDIBiotyper® System (CA, sirius CA, orsirius one CA) to aid in the diagnosisof bacterial and fungal infections.	The BD Kiestra™ IdentifAmodule is an automated invitro diagnostic specimenpreparation system for usewith the BD Kiestra™Laboratory AutomationSolution to prepare MALDItargets for the BrukerMALDI Biotyper® CASystem for the qualitativeidentification anddifferentiation ofmicroorganisms usingmatrix-assisted laserdesorption/ionization-timeof flight mass spectrometry(MALDI-TOF MS) analysisof colonies grown on platedculture media from humanspecimens.The BD Kiestra™ IdentifAis indicated for use in theclinical laboratory with theReadA Compact and BrukerMALDI Biotyper® CASystem to aid in thediagnosis of bacterial andfungal infections.
BD Kiestra™ ReadAmodule	ReadA or ReadA Compact	ReadA Compact
Bruker MALDIBiotyper® System	Bruker MALDI Biotyper® CA System,Bruker MALDI Biotyper® sirius CASystem, or Bruker MALDI Biotyper®sirius one CA System	Bruker MALDI Biotyper®CA System
General Device Characteristic Similarities
Regulation	Same	21 CFR § 866.3378
Product Code	Same	QQV, QBN
Sample Type	Same	Isolated colonies on platedculture media
MALDI TargetPreparation	Same	Extended Direct Transfer(eDT) Sample PreparationProcedure
Device & PredicateDevice:	Device:K222563	Predicate:K191964
Amount of Organismon Target	Same	Meets Bruker's Limit ofDetection
Quality Controls	Same	US IVD Bacterial TestStandard (BTS)
Matrix	Same	US IVD HCCA Matrix
Targets	Same	MBT Biotarget 96 US IVD(96-spot disposable) targetUS IVD 48 Spot (48-spotreusable) target
Target Loading onMALDI-TOF MS	Same	Manual
Colony PlateVisualization	Digital image from the BD ReadA orReadA Compact module	Digital image from the BDReadA Compact module
Organism Preparation	Same	Suspension of coloniesprepared in deionized waterby pipettor
Number of ColoniesSampled	Same	Up to 9 per microbialsuspension or target spot
Alternative Methodsof MALDI TargetPreparation	Same	None
Sample and ReagentApplication	Same	Automated
Drying of TargetPlate	Same	35 ± 2°C
Results Achieved	Same	Prepared MALDI target
Results Reported	Same	None
Technology	Same	Robotic x-y-z platformusing pipetting system andonboard nephelometry

Table 1: Comparison to the Predicate Device

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D Substantial Equivalence:

Table 1 provides the similarities and differences between the BD Kiestra™ IdentifA and the predicate device. In addition to the items identified, there is no difference between the BD Kiestra™ IdentifA and the predicate device in terms of human factors, design, analytical performance, carryover, limit of detection, reagent deck stability, and electrical, chemical, thermal, and mechanical safety.

The studies conducted support that the modified device, BD Kiestra™ IdentifA is substantially equivalent to the predicate device. The differences are not critical to the intended use of the device and do not affect safety and efficacy.

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VI Standards/Guidance Documents Referenced:

Deciding When to Submit a 510(k) for a Change to an Existing Device (issued October 25, . 2017).

VII Performance Characteristics (if/when applicable):

Analytical Performance: A

1. Accuracy (Instrument):
  Colony Picking Accuracy, Camera Equivalency, and Identification Accuracy The ability of the BD Kiestra IdentifA to pick the colonies designated by the operator from the digital image obtained by the BD Kiestra™ ReadA, visual interpretation of images generated by the BD Kiestra ReadA with a 25MP camera versus BD Kiestra ReadA Compact with a 5MP camera, and evaluation of IVD Bruker MALDI Biotyper® sirius CA System analysis was assessed in three separate studies described below.

Study 1 :

In the first study, one BD Kiestra IdentifA instrument was used to pick designated colonies from 205 mixed cultures of Escherichia coli (ATCC 25922; as representative of large bacterial colonies) and Streptococcus pyogenes (ATCC 19615; as representative of small bacterial colonies) plated on TSA with 5% sheep blood agar and incubated aerobically for 24 and 48 hours at 35°C. Picking of the correct colonies was confirmed by visual inspection of the plates and comparison to the original digital images. All (100%) 1230 colonies were picked successfully.

Picking of colonies was confirmed by Bruker MALDI identification using the interpretive criteria for species identification described in Bruker MALDI labeling for High Confidence (log score > 2.00), Low Confidence (log score 1.70-1.99), and No Identification (log score < 1.70) levels. Confirmation of colony picking accuracy was conducted with a IVD Bruker MALDI Biotyper® sirius CA System for analysis. Two (2) isolates were aborted with no MALDI result, leaving a total of 408 isolate MALDI ID results. All (100%) of 408 MALDI target spots provided the expected identification, with High Confidence Log(score) values ≥ 2.00. These results demonstrate the accuracy of colony picking and are acceptable.

The results of the study showed the BD Kiestra™ ReadA met the same acceptance criteria as previously shown for the BD Kiestra™ ReadA Compact (see K191964). Therefore, the BD Kiestra™ IdentifA pick accuracy performance utilizing the BD Kiestra™ ReadA is equivalent to BD Kiestra™ IdentifA pick accuracy performance utilizing the BD Kiestra™ ReadA Compact.

Study 2:

In the second study, 15 microorganisms representing varying colony morphologies were plated in three dilutions (103, 104, 105 CFU/mL) on two types of solid media: 1) BD BBL™ MacConkey II Agar (MAC), and 2) BD BBL™ Trypticase Soy Agar™ with 5% Sheep Blood (TSA II). Culture plate images were captured by one BD Kiestra ReadA™ Compact system with a 5MP camera and three BD Kiestra ReadA™ systems with 25MP cameras. Three operators representative of the intended user interpreted the culture plate images and assigned a minimal morphological identification (MMI) code based on colony

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morphology/hemolysis/size/color characteristics. MMI results for each plate image captured by the BD Kiestra™ ReadA was compared to those from the BD Kiestra™ ReadA Compact. A total of 270 plate images were captured with the BD Kiestra™ ReadA system with a 25MP camera (15 microorganisms x 3 dilutions x 2 media types x 3 systems) and a total of 90 plate images were captured with the BD Kiestra™ ReadA Compact with a 5MP camera (15 microorganisms x 3 dilutions x 2 media types x 1 system).

The overall MMI percent agreement between BD Kiestra™ ReadA (25MP) and the BD Kiestra™ ReadA Compact (5MP) plate images was 99% for TSA II media and 100% for MAC media. Two of the three BD Kiestra™ ReadA (25MP) systems had 100% agreement with the BD Kiestra™ ReadA Compact (5MP) system. On the third BD Kiestra™ ReadA (25MP) system, one reader had one organism result, Candida albicans on TSA II media, that resulted in a "no growth" (NG) MMI result versus the expected "cream/white colonies, feet may be present, possible Candida albicans" (YST-CR/WH) result. That reader's BD Kiestra™ ReadA Compact (5MP) system result for the same organism yielded the expected MMI code. This discrepancy occurred for the lowest dilution (102 CFU/mL), which was anticipated to result in some NG outcomes. Due to the challenging inoculum concentration and that this discrepancy was observed for a singular result, it was determined that there are no significant discrepancies or trending observed for any specific colony types that would necessitate any limitations in device labeling.

The results of the study demonstrated that the 5MP camera on the BD Kiestra™ ReadA Compact system generates equivalent images to the 25MP camera on the BD KiestraTM ReadA system. The camera utilized had no impact on the user's interpretation of the culture plate image. Therefore, the BD Kiestra™ ReadA and BD Kiestra™ ReadA Compact systems are equivalent and both are acceptable for use with the BD Kiestra™ IdentifA system.

Studv 3:

In the third study, a total of 37 Gram-positive bacteria, Gram-negative bacteria, and yeast organisms were cultured from stock isolates onto TSA II with 5% SB media plates for bacteria, and onto SAB Dextrose media plates for yeast. The plates were incubated in O2 or CO2, as appropriate, at 35 °C ± 2 °C for 18-24 hours.

Using the BD Synapsys™ informatics system. isolated colonies were selected and a MALDI test was ordered for each selected isolate on each plate. An isolate suspension was created for each organism on a BD Kiestra™ IdentifA and Bruker MALDI target plates were spotted using either 48-spot reusable polished steel or 96-spot disposable target plates. Two (2) spots were utilized per suspension on the target plates. For each organism (utilizing a single suspension source), the target plates were transferred to a Bruker MALDI Biotyper® CA System to read the first spot, and the same target plate was then transferred to a Bruker MALDI Biotyper® sirius CA System to read the second spot. Each organism was read on both Bruker MALDI Biotyper® Systems for three (3) days to verify repeatability. Isolate results from the Bruker MALDI Biotyper® CA System and the Bruker MALDI Biotyper® sirius CA System were compared for MALDI ID differences using the Bruker interpretive criteria for species identification described in Study 1. The two spots' log(score) values were in the same log(score) value range for 100% (111/11) of the tested organisms. No isolates had more than one log(score) value range difference.

The results of the study showed the BD Kiestra™ IdentifA can be used to prepare Bruker MALDI target plates that can be analyzed on either the Bruker MALDI Biotyper" CA

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System, or Bruker MALDI Biotyper® sirius CA System, meeting the same acceptance criteria as previously shown in K191964 and producing equivalent identification results on either MALDI system. This study utilized the Bruker MALDI Biotyper® sirius CA System, but the results are applicable to both the sirius CA system and the Bruker MALDI Biotyper® sirius one CA System, as there is no difference between the two systems in CA mode.

1. Linearity:
  Not applicable.
1. Analytical Specificity/Interference:
  Not applicable.
1. Assay Reportable Range:
  Not applicable.
1. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
  Not applicable.
1. Detection Limit:
  Not applicable.
1. Assay Cut-Off:
  Not applicable.

B Clinical Studies:

1. Clinical Sensitivity: Not applicable
1. Clinical Specificity:

Not applicable

1. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not applicable
C Clinical Cut-Off:

Not applicable

D Expected Values/Reference Range:
Not applicable

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

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Becton, Dickinson and Company Becton, Brekinson Circle
7 Loveton Circle
Sparks, MD 21152
USA

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IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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.