LabPro Data Management System is a Microsoft® Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other pre-defined parameters, against a series of established rules/ alerts and notifies the user of unusual, and/or critical conditions, which may warrant further analysis or action.

LabPro-MBT software is a functional subset of LPDMS intended to electronically transfer and display organism identifications from the Bruker MALDI Biotyper System to the LabPro Data Management System. LabPro-MBT software is a device that is intended to electronically transfer medical device data, without controlling or altering the functions or parameters of any connected medical devices.

Device Description

The proposed LabPro Data Management System device is a system intended to be used in laboratory settings by trained personnel to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments, manually entered panels and select third party microbiology instruments.

The LabPro AlertEx is a functional subset of the LabPro Data Management System and analyzes Beckman Coulter ID and AST data against a series of established rules/alerts and notifies the user of unusual, and/or critical conditions.

The LabPro MBT is an optional subset of the LabPro Data Management System that provides connectivity to a Bruker MALDI Biotyper (MBT) System. The LabPro MBT subset software allows for transfer and display of organism identifications from the Bruker MALDI Biotyper System to the proposed LabPro Data Management System.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LabPro Data Management System:

The provided text is a 510(k) summary for the LabPro Data Management System. It states that clinical trials are not applicable, and instead, "Performance Bench Testing" was performed. However, the document does not provide specific acceptance criteria or detailed results of this performance bench testing. It only generally states that "All testing passed demonstrating that the proposed LabPro Data Management System device is substantially equivalent to the predicate device."

Therefore, much of the requested information cannot be definitively extracted from this document. I will provide what can be inferred or is explicitly stated and note where information is missing.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It focuses on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (General)
Maintain parity with currently available operating systems and databases, cybersecurity, programming languages, and hardware platforms.	The device has been updated to meet these standards.
Consolidate AlertEx into the LabPro Data Management System software.	Achieved.
Support additional languages.	Achieved.
Reorganize to improve the presentation of help documentation and Alert rules.	Achieved.
Connectivity of multiple computers into a single network to improve system usability.	Achieved.
Connectivity to multiple WalkAway and autoSCAN-4 instruments to improve usability.	Achieved.
Connectivity to a Bruker MALDI Biotyper.	Achieved (via LabPro-MBT software).
Function as intended to manage microbial identification (ID) and antimicrobial susceptibility test (AST) results.	The proposed device performs as intended in all aspects of the predicate device's mapped functionality characteristics, and "all testing passed."
Provide a safe and secure software product.	The safety aspects were "thoroughly tested in accordance with validation practices."
Functionality and performance demonstrate substantial equivalence to the predicate device.	The device "performs as intended in all aspects of the predicate devices' mapped functionality characteristics."

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Performance Bench Testing was performed" but does not give the number of cases, data points, or a description of the dataset used for this testing.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Since the testing was "Performance Bench Testing" for a data management system, it's unlikely that traditional "ground truth" derived from human experts in a diagnostic context (e.g., radiologists) would be directly applicable. The "ground truth" for a data management system would likely refer to the correctness and accuracy of its data handling, processing, and display abilities, which would be verified against expected outputs or known correct data.
Adjudication method for the test set:
- Not specified. This is typically relevant for studies involving human interpretation or subjective assessments. For a data management system's "Performance Bench Testing," adjudication methods like 2+1 or 3+1 are generally not applicable. Verification would likely involve comparing software outputs to expected correct results.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. The device is a "software only product" for data management, not an AI diagnostic tool that assists human readers. The document explicitly states, "Clinical performance testing is not applicable for the proposed LabPro Data Management System, as it is a software only product."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, "Performance Bench Testing" was done, which would evaluate the algorithm/software's standalone performance in managing and processing data. However, the details of what this testing involved (e.g., specific metrics, test cases) are not provided. The phrase "algorithm only" is perhaps not the most precise for a data management system, as its core function is to handle data correctly and robustly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For a data management system, the "ground truth" would likely involve the correctness of data transfer, storage, processing, and adherence to defined rules/alerts. This would be established by comparing the software's output/behavior against pre-defined, known-correct inputs and expected outputs, as validated by internal testing protocols and specifications.
The sample size for the training set:
- Not applicable/Not specified. This is not a machine learning or AI algorithm in the context of generating predictive outputs from training data. It is a data management system. Therefore, there is no "training set" in the conventional sense.
How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the software's functionality is its adherence to design specifications and correct operation, which would be established during its development and verification/validation processes.

Summary

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August 30, 2020

Beckman Coulter Inc. Christina Thomas Staff, Regulatory Affairs 1584 Enterprise Blvd West Sacramento, California 95691

Re: K201405

Trade/Device Name: LabPro Data Management System Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, Dated: May 28, 2020 Received: June 1, 2020

Dear Christina Thomas:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

Enclosure

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Indications for Use

510(k) Number (if known) K201405

Device Name LabPro Data Management System

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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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular graphic on the left and the company name "BECKMAN COULTER" in black text on the right. The graphic features two curved white lines within the red circle, creating a stylized, abstract design. The text is in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER".

510(k) Summary

(in accordance with 21 CF 807.92)

Date: August 28, 2020

Submitter:

Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691, USA

Contact:

Name: Christina Thomas Staff, Regulatory Affairs Title: Phone: 916.374.2215 Email: clthomas@beckman.com

Proposed Device Information:

Trade Name:	LabPro Data Management System
Common Name:	LabPro
510(k) Number:	K201405
Classification Regulation:	866.1645
Product Code:	LON
Device:	System, Test, Automated, Antimicrobial Susceptibility, ShortIncubation
Regulation Description:	Fully automated short-term incubation cycle antimicrobialsusceptibility system
Review Panel:	Microbiology
Device Class:	2

Predicate Device Information:

Trade Name:	Dade Behring LabPro Data Management System v3.01
Common Name:	LabPro
510(k) Number:	K070346
Classification Regulation:	866.1645
Product Code:	LON
Device:	System, Test, Automated, Antimicrobial Susceptibility, ShortIncubation
Regulation Description:	Fully automated short-term incubation cycle antimicrobialsusceptibility system
Review Panel:	Microbiology
Device Class:	2

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Image /page/4/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular shape on the left, with two white curved lines running through it. To the right of the circular shape is the company name, "BECKMAN COULTER," written in a bold, sans-serif font. The word "BECKMAN" is stacked above the word "COULTER."

Device Description

Indications for Use

LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other pre-defined parameters, against a series of established rules/ alerts and notifies the user of unusual, and/or critical conditions, which may warrant further analysis or action.

Substantial Equivalence

The proposed LabPro Data Management System has been updated to maintain parity with currently available operating systems and databases, cybersecurity, programming languages and hardware platforms. In addition to technological advances, the proposed LabPro Data Management System offers improvements to the user experience which include consolidation of AlertEx into the LabPro Data Management System software, support of additional languages, reorganization to improve the presentation of help documentation and Alert rules, connectivity of multiple computers into a single network to improve system usability, connectivity to multiple WalkAway and autoSCAN-4 instruments to improve usability and connectivity to a Bruker MALDI Biotyper.

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Image /page/5/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red abstract symbol on the left and the company name "BECKMAN COULTER" in black text on the right. The symbol is composed of two curved shapes that resemble waves or stylized ribbons, stacked on top of each other. The company name is written in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER."

The differences between the proposed software and predicate device do not impact the core functionality and intended use of the LabPro Data Management System: i.e., to manaqe microbial identification (ID) and antimicrobial susceptibility test (AST) results from patient samples and provide the interface to ID and AST instruments attached to the system. Rather the changes enhance the overall flexibility and use of the system and provide a safe and secure software product for use in the microbiology clinical laboratory setting.

The proposed LabPro Data Management System software device and its predicate are equivalent to, or the same, with respect to mapped intended use, functionality, performance, technological characteristics as well as safety and effectiveness.

Clinical Trials

Clinical performance testing is not applicable for the proposed LabPro Data Management System, as it is a software only product.

Performance Bench Testing was performed. See Section 18 for Performance Bench Testing.

Conclusion

The proposed LabPro Data Management System was developed in accordance with 820.30 Design Controls as well as the "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" The software was thoroughly tested including verification and validation to ensure it will be as safe, as effective, and performed as well as the predicate device's substantially mapped functionality, when utilized within its intended use and in accordance with labeling, as demonstrated by the testing performed.

Based on the functionality and performance comparison, technological characteristic comparison and the intended use, the proposed LabPro Data Management System software device performs as intended in all aspects of the predicate devices' mapped functionality characteristics. The safety aspects of the proposed LabPro Data Management System device have been thoroughly tested in accordance with validation practices as outlined in 820.30, Design Controls. All testing passed demonstrating that the proposed LabPro Data Management System device is substantially equivalent to the predicate device in terms of intended use, functionality, performance, technological characteristics as well as safety and effectiveness.

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”