The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.03 to 8 ug/ml to the test panel.

The organisms which may be used for Moxifloxacin susceptibility testing in this panel are:

Streptococcus pneumoniae (including penicillin resistant strains) Streptococcus pyogenes Streptoccocus agalactiae Streptococcus constellatus Streptococcus anginosus Viridans group streptococci

Device Description

MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MicroScan® MICroSTREP plus® Panels with Moxifloxacin, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA Guidance Document: "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA")	Reported Device Performance (Moxifloxacin)
Substantial Equivalent Performance (compared to a CLSI frozen Reference Panel)	Overall Essential Agreement of 97.3%
Acceptable Reproducibility and Precision	Demonstrated acceptable reproducibility and precision with Moxifloxacin
Acceptable Quality Control Testing	Demonstrated acceptable results for Moxifloxacin

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a single number of isolates. However, the study mentions:
- "fresh and stock Efficacy isolates"
- "stock Challenge strains"
- The overall Essential Agreement of 97.3% for Moxifloxacin suggests a substantial number of isolates were tested to achieve this agreement rate across different concentrations.
Data Provenance: Not explicitly stated (e.g., country of origin). The data is retrospective, as it compares the performance of the device to an established CLSI frozen Reference Panel.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the test set was not established by individual experts in this context. Instead, it was established by a CLSI frozen Reference Panel. This panel itself represents a consensus standard for antimicrobial susceptibility testing, implying that its development and validation involved a panel of experts in microbiology and antimicrobial susceptibility. No specific number or qualifications of experts are given for the initial establishment of the CLSI reference method.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1) is described. The comparison was directly between the MicroScan MICroSTREP plus Panel and the CLSI frozen Reference Panel. For challenge strains, the method was comparison to "Expected Results determined prior to the evaluation," which implies pre-defined reference values.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This study focuses on the agreement between the device and a reference method, not on human reader performance with or without AI assistance. While the panel can be read manually or by the MicroScan® WalkAway System, the study primarily evaluates the device's accuracy against the CLSI reference.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The "MicroScan® MICroSTREP plus® Panel" itself is the "algorithm/device" being tested. Its performance (Essential Agreement) was compared directly to the CLSI frozen Reference Panel, representing its standalone accuracy. While it can be read manually, the core evaluation confirms the performance of the panel itself.

7. The Type of Ground Truth Used

The primary ground truth used was a CLSI frozen Reference Panel. For "Challenge strains," the ground truth was "Expected Results determined prior to the evaluation," which would have been established using a recognized reference method, likely aligned with CLSI standards. This is a form of expert consensus standard in microbiology.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning or AI development. This device is an antimicrobial susceptibility test panel, which operates based on biochemical reactions and defined dilutions, not a machine learning algorithm that requires a separate training set. Its "development" would involve optimizing dilutions and components to match reference methods.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit "training set" described for a machine learning model, this question is not applicable to the information provided. The "ground truth" for the device's development would be established through established microbiological reference methods (like CLSI standards), but this is not a separate training set as understood in AI/ML contexts.

Summary

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JUL 2 0 2011

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Siemens Healthcare Diagnostics
Contact name:	Shannon Popson, Regulatory Technical Specialist
Fax:	916-374-3330
Date prepared:	April 20, 2011
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus® Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	New antimicrobial - Moxifloxacin
Predicate device:	MicroScan MICroSTREP plus Panels - Levofloxacin (K020556)

510(k) Summary:

The proposed MicroScan MICroSTREP plus Panel demonstrated substantially equivalent performance when compared with an CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. The Premarket Notification (510[k]) presents data in support of the MicroScan MICroSTREP plus Panel with Moxifloxacin.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The MICroSTREP plus Panel demonstrated acceptable performance with an overall Essential Agreement of 97.3% for Moxifloxacin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Moxifloxacin, regardless of which read method (manual and WalkAway® instrument) was used with the turbidity inoculation method.

Quality Control testing demonstrated acceptable results for Moxifloxacin.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract bird or wing design, composed of several curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Shannon Popson Regulatory Technical Specialist 1584 Enterprise Blvd. West Sacramento, CA 95691

JUL 20 2011

Re: k11205

Trade/Device Name:	MicroScan®MICroSTREP plus Panels
Regulation Number:	21CFR §866.1640
Regulation Name:	Antimicrobial Susceptibility Test Powder
Regulatory Class:	Class II
Product Code:	LRG, JWY, LTW
Dated:	July 14, 2011
Received:	July 15, 2011

Dear Ms. Popson:

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 (fav the indications for use stated in the enclosure) to legally marketed predicate devices market to in interestate 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, Drig, 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 The general controls provisions of the Act include requirements for annual registration, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section

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Page 2 – Shannon Popson

510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (011) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vau, attopm

Sally A. Hoivat, M Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: MicroScan® MICroSTREP plus® with Moxifloxacin (0.03 – 8 ug/ml)

Indications For Use:

This particular submission is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.03 to 8 ug/ml to the test panel.

The organisms which may be used for Moxifloxacin susceptibility testing in this panel are:

Streptococcus pneumoniae (including penicillin resistant strains) Streptococcus pyogenes Streptoccocus agalactiae Streptococcus constellatus Streptococcus anginosus Viridans group streptococci

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie L. Poole

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111205

Page 1 of 1

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).