The MicroScan® Synergies plus® Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial vancomycin, at concentrations of 0.25 to 64 ug/ml, to the test panel.

The gram-positive organisms which may be used for vancomycin susceptibility testing in this panel are:

Enterococcus spp. (e.g., Enterococcus faecalis) .
Staphylococcus spp. ●
Staphylococcus aureus (including methicillin-resistant strains) .
Staphylococcus epidermidis (including methicillin-resistant ● strains)

Device Description

MicroScan® Synergies plus Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, are designed for use in determining quantitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing and facultative anaerobic gram-positive staphylococci and enterococci.

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 Synergies plus® Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI System, or equivalent, for 4.5 -18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

This 510(k) summary describes a device modification for an existing antimicrobial susceptibility test (AST) system. The modification involves updating the product labeling with new Staphylococcus aureus interpretive criteria for vancomycin.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA's "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems")	Reported Device Performance (Essential Agreement for vancomycin against S. aureus)
Implied to be met by "acceptable performance"	97.6% Essential Agreement

Note: The specific numerical acceptance criteria from the FDA guidance document are not explicitly stated in the provided text. However, the document states the device demonstrated "acceptable performance" and achieved 97.6% Essential Agreement, implying this met the pre-defined criteria. Essential Agreement (EA) for AST devices typically refers to the agreement between the investigational device and the reference method within ±1 dilution.

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

Sample Size: Not explicitly stated as a number. The text mentions "Challenge strains were compared to Expected Results determined prior to the evaluation."
Data Provenance: The S. aureus data came from a "previously cleared vancomycin external evaluation (K060312)." This indicates the data was retrospective relative to this specific 510(k) submission, as it was collected for an earlier clearance. The country of origin is not specified, but given the submission to the US FDA and Siemens Healthcare Diagnostics' presence, it's likely primarily US-based or multi-site clinical trial data.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. However, the ground truth was established by comparing the challenge strains to "Expected Results determined prior to the evaluation," and this evaluation used a CLSI frozen Reference panel. This implies the ground truth was based on a highly standardized and accepted reference method in the field of microbiology, which typically has expert consensus underlying its establishment.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified. Ground truth was established by comparison to a CLSI frozen Reference panel, rather than human expert consensus requiring adjudication on individual cases.

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

MRMC Study: No, this is not an MRMC study. This device is an automated in vitro diagnostic (IVD) system for antimicrobial susceptibility testing, which does not involve human readers interpreting images or data directly in a comparative effectiveness study against AI. The comparison is between the automated device and a reference laboratory method.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance: Yes. The study directly evaluates the performance of the MicroScan® Synergies plus® Gram-Positive MIC/Combo Panel (the algorithm/device) against a frozen Reference Panel. This is a standalone performance evaluation of the device without human-in-the-loop performance being the primary subject of the comparison.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used was a CLSI frozen Reference panel. This is a highly standardized and validated laboratory method for determining antimicrobial susceptibility, widely accepted as a "gold standard" in microbiology. The reference panel essentially provides the "true" MIC values and interpretive categories (S, I, R) for the challenge strains.

8. Sample Size for the Training Set

Sample Size: This information is not provided in the summary. As an in vitro diagnostic device, the "training set" concept is different from AI/ML models. It would refer to the strains and data used during the development and optimization of the MicroScan® system's AST methodology.

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

Ground Truth Establishment for Training Set: This information is not provided in the summary. Similar to point 8, the ground truth for any development/training would likely involve standard reference methods, possibly including CLSI guidelines and expert microbiology protocols, but the specifics are not detailed.

Summary

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KO92919

OCT 2 3 2009

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510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Siemens Healthcare Diagnostics
Contact name:	Shannon Popson, Regulatory Affairs Senior Technical Specialist
Fax:	916-374-3330
Date prepared:	September 11, 2009
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® Synergies plus® Gram-Positive MIC/Combo Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	Device Modification - Evaluation of Vancomycin (K060312) versusaureus interpretive criteria (S ≤ 2, I = 4 -8, R ≥ 16).
Predicate device:	MicroScan® Synergies plus® Gram-Positive MIC/Combo Panels

510(k) Summary:

The proposed MicroScan® Synergies plus® Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a 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 March 5, 2007. The Premarket Notification (510[k]) presents data in support of the MicroScan® Synergies plus® Gram-Positive MIC/Combo Panel with vancomycin.

Vancomvcin has been cleared for susceptibility testing via Premarket Notification submissions. The Special Premarket Notification (510{k}) presents support of a request for a device modification, the updating of the product labeling with S. aureus interpretive criteria of (S ≤ 2, 1 = 4 -8, R ≥ 16).

The S. aureus data from the previously cleared vancomycin external evaluation (K060312) was compared to the performance of a CLSI frozen Reference panel utilizing the revised interpretative criteria (S ≤ 2. I = 4 -8. R ≥ 16). Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of 97.6% for vancomycin when compared with the frozen Reference panel.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

OCT 2 3 2009

Ms. Shannon Popson Regulatory Affairs Senior Technical Specialist Siemens Healthcare Diagnostics 2040 Enterprise Blvd West Sacramento, CA 95691

Re: K092919 Trade/Device Name: MicroScan® Synergies plus® Gram - Positive MIC/Combo Panels with Vancomycin (0.25 - 64 mcg/ml) Regulation Number: 21 CFR 866.1640 21 CFR 866.1645 Regulation Name: Antimicrobial Susceptibility Test Powder Fully automated short-term incubation cycle antimicrobial susceptibility system

Regulatory Class: Class II Product Code: LON, JWY Dated: August 24, 2009 Received: September 23, 2009

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Freddie Lu-Poole, MS
for

Sally A. Hojvat, M.Sc., Ph.D. 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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Indication for Use ·

510(k) Number (if known): 《♡오일 |9

Device Name: MicroScan® Synergies plus® Gram-Positive MIC/Combo Panels with Vancomycin (0.25 - 64 mcg/ml)

Indication For Use:

This particular submission is for the addition of the antimicrobial vancomycin, at concentrations of 0.25 to 64 ug/ml, to the test panel.

The gram-positive organisms which may be used for vancomycin susceptibility testing in this panel are:

Enterococcus spp. (e.g., Enterococcus faecalis) .
Staphylococcus spp. ●
Staphylococcus aureus (including methicillin-resistant strains) .
Staphylococcus epidermidis (including methicillin-resistant ● strains)

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ledalitha Poole

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

510(k) K092919

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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.”