The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent suscept of colonies grown on solid media of rapidly growing arcoire and the stores of the stores of the stores of the stores of the stores of the lock of the lock for t on anous at 3 visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the evaluation of antimicrobi vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels utilizing the updated Staphylococcus aureus interpretative criteria (S ≤ 2, I = 4 -8, R ≥ 16).

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

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

Device Description

MicroScan Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 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

Here's a breakdown of the acceptance criteria and the study details for the MicroScan Dried Gram-Positive MIC/Combo Panels, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement (compared with CLSI frozen Reference Panel)	99.3% for vancomycin

Study Details

2. Sample size used for the test set and the data provenance:

The document mentions "stock and fresh isolates (Efficacy phase)" and "challenge strains (Challenge phase)."
Sample Size:
- The exact sample size for the "stock and fresh isolates" and "challenge strains" is not explicitly stated in the provided text.
- The document does say the data was collected from "external validation of vancomycin."
Data Provenance: The provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated. The phrase "external validation" suggests it was not solely internal testing. The study design comparing against a CLSI frozen Reference Panel implies specific methodological rigor.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number or qualifications of experts used to establish the ground truth. Ground truth for the reference panel is typically established through standardized laboratory methods (e.g., CLSI guidelines).

4. Adjudication method for the test set:

The document does not describe an adjudication method involving multiple human readers for the test set. The comparison is between the device's results and a "CLSI frozen Reference Panel," which represents the established ground truth.

5. 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 comparative effectiveness study was done. This device is an automated antimicrobial susceptibility test (AST) system, not an AI-assisted diagnostic device for human interpretation. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, this study represents a standalone evaluation of the device. The "MicroScan Dried Gram-Positive MIC/Combo Panels" are designed to determine susceptibility by reading the minimum inhibitory concentration (MIC) after incubation, either visually or with MicroScan instrumentation. The evaluation compares this system's performance against a reference method without human interpretation as part of the primary outcome measure.

7. The type of ground truth used:

The ground truth used was a CLSI frozen Reference Panel, and for challenge strains, "Expected Results determined prior to the evaluation." This implies a reference standard method (broth microdilution according to Clinical and Laboratory Standards Institute guidelines) as the ground truth.

8. The sample size for the training set:

The document does not mention a distinct "training set" or its sample size. This is a premarket notification for a device modification, and the evaluation focuses on performance against a reference standard, not on training a machine learning algorithm.

9. How the ground truth for the training set was established:

This question is not applicable as the document does not describe a training set in the context of machine learning, nor does it detail how initial ground truth for general panel development (beyond this specific validation) was established. The focus is on validation against an existing, established reference standard for antimicrobial susceptibility testing.

Summary

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1091264

JUL 2 2 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:	April 21, 2009
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan Dried Gram-Positive MIC/Combo Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	Device Modification - Evaluation of reformulated Vancomycin (K051202)versus S. aureus interpretive criteria ( $S ≤ 2$ , $I = 4 -8$ , $R ≥ 16$ ).

Predicate device:	MicroScan Dried Gram-Positive MIC/Combo Panels

510(k) Summary:

The proposed MicroScan Dricd Gram-Positive MIC/Combo 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 March 5, 2007.

This Special Premarket Notification [510(k)] presents support of a request for a device modification and the updating of the product labeling with S. aureus interpretive criteria of (S < 2, I = 4 -8, R ≥ 16).

Data collected from the external validation of vancomycin (K051202) was processed using the modified S. aureus interpretive criteria (S ≤ 2, I = 4 -8, R ≥ 16). The Dried panel performance was compared with frozen Reference panels using stock and fresh isolates (Efficacy phase), and challenge strains (Challenge phase). Challenge strains were compared to Expected Results determined prior to the evaluation. The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of 99.3% 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 consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUL 2 2 2009

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

Re: K091264

Trade/Device Name: MicroScan® Dried Gram – Positive MIC/Combo Panels with Vancomycin (0.25 - 128 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, LRG,JWY,LTW Dated: July 14, 2009 Received: July 15, 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.

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

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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,

Luella ter Poole, MS

Sue A. Huse, M.S., Ph.D. Acting 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):

Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25 — 128 mcg/ml)

Indication For Use:

The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to
determine quantitative and/or qualitative antimicrobial agent suscept of colonies grown on solid media of rapidly growing arcoire and the stores of the stores of the stores of the stores of the stores of the lock of the lock for
t on anous at 3 visually or with MicroScan instrumentation, according to the Package Insert.

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

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

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

And/Or

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

Ludie Poole

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

510(k) K091267

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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).