MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025

K092919 · Siemens Healthcare Diagnostics · LON · Oct 23, 2009 · Microbiology

Device Facts

• Record ID: K092919
• Device Name: MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
• Applicant: Siemens Healthcare Diagnostics
• Product Code: LON · Microbiology
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

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 Story

MicroScan® Synergies plus® Gram-Positive MIC/Combo Panels are miniaturized broth dilution susceptibility tests. Panels contain dehydrated antimicrobial agents; rehydrated with Synergies plus® Pos Broth after inoculation with standardized organism suspensions. Panels incubated in WalkAway® SI system (or equivalent) for 4.5-18 hours. System reads minimum inhibitory concentration (MIC) by identifying lowest concentration inhibiting growth. Used in clinical laboratories by trained personnel. Output provides quantitative MIC values to assist clinicians in selecting appropriate antimicrobial therapy for gram-positive infections.

Clinical Evidence

Performance evaluated using 549 clinical isolates and 78 challenge strains. Combined Rapid Read results showed 97.6% Essential Agreement and 97.9% Categorical Agreement. S. aureus-specific analysis (n=208) showed high agreement across all read methods (Rapid, Overnight Instrument, Overnight Manual). Minor errors increased slightly with new criteria but remained within acceptable limits per FDA guidance. No change in major error rates. Bench testing confirmed performance is acceptable.

Technological Characteristics

Miniaturized broth dilution panels; dehydrated antimicrobial agents in wells. Rehydrated with Synergies plus® Pos Broth. Incubation 4.5-18 hours at 35°C. Automated reading via WalkAway® SI system or visual reading. Connectivity via instrument integration.

Indications for Use

Indicated for the determination of susceptibility to Vancomycin in gram-positive enterococci and staphylococci.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• MicroScan® Synergies plus® Gram-Positive MIC/Combo Panels (K060312)

Submission Summary (Full Text)

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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) versus<br>aureus interpretive criteria (S ≤ 2, I = 4 -8, R ≥ 16). |
| Predicate device: | MicroScan® Synergies plus® Gram-Positive MIC/Combo Panels |

#### 510(k) Summary:

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.

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 [phone]. 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 [phone] or [phone] 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:

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)

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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