← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K092919 # MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 (K092919) _Siemens Healthcare Diagnostics · LON · Oct 23, 2009 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K092919 ## Device Facts - **Applicant:** Siemens Healthcare Diagnostics - **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md) - **Decision Date:** Oct 23, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.1645 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## 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. ## Regulatory 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](/device/K060312.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SPECIAL 510(k): Device Modification ODE Review Memorandum (Decision Making Document is Attached) To: THE FILE RE: DOCUMENT NUMBER K_092919 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. MicroScan® Synergies plus® Gram-Positive MIC/Combo Panels k060312 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. The modification was - Updating of the product labeling with S. aureus interpretive criteria of S ≤ 2; I = 4 - 8; R ≥ 16 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and | Similarities | | | | --- | --- | --- | | Item | Current | Modified | | Product Name | MicroScan® Synergies plus® Gram-Positive MIC/Combo Panels | Same | | Intended use | Determination of susceptibility to Vancomycin with gram-positive enterococci and staphylococci | Same | | Technologies | Fully Automated Short-Term (16 hours) Incubation Cycle Microdilution MIC Susceptibility Tests Overnight Microdilution MIC Susceptibility Tests | Same | | Antibiotic | Vancomycin 0.25 – 64 μg/mL | Same | | Labeling Limitations | S. aureus isolates with MICs of 8 – 16 μg/mL on MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels will be held to 16/18 hours for overnight instrument or visual reporting of vancomycin. | Same | | Differences | | | | Item | Current | Modified | | S. aureus Interpretive Criteria | ≤4 (S), 8 – 16 (I), ≥32 (R) | S ≤ 2; I = 4 – 8; R ≥ 16 | 5. A Design Control Activities Summary which includes: {1} 2 a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. ## The design control activities performed Vancomycin, on MicroScan® Synergies plus™ Gram-Positive Panels, was evaluated and cleared (K060312) with three read methods Rapid (WalkAway® SI, <16 hours), Overnight Instrument (WalkAway® SI, 16/18 hours) and Overnight Manual (manual/visual read, 16-20 hours), by comparing Dried panel performance with frozen Reference Panels using stock and fresh isolates (Efficacy phase), challenge strains (Challenge phase), and QC strains (QC testing). Challenge strains were compared to Expected Results determined prior to the evaluation. Data collected from the external validation of vancomycin (K060312) was processed using the modified S. aureus interpretive criteria (S ≤ 2, I = 4 -8, R ≥ 16). The Microdilution Inhibitory Concentration (MIC) interpretive standards for vancomycin were modified by the Clinical Laboratory Standards Institute (CLSI) in January 2006. Reference CLSI Document M100 – S16 (Performance Standards for Antimicrobial Susceptibility Testing; Sixteenth Informational Supplement). These revised interpretive criteria were approved by the FDA for drug manufacturer, Baxter Healthcare, Inc., in April of 2008. The gram-positive Vancomycin Efficacy phase was conducted with a total of five hundred and forty nine (549) isolates, including seventy three (73) stock and four hundred and seventy six (476) fresh clinical isolates. The Challenge phase was conducted with 78 challenge isolates. The combined Rapid Read results, from the Efficacy and Challenge studies, demonstrated overall Essential Agreement of 97.6% (565/579) and Categorical Agreement of 97.9% (567/579) when processed using the modified S. aureus interpretive criteria (S ≤ 2, I = 4 -8, R ≥ 16). Below is a summary of the performance of S. aureus with the **new interpretive criteria** using the different read methods {2} 3 | Read Method | Organism | No. Tested | Essential Agreement | Categorical Agreement | Min Error s | Maj Error s | Very Maj Error s | | --- | --- | --- | --- | --- | --- | --- | --- | | Rapid Dried <16 hours | All | 579 | 565/579 (97.6) | 567/579 (97.9) | 7 (1.2) | 5 (1.0) | 0 | | Dried Overnight Instrument | All | 627 | 613/627 (97.8) | 615/627 (98.1) | 9 (1.4) | 3 (0.6) | 0 | | Dried Overnight Manual | All | 627 | 616/627 (98.2) | 618/627 (98.6) | 7 (1.1) | 2 (0.4) | 0 | | Rapid Dried <16 hours | S. aureus only | 208 | 205/208 (98.6) | 205/208 (98.6) | 2 (1.0) | 1 (0.5) | 0 | | Dried Overnight Instrument | S. aureus only | 208 | 205/208 (98.6) | 204/208 (98.1) | 3 (1.4) | 1 (0.5) | 0 | | Dried Overnight Manual | S. aureus only | 208 | 207/208 (99.5) | 206/208 (99) | 2 (1.0) | 0 | 0 | NOTE: Efficacy and Challenge total for the Rapid Instrument Read Method equaled 579 isolates. Results for 42 Efficacy isolates and 6 Challenge isolates were not reported due to read times ≥16 hours. The 3 VRSA isolates are included in the Combined Efficacy and Challenge data. The table below reflects performance of S. aureus using the old interpretive criteria as presented in k060312 | Read Method | Organism | No. Tested | Essential Agreement | Categorical Agreement | Min Error s | Maj Error s | Very Maj Error s | | --- | --- | --- | --- | --- | --- | --- | --- | | Rapid Dried <16 hours | S. aureus only | 208 | 204/207 (98.6) | 205/208 (98.6) | 0 | 1 (0.5) | 0 | | Dried Overnight Instrument | S. aureus only | 208 | 205/208 (98.6) | 204/207 (98.6) | 0 | 1 (0.5) | 0 | | Dried Overnight Manual | S. aureus only | 208 | 208/208 (100) | 206/207 (99.2) | 0 | 0 | 0 | There were more minor errors observed with the new interpretive criteria for S. aureus, specifically, there were 2 minor errors with the Rapid read method(<16 hours), 3 minor errors with the dried overnight instrument method, and 2 minor errors with the dried overnight manual method. However, the number of minor errors is within the acceptable limits as recommended in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems. There were no minor errors observed with S. aureus using the old interpretive criteria. The number of major errors did not change when either the old or new interpretive criteria were used with all read methods. Considering the EA and CA of >97%, the overall performance of S. aureus with the new interpretive criteria is acceptable. {3} 4 6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices). The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K092919](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K092919) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com