(174 days)
The MicroScan® Dried 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 bacteria. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the reformulated 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:
Enterococci (e.g., Enterococcus faecalis)
Staphylococci. including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillinresistant strains)
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 bacteria.
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. For accurate detection of vancomycin resistance with enterococcus species, panels were incubated to 24 hours.
The provided text describes the acceptance criteria and study for the MicroScan Dried Gram-Positive MIC/Combo Panels with Vancomycin.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (FDA Guidance) | Reported Device Performance |
|---|---|---|
| Overall Essential Agreement (EA) with Reference Panel | Acceptable performance, specifically for AST systems (Class II Special Controls Guidance) | 99.4% (for vancomycin) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation, and "Efficacy, Challenge and Reproducibility isolates" for reproducibility testing. However, the exact number of isolates (sample size) for the test set is not explicitly stated.
- Data Provenance: The text does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective, though the description of the "external evaluation" and "Challenge strains" suggests a prospective testing methodology.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. The ground truth was established by comparison with a "CLSI frozen Reference Panel," but there's no mention of human experts defining this ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the given text. The comparison was made against a CLSI frozen Reference Panel, implying a direct comparison rather than an adjudication process involving multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is an in vitro diagnostic for antimicrobial susceptibility testing, not an AI-assisted diagnostic device for human readers. Therefore, the concept of human reader improvement with or without AI assistance is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The device (MicroScan Dried Gram-Positive MIC/Combo Panel) "demonstrated substantially equivalent performance when compared with an CLSI frozen Reference Panel." This comparison assesses the algorithm/device's performance in determining MIC values independently. The panel can be read visually or with MicroScan instrumentation, indicating both a potential human-in-the-loop and a standalone (instrument-read) performance. The performance metric of 99.4% Essential Agreement relates to the panel's direct performance.
7. The Type of Ground Truth Used
The ground truth used was a CLSI frozen Reference Panel. This panel's results are considered the gold standard for comparison in antimicrobial susceptibility testing for the purpose of this submission.
8. The Sample Size for the Training Set
This information is not provided in the given text. The document describes the testing and comparison with a reference panel, but does not detail a separate "training set" for the device, as it is a panel design for inherent chemical and biological interactions, not a machine learning algorithm that requires explicit training data in the same way.
9. How the Ground Truth for the Training Set Was Established
Since a training set (in the context of machine learning) is not explicitly mentioned or clearly applicable to this type of device (a chemical/biological testing panel), the method for establishing its ground truth is not provided. The "ground truth" reference (CLSI frozen Reference Panel) is used for evaluation of the device's performance.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BECKMAN COULTER SHANON POPSON REGULATORY TECHNICAL SPECIALIST 1584 ENTERPRISE BLVD WEST SACRAMENTO CA 95691
July 2, 2015
Re: K150039
Trade/Device Name: MicroScan Dried Gram Positive MIC/combo Panels With Vancomycin (0.25-64 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LTT, JWY, LRG, LTW Dated: June 8, 2015 Received: June 9, 2015
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S for
Sally Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
MicroScan Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25 - 64 µg/ml)
Indications for Use (Describe)
The MicroScan® Dried 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 bacteria. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the reformulated 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:
Enterococci (e.g., Enterococcus faecalis)
Staphylococci. including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillinresistant strains)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Siemens Healthcare Diagnostics |
|---|---|
| Contact name: | Shannon Popson, Regulatory Technical Specialist |
| Phone: | 916-374-3330 |
| Fax: | 916-374-2119 |
| Date prepared: | January 6, 2015 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25-64µg/ml) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | Antimicrobial agent - Vancomycin |
| Predicate device: | MicroScan Dried Gram-Positive MIC/Combo Panels - Ceftaroline (K123933) |
510(k) Summary:
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 bacteria.
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. For accurate detection of vancomycin resistance with enterococcus species, panels were incubated to 24 hours.
The proposed MicroScan Dried 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 August 28, 2009. The Premarket Notification (510[k]) presents data in support of the MicroScan Dried Gram-Positive MIC/Combo Panel with yancomvoin.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. Efficacy, Challenge and Reproducibility isolates were tested using all inoculation and reading methods. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Positive Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to a frozen Reference panel result collected as a matched pair. The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of 99.4% for vancomycin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with vancomycin, regardless of which inoculum method (i.e., Turbidity and Prompt™), or instrument (autoSCAN®-4 and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for vancomycin.
§ 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).