(174 days)
No
The description focuses on traditional broth dilution methods and visual or instrument-assisted reading, with no mention of AI or ML for analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) tool used to determine the susceptibility of bacteria to antimicrobial agents, rather than directly treating a condition or having a therapeutic effect on a patient.
Yes
The device is used to determine the susceptibility of bacteria to antimicrobial agents, which is a diagnostic purpose to guide treatment.
No
The device description clearly states it is a "Dried Gram-Positive MIC/Combo Panel" which is a physical panel containing dehydrated antimicrobial agents. It is a hardware component used in laboratory testing. While it can be read with MicroScan instrumentation (which may involve software), the core device itself is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to determine antimicrobial agent susceptibility of bacteria. This is a diagnostic test performed in vitro (outside the body) on a sample (bacterial colonies).
- Device Description: The description details how the test works by rehydrating dehydrated antimicrobial agents with a suspension of the organism and observing growth inhibition. This is a standard method for in vitro susceptibility testing.
- Performance Studies: The performance studies compare the device's performance to a reference panel, which is typical for validating an IVD.
- Predicate Device: The predicate device listed (K123933) is also an Antimicrobial Susceptibility Test (AST) System, which falls under the category of IVDs.
The device is designed to provide information about the susceptibility of bacteria to antimicrobial agents, which is crucial for guiding treatment decisions. This fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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)
Product codes
LTT, JWY, LRG, LTW
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies
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.
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.
Key Metrics
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.
Predicate Device(s)
MicroScan Dried Gram-Positive MIC/Combo Panels - Ceftaroline (K123933)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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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Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented. The image appears to be a logo or branding element.
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.