(84 days)
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No
The document describes a traditional broth dilution susceptibility test and its performance compared to a reference method. There is no mention of AI or ML in the device description, intended use, or performance studies. While the device can be read with instrumentation, the description of the reading process does not suggest the use of AI/ML for interpretation.
No
The device is used for in vitro diagnostic testing of antimicrobial susceptibility and does not directly treat or prevent any medical condition.
Yes
This device is used to determine the susceptibility of bacteria to antimicrobial agents, which provides information crucial for guiding patient treatment. This falls under the definition of a diagnostic device as it aids in identifying the best course of action for a patient's condition.
No
The device description clearly outlines a physical panel with dehydrated antimicrobial agents that are rehydrated and incubated. While it can be read with MicroScan instrumentation, the core component is a physical panel, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device 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." This is a diagnostic test performed in vitro (outside the body) on biological samples (bacterial colonies).
- Device Description: The description details a "miniaturization of the broth dilution susceptibility test," which is a standard laboratory method for determining the susceptibility of bacteria to antibiotics. This further confirms its use in a diagnostic setting.
- Performance Studies: The performance studies compare the device's performance to a "CLSI frozen Reference panel," which is a common practice for validating IVD devices used in clinical microbiology. The metrics reported (Essential Agreement) are also typical for evaluating the performance of AST (Antimicrobial Susceptibility Test) systems, which are a type of IVD.
- Predicate Device: The predicate device listed (K003619; MicroScan Dried Gram-Positive MIC/Combo Panels - Linezolid) is also an AST system, indicating that this type of device is classified as an IVD.
Therefore, based on the provided information, the MicroScan® Dried Gram-Positive MIC/Combo Panel, with the addition of Ceftaroline, is clearly 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 addition of the antimicrobial Ceftaroline at concentrations of 0.06 to 16 mcg/ml to the test panel.
The gram-positive organisms which may be used for Ceftaroline susceptibility testing in this panel are:
Staphylococcus aureus
methicillin-susceptible and methicillin-resistant isolates - skin isolates only
- methicillin-susceptible isolates community-acquired bacterial pneumonia isolates -
Prescription Use
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skin
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. S. aureus clinical isolates were evaluated using only the turbidity inoculation method and read manually. 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 Expected Results determined prior to the evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Ceftaroline.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. S. aureus clinical isolates were evaluated using only the turbidity inoculation method and read manually. 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 Expected Results determined prior to the evaluation. The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of 99.0% for Ceftaroline when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Ceftaroline, 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 Ceftaroline.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 99.0%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
MAR 1 4 2013
SIEMENS
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Siemens Healthcare Diagnostics |
|---|---|
| Contact name: | Elisabeth Warriner, Regulatory Technical Specialist |
| Phone: | 916-374-3244 |
| Fax: | 916-372-6418 |
| Date prepared: | March 12, 2013 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels with Ceftaroline (0.06-16 |
| mcg/ml) | |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | New antimicrobial - Ceftaroline |
| Predicate device: | MicroScan Dried Gram-Positive MIC/Combo Panels - Linezolid (K003619) |
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.
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 Ceftaroline.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. S. aureus clinical isolates were evaluated using only the turbidity inoculation method and read manually. 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 Expected Results determined prior to the evaluation. The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of 99.0% for Ceftaroline when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Ceftaroline, 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 Ceftaroline.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, with three curved lines representing a staff and a serpentine form at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 14, 2013
Siemens Healthcare Diagnostics C/O Elisabeth Warriner Regulatory Technical Specialist 2040 Enterprise Blvd. West Sacramento, CA 95691
Re: K123933
Trade/Device Name: MicroScan Dried Gram-Positive MIC/Combo Panels with Ceftaroline (0.06 - 16 mdg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, JWY, LRG, LTW Dated: December 17, 2012 Received: December 20, 2012
Dear Ms. Warriner:
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 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
2
Page 2 - Ms. Warriner
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely yours,
Uwe Schierf -S for
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K123933 510(k) Number (if known):
Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Ceftaroline (0.06 - 16 mcg/ml)
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 addition of the antimicrobial Ceftaroline at concentrations of 0.06 to 16 mcg/ml to the test panel.
The gram-positive organisms which may be used for Ceftaroline susceptibility testing in this panel are:
Staphylococcus aureus
methicillin-susceptible and methicillin-resistant isolates - skin isolates only ●
- methicillin-susceptible isolates community-acquired bacterial pneumonia isolates -
V Prescription Use · (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 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 Devices (OIVD)
Uwe Scherf 2013.03.14 16:37:20=0
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K123933 510(k)
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