(82 days)
Not Found
No
The device description and performance studies focus on traditional broth dilution methods and comparison to a reference panel, with no mention of AI or ML algorithms for interpretation or analysis. The alternative reading method using the WalkAway System is mentioned, but the description of the system's function does not indicate AI/ML capabilities.
No.
The device is an in vitro diagnostic tool used to determine the susceptibility of bacteria to antimicrobial agents, not a device used for therapy or treatment.
Yes
The device determines quantitative and/or qualitative antimicrobial agent susceptibility of colonies, which is a diagnostic function used to guide treatment decisions.
No
The device is a physical panel containing dehydrated antimicrobial agents, which is rehydrated and incubated. While it can be read by a system (MicroScan WalkAway), the core device itself is a physical panel, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used to determine the susceptibility of microorganisms (aerobic streptococci) to antimicrobial agents. This is a classic example of an in vitro diagnostic test, as it analyzes a sample (bacterial colonies) outside of the body to provide information about a patient's condition (how well an infection might respond to certain antibiotics).
- Device Description: The description details a miniaturized broth dilution susceptibility test, which is a common method used in clinical microbiology laboratories for diagnostic purposes.
- Performance Studies: The performance studies compare the device's results to a reference panel, which is standard practice for validating the accuracy of diagnostic tests. The metric of "Essential Agreement" is also a common measure used in evaluating the performance of AST devices.
- Predicate Device: The mention of a predicate device (MicroScan MICroSTREP plus Panels - Levofloxacin) with a K number (K020556) indicates that this device is being submitted for regulatory clearance as a medical device, specifically an IVD, by demonstrating substantial equivalence to a previously cleared device.
All of these factors strongly indicate that the MicroScan® MICroSTREP plus® Panel, with the addition of Moxifloxacin, is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.03 to 8 ug/ml to the test panel.
The organisms which may be used for Moxifloxacin susceptibility testing in this panel are:
Streptococcus pneumoniae (including penicillin resistant strains) Streptococcus pyogenes Streptoccocus agalactiae Streptococcus constellatus Streptococcus anginosus Viridans group streptococci
Product codes
LRG, JWY, LTW
Device Description
MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
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 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus 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 MICroSTREP plus 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 MICroSTREP plus Panel with Moxifloxacin.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The MICroSTREP plus Panel demonstrated acceptable performance with an overall Essential Agreement of 97.3% for Moxifloxacin when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Moxifloxacin, regardless of which read method (manual and WalkAway® instrument) was used with the turbidity inoculation method.
Quality Control testing demonstrated acceptable results for Moxifloxacin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 97.3%
Predicate Device(s)
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).
0
JUL 2 0 2011
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Siemens Healthcare Diagnostics |
|---|---|
| Contact name: | Shannon Popson, Regulatory Technical Specialist |
| Fax: | 916-374-3330 |
| Date prepared: | April 20, 2011 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus® Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Moxifloxacin |
| Predicate device: | MicroScan MICroSTREP plus Panels - Levofloxacin (K020556) |
510(k) Summary:
MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.
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 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.
The proposed MicroScan MICroSTREP plus 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 MICroSTREP plus Panel with Moxifloxacin.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The MICroSTREP plus Panel demonstrated acceptable performance with an overall Essential Agreement of 97.3% for Moxifloxacin when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Moxifloxacin, regardless of which read method (manual and WalkAway® instrument) was used with the turbidity inoculation method.
Quality Control testing demonstrated acceptable results for Moxifloxacin.
1
Image /page/1/Picture/1 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 bird or wing design, composed of several curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Shannon Popson Regulatory Technical Specialist 1584 Enterprise Blvd. West Sacramento, CA 95691
JUL 20 2011
Re: k11205
| Trade/Device Name: | MicroScan®MICroSTREP plus Panels |
|---|---|
| Regulation Number: | 21CFR §866.1640 |
| Regulation Name: | Antimicrobial Susceptibility Test Powder |
| Regulatory Class: | Class II |
| Product Code: | LRG, JWY, LTW |
| Dated: | July 14, 2011 |
| Received: | July 15, 2011 |
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 (fav the indications for use stated in the enclosure) to legally marketed predicate devices market to in interestate 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, Drig, 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such 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 (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. This letter will allow you to begin marketing your device as described in your Section
2
Page 2 – Shannon Popson
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 advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (011) 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Vau, attopm
Sally A. Hoivat, M Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: MicroScan® MICroSTREP plus® with Moxifloxacin (0.03 – 8 ug/ml)
Indications For Use:
The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.03 to 8 ug/ml to the test panel.
The organisms which may be used for Moxifloxacin susceptibility testing in this panel are:
Streptococcus pneumoniae (including penicillin resistant strains) Streptococcus pyogenes Streptoccocus agalactiae Streptococcus constellatus Streptococcus anginosus Viridans group streptococci
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie L. Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111205
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