(266 days)
The MicroScan MICroSTREP plus Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic Streptococcus pneumoniae. After inoculation. panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the MicroScan Procedural Manual. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
This particular Special 510(k) submission is for the addition of updated Streptococcus pneumoniae susceptibility test interpretative criteria for use with tetracycline at concentrations of 0.06 - 16 µg/mL on the MicroSCREP plus Panel (modification to K020939 and K062923).
Tetracycline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert and/or as listed on the FDA Susceptibility Test Interpretative Criteria web site.
Streptococcus spp. Streptococcus pneumoniae
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. After inoculation, panels are incubated for 20 - 24 hours at 35° + 1° in a non-CO2 incubator, and read according to the Procedural Manual.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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 115uL Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. 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. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
The provided text describes a 510(k) premarket notification for a medical device, specifically the "MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 ug/mL)". The document details the device's indications for use, its classification, and a summary of the studies conducted to demonstrate its performance.
Here's an analysis to extract the requested information, noting that some details typically found in a comprehensive study report (like the exact number of experts or the specific sample sizes for training sets) are often summarized or omitted in a 510(k) summary.
Device: MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 ug/mL)
Purpose of 510(k) Submission: Addition of updated Streptococcus pneumoniae susceptibility test interpretative criteria for use with tetracycline.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for Antimicrobial Susceptibility Test (AST) systems, as stated in the text, refer to the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. While the document doesn't explicitly list a table of acceptance criteria with specific numeric thresholds, it does state that the device demonstrated "substantially equivalent performance" and "acceptable performance" based on Essential Agreement (EA) and Categorical Agreement (CA) when compared to a CLSI frozen Reference Panel.
Based on the provided text, the criteria and performance are:
| Acceptance Criteria (Implicit from Guidance) | Reported Device Performance (vs. CLSI frozen Reference panel) |
|---|---|
| Substantial Equivalence in Performance (as per FDA Guidance) | Streptococcus pneumoniae Essential Agreement (EA) of 90.2% |
| Acceptable Performance (as per FDA Guidance) | Streptococcus pneumoniae Categorical Agreement (CA) of 99.7% |
| Acceptable Reproducibility and Precision | Acceptable reproducibility and precision for tetracycline (demonstrated in K020939 and K062923) |
| Acceptable Quality Control Testing | Acceptable results for tetracycline |
Note on "Acceptance Criteria" for AST devices: Typically, the FDA guidance for AST devices specifies thresholds for Essential Agreement (EA) and Categorical Agreement (CA). For example, EA for a new AST device is often expected to be ≥ 90% and CA is often expected to be ≥ 90% or 95% depending on the specific guidance and organism/drug combination. The reported values of 90.2% EA and 99.7% CA meet commonly accepted thresholds for AST devices.
2. Sample Sizes and Data Provenance
- Test Set Sample Size: The text states "The external evaluations were conducted with fresh and Challenge isolates." It does not provide an exact number or breakdown of these isolates for the test set. It mentions "combined efficacy and challenge data".
- Data Provenance: The document does not specify the country of origin for the data. The study was a comparison against a CLSI frozen Reference Panel, suggesting the data would have been collected in a controlled laboratory setting. It is implied to be prospective in the sense that the "external evaluations" were designed to confirm the acceptability of the updated STIC.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number of experts used to establish the ground truth for the test set.
- The ground truth was established by comparison to a "CLSI frozen Reference Panel." This implies that the reference standard for Minimum Inhibitory Concentration (MIC) determination was used, which adheres to CLSI (Clinical and Laboratory Standards Institute) methodologies. While CLSI methods are expert-developed and standardized, the document does not speak to specific "experts" for this particular study's ground truth assessment.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method (e.g., 2+1, 3+1). The comparison was made against a "CLSI frozen Reference Panel," which serves as the gold standard, so an adjudication process among human readers comparing findings would typically not be relevant in this type of in vitro diagnostic study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is an in vitro diagnostic (IVD) antimicrobial susceptibility test panel. It is designed to provide quantitative or qualitative susceptibility results, which are then interpreted by clinicians. The study design focuses on the accuracy of the device's output (MIC) compared to a reference method, not on human interpretation or the assistance of AI in clinical decision-making. No "AI assistance" component is mentioned for this device.
6. Standalone (Algorithm Only) Performance
- Yes, performance was evaluated in a standalone manner in the sense that the device's measurements (MIC values) were directly compared to the CLSI frozen Reference Panel. The reported EA and CA values reflect the performance of the device itself (including its rehydration, incubation, and reading, either manually or by a MicroScan WalkAway instrument) against a recognized gold standard. The text states: "The Dried MICroSTREP plus Panel inoculated with the turbidity inoculation method and manually read demonstrated acceptable performance...". This means the device's output was assessed independently.
7. Type of Ground Truth Used
- The type of ground truth used was expert consensus / reference method, specifically a CLSI frozen Reference Panel. This panel provides established, standardized Minimum Inhibitory Concentration (MIC) values according to CLSI guidelines, which are developed and validated by experts in antimicrobial susceptibility testing.
8. Sample Size for the Training Set
- The document does not specify a training set sample size. This type of submission (updated STIC for an existing panel) typically involves performance evaluation against a reference method rather than a machine learning training paradigm with separate training and test sets in the conventional sense. The "efficacy and challenge data" mentioned refers to the evaluation of the device performance, not the training of an underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
- As the document does not mention a "training set" in the context of an algorithm or machine learning, the question of how its ground truth was established is not directly applicable to this submission. The ground truth for the performance evaluation (test set equivalent) was established by comparison to a CLSI frozen Reference Panel, which represents a highly standardized and accepted reference method in microbiology.
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May 18, 2021
Beckman Coulter, Inc. Elaine Duncan Senior Analyst Regulatory Affairs 1584 Enterprise Blvd. West Sacramento, California 95691
Re: K202423
Trade/Device Name: MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LTT, LRG, JTZ, LTW Dated: August 12, 2020 Received: August 25, 2020
Dear Elaine Duncan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202423
Device Name
MicroScan MICroSTREP plus Panels with Tetracycline (0.06 - 16 ug/mL)
Indications for Use (Describe)
The MicroScan MICroSTREP plus Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic Streptococcus pneumoniae. After inoculation. panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the MicroScan Procedural Manual. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
This particular Special 510(k) submission is for the addition of updated Streptococcus pneumoniae susceptibility test interpretative criteria for use with tetracycline at concentrations of 0.06 - 16 µg/mL on the MicroSCREP plus Panel (modification to K020939 and K062923).
Tetracycline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert and/or as listed on the FDA Susceptibility Test Interpretative Criteria web site.
Streptococcus spp. Streptococcus pneumoniae
| Type of Use (Select one or both, as applicable) | |
|---|---|
| > 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 logo for Beckman Coulter. The logo consists of a red circular symbol on the left, with two curved white lines inside. To the right of the symbol is the text "BECKMAN" in bold, followed by "COULTER" in a larger, bolder font. The text is black.
Special 510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Beckman Coulter |
|---|---|
| Contact name: | Elaine Duncan, Senior Analyst Regulatory Affairs |
| Phone: | 916-374-3279 |
| Fax: | 916-374-2480 |
| Date prepared: | August 12, 2020 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus Panels with Tetracycline (Te) (0.06 - 16 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Codes: | LTT, LRG, JWY, JTZ |
| Special 510(k) Notification: | Updated FDA-recognized STIC for Streptococcus pneumoniae with Tetracycline |
| Predicate device: | MicroScan MICroSTREP plus Tetracycline - (K020939 and K062923) |
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. After inoculation, panels are incubated for 20 - 24 hours at 35° + 1° in a non-CO2 incubator, and read according to the Procedural Manual.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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 115uL Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. 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. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
The proposed updated Streptococus pneumoniae FDA-recognized STIC for use with the MicroScan MICroSTREP plus Panels with tetracycline demonstrated substantially equivalent performance when compared with a 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. This Special Premarket Notification (510[k]) presents combined efficacy and challenge data in support of the application of updated Streptococcus pneumoniae STIC for use with MicroScan MICroSTREP plus Panels with tetracycline.
The external evaluations were conducted with fresh and Challenge isolates. The external evaluations were designed to confirm the acceptability of the updated STIC for use with the Dried MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. The Dried MICroSTREP plus Panel inoculated with the turbidity inoculation method and manually read demonstrated acceptable performance with Streptoccus pneumoniae Essential Agreement (EA) of 90.2% and Categorical Agreement (CA) of 99.7% for tetracycline when compared with the frozen Reference panel.
Reproducibility testing located in K020939 and K062923 demonstrated acceptable reproducibility and precision with tetracycline, regardless of which read method (i.e., manual or WalkAway system) was used.
Quality Control testing demonstrated acceptable results for tetracycline.
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries,
§ 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).