(31 days)
To determine antimicrobial agent susceptibility
MicroScan Dried Gram-Negative 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-negative bacilli. 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.
This document describes a Special 510(k) submission for a medical device called the MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem, specifically for an additional indication for use with Acinetobacter spp. The information provided allows us to extract the acceptance criteria and study details.
Here's the breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
| Criterion | Acceptance Criteria (Target) | Reported Device Performance (Acinetobacter spp. with Meropenem) |
|---|---|---|
| Essential Agreement (EA) | Not explicitly stated, but typically ≥ 90% for AST systems | 91.1% |
| Categorical Agreement (CA) | Not explicitly stated, but typically ≥ 90% for AST systems | 98.2% |
| Inoculum and Instrument Reproducibility | "Acceptable reproducibility and precision" | Demonstrated acceptable reproducibility and precision. |
| Quality Control | "Acceptable results" | Demonstrated acceptable results. |
Note: While specific percentage thresholds for EA and CA acceptance are not explicitly stated in the provided text, for Antimicrobial Susceptibility Test (AST) systems, FDA guidance typically expects Essential Agreement and Categorical Agreement to be at least 90% for new indications.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "combined efficacy and challenge data" and "external evaluations" conducted with "fresh and stock Efficacy and Challenge isolates." However, the specific sample size (number of isolates/strains) used for the test set is NOT explicitly provided in the text.
The provenance of the data is not specified in terms of country of origin. The study appears to be prospective as it involves "external evaluations" and testing with "fresh and stock" isolates and comparison to a CLSI frozen Reference panel, implying new data generation for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states that the device performance was compared "with a CLSI frozen Reference Panel." A CLSI (Clinical and Laboratory Standards Institute) reference panel implies a well-established and validated method for determining antimicrobial susceptibility, which serves as the gold standard.
The document does NOT explicitly state the number of experts or their qualifications involved in establishing the ground truth using the CLSI frozen Reference Panel. The CLSI method itself is the 'expert' in this context, representing a consensus-driven standard.
4. Adjudication Method for the Test Set
The document does not describe an "adjudication method" in the sense of multiple human readers independently assessing results and then resolving discrepancies. Instead, the study's design involves:
- Comparing the MicroScan Dried Gram-Negative MIC/Combo Panels with a CLSI frozen Reference panel. This reference panel serves as the definitive gold standard.
- The agreement metrics (Essential Agreement and Categorical Agreement) are calculated by comparing the results from the device to the results from the CLSI reference panel.
Therefore, an explicit human adjudication process is not applicable or described for this type of test, as the ground truth is established by a standardized laboratory method (CLSI).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was NOT done. This type of study (MRMC) is typically relevant for interpretative diagnostic devices where human readers evaluate images or data, and AI assists or replaces them. This submission is for an in-vitro diagnostic (IVD) device that determines antimicrobial susceptibility, not for image interpretation or diagnosis by human readers in the classical sense of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary performance evaluation appears to be a standalone (algorithm only) assessment. The "MicroScan Dried Gram-Negative MIC/Combo Panels" and associated instruments (WalkAway instrument) determine the MIC, which is then directly compared to the CLSI reference panel. While human operators are involved in setting up the test and reading the final MIC (which is then used to determine susceptibility), the comparison metrics (EA and CA) directly assess the output of the device relative to the reference method, not the human interpretation of that output.
7. The Type of Ground Truth Used
The type of ground truth used is a CLSI frozen Reference Panel. This represents a highly standardized and validated laboratory method for determining antimicrobial susceptibility, considered the gold standard for AST devices.
8. The Sample Size for the Training Set
The document does NOT specify the sample size for the training set. This submission is a Special 510(k) for an additional indication for an existing device. It focuses on the performance data for the specific indication requested (Acinetobacter spp. with Meropenem). Information regarding the original training set for the broader device development is not provided.
9. How the Ground Truth for the Training Set Was Established
Since the training set sample size is not provided, how its ground truth was established is also not described in this document. For AST devices, the ground truth for training (if an AI/ML component were heavily involved in the core susceptibility determination, which doesn't appear to be the case here as it's an assay system) would typically also be established using CLSI reference methods or other well-accepted laboratory standards for bacterial identification and susceptibility.
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June 29, 2020
Beckman Coulter, Inc. Elaine Duncan Senior Analyst Regulatory Affairs 1584 Enterprise Blvd. West Sacramento, California 95691
Re: K201423
Trade/Device Name: MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, JWY, LRG, LTW Dated: May 26, 2020 Received: May 29, 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
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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 803) 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 (OS) 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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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: | May 26, 2020 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer)(0.004 - 32 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| Special 510(k) Notification: | Additional Indications for Use – Acinetobacter spp. with Meropenem |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels Meropenem - (K192355 |
510(k) Summary:
MicroScan Dried Gram-Negative 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-negative bacilli.
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 additional indications for use. Acinetobacter species, with the MicroScan Dried Gram-Negative MIC/Combo Panel with meropenem 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 addition for Acinetobacter species indications for use with MicroScan Dried Gram-Negative MC/Combo Panel with meropenem.
The external evaluations were conducted with fresh and stock Efficacy and Challenge isolates. The external evaluations were designed to confirm the acceptability of the proposed additional indications for use with the Dried Gram-Negative Panel by comparing its performance with a CLSI frozen Reference panel. The Dried Gram-Negative Panel inoculated with Prompt® and read on the WalkAway instrument demonstrated acceptable performance with Acinetobacter spp. Essential Agreement (EA) of 91.1% and Categorical Agreement (CA) of 98.2% for meropenem when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with meropenem, regardless of which inoculum method (i.e., Turbidity or Prompt®), or instrument (autoSCAN-4 instrument or WalkAway system) was used.
Quality Control testing demonstrated acceptable results for meropenem.
Beckman Coulter, the stylized logo, and the Beckner Coulter product and service marks or registered trademarks of <man Coulter. Inc. in the United States and other countries
is a registered trademark of 3M Company, St. Paul, MN USA
§ 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).