(188 days)
To determine antimicrobial agent susceptibility
To determine gram-negative and gram-positive bacterial susceptibility against the antimicrobial agent Grepafloxacin.
There are no organisms for which MicroScan® panels are intended for testing, that are included in the 'Indications and Usage' as stated in the FDA approval of Grepafloxacin.
The following secondary organisms included for the testing of MicroScan® panels have in vitro data but the safety and effectiveness in treating clinical infections have not been established: Citrobacter freundii, Citrobacter (diversus) koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis (methicillin-susceptible), Streptococcus agalactiae, Streptococcus pyogenes.
The MicroScan® Dried Gram-Positive MIC/Combo Panels with Grepafloxacin are not intended for use with Streptococcus pneumoniae and viridans streptococci.
Microdilution Minimum Inhibitory Concentration (MIC) Panels
MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels
Acceptance Criteria and Device Performance Study
The provided document describes the 510(k) submission for the MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels with Grepafloxacin, intended to determine antimicrobial agent susceptibility. The study aims to demonstrate substantial equivalence to an NCCLS frozen Grepafloxacin Reference Panel.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the statement that the device demonstrated "acceptable performance" and "substantially equivalent" performance when compared to the predicate device, as per the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991). The primary metric for performance appears to be "Essential Agreement" with the reference panel.
| Metric | Acceptance Criteria (Implicit from "acceptable" performance vs. predicate) | Reported Device Performance (Gram-Negative) | Reported Device Performance (Gram-Positive) |
|---|---|---|---|
| Overall Essential Agreement | Not explicitly stated numerically, but implied to be high for "acceptable performance" and "substantially equivalent." | 98.8% | 97.5% |
| Reproducibility & Precision | Acceptable | Acceptable | Acceptable |
| Quality Control | Acceptable | Acceptable | Acceptable |
Note: The document does not provide specific numerical thresholds for "acceptable" Essential Agreement, reproducibility, precision, or quality control. Such thresholds would typically be found in the referenced FDA DRAFT document or the study protocol itself. However, the reported values are presented as meeting these unspecified "acceptable" criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The external evaluations were conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
- Sample Size: The document does not explicitly state the total number of isolates (sample size) used for either the gram-negative or gram-positive evaluations.
- Data Provenance: The country of origin for the data is not specified. The study is described as "external evaluations," which typically implies a prospective design where the new device's performance is compared against a reference standard using various new samples. Given the nature of antimicrobial susceptibility testing, this would be a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (antimicrobial susceptibility testing) does not typically involve human experts establishing a "ground truth" through visual assessment or clinical judgment in the same way as, for example, an imaging study.
Instead, the "ground truth" (or reference standard) is established by the NCCLS frozen Grepafloxacin Reference Panels. The performance of this reference panel itself is established through a standardized, controlled laboratory procedure, not through expert consensus in the traditional sense. Therefore, the concept of "number of experts" and "qualifications of experts" for ground truth establishment is not directly applicable here.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple human readers independently assess data and discrepancies need to be resolved. This is not directly applicable to an antimicrobial susceptibility testing study comparing results against a laboratory-defined reference standard (the NCCLS panel). The comparison is numerical and algorithmic, not based on human interpretation that requires adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study is not mentioned and would not be relevant for this type of device. This device is a diagnostic testing panel designed to determine antimicrobial susceptibility, not an AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the study primarily reflects the "standalone" performance of the MicroScan® Dried panels. The comparison is directly between the results generated by the MicroScan® panels and the NCCLS frozen reference panels. While a human technician operates the panels, the "performance" being evaluated is the accuracy of the panel's determination of MIC values and susceptibility categories compared to the reference, not the human interpretation of ambiguous signals. The document mentions instrument reproducibility testing with "autoScan-4 and WalkAway®," suggesting automated reading, which further supports the "standalone" nature of the performance assessment.
7. The Type of Ground Truth Used
The ground truth used is a reference standard, specifically the NCCLS frozen Grepafloxacin Reference Panels. This is a laboratory-established standard for determining minimum inhibitory concentrations (MICs) of antimicrobial agents.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of this device. Antimicrobial susceptibility panels like this are typically developed based on established microbiological principles and validated against known reference methods, rather than being "trained" like a machine learning algorithm. The study described focuses on validation (testing set performance).
9. How the Ground Truth for the Training Set was Established
As no "training set" for an algorithm is mentioned in the application, this question is not directly applicable. If one were to consider the broader development of the MicroScan® technology, the "ground truth" for establishing the design and performance characteristics of such panels would be rooted in decades of microbiological research, standardized methods (like those from NCCLS/CLSI), and clinical correlation of MIC values with treatment outcomes, but this is beyond the scope of this specific 510(k) submission.
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DADE MICROSCAN INC. 1584 Enterprise Boulevard West Sacramento, CA 95691 Tel: +1 (916) 372-1900
DADE BEHRING
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Sr. Regulatory Affairs Specialist |
| Fax: | 916-374-3144 |
| Date prepared: | October 16, 1998 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Grepafloxacin |
| Predicate device: | NCCLS Frozen Grepafloxacin Reference Panels |
510(k) Summary:
The proposed MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panel with Grepationalin demonstrated substantially equivalent performance with an NCCLS frozen Grepafloxacin Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).
The Premarket Notification (510[k]) presents data in support of the new antimicrobial, Grepafloxacin, for the MicroScan® Dried Gram Negative and Gram Positive MIC/Combo Panels.
Both the gram-negative and gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Grepafloxacin panels by comparing their performance with an NCCLS frozen Grepafloxacin Reference panel.
The Dried gram-negative Grepafloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 98.8% when compared with the frozen Grepafloxacin Reference panel. The Dried gram-positive Grepafloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 97.5% when compared with the frozen Grepafloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; both the gram-negative and the grampositive Dried Grepafloxacin panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway") was used.
Quality Control performance was acceptable for both the gram-negative and the gram-positive Dried Grepafloxacin panels.
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1999
Cynthia Van Duker Senior Associate, Regulatory Affairs Dade Microscan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K983711
Trade Name: MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels with Grepafloxacin Product Code: JWY Dated: March 25, 1999 Received: March 26, 1999
Dear Ms. Van Duker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment B
Indications for Use Statement
| 510(k) No.: | K983711 |
|---|---|
| Device Name: | MicroScan® Dried Gram-Negative and Gram-PositiveMIC/Combo Panels with Grepafloxacin (0.002 - 8 mcg/mlon the gram-negative and gram-positive panels) |
| Indications for Use: | To determine gram-negative and gram-positive bacterialsusceptibility against the antimicrobial agent Grepafloxacin. |
| There are no organisms for which MicroScan® panels areintended for testing, that are included in the 'Indications andUsage' as stated in the FDA approval of Grepafloxacin.The following secondary organisms included for the testingof MicroScan® panels have in vitro data but the safety andeffectiveness in treating clinical infections have not beenestablished: Citrobacter freundii, Citrobacter (diversus)koseri, Enterobacter aerogenes, Enterobacter cloacae,Escherichia coli, Klebsiella oxytoca, Klebsiellapneumoniae, Morganella morganii, Proteus mirabilis,Proteus vulgaris, Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis (methicillin-susceptible), Streptococcus agalactiae, Streptococcuspyogenes.The MicroScan® Dried Gram-Positive MIC/Combo Panels |
with Grepafloxacin are not intended for use with Streptococcus pneumoniae and viridans streptococci.
Woody Dubois
(Division Sign-Off) Division of Clinical Laboratory Devices K9837 510(k) Number
PRESCRIPTION USE X
§ 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).