(46 days)
To determine gram-negative bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing* include: Gram-Negative Bacteria Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa
Microdilution Minimum Inhibitory Concentration (MIC) Panel, MicroScan® Dried Gram-Negative MIC/Combo Panels
This document describes the acceptance criteria and study for the MicroScan® Dried Gram-Negative MIC/Combo Panels with Meropenem.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | Acceptable performance when compared with an NCCLS frozen Meropenem Reference panel (as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" dated May 31, 1991). | Demonstrated substantially equivalent performance with an overall Essential Agreement of 99.1% when compared with the frozen Meropenem Reference panel. |
| Reproducibility | Acceptable reproducibility and precision for gram-negative Dried Meropenem panels, regardless of inoculum method or instrument used. | Demonstrated acceptable reproducibility and precision with both Turbidity and Prompt inoculum methods, and with autoScan-4 and WalkAway instruments. |
| Quality Control | Acceptable Quality Control performance for gram-negative Dried Meropenem panels. | Acceptable Quality Control performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The external evaluations were conducted on "fresh and stock Efficacy isolates and stock Challenge strains" of gram-negative bacteria.
- Sample Size: The exact number of isolates/strains used for the test set is not explicitly stated in the provided text.
- Data Provenance: Not specified directly (e.g., country of origin). The evaluation used "fresh and stock Efficacy isolates and stock Challenge strains," implying a laboratory-based evaluation with well-characterized samples. It is a prospective study in the sense that performance was evaluated against a reference standard in a controlled setting for premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The ground truth for the test set was established by the NCCLS frozen Meropenem Reference Panel, which is a standardized method, not by individual experts in a subjective assessment. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically applied in image analysis or clinical diagnosis studies is not directly applicable here. The "expertise" is embedded in the scientific rigor and standardization of the NCCLS reference method.
4. Adjudication Method for the Test Set
- No explicit adjudication method (like 2+1 or 3+1) is mentioned. The comparison was directly between the test device's results and the results from the NCCLS frozen Meropenem Reference panel, which serves as the established gold standard. Discrepancies would be analyzed according to the "FDA DRAFT document Review Criteria for Assessment of Antimicrobial Susceptibility Devices," but no "adjudication" by multiple human reviewers for individual cases is implied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed in the context of human readers improving with or without AI assistance. This study evaluates an automated diagnostic device (MIC panel) against a reference standard, not the performance of human readers.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- Yes, a standalone performance study was done. The entire evaluation focuses on the performance of the MicroScan® Dried Gram-Negative MIC/Combo Panels with Meropenem itself (the "algorithm/device") in determining antimicrobial susceptibility. The "Essential Agreement" of 99.1% is a direct measure of this standalone performance compared to the reference. Human intervention is limited to standard laboratory procedures for preparing and reading the panels, not interpreting complex outputs.
7. Type of Ground Truth Used
- The ground truth used was a reference standard method: the NCCLS frozen Meropenem Reference Panel. This is a scientifically established and recognized method for determining antimicrobial susceptibility, serving as the benchmark for accuracy.
8. Sample Size for the Training Set
- The provided text does not specify a sample size for a training set. For this type of device (microbiological susceptibility panel), the "training" analogous to machine learning often involves extensive R&D, formulation optimization, and preliminary testing, rather than a distinct "training set" of patient data as might be found in AI/ML applications. The reported study focuses on validation against a reference standard.
9. How the Ground Truth for the Training Set Was Established
- As no distinct "training set" is mentioned, the method for establishing its ground truth is also not applicable or described in the provided text. The development of such panels relies on established microbiological principles, reference strains, and internal validation, rather than a formal "training set" with independently established ground truth in the context of this 510(k) summary.
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Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem Premarket Notification April 11, 1997
MAY 3.0 1997
DADE INTERNATION/
MicroScan Inc 1584 Enterprise Boulevard West Sacramento, CA 95691 916.372.1900
510(k) Submission Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Sharolyn Lentsch, Sr. Regulatory Affairs Administrator |
| Fax: | 916-374-3144 |
| Date prepared: | April 11, 1997 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panel |
| Trade Name: | MicroScan® Dried Gram-Negative MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Meropenem |
| Predicate device: | NCCLS Frozen Meropenem Reference Panels |
510(k) Summary:
The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel with Meropenem demonstrated substantially equivalent performance when compared with an NCCLS frozen Meropenem 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, Meropenen, for the MicroScan® Dried Gram-Negative MIC/Combo Panels.
The gram-negative 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 Meropenem panels by comparing their performance with an NCCLS frozen Meropenem Reference panel.
The Dried gram-negative Meropenem panel demonstrated acceptable performance with an overall Essential Agreement of 99.1% when compared with the frozen Meropenem Reference panel.
Inoculum and instrument reproducibility testing was conducted; the gram-negative Dried Meropenem 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 the gram-negative Dried Meropenem panels.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sharolyn J. Lentsch Sr. Regulatory Affairs Administrator Dade International MicroScan Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
MAY 30 1997
Re: K971376
Trade Name: MicroScan® Dried Gram-Negative MIC/Combo Panels/Meropenem Regulatory Class: II Product Code: JWY Dated: April 11, 1997 Received: April 14, 1997
Dear Ms. Lentsch:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 vour 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 Butman
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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Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenern Premarket Notification April 11, 1997
Intended Use Statement
To be assigned by FDA 510(k) No .: - -------------Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels with Meropenem (0.004 - 32 mcg/ml) To determine gram-negative bacterial susceptibility against the Indications for Use: antimicrobial agent Meropenem. Organisms with indications for testing* include: Gram-Negative Bacteria Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa
- As taken from the Indications and Usage section of the manufacturer's package insert (as provided by the Meropenem manufacturer, Zeneca Pharmaceuticals).
Okaim Hansen
510fk) Number
§ 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).