(63 days)
To determine gram-positive bacterial susceptibility against the antimicrobial agent Levofloxacin. Organisms with indications for testing* include:
Levofloxacin Gram-Positive Bacteria Enterococcus faecalis Staphylococcus aureus Streptococcus pyogenes
- As taken from the Indications and Usage section of the manufacturers' package insert (Ortho-McNeil).
Microdilution Minimum Inhibitory Concentration (MIC) Panels, MicroScan® Dried Gram-Positive MIC/Combo Panels
Acceptance Criteria and Device Performance for MicroScan® Dried Gram-Positive MIC/Combo Panels with Levofloxacin
This report details the acceptance criteria and the study demonstrating the performance of the MicroScan® Dried Gram-Positive MIC/Combo Panels with Levofloxacin, as described in the 510(k) submission K972688.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991). The primary metric used is Essential Agreement.
| Acceptance Criteria (Essential Agreement) | Reported Device Performance (Essential Agreement) |
|---|---|
| Defined by FDA DRAFT document | 99.4% |
Note: The specific numerical threshold for "acceptable" Essential Agreement from the FDA DRAFT document is not explicitly stated in the provided text, but the reported 99.4% was deemed acceptable by the FDA.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The exact number of isolates used in the "external evaluations" (test set) is not specified. However, the evaluation included "fresh and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: The document does not explicitly state the country of origin. The study was conducted by Dade MicroScan Inc. in West Sacramento, CA, suggesting the data was likely generated within the United States. The study appears to be retrospective for the stock isolates and challenge strains, and possibly includes prospective components for "fresh" efficacy isolates.
3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth
- Number of Experts: The document does not specify the number of individual experts used to establish ground truth.
- Qualifications of Experts: Not specified.
- Adjudication Method: Not applicable. The ground truth was established by comparing the device's performance to an NCCLS frozen Levofloxacin Reference Panel, which serves as the gold standard, rather than relying on human expert consensus.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as this device is an automated in vitro diagnostic for determining antimicrobial susceptibility, not a device requiring human interpretation of complex cases. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable.
5. Standalone Performance Study
Yes, a standalone performance study was done. The entire premise of the 510(k) submission and the "external evaluations" was to demonstrate the performance of the MicroScan® Dried Gram-Positive MIC/Combo Panel with Levofloxacin (the algorithm/device) against a reference standard without human intervention in the result interpretation.
6. Type of Ground Truth Used
The type of ground truth used was a reference standard: an NCCLS frozen Levofloxacin Reference Panel. This panel is considered the gold standard for susceptibility testing for comparison purposes.
7. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. The product being validated is a panel for susceptibility testing, and the development process likely involved internal optimization and validation, but specific data used for "training" in the modern AI sense is not described. The provided information focuses on the validation of the final product.
8. How Ground Truth for the Training Set Was Established
As a distinct "training set" is not explicitly mentioned, the method for establishing its ground truth is also not described. For the overall development and validation, the ground truth would have been established by comparison to reference methods, similar to the validation process itself (e.g., NCCLS reference panels).
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Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Levofloxacin Premarket Notification K972688 - Amendment 1 August 29, 1997
SEP - 8 1997
510(k) Summary
DADE INTERNATIONAL
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: | July 3, 1997 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Positive MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Levofloxacin |
| Predicate device: | NCCLS Frozen Levofloxacin Reference Panels |
510(k) Summary:
The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Levofloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Levofloxacin 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 a new antimicrobial Levofloxacin, for the MicroScan® Dried Gram-Positive MIC/Combo Panels.
The 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 Levofloxacin panel by comparing its performance with an NCCLS frozen Levofloxacin Reference panel.
The Dried Gram-Positive Levofloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 99.4% when compared with the frozen Levofloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; both the Gram-Positive Dried Levofloxacin panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway Systems) was used.
Quality Control performance was acceptable for both the Gram-Positive Dried Levofloxacin panels.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 8 1997
Ms. Sharolyn Lentsch Senior Requlatory Affairs Administrator Dade International MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691
Re: K972688 MicroScan® Dried Gram Positive MIC/Combo Panels New Trade Name: Antimicrobial - Levofloxacin Regulatory Class: II Product Code: JWY II LRG Dated: July 3, 1997 Received: July 7, 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 Reqister. 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 Requlations.
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Paqe 2
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 Putman
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 Positive MIC/Combo Panels with Levofloxacin Premarket Notification K972688 - Amendment 1 August 29, 1997
Intended Use Statement
510(k) No .:
Device Name:
MicroScan® Dried Gram-Positive MIC/Combo Panels with Levofloxacin (0.015-32 µg/ml)
Indications for Use:
To determine gram-positive bacterial susceptibility against the antimicrobial agent Levofloxacin. Organisms with indications for testing* include:
Levofloxacin Gram-Positive Bacteria Enterococcus faecalis Staphylococcus aureus Streptococcus pyogenes
- As taken from the Indications and Usage section of the manufacturers' package insert (Ortho-McNeil).
Ae R1
/ for Prescription Use
970829L.DOC
§ 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).