(52 days)
To determine gram-negative bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Gram-Negative Bacteria Enterobacter cloacae Klebsiella pneumoniae * As taken from the Indications and Usage section of the manufacturer's package insert (as provided by the Sparfloxacin manufacturer, Rhone Poulenc Rorer Pharmaceuticals).
Microdilution Minimum Inhibitory Concentration (MIC) Panel, MicroScan® Dried Gram-Negative MIC/Combo Panels
Here's an analysis of the provided text regarding the Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Sparfloxacin, addressing your specific points:
Acceptance Criteria and Study Details
The provided document describes a premarket notification for a new antimicrobial agent (Sparfloxacin) on an existing device. The acceptance criteria for such devices typically revolve around demonstrating substantial equivalence to a predicate device, as defined by FDA guidelines.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived) | Reported Device Performance |
|---|---|
| Overall Essential Agreement with NCCLS frozen Sparfloxacin Reference Panel should be acceptable. | 99.1% Overall Essential Agreement |
| Acceptable reproducibility and precision across different inoculum methods and instruments. | Demonstrated acceptable reproducibility and precision. |
| Acceptable Quality Control performance. | Quality Control performance was acceptable. |
Note: The document refers to the "FDA DRAFT document 'Review Criteria for Assessment of Antimicrobial Susceptibility Devices' (dated May 31, 1991)" for the definition of "substantially equivalent performance." Without this specific draft document, the exact numerical acceptance criteria for "acceptable" are not explicitly stated within the provided text. However, the reported 99.1% Essential Agreement is presented as meeting this "acceptable performance."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size for the test set (number of isolates/strains tested). It mentions that "external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in nature using "stock" strains, and potentially prospective for "fresh Efficacy isolates."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The ground truth for antimicrobial susceptibility testing is typically established using a recognized reference method (in this case, an NCCLS frozen Sparfloxacin Reference Panel), not by expert consensus interpreting images or clinical data.
4. Adjudication Method for the Test Set
The concept of "adjudication method" (e.g., 2+1, 3+1) is not applicable here. This is typically used in studies involving human interpretation of clinical data or images. In this context, the comparison is directly between the result from the MicroScan panel and the result from the NCCLS reference panel. Any discrepancies would likely be resolved by re-testing or review of the raw data, rather than expert adjudication in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted. This type of study is relevant for devices that involve human interpretation of medical images or clinical data, where the performance of human readers with and without AI assistance is being evaluated. This device is an automated in vitro diagnostic for antimicrobial susceptibility, not an image analysis or clinical decision support AI.
6. Standalone (Algorithm Only) Performance
The study primarily evaluates the standalone performance of the device (MicroScan panel) compared to the reference method (NCCLS frozen panel). The outcome is the "Essential Agreement" between the device's reading and the ground truth. There is no human-in-the-loop component being assessed in terms of interpretation or decision-making for susceptibility results.
7. Type of Ground Truth Used
The type of ground truth used is a reference method standard. Specifically, the "NCCLS frozen Sparfloxacin Reference Panel" served as the gold standard against which the performance of the MicroScan Dried Gram-Negative MIC/Combo Panels with Sparfloxacin was measured.
8. Sample Size for the Training Set
The document does not report a sample size for a training set. This is consistent with the nature of the device. This is not a machine learning or AI algorithm in the contemporary sense that would require a distinct "training set" to develop its internal logic. The device's mechanism for determining MIC values is based on established biochemical reactions and readouts, not on learning from a large dataset. The "external evaluations" described are for validation, not training.
9. How Ground Truth for the Training Set Was Established
Since there is no reported training set in the context of machine learning, the question of how its ground truth was established is not applicable. The device's underlying principles are based on microbiological and chemical assays, and its accuracy is validated against a recognized reference standard rather than being "trained" on a dataset with pre-established ground truth.
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Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Sparfloxacin Premarket Notification June 9, 1997
DADE
AUG - I
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: | June 9, 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 - Sparfloxacin |
| Predicate device: | NCCLS Frozen Sparfloxacin Reference Panels |
510(k) Summary:
1 ( F I
F
The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel with Sparfloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Sparfloxacin 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/k1) presents data in support of the new antimicrobial, Sparfloxacin, 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 Sparfloxacin panels by comparing their performance with an NCCLS frozen Sparfloxacin Reference panel.
The Dried Gram-Negative Spartloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 99.1% when compared with the frozen Sparfloxacin Reference panel.
Inoculum and instrument reproducibility testing was conducted; the Gram-Negative Dried Sparfloxacin 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 the Gram-Negative Dried Sparfloxacin panels.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle's head is on the left side of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sharolyn J. Lentsch Sr. Regulatory Affairs Administrator Dade MicroScan Inc. 1584 Enterprise Boulevard ---West Sacramento, California 95691
AUG - I 1997
Re: K972180
Trade Name: MicroScan® Dried Gram-Negative MIC/Combo Panels/sparfloxacin Regulatory Class: II Product Code: JWY Dated: June 9, 1997 Received: June 10, 1997
Dear Ms. Lentsch:
【出现场的空】【
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 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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Page 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 vours.
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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Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Sparfloxacin Premarket Notification June 9, 1997
Intended Use Statement
| 510(k) No.: | To be assigned by FDA |
|---|---|
| Device Name: | MicroScan® Dried Gram-Negative MIC/Combo Panels withSparfloxacin (0.015 - 32 mcg/ml) |
| Indications for Use: | To determine gram-negative bacterial susceptibility against theantimicrobial agent Sparfloxacin. Organisms with indications fortesting* include:Gram-Negative BacteriaEnterobacter cloacaeKlebsiella pneumoniae |
| * As taken from the Indications and Usage section of the |
Kayonne Muriel, for Adaleen Penka
(Division Sign Off)
manufacturer's package insert (as provided by the Sparfloxacin
manufacturer, Rhone Poulenc Rorer Pharmaceuticals).
(División Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972180
Prescription Use j (Per 21 CFR 801.109) OR
Over-The Counter Use _
(Optional Format 1-2-96)
SPAR510K.DOC
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§ 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).