(66 days)
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
This 510(k) notification is for the addition of Trovafloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for use in determining the susceptibility of C. freundi, E. aerogenes, E. coli, K. pneumoniae, Morganella morganii, P. mirabilis, P. vulgaris, P. aeruginosa, E. faecalis and methicillin susceptible strains of S. aureus and S. evidermidis. Clinical testing of S. pneumoniae with Trovafloxacin has not been performed with the Pasco system.
Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and then observed for visible growth or color changes as described in the package insert.
The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
Acceptance Criteria and Device Performance Study for Pasco MIC and MIC/ID Panels with Trovafloxacin
The information below describes the acceptance criteria and the study proving the device meets these criteria, specifically for the addition of Trovafloxacin to the Pasco MIC and MIC/ID panels.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for antimicrobial susceptibility testing devices typically involve evaluating Essential Agreement (EA), Category Agreement (CA), Major Errors (M), and Very Major Errors (VM) against a reference method. The "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991) by the FDA is referenced as the guideline for these criteria, though specific numerical thresholds are not explicitly stated in the provided text. However, the reported performance metrics indicate acceptable levels for these criteria.
| Performance Metric | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance |
|---|---|---|
| Gram-Negative Isolates | ||
| Essential Agreement (EA) | Acceptable high percentage (e.g., >90-95%) | 99.7% |
| Major Errors (M) | Acceptable low percentage (e.g., <3%) | 0 |
| Very Major Errors (VM) | Acceptable low percentage (e.g., <3%) | 0 |
| Category Agreement (CA) | Acceptable high percentage (e.g., >90-95%) | 97% |
| Minor Errors (Total) | Implied to be within acceptable limits | 10 random |
| Gram-Positive Isolates | ||
| Essential Agreement (EA) | Acceptable high percentage (e.g., >90-95%) | 99.6% (initial), 100% (retest) |
| Major Errors (M) | Acceptable low percentage (e.g., <3%) | 1 (initial, resolved on retest) |
| Very Major Errors (VM) | Acceptable low percentage (e.g., <3%) | Not explicitly stated as 0 for initial, but implied acceptable overall |
| Category Agreement (CA) | Acceptable high percentage (e.g., >90-95%) | 98% |
| Minor Errors (Total) | Implied to be within acceptable limits | 5 random |
| Reproducibility | Within +/- 1 dilution for a high percentage | 99.5% within +/- 1 dilution |
| QC Endpoints | Within recommended acceptable ranges | Within recommended acceptable ranges |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size for Test Set: Not explicitly stated as a number. The study used "CDC challenge strains and clinical isolates." The results are presented for "gram-negative isolates" and "gram-positive isolates," indicating multiple species within each group were tested. Given the detail of percentages for EA, CA, and errors, it implies a substantial number of isolates were tested to achieve these statistics.
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Data Provenance: The study was "performed at two sites." The specific country of origin is not explicitly stated. The use of "CDC challenge strains" suggests a U.S. context or at least strains relevant to infectious disease surveillance by the CDC. The use of "clinical isolates" suggests a prospective or retrospective collection from patient samples at the two testing sites. The document doesn't specify if it was purely prospective or included retrospective samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the given text. While a "reference panel" was used for comparative testing, the process for establishing the ground truth of this reference panel (e.g., number of expert microbiologists, their experience) is not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the given text. It is stated that a Major error observed in gram-positive isolates was "resolved upon retest," which suggests some form of review or re-evaluation process but not a formal adjudication method (like 2+1 or 3+1 expert consensus).
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
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is there any mention of Artificial Intelligence (AI) assistance in this context. This device is an in-vitro diagnostic assay, not an AI-powered image analysis or diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This study evaluates the performance of the Pasco MIC and MIC/ID panels, which are laboratory devices that produce results (MIC values, qualitative categories) based on biochemical reactions and growth patterns. The "algorithm" here is the interpretive criteria used by the device, and its "standalone" performance is what is being directly measured against a reference panel. There isn't a human-in-the-loop component in the device's direct output that would typically be evaluated in such a study for an AI system. The final reading of the panel might involve human observation, but the device itself is designed to provide results directly.
7. The Type of Ground Truth Used
The ground truth for the test set was established by a reference panel. The specific methodology of this reference panel, but it is implied to be a well-established and accepted method for antimicrobial susceptibility testing, as it is used for comparison in regulatory submissions. Given the context, this reference panel likely utilizes a recognized method (e.g., broth microdilution or agar dilution as defined by NCCLS standards) interpreted by experienced microbiologists to determine the true MIC and category.
8. The Sample Size for the Training Set
This information is not applicable in the context of this 510(k) submission as described. The device is a traditional in-vitro diagnostic (antimicrobial susceptibility test) and does not rely on a machine learning model that would require a dedicated "training set" in the sense of AI/ML development. The "training" for such devices typically involves the manufacturer's internal development and optimization processes, rather than a separate, formally defined "training set" for the purpose of a regulatory study.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, a formal "training set" with ground truth in the context of AI/ML is not relevant here. The device's operational parameters (e.g., concentration ranges, interpretive criteria) are established through a combination of scientific principles, prior research, and adherence to recognized standards like those from NCCLS (now CLSI).
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PASCO LABORATORIES
12750 WEST FORTY-SECOND AVENUE WHEAT RIDGE, COLORADO 80033 (303) 423-9504 0-321-9813 X (303) 467-2313
A Subsidiary of DHF
MAY 1 8 1998
510(k) SUMMARY (page 1 of 2)
DATE:
March 12, 1998
CONTACT PERSON:
Linda K. Dillon Barbara C. Lamoureux
Pasco MIC and MIC/ID Panels
TRADE NAME OF DEVICE:
Antimicrobial Susceptibility Test COMMON NAME:
Class II Antimicrobial Susceptibility CLASSIFICATION NAME: Test Microbiology Panel #83
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently K974362, February 12, 1998 RE: Cefepime; K973317, November 14, 1997 RE: Cefpodoxime; K973695, November 5, 1997 RE: Meropenem; K972567, August 20,1997 RE: Sparfloxacin; K971951, August 15, 1997 RE: Levofloxacin; and K946126, January 17, 1995 RE: Detection of Resistant pneumococci), the FDA has determined the Pasco panels to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by
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510(k) SUMMARY (page 2 of 2)
(3)
DESCRIPTION OF THE DEVICE:
Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and then observed for visible growth or color changes as described in the package insert.
The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
INTENDED USE FOR THE PASCO MIC AND MIC/ID PANELS: PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING: Test panels containing Trovafloxacin at concentrations ranging from 16 to 0.03 mcq/ml were prepared in-house at Pasco using routine manufacturing procedures. Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates.
Test results of the gram-negative isolates demonstrated acceptable Essential Agreement (EA) of 99.7%. No Major (M) or Very Major (VM) errors were observed. Category Agreement (CA) was 97% with ten random minor errors noted.
Test results of the gram-positive isolates demonstrated acceptable Essential Agreement (EA) of 99.6% on initial testing and 100% after retesting. One Major error was observed on initial testing of Enterococcusfaecalis, however this was resolved upon retest. Category Agreement (CA) was 98% with five random errors noted.
QC endpoints from both the reference and Pasco panels throughout testing were within the recommended acceptable ranges listed in the product information and NCCLS. Reproducibility testing at each site demonstrated 99.5% within the acceptable plus or minus 1 dilution.
The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 8 1998
Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
Re: K980955
Trade Name: Pasco MIC and MIC/ID Panels/Trovafloxacin Regulatory Class: II Product Code: JTN Dated: March 12, 1998 Received: March 13, 1998
Dear Ms. Dillon:
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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 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
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Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of Trovafloxacin
Indication For Use:
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
This 510(k) notification is for the addition of Trovafloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for use in determining the susceptibility of C. freundi, E. aerogenes, E. coli, K. pneumoniae, Morganella morganii, P. mirabilis, P. vulgaris, P. aeruginosa, E. faecalis and methicillin susceptible strains of S. aureus and S. evidermidis. Clinical testing of S. pneumoniae with Trovafloxacin has not been performed with the Pasco system.
Woody Dubois
n of Clinical Laboratory Devices 510(k) Number
801.109 1
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).