(73 days)
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.
This 510(k) notification is for the addition of Trovafloxacin to Pasco panels at concentrations of 8-0.03 mcg/ml for use in determining the susceptibility of S. ppeumoniae and non-pneumococcal streptococci.
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 panels are 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 for Pasco MIC and MIC/ID Panels with Trovafloxacin
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (from FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991)) | Reported Device Performance (Trovafloxacin with S. pneumoniae) | Reported Device Performance (Trovafloxacin with Non-pneumococcal streptococci) |
|---|---|---|---|
| Essential Agreement (EA) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable Essential Agreement" | 98.7% | 99.3% |
| Major Errors (M) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" (i.e., low or none observed) | 0 | 0 |
| Very Major Errors (VM) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" (i.e., low or none observed) | 0 | 0 |
| Minor Errors | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" (i.e., low or none observed) | 0 | 0 |
| Category Agreement (CA) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" | 100% | 100% |
| Random Minor Errors | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" (i.e., low or none observed) | 0 | 0 |
| QC Endpoints (S. pneumoniae ATCC 49619) | Within recommended NCCLS acceptable range | Within recommended NCCLS acceptable range | Not applicable (Specific to S. pneumoniae) |
| Reproducibility | Overall reproducibility within plus or minus 1 dilution | 100% within acceptable plus or minus 1 dilution | 100% within acceptable plus or minus 1 dilution |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- S. pneumoniae strains: 101
- Non-pneumococcal streptococci strains: 130
- Reproducibility testing: 12 organisms at each of two sites, with 10 organisms having on-scale endpoints.
- Data Provenance: The comparative testing was performed at two sites (specific locations not provided in the text). The data utilized CDC challenge strains and clinical isolates. The text does not specify the country of origin, but the submission is to the US FDA. The study appears to be prospective, as it involves newly prepared panels and comparative testing against a reference panel.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their qualifications. The "reference panel" is used for comparative testing, suggesting that its results served as the ground truth. However, details on how the reference panel's results were established or verified by experts are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set results. The comparison is made between the Pasco test panel and a "reference panel."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study is focused on the performance of the automated antimicrobial susceptibility testing device itself against a reference method, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Test results of the 101 S. pneumoniae strains" and "Test results of the 130 non-pneumococcal streptococci strains" indicate the performance of the Pasco MIC and MIC/ID panels (the algorithm/device) in determining antimicrobial susceptibility (MIC values and categorical interpretations) against a reference method. The "reproducibility testing" also evaluates the standalone consistency of the device.
7. Type of Ground Truth Used
The ground truth for the comparative testing was established by a reference panel. The document states, "Comparative testing of the Pasco test panel to a reference panel was performed..." This implies that the MIC results obtained from the reference panel were considered the gold standard against which the Pasco panels were evaluated for essential agreement and categorical agreement. The nature of this reference panel (e.g., whether it used a manual broth microdilution method, another cleared automated system, or expert-read plates) is not detailed.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This type of submission (510(k)) for an antimicrobial susceptibility test typically focuses on validation and comparison to an established reference method rather than describing the development and training of a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth was established.
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OCT 8 1999
510(k) SUMMARY (page 1 of 2)
| DATE: | July 26, 1999 |
|---|---|
| CONTACT PERSON: | Linda K. DillonChuck Lakel |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility Test Microbiology Panel#83 |
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently: K982235, July 30, 1998 RE: Minocycline; K982156, July 29, 1998 RE: Cefdinir; K980955 May 18, 1998 RE: Trovafloxacin; 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 the courts.
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 panels are then observed for visible growth or color changes as described in the package insert.
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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 8-0.03 mcg/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 101 S. pneumoniae strains demonstrated acceptable Essential Agreement (EA) of 98.7%. No major (M), very major (VM), or minor errors were observed. Category agreement (CA) was 100% with no random minor errors noted. Test results of the 130 non-pneumococcal streptococci strains demonstrated acceptable Essential Agreement (EA) of 99.3%. No major (M), very major (VM), or minors errors were observed. Category Agreement (CA) was 100% with no random minor errors noted.
QC endpoints for the OC organism S. pneumoniae ATCC 49619 from both the reference and Pasco panels throughout testing were within the recommended NCCLS acceptable range.
Reproducibility testing of 12 organisms at each site provided 10 organisms with on-scale endpoints. Overall reproducibility data demonstrated 100% 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
8 1999 OCT
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
K992507 Re: Trade Name: PASCO MIC and MIC/ID Panels (Trovafloxacin) Regulatory Class: II Product Code: JTN Dated: July 26, 1999 Received: July 27, 1999
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 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.
İf 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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Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of Trovafloxacin
5
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 8-0.03 mcg/ml for use in determining the susceptibility of S. ppeumoniae and non-pneumococcal streptococci.
Woody Dubois
ical Laboratory Devices Division of Clin Kag 2 510(k) Number _
Prescription Use ^ (Per 21 CFR 801.109) OR
Over-The Counter Use
(Optional Format 1-2-96)
§ 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).