(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 Cefepime to Pasco panels at concentrations of 0.03-4 mcg/ml for use in determining the susceptibility of S. pneumoniae 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.
The provided document describes the 510(k) submission for the Pasco MIC and MIC/ID Panels, specifically for the addition of Cefepime. The document outlines the studies performed to demonstrate substantial equivalence to predicate devices.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Essential Agreement (EA) for S. pneumoniae | 99.4% (initial testing), 100% (retesting) |
| Major (M) Errors for S. pneumoniae | None observed |
| Very Major (VM) Errors for S. pneumoniae | None observed |
| Minor Errors for S. pneumoniae | 15 random minor errors noted (all within EA) |
| Category Agreement (CA) for S. pneumoniae | 100% |
| Essential Agreement (EA) for non-pneumococcal strains | 100% (initial testing) |
| Major (M) Errors for non-pneumococcal strains | None observed |
| Very Major (VM) Errors for non-pneumococcal strains | None observed |
| Minor Errors for non-pneumococcal strains | 6 random minor errors noted (all within EA) |
| Category Agreement (CA) for non-pneumococcal strains | 100% |
| QC endpoints for S. pneumoniae ATCC 49619 | Within NCCLS recommended acceptable range |
| Reproducibility (within +/- 1 dilution) | 100% |
Note: The document states that the acceptable Essential Agreement (EA) was met for both S. pneumoniae and non-pneumococcal strains, and no major, very major, or minor errors were observed for either group in relation to the primary agreement metrics. The minor errors mentioned were noted as "all of which were within EA," implying they did not impact the overall essential agreement. The specific numerical thresholds for "acceptable" EA, Major, Very Major, and Minor errors are not explicitly listed in this document but are standard for antimicrobial susceptibility testing devices.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- S. pneumoniae strains: 101
- Non-pneumococcal strains: 130
- Reproducibility testing: 12 organisms at each of two sites (totaling 24 organisms, though only 9 yielded on-scale endpoints).
- Data Provenance: Retrospective and prospective. The document states "Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates." "Clinical isolates" imply prospective or recently isolated samples, while "CDC challenge strains" are laboratory-maintained reference strains. The country of origin is not explicitly stated but is implicitly the USA, given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing the ground truth. The comparison was made against a "reference panel," which typically implies a validated method (like broth microdilution or agar dilution as per CLSI/NCCLS standards) rather than direct expert interpretation of raw results. The expertise would lie in the laboratory personnel conducting these reference methods.
4. Adjudication method for the test set
The document does not describe an adjudication method involving multiple readers. The comparison is between the Pasco panel's results and a "reference panel," implying a single, established reference method for each isolate's susceptibility determination.
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
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. This document pertains to an antimicrobial susceptibility test panel, which is an in-vitro diagnostic device, not an AI-powered image analysis or diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the Pasco MIC and MIC/ID Panels as a standalone device, without human intervention in the primary measurement function. The device itself generates the MIC values based on visible growth or color changes after incubation. Human input is involved in inoculating the panels, incubating them, and visually interpreting the results (or potentially using an automated reader, though not specified here). The "standalone" performance here refers to the accuracy of the device's output compared to a reference standard. The study demonstrates the standalone performance of the Pasco panel in determining MICs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established by comparison to a "reference panel." This typically refers to a validated reference method for antimicrobial susceptibility testing, such as broth microdilution or agar dilution, which are considered the gold standard for determining MIC values. The results from this reference method serve as the ground truth against which the Pasco panel's performance (Essential Agreement and Category Agreement) is measured. The "CDC challenge strains" are also a form of standardized ground truth.
8. The sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional in-vitro diagnostic device, and the method for developing these panels involves established microbiological and manufacturing processes, not algorithm training. The "test panels containing Cefepime... were prepared in-house at Pasco using routine manufacturing procedures," indicating standard product development rather than a specific algorithmic training phase.
9. How the ground truth for the training set was established
As there's no mention of a "training set" in the context of an algorithm, this question is not applicable. The device itself (the panel with varying concentrations of antimicrobial agents) is the product, and its performance is validated against established reference methods.
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SEP 3 1999
KG92108
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510(k) SUMMARY (page I of 2)
| DATE: | June 17, 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 Cefepime at concentrations ranging from 0.03-4 mcg/ml were prepared inhouse 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 Acreement (EA) of 99.4% upon initial testing and an EA of 100% on retesting. No major (M), very major (VM) or minor errors were observed. Category agreement (CA) was 100% with 15 random minor errors noted (all of which were within EA). Test results of the 130 non-pneumococcal strains demonstrated acceptable Essential Agreement (EA) of 100% on initial testing. No major (M), very major (VM) or minor errors were observed. Category Agreement (CA) was 100% with 6 random minor errors noted (all of which were within EA).
QC endpoints for the QC 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 9 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP, 3 1999
Ms. Linda K. Dillon Technical Manager PASCO Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
K992108 Re: Trade Name: PASCO MIC and MIC/ID Panels (Cefepime) Regulatory Class: II Product Code: JWY Dated: June 17, 1999 Received: June 22, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
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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Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of Cefepime
す
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 Cefepime to Pasco panels at concentrations of 0.03-4 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.
Woody Dubois
on of Clinical I 510(k) 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).