(70 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 Cefuroxime 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.
Acceptance Criteria and Device Performance Study for Pasco MIC and MIC/ID Panels (Cefuroxime)
This document describes the acceptance criteria and the study that demonstrates the Pasco MIC and MIC/ID Panels, specifically with the addition of Cefuroxime, meet these criteria for antimicrobial susceptibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (S. pneumoniae) | Reported Device Performance (Non-pneumococcal strains) |
|---|---|---|---|
| Essential Agreement (EA) | Acceptable Agreement | 100% | 100% |
| Major (M) Errors | No major errors observed | 0 | 0 |
| Very Major (VM) Errors | No very major errors observed | 0 | 0 |
| Minor Errors | Minimal sporadic errors | 1 random minor error | 1 random minor error |
| Category Agreement (CA) | Acceptable Agreement | 100% (within EA despite 1 minor error) | 100% (within EA despite 1 minor error) |
| QC Endpoints (S. pneumoniae ATCC 49619) | Within recommended NCCLS acceptable range | Within recommended NCCLS acceptable range | N/A (specific to S. pneumoniae) |
| Reproducibility | 100% within +/- 1 dilution | 100% within +/- 1 dilution (for 6 on-scale organisms) | 100% within +/- 1 dilution (for 6 on-scale organisms) |
Note: The acceptance criteria for essential agreement, categorical agreement, and error rates are implied by the statement "demonstrated acceptable Essential Agreement (EA)" and the reporting of specific percentages and zero errors. The reference to the "FDA draft document 'Review Criteria For Assessment Of Antimicrobial Susceptibility Devices' (May 1991)" suggests these criteria are aligned with regulatory guidance at the time.
2. Sample Size Used for the Test Set and Data Provenance
- S. pneumoniae strains: 101
- Non-pneumococcal strains: 130
- QC organism: S. pneumoniae ATCC 49619
- Reproducibility organisms: 12 organisms
- Data Provenance: The study used "CDC challenge strains and clinical isolates." This indicates a mix of well-characterized reference strains and samples collected from clinical settings. The study was conducted at "two sites." The information does not explicitly state the country of origin, but given the FDA submission, it is highly likely to be US-centric. The data is prospective as it describes the testing performed for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "Radiologist with 10 years of experience"). However, for antimicrobial susceptibility testing, the reference panel itself serves as the ground truth, and its results are established by trained microbiologists following standardized laboratory procedures. The "reference panel" is a recognized and validated method.
4. Adjudication Method
The document does not describe an explicit "adjudication method" in the context of resolving discrepancies between multiple readers or experts. In this type of in vitro diagnostic study, the comparison is made between the test device's results and a pre-established "reference panel" result. Discrepancies would typically be analyzed against the established reference, not through an adjudication process among multiple primary readers of the test device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described. This type of study is more common in diagnostic imaging where multiple human readers interpret cases with and without AI assistance. This study focuses on the performance of an in vitro diagnostic device (antimicrobial susceptibility panel) against a reference method.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "Pasco MIC and MIC/ID Panels" are automated or semi-automated systems that provide quantitative MIC values and/or categorical interpretations based on microbial growth. The study directly assesses the performance of these panels (the "device") against a reference standard. While human observation is required to read the results (e.g., "observed for visible growth or color changes"), the performance metrics (Essential Agreement, Category Agreement, error rates) reflect the device's ability to produce results comparable to the reference, independent of human interpretation variability once the basic reading method is followed.
7. Type of Ground Truth Used
The primary ground truth used was a reference panel. The "Comparative testing of the Pasco test panel to a reference panel was performed at two sites." This reference panel would typically be a highly standardized and validated method for determining antimicrobial susceptibility, such as broth microdilution or agar dilution as outlined by organizations like the Clinical and Laboratory Standards Institute (CLSI) or similar national/international standards. The "CDC challenge strains" further support the use of well-characterized isolates for validation.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. This is typical for a traditional in vitro diagnostic device that doesn't utilize machine learning models. The device's "training" in this context is the manufacturing process, quality control, and pre-validation efforts to ensure reliable performance across a range of antimicrobials and organisms, rather than an algorithmic training phase on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit "training set" for a machine learning algorithm as described in this submission, the concept of establishing ground truth for a training set is not directly applicable. The "ground truth" for the device's development and validation (its underlying mechanism) comes from established microbiological principles of antimicrobial susceptibility testing, which are validated through the performance studies (as described above) against recognized reference methods and established QC organisms.
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AUG 30 1999
(2)
510(k) SUMMARY (page 1 of 2)
| DATE: | June 16, 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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510(k) SUMMARY (page 2 of 2)
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:
ﺳﻬﺎ،
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 Cefuroxime 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 Agreement (EA) of 100% on initial testing. No major (M), very major (VM) or minor errors were observed. Category agreement (CA) was 100% with 1 random minor error noted (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 1 random minor error noted (within EA).
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 6 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
AUG 30 1999
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
Re: K992076 Trade Name: PASCO MIC and MIC/ID Panels Regulatory Class: II Product Code: JTN Dated: June 16, 1999 Received: June 21, 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 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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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrlv/dsma/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
Enclosure
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Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of Cefuroxime
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 Cefuroxime 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
(Division Sign Off) Division of Clinical Laboratory Devices K99076 510(k) Number _
PRESCRIPTION USE X
§ 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).