(74 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 Meropenem to Pasco panels at concentrations of 2-0.03 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pasco MIC and MIC/ID Panels (Meropenem), structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| S. pneumoniae | ||
| Essential Agreement (EA) | High (e.g., typically >90-95% for AST devices) | Initial Testing: 98.1% |
| Retesting: 98.7% | ||
| Major Errors (M) | Low (e.g., typically <1.5-3%) | Initial Testing: 1 major error observed (retest did not resolve) |
| Category Agreement (CA) | High (e.g., typically >90-95% for AST devices) | 99.4% (with 2 additional random categorical errors within EA) |
| Non-pneumococcal streptococci | ||
| Essential Agreement (EA) | High (e.g., typically >90-95% for AST devices) | 100% |
| Major Errors (M) | Low (e.g., typically <1.5-3%) | 0 |
| Very Major Errors (VM) | Low (e.g., typically <1.5-3%) | 0 |
| Minor Errors | Low (e.g., typically <5-10%) | 0 |
| Category Agreement (CA) | High (e.g., typically >90-95% for AST devices) | 100% (with 1 random categorical error within EA) |
| QC Endpoints (S. pneumoniae ATCC 49619) | Within recommended NCCLS acceptable range | Within recommended NCCLS acceptable range (with one exception within range on next test date) |
| Reproducibility | Plus or minus 1 dilution for 100% of organisms | 100% within acceptable plus or minus 1 dilution (for 7 organisms with on-scale endpoints) |
Note: The document refers to the FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991) for the substantial equivalence. While specific numerical acceptance criteria are not explicitly stated as "acceptance criteria," the reported performance is presented as "acceptable" in comparison to these implied standards.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Organisms:
- S. pneumoniae: 101 strains
- Non-pneumococcal streptococci: 130 strains
- Data Provenance: The study used "CDC challenge strains and clinical isolates." This indicates a mix of well-characterized reference strains and real-world clinical samples, suggesting a prospective or retrospective collection depending on how the clinical isolates were sourced. The study was performed at two sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications. However, it indicates that the comparison was made against a "reference panel" and "NCCLS acceptable range" for QC. This implies that the ground truth was established by a recognized reference method (likely a standard microdilution method) and interpreted by individuals trained in microbiological susceptibility testing, presumably following NCCLS guidelines. The involvement of "CDC challenge strains" further suggests that the 'ground truth' for these strains would have been well-established.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method. However, for the single major error in S. pneumoniae testing, it states that "retest results were acceptable, this error was not considered resolved since the reference method MIC results did not change." This implies that the reference method's result effectively served as the final arbiter (ground truth) and that retesting or alternative interpretation was not deemed to supersede the initial reference result.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- This study is focused on the performance of an automated device (Pasco MIC and MIC/ID Panels) compared to a reference method, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done.
- The entire evaluation described is of the Pasco MIC and MIC/ID Panels' ability to determine antimicrobial susceptibility, functioning as a standalone device, by comparing its results to a reference method. There is no human-in-the-loop component described for the interpretation of the panels in this study.
7. Type of Ground Truth Used
The ground truth used was primarily a reference method (e.g., standard microdilution susceptibility testing) as evidenced by the comparison to a "reference panel" and the statement that "the reference method MIC results did not change" after retesting the major error. Additionally, "CDC challenge strains" would have well-established susceptibility profiles. The QC endpoints were compared against "recommended NCCLS acceptable range," which are established standards for susceptibility testing.
8. Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. This type of device (antimicrobial susceptibility test panel) typically has pre-defined reagent concentrations (Meropenem at 2-0.03 mcg/ml) and an established interpretation algorithm (visible growth or color changes as described in the package insert). The "challenge strains" and "clinical isolates" mentioned are implied to be part of the validation/test set.
9. How the Ground Truth for the Training Set Was Established
Since no specific training set is mentioned in the context of machine learning, this question is not directly applicable. If an algorithm were involved (rather than pre-defined chemical reactions and visual interpretation), the ground truth for training would typically be established through expert interpretation of a reference method on a large dataset, similar to the ground truth described for the test set. However, for this device, the "training" (development) of the product likely involved optimizing the chemical formulation and concentrations to align with established antimicrobial susceptibility testing principles and NCCLS guidelines.
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OCT 1 2 1999
510(k) SUMMARY (page 1 of 2)
| DATE: | July 27, 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:
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 Meropenem at concentrations ranging from 2-0.03 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 98.1% upon initial testing and an EA of 98.7% upon retesting. One major (M) error was observed upon initial testing and although retest results were acceptable, this error was not considered resolved since the reference method MIC results did not change. Category agreement (CA) was 99.4% with 2 additional random categorical errors noted (which were within EA). Test results of the 130 non-pneumococcal streptococci strains demonstrated acceptable Essential Agreement (EA) of 100%. No major (M) or very major (VM) or minor errors were observed. Category Agreement (CA) was 100% with 1 random categorical error noted (which was 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 with the exception of one test panel result of ≤ 0.03 mcg/ml at the CDC which was within range on the next test date.
Reproducibility testing of 12 organisms at each site provided 7 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 OC 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 & Human Services. The logo consists of a stylized image of an eagle or bird in flight, composed of three curved lines. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
.
OCT 1 2 1999
Ms. Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033
· K992546 Re:
Trade Name: Pasco MIC and MIC/ID Panels (Meropenem) Regulatory Class: II Product Code: JTN Dated: July 27, 1999 Received: July 30, 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Dutman
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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5
Device Name:
PASCO MIC and MIC/ID Panels; Inclusion of Meropenem
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 Meropenem to Pasco panels at concentrations of 2-0.03 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.
Prescription Use ) (Per 21 CFR 801.109)
Woody Dubois
510(k) Number
§ 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).