(37 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 the antimicrobial Moxifloxacin at concentrations of 0.015 - 8 mcg/ml to Pasco Panels. Moxifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only)
Aerobic Gram-negative microorganisms Klebsiella pneumoniae
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms Staphylococcus epidermidis (methicillin-susceptible strains only)
Aerobic Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Proteus mirabilis
Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a batterv of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution 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 a breakdown of the acceptance criteria and study details for the Pasco MIC and MIC/ID Panels based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Staphylococci spp.: Not explicitly stated, but inferred to be a high percentage, typically >90% for AST devices. Enterobacteriaceae: Not explicitly stated, but inferred to be a high percentage, typically >90% for AST devices. | Staphylococci spp.: 100% EA. Enterobacteriaceae: 99.8% EA. |
| Major (M) Errors | Staphylococci spp.: No major errors. Enterobacteriaceae: No major errors. | Staphylococci spp.: No major (M) errors observed. Enterobacteriaceae: No major (M) errors observed. |
| Very Major (VM) Errors | Staphylococci spp.: No very major errors. Enterobacteriaceae: No very major errors. | Staphylococci spp.: No very major (VM) errors observed. Enterobacteriaceae: No very major (VM) errors observed. |
| Category Agreement (CA) | Staphylococci spp.: Acceptable (typically >90-95% for AST devices). Enterobacteriaceae: Acceptable (typically >90-95% for AST devices). | Staphylococci spp.: 98.2% CA. Enterobacteriaceae: 98.6% CA. |
| Minor Discrepancies | Defined as not impacting EA. | Staphylococci spp.: 11 minor discrepancies noted, all within EA. Enterobacteriaceae: 12 random minor discrepancies, all within EA. |
| QC Endpoints | Acceptable for NCCLS recommended QC organisms (S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922, P. aeruginosa ATCC 27853) using both reference and test methodology. | Acceptable for all tested QC organisms (S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922 and P. aeruginosa ATCC 27853) from panels using both the reference and test methodology. |
| Inter-site Reproducibility | High percentage, inferred to be close to 100%. | 99%. |
| Intra-site Reproducibility | High percentage, inferred to be close to 100%. | 100% for 1 site, 99% for another, and 98% for the third site. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Staphylococci spp.: 410 (challenge and clinical isolates)
- Enterobacteriaceae: 574 (challenge and clinical isolates)
- Reproducibility testing: 10 organisms at each of the three sites, tested on three separate days in triplicate.
- QC organisms: S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922, and P. aeruginosa ATCC 27853.
- Data Provenance: The document states "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently." It does not specify the country of origin, but given the FDA 510(k) submission, it's highly likely to be U.S.-based or from regions with comparable clinical practices. It implies a mix of prospective (fresh clinical isolates) and retrospective (stock clinical isolates, challenge strains) data for the performance evaluation.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. For Antimicrobial Susceptibility Testing (AST) devices, the "reference methodology" (e.g., broth microdilution or agar dilution as defined by CLSI/NCCLS standards) is typically considered the ground truth, and its results are interpreted by trained laboratory personnel, not necessarily "experts" in the context of a panel review.
4. Adjudication Method for the Test Set
No explicit adjudication method (like 2+1, 3+1) is mentioned. For AST devices, the ground truth is established by the reference method, and the test device's results are compared directly to this reference. Discrepancies are categorized (major, very major, minor) based on established criteria for AST performance studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, nor is it applicable in this context. This device is an automated or semi-automated diagnostic test (Antimicrobial Susceptibility Test panel), not an imaging or interpretation aid for human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was clearly done. The Pasco MIC and MIC/ID Panels are designed to provide quantitative or qualitative antimicrobial susceptibility results directly. The "Pasco methodology" results were compared directly against "reference methodology," demonstrating its performance in isolation, without human intervention for result interpretation beyond reading the panel itself.
7. Type of Ground Truth Used
The ground truth was established using reference methodology, specifically comparing results from the Pasco panels with those obtained through a recognized "reference methodology" for antimicrobial susceptibility testing. This reference method is the accepted standard against which new AST devices are evaluated.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its size. In the context of a 510(k) for an AST panel, manufacturers develop the panel and its interpretation criteria. The provided data (challenge, clinical, and QC strains) is the "test set" used to demonstrate performance against the reference method for regulatory clearance. It's not a machine learning model that requires a distinct training and testing set in the same way an AI algorithm would.
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly defined "training set" for an AI model, this question is not fully applicable. However, the methods used to establish ground truth for the performance evaluation were "reference methodology," meaning established, standard laboratory procedures for determining antimicrobial susceptibility, such as broth microdilution, which yield the Minimum Inhibitory Concentration (MIC) values considered the gold standard.
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510(k) SUMMARY (page 1 of 3)
| DATE: | March 24, 2003 |
|---|---|
| CONTACT PERSON: | Linda K. DillonChuck LakelPasco Laboratories12750 West 42nd AvenueWheat Ridge, Co 80033303-423-9504 |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility TestMicrobiology Panel #83 |
SUBSTANTIAL EQUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panel: K011116, April 24, 2001 RE: ESBL Confirmatory Test; K010508, April 23, 2001 RE: ESBL Screen Test; K020331, March 20, 2002 RE: Ertapenem; K001953, August 10, 2000 RE: Amoxicillin; K001887, August 9, 2000 RE: Ampicillin; K001721, August 4, 2000 RE: Clarithromycin; K001612, July 18, 2000 RE: Linezolid; K001516, July 12, 2000 RE: Moxifloxacin; K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid; K992646, October 19, 1999 RE: Penicillin; K992647, October 19, 1999 RE: Erythromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone; K992568, October 14, 1999 RE: Cefotaxime; K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem: K992420, September 27, 1999 RE: Sparfloxacin; K992296, September 21, 1999 RE: Vancomycin; K992297, September 3, 1999 RE: Levofloxacin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cefuroxime; K992059, August 30, 1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: Amoxicillin/Clavulanic Acid; 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
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510(k) SUMMARY (page 2 of 3)
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:
Pasco Panels are used for quantitatively measuring the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a batterv of antimicrobial agents and determining the biochemical identification of those organisms. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution 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.
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: Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains were tested concurrently using both Pasco methodology and reference methodology in panels contained Moxifloxacin at concentrations ranging from 0.015 - 8 mcg/ml. Testing was conducted at three test sites.
Test results of 410 challenge and clinical Staphylococci spp. demonstrated an Essential Agreement (EA) of 100%. No maior (M) or very maior (VM) errors were observed. Category agreement (CA) was 98.2% with 11 minor discrepancies noted, all of which were with EA.
Test results of 574 challenge and clinical Enterobacteriaceae demonstrated an Essential Agreement (EA) of 99.8%. No major (M) or very major (VM) errors were observed. Category Agreement (CA) was acceptable at 98.6% with 12 random minor discrepancies, all of which were within EA.
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510(k) SUMMARY (page 3 of 3)
QC endpoints for the NCCLS recommended QC organisms (S. aureus ATCC 29213, E. faecalis ATCC 29212, E. coli ATCC 25922 and P. aeruginosa ATCC 27853) from panels using both the reference and test methodology were acceptable.
Reproducibility testing of 10 organisms at each site on three separate days in triplicate demonstrated inter-site reproducibility of MIC results of 99%. Intra-site reproducibility of MIC results was 100% for 1site with the 2 other sites demonstrating 99% and 98%.
The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the emblem.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 2 2003
Ms. Linda K. Dillon R&D Manager BD Diagnostics Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
K030933 Re:
Trade/Device Name: PASCO MIC and MIC/ID Panels Moxifloxacin, 0.015-8 ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 24, 2003 Received: March 25, 2003
Dear Ms. Dillon:
This letter corrects our substantially equivalent correction letter of Jun 12, 2003, regarding the PASCO MIC and MIC/ID Panels, Moxifloxacin, 0.015-8 ug/ml. The concentration of Moxifloxacin has been corrected from 0.15-8 ug/ml to 0.015-8 ug/ml.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: PASCO MIC and MICAD Panels
Indications For Use: Inclusion of Moxifloxacin
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 the antimicrobial Moxifloxacin at concentrations of 0.015 - 8 mcg/ml to Pasco Panels. Moxifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only)
Aerobic Gram-negative microorganisms Klebsiella pneumoniae
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms Staphylococcus epidermidis (methicillin-susceptible strains only)
Aerobic Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Proteus mirabilis
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| Prescription Use(Per 21 CRF 801.109) | Over-The-Counter Use ______ |
| 510(k) Number | K030933 (Optional Format 1-2-96) |
§ 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).