(32 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 the antimicrobial Gemifloxacin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae. Gemifloxacin 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
Streptococcus pneumoniae (including penicillin-resistant strains)
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms
Streptococcus pvogenes
Pasco Panels are used for quantitatively measuring 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. 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.
The provided 510(k) summary describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Pasco MIC and MIC/ID Panels for Gemifloxacin.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | High percentage (e.g., typically >90% to establish substantial equivalence based on FDA guidance for AST systems) | 99.7% for Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae |
| Major (M) Errors | No significant number (typically very few or none are acceptable) | None observed |
| Very Major (VM) Errors | No significant number (typically very few or none are acceptable) | None observed |
| Category Agreement (CA) | Acceptable percentage (e.g., typically >90% based on FDA guidance for AST systems) | 99.0% |
| Minor Discrepancies | Low number, ideally within EA | 7 random minor discrepancies, all within EA with the exception of one. |
| Reproducibility (Inter-site) | High percentage (e.g., 95-100%) | 100% |
| Reproducibility (Intra-site) | High percentage (e.g., 95-100%) | 100% |
| QC Endpoints | Acceptable according to NCCLS recommended QC organisms | Acceptable for S. pneumoniae ATCC 49619 |
Explanation of Implied Acceptance Criteria: The document refers to "Substantial Equivalence as outlined in the FDA document 'Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA'." This guidance typically sets high thresholds for agreement (Essential Agreement, Category Agreement) and low thresholds for errors (Major and Very Major errors) for AST systems to be considered substantially equivalent.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size (Test Set): 570 challenge and clinical isolates (Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae).
- Data Provenance: The study used "Challenge strains, fresh clinical isolates, stock clinical isolates and QC strains." The country of origin is not explicitly stated in this document but is generally assumed to be within the US for FDA submissions unless otherwise specified. The study included both retrospective (stock clinical isolates) and prospective (fresh clinical isolates) data components, along with pre-defined challenge and QC strains.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- The document does not explicitly state the number of experts or their qualifications for establishing the ground truth.
- However, the "reference methodology" is used to establish the ground truth. This "reference methodology" for antimicrobial susceptibility testing typically refers to standardized methods like broth microdilution or agar dilution as described by CLSI (formerly NCCLS), which are overseen and interpreted by trained laboratory professionals (e.g., clinical microbiologists, medical technologists with expertise in AST).
4. Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method for reconciling discrepancies between different readers or methods.
- The comparison is made between the "Pasco methodology" and "reference methodology." Any discrepancies (like minor discrepancies) are reported, but a formal adjudication process (e.g., a third expert review) is not detailed.
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 MRMC study was done. This submission is for an Antimicrobial Susceptibility Test (AST) panel, which is a laboratory diagnostic device, not an AI-driven imaging or diagnostic aid for human readers. It measures bacterial susceptibility directly. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is a standalone device study. The "Pasco methodology" (the device under review) is compared directly to a "reference methodology." The performance metrics (EA, CA, errors, reproducibility) are derived from the device's output and compared to the ground truth established by the reference method. There is no mention of a human-in-the-loop component for the device's performance evaluation as it is an automated or semi-automated system for determining MICs.
7. The Type of Ground Truth Used:
- Expert Consensus / Reference Method Data: The ground truth was established by "reference methodology." For AST, this typically means a validated, gold-standard laboratory susceptibility testing method (e.g., broth microdilution or agar dilution according to CLSI guidelines), which serves as the consensus reference for determining true MIC values and susceptibility categories.
8. The Sample Size for the Training Set:
- Not Applicable / Not Explicitly Stated: This type of device (AST panel) does not typically involve a "training set" in the context of machine learning or AI models with algorithms that learn from data. The device's performance is based on its physical/chemical design and measurement principles, not on algorithmic learning from a large dataset. The "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains" mentioned are part of the test set used for validation.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no "training set" in the context of an AI/ML algorithm for this AST device, this question is not relevant. The ground truth for the test set was established by the "reference methodology" as described in point 7.
{0}------------------------------------------------
SEP 1 5 2003
KO32518
Image /page/0/Picture/2 description: The image contains a circled number 2. The number 2 is written in a simple, slightly slanted font. The circle around the number is complete and appears to have been drawn with a pen or marker.
510(k) SUMMARY
| (page | 1 of 3) |
|---|---|
| ------- | --------- |
| DATE: | August 8, 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 EOUIVALENCE:
In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panel: K031727. July 30. 2003 RE Gemifloxacin: K031205. June 13, 2003 RE: Linezolid; K031103, June 12, 2003 RE: Ertapenem; K030933, May 1, 2003 RE: Moxifloxacin; K030620, April 14, 2003 RE: Gatifloxacin; 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 (nonfastidious): 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
{1}------------------------------------------------
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 battery 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 OC strains were tested concurrently using both Pasco methodology and reference methodology in panels that contained Gemifloxacin at concentrations ranging from 0.015 - 4 mcg/ml. Testing was conducted at three test sites.
Test results of 570 challenge and clinical Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae demonstrated an Essential Agreement (EA) of 99.7%. No major (M) or very major (VM) errors were observed. Category Agreement (CA) was acceptable at 99.0% with 7 random minor discrepancies, all of which were within EA with the exception of one.
{2}------------------------------------------------
510(k) SUMMARY (page 3 of 3)
OC endpoints for the NCCLS recommended QC organisms (S. pneumoniae ATCC 49619) 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 100%. Intra-site reproducibility of MIC results was 100% for all three sites.
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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 5 2003
Ms. Linda K. Dillon R&D Manager BD Diagnostic Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
Re: K032518
Trade/Device Name: PASCO MIC and MIC/ID Panels Gemifloxacin, 0.015-4 ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: August 8, 2003 Received: August 16, 2003
Dear Ms. Dillon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have deternined 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 (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
Page 2 -
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 yours,
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
{5}------------------------------------------------
Page 1 of 1
6
510(k) Number (if known): الك 32 32 ك
Device Name: PASCO MIC and MIC/ID Panels
Indications For Use: Inclusion of Gemifloxacin
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 Gemifloxacin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae. Gemifloxacin 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
Streptococcus pneumoniae (including penicillin-resistant strains)
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms
1000 States of the same of the states of the same of the states of the states of the states of the states of the states of the states of the states of the states of the state
Streptococcus pvogenes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CRF 801.109) | ✓ | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | -------------------------------------------------- |
| Division Sign-Off | Sam ctgf 9/11/03 |
|---|---|
| ------------------- | ------------------ |
Office of In Vitro Diagnostic
Evaluation and Safety
510(k) K032518
§ 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).