(28 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 Gatifloxacin at concentrations of 0.03 - 8 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae. Gatifloxacin 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 (penicillin-susceptible strains)
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms Streptococcus pneumoniae (penicillin-resistant strains) Streptococcus pyogenes
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.
This document describes the regulatory submission for the PASCO MIC and MIC/ID Panels, specifically for the inclusion of the antimicrobial Gatifloxacin. The study aims to demonstrate that the device, when testing Gatifloxacin, is substantially equivalent to existing methods.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantifiable manner as "x% accuracy" or "y% sensitivity" for the overall device. Instead, the "Substantial Equivalence Testing" section describes performance metrics used to support substantial equivalence. The relevant criteria would be within the guidelines of the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA."
| Acceptance Criteria (Implied from the Guidance Document) | Reported Device Performance (Pasco MIC/ID Panel with Gatifloxacin) |
|---|---|
| Sufficient Essential Agreement (EA) with reference methodology | 100% Essential Agreement (EA) with reference methodology |
| Acceptable Category Agreement (CA) with reference methodology | 99.7% Category Agreement (CA) with reference methodology |
| Absence of Major (M) or Very Major (VM) errors | No Major (M) or Very Major (VM) errors observed |
| Acceptable QC endpoints for recommended QC organisms | OC endpoints for NCCLS recommended QC organisms (S. pneumoniae ATCC 49619) were acceptable |
| Acceptable Inter-site Reproducibility of MIC results | 100% inter-site reproducibility of MIC results |
| Acceptable Intra-site Reproducibility of MIC results | 100% intra-site reproducibility of MIC results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 570 challenge and clinical Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae.
- Data Provenance: The data involved "challenge strains, fresh clinical isolates, stock clinical isolates and OC strains." This implies a mix of prospectively collected clinical isolates and retrospectively accessed stock/challenge strains. The country of origin is not specified, but given the FDA submission, it is likely that the testing was conducted in the USA or in facilities adhering to US regulatory standards. The testing was performed at "three test sites."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth was established by "reference methodology." In the context of Antimicrobial Susceptibility Testing (AST), this typically refers to a standardized laboratory method (e.g., broth microdilution or agar dilution) performed by trained microbiologists following established guidelines (such as those from the National Committee for Clinical Laboratory Standards - NCCLS, now CLSI).
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the test set. Given that the ground truth is established by a "reference methodology," it's implied that the reference method's result is considered the gold standard, and the device's results are compared against it. Discrepancies (minor, major, very major errors) are noted, but a post-hoc adjudication process by independent experts is not mentioned for the 570 isolates.
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
This is not an AI/CAD device. The product is an Antimicrobial Susceptibility Test (AST) system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The "reading" of the panels involves observing visible growth or color changes, which is a direct observation by a trained laboratory professional.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not an AI/CAD device. It is a laboratory diagnostic kit. Therefore, a standalone algorithm performance study is not applicable. The device (the microdilution panel) is the test system, and its output (MIC values) is read by a human.
7. The Type of Ground Truth Used
The ground truth used was reference methodology for antimicrobial susceptibility testing. This would typically involve a standard, validated laboratory method for determining minimum inhibitory concentrations (MICs), such as broth microdilution or agar dilution, performed according to recognized protocols (e.g., NCCLS/CLSI guidelines).
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" in the context of machine learning or AI. This is a conventional diagnostic system, not an AI system that undergoes training in that sense. The "Substantial Equivalence Testing" described with 570 isolates likely served as the primary validation dataset for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this question is not applicable. The primary validation (test set) ground truth was established by "reference methodology."
{0}------------------------------------------------
AUG 1 9 2003
(2)
510(k) SUMMARY (page 1 of 3)
| DATE: | July 21, 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: 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 (non-fastidious); K992717. November 2, 1999 RE: Synercid: K992646. October 19. 1999 RE: Penicillin: K992647. October 19, 1999 RE: Ervthromycin: 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 Gatifloxacin at concentrations ranging from 0.03 - 8 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 100%. No major (M) or very major (VM) errors were observed. Category Agreement (CA) was acceptable at 99.7% with 2 random minor discrepancies, all of which were within EA.
{2}------------------------------------------------
510(k) SUMMARY (page 3 of 3)
(4)
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 17 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}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo with a circular border and a stylized graphic in the center. The graphic consists of three curved lines that appear to be stacked on top of each other, creating a sense of movement or flow. The logo is simple and abstract, with a focus on the lines and their arrangement within the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 9 2003
Ms. Linda K. Dillon R&D Manager BD Diagnostics Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440
Re: K032259
Trade/Device Name: PASCO MIC and MIC/ID Panels Gatifloxacin, 0.03-8 µg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: July 21, 2003 Received: July 22, 2003
Dear Ms. Dillon:
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 vour 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 Putman
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PASCO MIC and MIC/ID Panels
Indications For Use: Inclusion of Gatifloxacin
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 Gatifloxacin at concentrations of 0.03 - 8 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae. Gatifloxacin 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 (penicillin-susceptible strains)
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms Streptococcus pneumoniae (penicillin-resistant strains) Streptococcus pyogenes
(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
| Division Sign-Off | Over-The-Counter Use |
|---|---|
| (Optional Format 1-2-96) |
Jayantapre 8/15/03
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K032259
§ 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).