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 Imipenem to Pasco panels at concentrations of 0.015 to 2 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.

Device Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pasco MIC and MIC/ID Panels, focusing on the addition of Imipenem:

Acceptance Criteria and Device Performance

Acceptance Criteria (Not explicitly stated as criteria, but implied by performance)	Reported Device Performance
S. pneumoniae strains:
Acceptable Essential Agreement (EA)	98.7% (with 1 minor error)
Acceptable Major (M) errors	Not observed
Acceptable Very Major (VM) errors	Not observed
Acceptable Category Agreement (CA)	100% (with 9 additional random minor errors noted, all within EA)
Non-pneumococcal strains:
Acceptable Essential Agreement (EA)	100% (on initial testing)
Acceptable Major (M) errors	Not observed
Acceptable Very Major (VM) errors	Not observed
Acceptable Minor errors	Not observed
Acceptable Category Agreement (CA)	100% (with no random minor errors noted)
Reproducibility:
Overall reproducibility within ±1 dilution	100%
*QC Endpoints (for S. pneumoniae* ATCC 49619):**
Within recommended NCCLS acceptable range	Within recommended NCCLS acceptable range (from both reference and Pasco panels throughout testing)

Study Details

Sample size used for the test set and the data provenance:
- S. pneumoniae strains: 101 strains. The provenance is described as "CDC challenge strains and clinical isolates," tested at two sites.
- Non-pneumococcal strains: 130 strains. The provenance is described as "CDC challenge strains and clinical isolates," tested at two sites.
- Reproducibility testing: 12 organisms at each site.
- Data Provenance: The text indicates "two sites" for comparative testing but does not specify the country of origin. It uses "CDC challenge strains," which usually refers to strains from the Centers for Disease Control and Prevention (USA), and "clinical isolates," which suggests recent patient samples. The study appears to be prospective in nature for these tests, as they were "performed at two sites."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts or their qualifications for establishing the ground truth. The "reference panel" is used for comparison, implying a gold standard or a method accepted as ground truth, but who interpreted or established that ground truth is not mentioned.
Adjudication method for the test set:
The document does not specify an adjudication method like 2+1 or 3+1. The ground truth appears to be established by a "reference panel" and then compared to the Pasco test panel's results.
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 applicable. The device described is an Antimicrobial Susceptibility Test panel, not an AI-assisted diagnostic tool for human readers. It's an in-vitro diagnostic device that provides quantitative or qualitative results.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this can be considered a standalone performance study. The device, the Pasco MIC and MIC/ID Panels, is designed to produce results (MIC, essential agreement, category agreement) based on the growth or non-growth of organisms. The "performance" refers to the accuracy of the panel itself in determining susceptibility, not the performance of a human interpreting an image or output from an algorithm in a human-in-the-loop scenario. The comparison is between the Pasco panel and a "reference panel."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established by a "reference panel". This typically refers to an established, validated method (e.g., broth microdilution or agar dilution as per NCCLS guidelines) that is considered the gold standard for antimicrobial susceptibility testing. The text also mentions "OC endpoints for the OC organism S. pneumoniae ATCC 49619... were within the recommended NCCLS acceptable range," indicating adherence to a recognized standard (NCCLS - National Committee for Clinical Laboratory Standards, now CLSI).
The sample size for the training set:
The document describes a "comparative testing" for device performance, but it does not mention a separate "training set" as would be typical for machine learning models. The study appears to be a validation of the device's performance against a reference method using challenge strains and clinical isolates.
How the ground truth for the training set was established:
Since no explicit training set is described in the context of machine learning, this question is not applicable. For the performance evaluation, the "reference panel" results served as the ground truth.

Summary

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AUG 30 1999

K992059

(2)

510(k) SUMMARY (page 1 of 2)

DATE:	June 15, 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:

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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:

SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING:

Test panels containing Imipenem at concentrations ranging from 0.015-2 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 98.7% with 1 minor error. No major (M) or very major (VM) errors were observed. Category agreement (CA) was 100% with 9 additional random minor errors noted (all of which were 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 no random minor errors noted.

OC 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 8 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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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures or birds in flight, arranged in a stacked formation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 30 1999

Ms. Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Ave. Wheat Ridge, Colorado 80033

K992059 Re:

Trade Name: Pasco MIC and MIC/ID Panels Regulatory Class: II Product Code: JWY Dated: June 15, 1999 Received: June 18, 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/cdrls/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:

K992059

Indication For Use:

PASCO MIC and MIC/ID Panels; Inclusion of Imipenem

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 Imipenem to Pasco panels at concentrations of 0.015 to 2 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.

Woody Dubois

510(k) Number.

PRESCRIPTION USE X

Regulation Number and Section

§ 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).