Use of Gemifloxacin 5μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Gemifloxacin. Indicated when there in a need witro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.

Active In Vitro and in clinical infections against:
Aerobic gram-positive microorganisms Streptococcus pneumoniae (including multidrug resistant strains)
Aerobic gram-negative microorganisms Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae (many strains are only moderately susceptible)

Active In Vitro Against:
Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus pyogenes

Aerobic gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca Proteus vulgaris

Device Description

Gemifloxacin 5μg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Gemifloxacin supplied by the drug manufacturer. Each Gemifloxacin disk is clearly marked on both sides with the agent and drug content. Gemifloxacin cartridges each contain 50 impregnated disks that are packed as either a single Gemifloxatin a single box, or in a package containing ten cartridges. Gemifloxacin disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "GEMIFLOXACIN 5µg, BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks." This document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria.

Specifically, the document does not provide a table of acceptance criteria or reported device performance metrics in the format requested. It also does not detail a specific study design (e.g., sample sizes, data provenance, expert methodologies, or statistical analyses) to demonstrate the device meets acceptance criteria.

The document states: "Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 21-158." This implies that the performance characteristics (zone size ranges) were established and approved elsewhere, likely as part of the drug's (Gemifloxacin's) New Drug Application (NDA). The 510(k) process for this device relies on demonstrating substantial equivalence to a predicate device (Ciprofloxacin 5 µg Sensi-Disc) and adhering to established standards (NCCLS Documents M2 and M100) for antimicrobial susceptibility testing.

Therefore, many of the specific questions cannot be answered directly from the provided text.

However, based on the information provided and common practices for such devices, here's what can be inferred or stated about the "acceptance criteria" and the "study" (or basis of claims):

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the zone sizes for interpretation and control organism limits "were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 21-158." It also refers to NCCLS Documents M2 and M100 for categorical interpretations (Susceptible, Intermediate, Resistant).

Therefore, the "acceptance criteria" for the performance of the Gemifloxacin Sensi-Disc would be the specific zone diameter breakpoints and control ranges detailed in the FDA-approved drug insert for Gemifloxacin and the relevant NCCLS documents. These criteria are performance specifications for determining antibiotic susceptibility, not performance metrics of the Sensi-Disc itself (like accuracy or precision in measuring zone sizes).

The document does not report actual device performance data (e.g., how accurately the Sensi-Disc produces zones that align with these breakpoints). It presumes that if used correctly according to the established methodology, the resulting zone sizes can be interpreted according to the approved criteria.

Acceptance Criterion (Inferred from Text)	Reported Device Performance (Not reported in the document)
Zone size ranges for interpretation of Gemifloxacin susceptibility (S/I/R) for specified microorganisms (as per FDA-approved drug insert for Gemifloxacin and NCCLS M2/M100).	The document does not provide specific zone size data generated by the device to demonstrate it meets these ranges. It refers to externally established criteria.
Control organism limits for quality control of the test (as per FDA-approved drug insert for Gemifloxacin and NCCLS M2/M100).	The document does not provide quality control data from using the device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. The document refers to the drug package insert ("Susceptibility Tests: Diffusion Techniques") for "SUBSTANTIAL EQUIVALENCE TESTING DATA." This implies the underlying data supporting the zone size breakpoints were part of the NDA for the drug, not specifically generated for this device's 510(k). The Indications for Use section lists various microorganisms, suggesting a broad range was tested, but no specific numbers are given.
Data Provenance: Not specified. Again, likely part of the NDA for Gemifloxacin, so methodology would be governed by those studies. Retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The establishment of "ground truth" (i.e., true susceptibility) for a new antibiotic typically involves a combination of in vitro MIC testing (often broth microdilution or agar dilution) correlated with clinical outcomes, ideally guided by expert panels in microbiology and infectious diseases. This process would have occurred during the development and approval of the Gemifloxacin drug (NDA 21-158), not during the 510(k) for this specific Sensi-Disc.

4. Adjudication method for the test set:

Not specified. The methodology for setting breakpoints typically involves robust statistical analysis and expert consensus, but the specific adjudication method for a test set is not detailed here.

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, an MRMC study was not done. This type of study (MRMC, AI-assisted reading) is not relevant to an antimicrobial susceptibility disc. This device is a manual, semi-quantitative test that relies on a trained technologist measuring zone diameters and interpreting them against established standards. AI is not mentioned or implied in its use.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This device is a manual test and requires human interaction (applying the disk, incubating, measuring zone, interpreting). There is no "algorithm only" component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for antimicrobial susceptibility testing is typically based on Minimum Inhibitory Concentration (MIC) values determined by standardized reference methods (e.g., broth microdilution). These MIC values are then correlated with clinical outcomes data. Expert committees (like CLSI, which evolved from NCCLS) use this data to establish clinical breakpoints for interpretation (S/I/R). The document refers to NCCLS M2 and M100, indicating that this is the basis for interpretation.

8. The sample size for the training set:

Not specified. As mentioned, the underlying data for establishing breakpoints comes from the drug's NDA and subsequent expert panel work, not a "training set" in the machine learning sense for this device's 510(k).

9. How the ground truth for the training set was established:

Not applicable in the machine learning "training set" context. The ground truth for interpreting susceptibility to Gemifloxacin was established through extensive microbiological studies (MIC determination) and clinical trials during the drug's development, reviewed by regulatory bodies and expert panels, leading to the approved breakpoints in the drug insert and NCCLS standards.

Summary

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510(k) Submission

Gemifloxacin 5ug BBL Sensi-Disc

FEB ] 0 2005

Date: February 1, 2005	510(k) SUMMARY
SUBMITTED BY:	Becton Dickinson and Company7 Loveton CircleSparks, MD 21152Phone 410-316-4206Fax: 410-316-4499
CONTACT NAME:	Bradford M. Spring, Manager, Regulatory Affairs
DATE PREPARED:	February 1, 2005
DEVICE TRADE NAME:	GEMIFLOXACIN 5µg, BBL™ Sensi-Disc™ AntimicrobialSusceptibility Test Disks
DEVICE COMMON NAME:	Antimicrobial Susceptibility Test Disks
DEVICE CLASSIFICATION:	21 CFR§866.1620, Class II (Product Code JTN),Susceptibility Test Disks, Antimicrobial
PREDICATE DEVICE:	Other BBL™ Sensi-Disc™(eg. Ciprofloxacin 5 µg, BBL™ Sensi-Disc™)

INTENDED USE:

Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility Alltimicroulal Susceptionity Fest Disks are asceller some quality of ug BBL" Sensi-Disc" is testing of claims. In determining the susceptibility to Gemifloxacin of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 21-158.

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DEVICE DESCRIPTION:

Agar diffusion susceptibility methods employing dried filter paper disks impregnated with Agar anradientrations of antimicrobial agents were developed in the 1940s. In order to specifications or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.

Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated.

DEVICE PRINCIPLE:

Disks containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus species] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the disks are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested with the antimicrobial agent is made by comparing zone diameters to those found in the respective organism tables of NCCLS Document M2 ("Performance Standards for Antimicrobial Disk Susceptibility Tests) and of NCCLS Document M100 ("Performance Standards for Antimicrobial Susceptibility Testing").

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DEVICE COMPARISON:

The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Gemifloxacin 5μg is similar to the BBL" Sensi-Disc " Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:

Both methods are for antimicrobial susceptibility testing using paper disks impregnated with . an antimicrobial agent.
Both methods have the same intended use. .
Both methods provide the user with antimicrobic minimum inhibitory concentration (MIC) . results based on measurements of zone diameters.
Both methods require the user to determine categorical interpretations (S/I/R) using the . measured zone diameters against NCCLS Approved Standards M2 and M100.
Both methods use pure cultures of bacterial isolates. .

The BBL " Sensi-Disc " Antimicrobial Susceptibility Test Disks - Gemifloxacin 5μg differs from the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:

BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks Gemifloxacin 5μg is a . susceptibility test that uses disks impregnated with the antimicrobic Gemifloxacin at a concentration of 5ug while the BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks -Ciprofloxacin 5 µg is a susceptibility test that uses disks impregnated with the antimicrobic Ciprofloxacin at a concentration of 5 ug.
BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk Gemifloxacin 5 µg is a . susceptibility test used to test a different battery of microorganisms than the BBL " Sensi-Disc Antimicrobial Susceptibility Test Disk - Ciprofloxacin 5 ug.

SUBSTANTIAL EQUIVALENCE TESTING DATA:

See the Gemifloxacin drug package insert, "Susceptibility Tests: Diffusion Techniques".

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 1 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bradford M. Spring Manager, Regulatory Affairs BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

K050062 Re:

K050062
Trade/Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Gemifloxacin 5 ug

Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disks Regulatory Class: Class II Product Code: JTN Dated: January 5, 2005 Received: January 11, 2005

Dear Mr. Spring:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1978, tire excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costicule 710- (110-) that as nevice, subject to the general controls provisions of the Act. The r ou may, mercrore, mainer and a ct include requirements for annual registration, listing of general controls provisions 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), if your device is classified (660 ace +6) trols. Existing major regulations affecting your device It may be subject to subil additions come regulations (CFR), Parts 800 to 895. In addition, FDA ean be found in Ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I Driver and inat your device complies with other requirements of the Act that I DA has made a sond regulations administered by other Federal agencies. You must of any I cuttar statutes and regulaments, including, but not limited to: registration and listing (21 compry with an the 1100 beep Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you w ough finding of substantial equivalence of your device to a legally promation in the 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, If you desire specific information and advertising of your device, please contact the Office of In of quostions on the prome Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may 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/industry/support/index.html

Sincerely yours,

Sally, a Horr

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

INDICATIONS FOR USE

510(k) Number (if known): K050062

Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Gemifloxacin 5ug

Indications for Use:

Use of Gemifloxacin 5μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is a indicated when there is a need to determine the susceptibility of bacteria to Gemifloxacin. 5µg Indicated when there in a need witro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.

Active In Vitro and in clinical infections against:

Aerobic gram-positive microorganisms Acrobic Erail pneumoniae (including multidrug resistant strains) Aerobic gram-negative microorganisms Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae (many strains are only moderately susceptible)

Active In Vitro Against:

Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus pyogenes

Aerobic gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca Proteus vulgaris

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Fuddite. Cook

vision Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) KD50062

Becton, Dickinson and Company

February 1, 2005

Regulation Number and Section

§ 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).