Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Voriconazole 1ug BBL" Sensi-Disc " is intended for use in determining the susceptibility to Voriconazole of a wide range of pathogens, 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 21-266.

Use of Voriconazole 1μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of pathogens to Voriconazole. The concentration of 1 ug has been shown to be active in vitro against most strains of Candida species listed below, as described in the FDA approved drug insert for this agent.

Active In Vitro and in Clinical Infections Against:

Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Active In Vitro Against:

Candida lusitaniae Candida guilliermondii

Device Description

Voriconazole 1ug BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Voriconazole supplied by the drug manufacturer. Each Voriconazole disk is clearly marked on both sides with the agent and drug content. Voriconazole cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Voriconazole disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate 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 Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.

AI/ML Overview

The provided 510(k) summary does not contain a specific acceptance criteria table or a detailed study section with performance metrics in numerical form. The submission focuses on establishing substantial equivalence to a predicate device for the Voriconazole 1µg BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks. Instead, it references the Voriconazole drug package insert, "Susceptibility Testing Methods: Diffusion Techniques" (Appendix 1) as the source of substantial equivalence testing data, which is not included in the provided text.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given 510(k) summary. 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 21-266." This implies that the acceptance criteria are existing standards (zone size ranges) from the FDA-approved drug insert for Voriconazole. The document does not present the specific zone sizes observed with the BBL™ Sensi-Disc™ Voriconazole 1 µg for various organisms.

Inferred Information:

Metric	Acceptance Criteria (Inferred from Drug Insert/CLSI)	Reported Device Performance (Not explicitly stated in this document)
Zone Diameter	Specific zone size ranges (mm) for Susceptible (S), Susceptible-Dose Dependent (S-DD), and Resistant (R) categories for various Candida species (e.g., C. albicans, C. glabrata, etc.)	Actual zone diameters observed during testing (not provided)
Control Organism	Specific zone size limits for quality control strains	Actual zone diameters observed for control strains (not provided)
Categorical Agreement	Agreement with reference method (likely MIC) for S/S-DD/R classifications	Percentage agreement (not provided)

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

The document states that the testing data is in the "Voriconazole drug package insert, "Susceptibility Testing Methods: Diffusion Techniques" (Appendix 1)." This appendix is not provided.
Therefore, the exact sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) are not available in this submission.

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

This information is not provided in the 510(k) summary. The ground truth for antimicrobial susceptibility testing typically comes from reference methods (like broth microdilution for Minimum Inhibitory Concentration - MIC), which are interpreted by trained laboratory personnel following standardized guidelines (e.g., CLSI). The involvement of "experts" in the sense of clinical specialists establishing grand truth is not typically applicable in this context.

4. Adjudication method for the test set

This information is not provided. For antimicrobial susceptibility testing, interpretations are generally made by comparing measured zone diameters to established breakpoints (from CLSI or the drug insert), rather than through an adjudication process among human readers.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is more common for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated.
The device (Antimicrobial Susceptibility Test Disk) is a semi-quantitative in vitro diagnostic device used to determine susceptibility, not a tool to assist human readers in interpreting complex cases. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable to this type of device.

6. Standalone (i.e., algorithm only without human-in-the loop performance) study

Yes, the device is designed for "standalone" performance in the sense that it provides a direct measurement (zone diameter) that is then interpreted based on established breakpoints. The "algorithm" here is the physical diffusion process and the subsequent measurement and comparison to predefined ranges. There isn't an "AI" algorithm in the modern sense.
The "performance" of the device itself (accuracy of drug impregnation, consistency of disk manufacturing, correlation of zone size to MIC) would have been established in the studies cited in the Voriconazole drug package insert. The 510(k) focuses on the substantial equivalence of the disk format and concentration to existing devices.

7. Type of ground truth used

The ground truth for antimicrobial susceptibility testing, which the BBL™ Sensi-Disc™ method correlates with, is typically Minimum Inhibitory Concentration (MIC) values determined by a reference method such as broth microdilution. These MIC values are then categorized into Susceptible (S), Susceptible-Dose Dependent (S-DD), or Resistant (R) based on established breakpoints.
The document implies this by stating: "The categorical interpretation [susceptible (S), susceptible-dose dependent (S-DD), or resistant (R)] for the organism being tested is made by comparing zone diameters to those found in the approved pharmaceutical package insert." These interpretations in the package insert are derived from correlation with MIC data.

8. Sample size for the training set

The 510(k) summary does not provide specific details about a "training set" in the context of machine learning. For traditional in vitro diagnostic devices like this, the "training" equivalent would be the extensive studies (spanning many years and numerous isolates) conducted to establish the correlation between zone diameters and MIC values, and to define the interpretive breakpoints for Voriconazole. This data would be part of the original drug's NDA (NDA 21-266).
Therefore, the sample size for the training set is not available in this document.

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

As mentioned above, the "ground truth" for establishing the interpretive criteria (i.e., the "training set" for breakpoints) would have been established through correlation studies comparing zone diameters to Minimum Inhibitory Concentration (MIC) values obtained using a reference method (e.g., broth microdilution) across a large and diverse collection of clinical isolates. These studies would have been part of the original drug development and regulatory approval (NDA 21-266).
These correlation studies aim to find the zone diameter breakpoints that best predict the MIC-based susceptibility categories (S, S-DD, R).

Summary

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510(k) Submission

510(k) SUMMARY

KO 32272

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone 410-316-4938Fax: 410-316-4499	OCT 02 2008
CONTACT NAME:	Janine Matlak, Regulatory Affairs Specialist
DATE PREPARED:	August 8, 2008
DEVICE TRADE NAME:	Voriconazole 1µg, BBL™ Sensi-Disc™ AntimicrobialSusceptibility Test Disks
DEVICE COMMON NAME:	Antimicrobial Susceptibility Test Disks
DEVICE CLASSIFICATION:	21 CFR§866.1620, Class II (Product Code JTN), SusceptibilityTest Disks, Antimicrobial
PREDICATE DEVICE:	Other BBL™ Sensi-Disc™(eg, Ciprofloxacin 5 µg, BBL™ Sensi-Disc™)

INTENDED USE:

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510(k) SUMMARY

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Active In Vitro Against:

Candida lusitaniae Candida guilliermondii

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DEVICE DESCRIPTION:

DEVICE PRINCIPLE:

Disks containing a wide variety of selected agents are applied to the surface of Mueller Hinton Agar plates, supplemented as needed and 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 agents in order to determine the agent(s) most suitable for use in therapy. The categorical interpretation [susceptible (S), susceptible-dose dependent (S-DD), or resistant (R)] for the organism being tested is made by comparing zone diameters to those found in the approved pharmaceutical package insert.

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DEVICE COMPARISON:

The BBL™ Sensi-Disc" Antimicrobial Susceptibility Test Disks - Voriconazole 1 ug is similar to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:

Both methods are for susceptibility testing using paper disks impregnated with an agent. .
Both methods are intended to test susceptibility to pathogenic isolates. .
Both methods provide the user with minimum inhibitory concentration (MIC) results based on . measurements of zone diameters.
Both methods require the user to determine categorical interpretations using the measured zone . diameters against CLSI Approved Standards.
Both methods use pure cultures of isolates. t

The BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks - Voriconazole 1 µg differs from the BBL " Sensi-Disc " Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:

BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks Voriconazole 1μg is a susceptibility test . that uses disks impregnated with Voriconazole at a concentration of 1 µg while the BBL™ Sensi-Disc Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg is a susceptibility test that uses disks impregnated with Ciprofloxacin at a concentration of 5 µg.
BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disk Voriconazole 1 ug is a susceptibility test . used to test a different battery of isolates than the BBL™ Antimicrobial Susceptibility Test Disk - Ciprofloxacin 5 ug.

SUBSTANTIAL EQUIVALENCE TESTING DATA:

See the Voriconazole drug package insert, "Susceptibility Testing Methods: Diffusion Techniques" (Appendix 1).

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1.0 INTRODUCTION

Becton, Dickinson and Company, BD Diagnostic Systems, is submitting this premarket notification in accordance with 21CFR5807.81 for a device being introduced into commercial distribution for the first time.

BD Diagnostic Systems is adding Voriconazole 1 µg to the currently available BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks product. Ciprofloxacin (5 µg), was added to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks product line when FDA clearance was granted per premarket notification #K874425. Disks containing Ciprofloxacin are being used as one example of this product line and are the predicate device for this submission.

1.1 Intended Use

Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Voriconazole lug BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Voriconazole of a wide range of pathogens, as described under Indications for Use (Section 1.2). Zone diameters used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, and received FDA approval under NDA 21-266.

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1.2 Indications for Use

Use of Voriconazole 1µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of pathogens to Voriconazole. The concentration of 1 ug has been shown to be active in vitro against most strains of Candida species listed below, as described in the FDA approved drug insert for this agent.

Active In Vitro and in Clinical Infections Against:

Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Active In Vitro Against:

Candida lusitaniae Candida guilliermondii

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2.0 DEVICE INFORMATION

2.1 Device Description

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

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).45 The procedure was adopted as a consensus standard by the Clinical Laboratory Standard Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated. 6.7,8

Becton, Dickinson and Company

1 Bauer, A.W., W.M.M. Kirby, J.C. Sherris, and M. Turck. 1966. Antibiotic susceptbillity testing by a standardized single disk method. Am. J Clin. Pathol. 45:493-496.

Allin Padler 18. 100 100.

3 Federal Register. 1972. Rules and regulations. Antibiotic susceptibility discs. Fed. Regist. 37:20526-20529. Erratum, 38:2756, 1973. * Encsson, H.M., and J.C. Sherris. 1971. Antibitic sensitivity testing. Report of an international collaborative study. Acta Pathol. Microbiol. Scand Sec. B. Sunnt 217:1-90.

Stand. Del E. Soppit Litter on Biological Standardization. 1977. Technical report series 610. W.H.O., Geneva.

8 Clinical and Laboratory Standards Institute (Fornerly NCCLS). 2006. Approved standard M2-A9. Performance standards for antimicrobial disk susceptibility tests, 90 ed. CLSI, Wayne, Pa.

Clinical and Laboratory Standards Institute (Formerly NCCLS). 2008. M100-S18 (M2). Performance Standards for Artimicrobial Susceptibility Testing; Eighteenth Informational Supplement. CLSI, Wayne, Pa.

Susceptiblity Testing, Lightenin mornations Ouplement. OLST, Varifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline. CLSI, Wayne, Pa.

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2.2 Device Principle

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3.0 DEVICE COMPARISON

The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Voriconazole 1 ug as described in this submission, is substantially equivalent to a legally marketed device for the susceptibility testing by agar disk diffusion method. The BBLTM Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Voriconazole 1 ug is substantially equivalent to all of the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks manufactured and marketed by Becton, Dickinson and Company for over 30 years. Specifically, the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Voriconazole 1 ug is substantially equivalent to BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Ciprofloxacin 5 µg (K874425). The Voriconazole 1 ug BBL™ Sensi-Disc™ has the same technological characteristics as its predicate, Ciprofloxacin 5 ug, BBLTM Sensi-DiscTM.

The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk - Voriconazole 1 ug is similar to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk -- Ciprofloxacin 5 ug in that:

Both methods are for susceptibility testing using paper disks impregnated with an agent. .
Both methods are intended to test susceptibility to pathogenic isolates. .
Both methods provide the user with minimum inhibitory concentration (MIC) results based on . measurements of zone diameters.
Both methods require the user to determine categorical interpretations using the measured zone . diameters against CLSI Approved Standards.
. Both methods use pure cultures of isolates.

The BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disks - Voriconazole 1 ug differs from the BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 ug in that:

BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disks Voriconazole lug is a susceptibility test . that uses disks impregnated with Voriconazole at a concentration of I ug while the BBL " Sensi-Disc Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg is a susceptibility test that uses disks impregnated with Ciprofloxacin at a concentration of 5 ug.
BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disk -- Voriconazole 1 ug is a susceptibility test . used to test a different battery of isolates than the BBL™ Sensi-Disc" Antimicrobial Susceptibility Test Disk - Ciprofloxacin 5 ug.

1 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 Ad, as applied under 21 CFR 807, Subpat E under which a device can be marketed r our re-out read approval or reclassification 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 U.S. Patent Laws or the courts.

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Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with an eagle in the center. The eagle is facing to the right and has its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 02 2008

Becton, Dickinson and Company c/o Ms. Janine Matlak Regulatory Affairs Specialist 7 Loveton Circle Sparks, MD 21152

K082272 Re:

Trade/Device Name: BBLTM Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Voriconazole 1ug

Regulation Number: 21 CFR§ 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc. Regulatory Class: Class II Product Code: JTN Dated: August 8, 2008 Received: August 11, 2008

Dear Ms. Matlak:

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 (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) 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 (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 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/industry/support/index.html

Sincerely yours,

Sale, a For

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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INDICATIONS FOR USE

14082272 510(k) Number (if known):

Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Voriconazolel Lg

Indications for Use:

Active In Vitro and in Clinical Infections Against:

Candida albicans Candida glabrata Candida krusei Candida parupsilosis Candida tropicalis

Active In Vitro Against:

Cundida lusitaniae Candida guilliermondii

Prescription Use V (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)

Freddie K. Poole

ion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K08 2272

Becton, Dickinson and Company

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).