HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby- Bauer). Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Use of HardyDisk™ AST Rezafungin 5ug (RZF5) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Rezafungin.

HardyDisk™ AST Rezafungin at concentration 5ug can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro. Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a medical device called HardyDisk™ AST Rezafungin 5ug (RZF5), which is an antimicrobial susceptibility test disc. The document states that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.

The acceptance criteria and study information are not directly about an AI/ML device, but rather about an antimicrobial susceptibility test. Therefore, many of the requested points, such as those related to AI assistance, human readers, experts, and adjudication methods, are not applicable.

Here's the relevant information that can be extracted from the provided text, adapted for the context of an antimicrobial susceptibility test:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria and reported device performance. It states that the device "can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro. Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis."

To determine the device's performance, one would typically compare the zone diameters obtained using the HardyDisk™ AST Rezafungin 5ug (RZF5) with a reference method (e.g., broth microdilution method) and evaluate criteria such as essential agreement (EA) and categorical agreement (CA). These specific performance metrics and their acceptance thresholds are not detailed in this particular document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. For an antimicrobial susceptibility test, the sample size would refer to the number of bacterial or fungal isolates tested, and provenance would include details about where these isolates were obtained and if the study was prospective or retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable in the traditional sense for an antimicrobial susceptibility test. The "ground truth" for AST is typically established by a reference method (e.g., CLSI broth microdilution) rather than expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for an antimicrobial susceptibility test in the context of expert adjudication. Adjudication typically applies to ambiguous cases requiring human interpretation.

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 information is not applicable as this is not an AI-assisted device and does not involve human readers interpreting cases.

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

This information is not applicable as this is not an AI/ML algorithm-based device.

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

For an antimicrobial susceptibility test, the "ground truth" for determining susceptibility or resistance of a microorganism to an antimicrobial agent is typically established by reference methods, such as the broth microdilution method according to a recognized standard (e.g., Clinical and Laboratory Standards Institute (CLSI) guidelines). This is inferred from the nature of the device, although not explicitly stated in the document.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML algorithm-based device that undergoes training.

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

This information is not applicable as this is not an AI/ML algorithm-based device that undergoes training.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services-USA seal, which features a stylized depiction of human figures. To the right of the seal, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font and is positioned above the rest of the text.

June 1, 2023

Hardy Diagnostics Anna Klavins Senior R&D and Performance Studies Manager 1430 West McCoy Lane Santa Maria, California 93455

Re: K230827

Trade/Device Name: HardyDisk AST Rezafungin 5ug (RZF5) Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: March 23, 2023 Received: March 27, 2023

Dear Anna Klavins:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ribhi Shawar -S

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230827

Device Name HardyDisk™ AST Rezafungin 5ug (RZF5)

Indications for Use (Describe)

Use of HardyDisk™ AST Rezafungin 5ug (RZF5) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of microorganisms to Rezafungin.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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).