HARDY DISK AMPICILLIN/SULBACTAM by HARDY DIAGNOSTICS

HardyDisk™ Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Acinetobacter spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., other streptococci and, by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae.

HardyDisk™ Ampicillin/Sulbactam is indicated for in vitro activity against gram negative organisms including Escherichia coli, Klebsiella spp., Proteus spp., Providencia spp., Morganella morganii, Haemophilus spp. and Neisseria gonorrhoeae.

HardyDisk™ Ampicillin/Sulbactam is also indicated for in vitro activity against gram positive organisms including Staphylococcus spp., enterococci, and Streptococcus spp., including S. pneumoniae.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called HardyDisk™ Ampicillin/Sulbactam 10/10mcg. This letter grants clearance for the device to be marketed, based on its substantial equivalence to a predicate device.

It's crucial to understand that this document is a regulatory clearance letter, not a scientific study report or clinical trial results. As such, it does not contain the detailed information required to fill out all aspects of your request. Specifically, it focuses on the administrative process of FDA clearance and the intended uses of the device.

However, I can extract the information that is present and explain why other requested information is not available in this particular document.

Here's an analysis of the acceptance criteria and study information that can be gleaned from the provided text, along with an explanation for missing data:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed reported device performance metrics in numerical form. The clearance is based on "substantial equivalence" to a predicate device, meaning its performance characteristics are considered sufficiently similar to an already legally marketed device for the same intended use.

The "Indications for Use Statement" lists the organisms against which the HardyDisk™ Ampicillin/Sulbactam is indicated for in vitro activity. This broadly describes the intended performance of the device rather than specific quantitative performance metrics or acceptance criteria.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
In vitro activity against specific gram-negative organisms, including Escherichia coli, Klebsiella spp., Proteus spp., Providencia spp., Morganella morganii, Haemophilus spp., and Neisseria gonorrhoeae.	The device is indicated for in vitro activity against these organisms.
In vitro activity against specific gram-positive organisms, including Staphylococcus spp., enterococci, and Streptococcus spp., including S. pneumoniae.	The device is indicated for in vitro activity against these organisms.
Performance in semi-quantitative in vitro susceptibility testing by agar diffusion (Kirby-Bauer) procedure, consistent with standardized methods for specific bacterial pathogens.	The device is used for this purpose, supporting its capability to perform according to established methods.
Substantial equivalence to already legally marketed predicate devices.	The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Explanation for Missing Information: A 510(k) clearance typically relies on demonstrating substantial equivalence, which can involve performance data but doesn't usually require presenting it in a detailed table with a priori acceptance criteria in the final clearance letter itself. Such data would be part of the larger 510(k) submission, not the FDA's decision letter.

2. Sample Size Used for the Test Set and Data Provenance:

Sample size used for the test set: Not specified in this document.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in this document.

Explanation for Missing Information: This level of detail regarding study design and data specifics is not typically included in the regulatory clearance letter. It would be part of the applicant's 510(k) submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

Explanation for Missing Information: This device is an in vitro diagnostic for antimicrobial susceptibility testing. Its "ground truth" would be established by laboratory methods, such as comparison to a reference susceptibility testing method, rather than human expert opinion on images or clinical cases. The concept of "experts establishing ground truth" as you've phrased it (e.g., radiologists) is more relevant to imaging or pathology devices. For an antibiotic susceptibility disk, the ground truth relates to the bacterial isolate's actual susceptibility/resistance profile, typically determined by a gold standard laboratory method.

4. Adjudication Method for the Test Set:

Adjudication method: Not applicable.

Explanation for Missing Information: As explained above, for an in vitro diagnostic like an antimicrobial susceptibility disk, "adjudication" in the sense of resolving human expert disagreements (e.g., 2+1, 3+1) is not relevant. The ground truth for such devices is determined by standardized laboratory reference methods, not subjective human assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

MRMC study: No.
Effect size of human readers improve with AI vs without AI assistance: Not applicable.

Explanation for Missing Information: The HardyDisk™ is an antimicrobial susceptibility disk, not an AI-powered diagnostic tool requiring human interpretation comparison. Therefore, an MRMC study and AI assistance improvement metrics are not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone performance: Not applicable in the context of an algorithm.

Explanation for Missing Information: This is an in vitro diagnostic disk, not an algorithm, so the concept of "standalone algorithm performance" doesn't apply. The device's performance is its inherent ability to produce inhibition zones in the presence of bacteria, which is then interpreted by a trained microbiologist.

7. The Type of Ground Truth Used:

Type of ground truth: The ground truth for in vitro diagnostic antimicrobial susceptibility testing typically involves a reference susceptibility testing method (e.g., broth microdilution or agar dilution as described by CLSI standards) against which the disk diffusion method is compared. This is a laboratory reference standard. Clinical outcomes data or pathology are not direct ground truths for susceptibility testing itself, though they might be used in broader clinical utility studies.

Explanation for Missing Information: While the document doesn't explicitly state the reference method, it implicitly refers to "Standardized methods for agar diffusion testing" (Kirby-Bauer) and the broader context of CLSI guidelines which define these reference methods.

8. The Sample Size for the Training Set:

Sample size for the training set: Not applicable for this type of device.

Explanation for Missing Information: This device is not an AI/ML algorithm that requires a "training set." Its development and validation are based on microbiological principles and comparison to established reference methods, not machine learning.

9. How the Ground Truth for the Training Set Was Established:

How ground truth was established: Not applicable for this type of device.

Explanation for Missing Information: Since there is no "training set" in the AI/ML sense, the establishment of ground truth for such a set is not relevant.

Summary of what the document does provide:

Device Name: HardyDisk™ Ampicillin/Sulbactam 10/10mcg
Regulatory Status: Class II, 510(k) cleared (K994067)
Intended Use: Semi-quantitative in vitro susceptibility testing by agar diffusion (Kirby-Bauer) for rapidly growing and certain fastidious bacterial pathogens.
Specific Organisms Indicated:
- Gram-negative: Escherichia coli, Klebsiella spp., Proteus spp., Providencia spp., Morganella morganii, Haemophilus spp., Neisseria gonorrhoeae.
- Gram-positive: Staphylococcus spp., enterococci, and Streptococcus spp., including S. pneumoniae.
Predicate Device: The clearance is based on substantial equivalence to a legally marketed predicate device.

To obtain the detailed study information you're seeking (sample sizes, specific quantitative performance data, details of comparison studies, etc.), you would typically need to consult the full 510(k) submission document for K994067, which is usually publicly available through FDA's databases like the Premarket Notification (510(k)) database. The clearance letter itself is just the FDA's decision based on its review of that submission.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three human figures.

JAN 1 4 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Melissa M. Traylor, RAC Director of Technical Services Regulatory Affairs Hardy Diagnostics 1430 West McCoy Lane Santa Maria, California 93455

K994067 Re:

Trade Name: HardyDisk™ Ampicillin/Sulbactam 10/10mcg Regulatory Class: II Product Code: JTN Dated: November 29, 1999 Received: December 1, 1999

Dear Ms. Traylor:

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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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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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Image /page/2/Picture/0 description: The image shows the logo for Hardy Diagnostics. The logo consists of a circular graphic on the left and the text "HARDY DIAGNOSTICS" on the right. The word "HARDY" is on top of the word "DIAGNOSTICS".

mail: Sales@Hardydiannostics.com Website: Hardvdiaanostic

Santa Maria, California 430 West McCov Lane Santa Maria, CA 93455 Tel: 18051 346-7766 Fax: 18051 346-7760

Salt Lake City, Utah 254 W Cottane Ave Sandv. UT 84070 Tel: (800) 995-4273 Fax: 18011562-3214

Phoenix, Arizona 535 W. Iron Ave., #105 Mesa A7 85210 Tel: 18001 995-8456 Fax: 16021 464-9828

510K Number K994067

Indications for Use Statement-HardyDisk ™ Ampicillin/Sulbactam 10/10mcg

HardyDisk™ Ampicillin/Sulbactam is also indicated for in vitro activity against gram positive organisms including Staphylococcus spp., enterococci, and Streptococcus spp., including S. pneumoniae.

Concurrence of CDRH-ODE

Woody Dubois
(Division Sign-off)

Division of Cli aboratory Devices 510(k) Number

Prescription Use
X
(per 21 CFR 801.109)

Over-the Counter-Use (Optional format 1-2-96)

Serving the laboratorian since 1 980 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

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).