HARDYDISK AST TELAVANCIN,30UG by HARDY DIAGNOSTICS

Use of HardyDisk™ Telavancin 30 µg for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telavancin. The concentration of Telavancin 30 ug has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections:

Methicillin-resistant staphylococci, streptococci, and vancomycinsusceptible enterococci.

Device Description

Not Found

AI/ML Overview

The document is a 510(k) premarket notification letter from the FDA regarding the Hardy Disk μg Telavancin, 30μg. It primarily focuses on the regulatory approval and indications for use, and does not contain the detailed study information needed to fully answer your request regarding acceptance criteria and performance studies.

However, based on the provided text, I can infer some information relevant to your request, specifically about the Indications for Use, which often form the basis for performance criteria in such devices.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria (Inferred from Indications for Use):
- The device should accurately determine the susceptibility of bacteria to telavancin.
- The concentration of Telavancin 30 ug should be "active against most isolates of the following microorganisms both in vitro and in clinical infections: Methicillin-resistant staphylococci, streptococci, and vancomycin-susceptible enterococci."
Reported Device Performance:
- The document states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. This is the primary "performance" reported from a regulatory standpoint in this letter.
- More specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, agreement rates with a reference method) are not provided in this document. Such data would typically be found in the more detailed 510(k) submission itself, not in the approval letter.

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

Not provided in this document. This information would be part of the technical data submitted to the FDA, not typically included in the approval letter.

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

Not provided in this document. This information is relevant for studies involving human interpretation (e.g., imaging devices), but for an antimicrobial susceptibility test disc, the "ground truth" is typically established via a reference method (e.g., broth microdilution) rather than expert consensus in the same way.

4. Adjudication method

Not applicable/Not provided in this document. For an AST disc, the determination of susceptibility or resistance is based on measuring zone sizes and comparing them to established breakpoints, rather than subjective expert adjudication.

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

Not applicable. This device is an antimicrobial susceptibility test disc, not an AI-powered diagnostic imaging or interpretation tool. MRMC studies are not relevant here.

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

Not applicable. This is a physical test disc, not an algorithm. The "performance" is its intrinsic ability to produce a measurable zone of inhibition when incubated with bacteria. Human interpretation (reading the zone size) is inherent to its use.

7. The type of ground truth used

Inferred: For antimicrobial susceptibility testing, the typical "gold standard" or ground truth is a reference antimicrobial susceptibility testing method, such as broth microdilution or agar dilution, performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. The document itself does not explicitly state the type of ground truth, but this is the standard for such devices.

8. The sample size for the training set

Not applicable/Not provided in this document. For a conventional AST disc, there isn't a "training set" in the machine learning sense. The disc's performance is based on its chemical composition and the drug concentration, which determine its interaction with bacteria. Calibration and validation are done against reference methods on a set of isolates, but it's not a "training set" for an algorithm.

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

Not applicable/Not provided in this document. (See point 8).

Summary of what is present in the document:

Device Name: Hardy Disk μg Telavancin, 30μg
Intended Use/Indications for Use: In vitro agar diffusion susceptibility testing to determine susceptibility of bacteria to telavancin. Specifically, it has been shown to be active against most isolates of Methicillin-resistant staphylococci, streptococci, and vancomycin-susceptible enterococci.
Regulatory Status: Substantially equivalent to a legally marketed predicate device.

To get the comprehensive information you requested (sample sizes, specific performance metrics, detailed study design), you would need to access the full 510(k) submission for K093807, which is a much more extensive technical dossier than the FDA approval letter provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of three wavy lines, which are meant to represent the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

JAN - 8 2010

Ms. Wendy Phillips Hardy Diagnostics 1430 McCoy Lane Santa Maria, CA 93455

Re: K093807

Trade/Device Name: Hardy Disk μg Telavancin, 30μg Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class: II Product Code: JTN Dated: December 10, 2009 Received: December 11, 2009

Dear Ms. Phillips:

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 class II (Special Controls), 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

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CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

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 in a larger font size than the word "DIAGNOSTICS", and it is placed above the word "DIAGNOSTICS".

Headquarters & Customer Se

1430 West McCoy Lane Santa Maria, CA 93455

phone: (800) 266-2222 fax: (805) 346-2760 email: sales@hardydiagnostics.com web: www.hardydiagnostics.com

Distribution Centers:

Phoenix, Arizona Salt Lake City, Utah Tacoma, Washington Lima, Ohio

Indications for Use

510(k) Number (if known):

Device Name: HardyDisk Telavancin, 30 ug

Indications for Use:

Methicillin-resistant staphylococci, streptococci, and vancomycinsusceptible enterococci.

Prescription Use Frescription Ose
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie L. Cole

Vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD93807

Image /page/2/Picture/20 description: The image shows a logo indicating ISO 13485 certification. The logo features the letters "QMI" inside a circle, with the word "REGISTERED" below it. Above the circle, the text "ISO 13485 CERTIFIED" is displayed, and below the circle, the certification number "CERT 1035006" is printed.

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).