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HardyDisk®1 Tigecycline Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer). Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821.
HardyDisk Tigecycline, 15 µg
The provided text describes the FDA's approval of the HardyDisk Tigecycline, 15 µg, an antimicrobial susceptibility test disc. It indicates that the device's acceptable performance was determined based on zone sizes for interpretation and control organism limits approved by the drug manufacturer under NDA Number 21-821. However, the document does not contain a detailed study description with acceptance criteria, reported performance, sample sizes, ground truth establishment, or any information about AI assistance or MRMC studies.
Therefore, many of the requested elements cannot be extracted from the given text.
Here's what can be provided based on the input:
Acceptance Criteria and Device Performance Study Information for HardyDisk Tigecycline, 15 µg
This device is an antimicrobial susceptibility test disc. The acceptance criteria and performance are related to the interpretation of zone sizes and control organism limits in semi-quantitative in vitro susceptibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821."
Unfortunately, the specific numerical acceptance criteria (e.g., minimum and maximum zone sizes for susceptibility, intermediate, and resistance categories) and the reported device performance against these criteria are not provided in the given text. This information would typically be detailed in the NDA 21-821 documentation, which is not part of this 510(k) summary.
2. Sample size used for the test set and the data provenance
The document does not provide information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). This information would likely be found in the supporting data for NDA 21-821.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication method for the test set
The document does not specify an adjudication method for the test set.
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 device is an antimicrobial susceptibility test disc, which is a laboratory diagnostic tool. The concept of AI assistance for human readers and MRMC studies is typically relevant for image-based diagnostics (e.g., radiology). Therefore, it is highly unlikely that an MRMC comparative effectiveness study involving AI assistance would be conducted for this type of device, and the document does not mention any such study or effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a physical disc used in a laboratory procedure where human interpretation of zone sizes is involved. It is not an algorithm-only device, and therefore, a standalone algorithm performance study is not applicable in the typical sense. The performance is intrinsically linked to the chemical properties of the disc and the methodology of the agar diffusion test, along with human reading and interpretation. The document does not describe a standalone (algorithm-only) performance study.
7. The type of ground truth used
The type of ground truth used for establishing the zone sizes and control organism limits would be based on clinical outcomes data or reference methods (e.g., broth microdilution or agar dilution minimum inhibitory concentration (MIC) testing) from the original drug development and approval process (NDA 21-821). The document states these were "determined by the drug manufacturer and received FDA approval under NDA Number 21-821."
8. The sample size for the training set
The concept of a "training set" as understood in machine learning is not applicable to this type of device. The development of the zone size interpretative criteria for antibiotic susceptibility tests involves extensive correlation studies between laboratory results (zone sizes, MICs) and clinical efficacy data. The document does not provide a sample size for a training set.
9. How the ground truth for the training set was established
As mentioned above, the concept of a "training set" in the context of machine learning is not directly applicable. The "ground truth" for establishing the interpretative criteria (zone sizes) for Tigecycline would have been established through a comprehensive process during the drug's development (NDA 21-821), involving:
- Correlation studies: Comparing inhibition zone diameters with MIC values obtained by a reference method (e.g., broth microdilution).
- Pharmacokinetic/Pharmacodynamic (PK/PD) modeling: Relating drug concentrations at the site of infection to MICs.
- Clinical Efficacy Data: Observing patient outcomes in clinical trials with infections caused by organisms with specific MICs or zone sizes.
- Expert Consensus: Input from clinical microbiologists and infectious disease experts.
The document indicates that these criteria were established by the drug manufacturer and approved by the FDA under NDA 21-821.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 3 2006
Mr. Andre Hsiung Director of Technical Services/R&D Hardy Diagnostics 1430 W. McCoy Lane Santa Maria, California 93455
K062245 Re:
Trade/Device Name: HardyDisk Tigecycline, 15 µg Regulation Number: 21 CFR § 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: II Product Code: JTN Dated: July 28, 2006 Received: August 7, 2006
Dear Mr. Hsiung:
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). 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.
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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)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Sally, attorn
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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YOUR MICROBIOLOGY SPECIALIST FOR 25 YEARS AND COUNTING
Indications for Use
K062245 510(k) Number (if known):
Device Name: HardyDisk Tigecycline, 15 µg
Indications for Use:
HardyDisk®1 Tigecycline Antimicrobial Sensitivity Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer). Zone sizes used for interpretation of tests and control organism limits were determined by the drug manufacturer and received FDA approval under NDA Number 21-821.
Prescription Use
(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)
Salazar
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062245
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Headquarters & Customer Service
1430 West McCoy Lane
Santa Maria, CA 93455
phone: (800) 266-2222
fax: (805) 346-2760
email: sales@hardydiagno
web: www.hardydiagnostic
Distribution Centers:
Phoenix, Arizona
(800) 995-8456
Salt Lake City, Utah
(800) 266-2222
Tacoma, Washington
(800) 266-2222
Lima, Ohio
(800) 266-2222
§ 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).