(27 days)
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No
The 510(k) summary describes a traditional in vitro diagnostic device (AST disks) used for manual susceptibility testing (Kirby-Bauer method). There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.
No
Explanation: This device is used for in vitro susceptibility testing of bacterial pathogens to determine their susceptibility to Eravacycline, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used for "in vitro susceptibility testing" to "determine the susceptibility of bacteria," which is a form of diagnosis to identify the appropriate treatment.
No
The device is a physical disk used for in vitro susceptibility testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the HardyDisk™ AST Disks are used for "semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure". The term "in vitro" is a key indicator of an IVD.
Furthermore, the description of the testing procedure (agar diffusion test) and the purpose (determining the susceptibility of bacteria) are consistent with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease. In this case, the specimens are bacterial pathogens, and the information is their susceptibility to antibiotics.
N/A
Intended Use / Indications for Use
HardyDisk™ AST 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, Staphylococus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Use of HardyDisk AST Eravacycline 2015 (ERV20) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria among the Enterobacteriaceae to Eravacycline.
HardyDisk AST Eravacycline at concentration 20μg can be used to determine the zone diameter (mm) of Eravacycline against the following bacteria among the Enterobacteriaceae.
Eravacycline has been shown to be active both clinically and in vitro against the following organisms: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
Eravacycline has been shown to be active in vitro against most of the following bacteria, but their clinical significance is unknown: Citrobacter koseri Klebsiella (Enterobacter) aerogenes.
Product codes (comma separated list FDA assigned to the subject device)
JTN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
September 26, 2018
Hardy Diagnostics Anna Klavins Performance Studies Microbiologist 1430 West McCoy Lane Santa Maria, California 93455
Re: K182357
Trade/Device Name: HardyDisk AST Eravacycline 20ug (ERV20) Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: Class II Product Code: JTN Dated: August 29, 2018 Received: August 30, 2018
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Steven R. Gitterman -S for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182357
Device Name HardyDiskTM AST Eravacycline 20ug (ERV20)
Indications for Use (Describe)
HardyDisk™ AST 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, Staphylococus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
Use of HardyDisk AST Eravacycline 2015 (ERV20) for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria among the Enterobacteriaceae to Eravacycline.
HardyDisk AST Eravacycline at concentration 20μg can be used to determine the zone diameter (mm) of Eravacycline against the following bacteria among the Enterobacteriaceae.
Eravacycline has been shown to be active both clinically and in vitro against the following organisms: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
Eravacycline has been shown to be active in vitro against most of the following bacteria, but their clinical significance is unknown: Citrobacter koseri Klebsiella (Enterobacter) aerogenes.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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