(65 days)
HardyDisk Meropenem/Vaborbactam 20/10 µg (MEV30) K172621
Not Found
No
The description focuses on the physical characteristics of the AST disc and its use in a standard agar diffusion test, with no mention of AI/ML for analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) antimicrobial susceptibility test disc used for susceptibility testing, not a device intended to treat or cure a disease or condition.
Yes
The device is an Antimicrobial Susceptibility Test (AST) disc, used for in vitro susceptibility testing, which determines the effectiveness of antibiotics against specific bacteria. This process provides information crucial for diagnosing and guiding treatment for bacterial infections.
No
The device is a physical disc impregnated with chemicals, used in a laboratory setting for antimicrobial susceptibility testing. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the discs are used in the "semi quantitative agar diffusion test method for in vitro susceptibility testing." In vitro diagnostic devices are used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease. Susceptibility testing is a key part of determining appropriate treatment for bacterial infections.
- Device Description: The description details a product (discs impregnated with antimicrobial agents) designed to be used in a laboratory setting for testing purposes.
- Performance Studies: The document describes performance studies comparing the device to a predicate device, which is a standard requirement for IVD submissions to regulatory bodies like the FDA.
The entire context of the document points to a device used outside of the body to test a sample (bacteria) to inform clinical decisions, which is the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Thermo Scientific™ Oxoid™Antimicrobial Susceptibility Test (AST) Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.
The Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30 can be used to determine susceptibility to Meropenem/Vaborbactam against the following bacteria for which Meropenem/Vaborbactam has been shown to be active both clinically and in vitro:
Escherichia coli
Klebsiella pneumoniae
Enterobacter cloacae species complex
Product codes (comma separated list FDA assigned to the subject device)
JTN
Device Description
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30μg) MEV30 Antimicrobial Susceptibility Test Discs are 6mm. discs prepared by impregnating high quality absorbent paper with accurately determined amounts of Meropenem and Vaborbactam. The Disc is clearly marked on both sides with the code MEV30. The code designates the agent (Meropenem/Vaborbactam) and the drug content (30µg).
Oxoid discs are supplied in cartridges containing 50 discs each, there are 5 cartridges per pack. Each cartridge is individually sealed together with a desiccant capsule in a foil covered seethrough blister pack. Oxoid discs can be dispensed using an Oxoid Disc Dispenser.
Meropenem/Vaborbactam Disc (30μg) MEV30 Disc Content: Meropenem 20μg / Vaborbactam10μg.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
The Oxoid Meropenem/Vaborbactam disc (30 µg, MEV30) was compared with a cleared disk (predicate) of the same antimicrobial, mass and concentration. The study included 300 clinical and 75 challenge isolates.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the disc has been assessed through a comparative study with a predicate device (Hardy Meropenem Vaborbactam disk) on clinical and challenge isolates. The study also included QC and reproducibility studies. A summary of the results is detailed in section 20. The conclusion from the studies was that the disc performance was equivalent to the predicate device.
The Oxoid Meropenem/Vaborbactam disc (30 µg, MEV30) was compared with a cleared disk (predicate) of the same antimicrobial, mass and concentration. The study included 300 clinical and 75 challenge isolates. The category agreement (CA) with the predicate was as follows:
Organism(s): Enterobacteriaceae 1, 2, 3
Total: 375
CA (#): 372
CA (%): 99.2
1 Including indicated organisms K. pneumoniae (184), Escherichia coli (121), and Enterobacter cloacae spp. Complex (35).
2The safety and efficacy of meropenem/vaborbactam in treating clinical infections due to Gram-Negative organisms other than Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex may or may not have been established in adequate and well-controlled clinical significance of such susceptibility
3The performance of Oxoid Meropenem/Vaborbactam disk (30 ug) MEV30 is unknown for Enterobacteriaceae with the following resistance mechanisms: overexpression of efflux pumps and/or lower expression of porins.
Product performance is in accordance with the recommendations of the manufacturer of the antibiotic.
Limitations: The ability of the Oxoid Meropenem/vaborbactam disc to detect resistance in species other than K. pneumoniae is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing.
Quality Control testing was completed in accordance with CLSI Performance Standards For Antimicrobial Disc Susceptibility Tests; Approved Standard - Twelfth Edition M02-A12 and Performance Standards for Antimicrobial Susceptibility Testing M100 - S27.
Quality Control testing was completed each day susceptibility testing is performed or weekly if satisfactory performance can be documented according to the CLSI Standard.
Control Zone Diameter Limits (mm) for organisms recommended to be tested are:
Klebsiella pneumoniae ATCC BAA-1705*: 21-27
Klebsiella pneumoniae ATCC BAA-2814*: 16-20
Escherichia coli ATCC 25922: 31-37
Klebsiella pneumoniae ATCC 700603: 29-35
*KPC-producing K. pneumoniae included for the QC of vaborbactam activity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Category agreement (CA) with the predicate was 99.2% for Enterobacteriaceae.
Susceptibility Interpretive Criteria for Meropenem/Vaborbactam Disc (30μg):
Pathogen: Enterobacteriaceae
Disc Diffusion Zone Diameter (mm):
S: >=17
I: 14-16
R:
§ 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2018
Oxoid Limited (Part of Thermo Fisher Scientific) Philip Brame Regulatory Affairs Manager Wade Road Basingstoke, RG24 8PW Gb
Re: K181975
Trade/Device Name: Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30ug) MEV30 Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: Class II Product Code: JTN Dated: July 23, 2018 Received: July 24, 2018
Dear Philip Brame:
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K181975
Device Name
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30ug) MEV30
Indications for Use (Describe)
Thermo Scientific™ Oxoid™Antimicrobial Susceptibility Test (AST) Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.
The Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30 can be used to determine susceptibility to Meropenem/Vaborbactam against the following bacteria for which Meropenem/Vaborbactam has been shown to be active both clinically and in vitro:
Escherichia coli Klebsiella pneumoniae Enterobacter cloacae species complex
| 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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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30μg) MEV30 is provided below.
| Device Common Name: | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg)
MEV30 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg)
MEV30 |
| Applicant: | Oxoid Ltd |
| Contact: | Philip Brame
Regulatory Affairs Manager Oxoid Ltd.
Wade Road Basingstoke
Hampshire RG24 8PW
United Kingdom
+44 (0)1256 694279
phil.brame@thermofisher.com |
| Date Prepared: | 23-JULY-2018 |
| Regulation: | 21 CFR 866.1620 |
| Panel: | Microbiology |
| Product Code: | JTN |
Indications for Use:
Thermo Scientific Oxoid Antimicrobial Susceptibility Test (AST) Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.
The Thermo Scientific Oxoid Meropenem /Vaborbactam Disc (30u) MEV 30 can be used to determine susceptibility to Meropenem/Vaborbactam against the following bacteria for which Meropenem/Vaborbactam has been shown to be active both clinically and in vitro:
- Escherichia coli ●
- Klebsiella pneumoniae ●
- Enterobacter cloacae species complex. ●
4
Device Description:
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30μg) MEV30 Antimicrobial Susceptibility Test Discs are 6mm. discs prepared by impregnating high quality absorbent paper with accurately determined amounts of Meropenem and Vaborbactam. The Disc is clearly marked on both sides with the code MEV30. The code designates the agent (Meropenem/Vaborbactam) and the drug content
(30µg).
Oxoid discs are supplied in cartridges containing 50 discs each, there are 5 cartridges per pack. Each cartridge is individually sealed together with a desiccant capsule in a foil covered seethrough blister pack. Oxoid discs can be dispensed using an Oxoid Disc Dispenser.
Meropenem/Vaborbactam Disc (30μg) MEV30 Disc Content: Meropenem 20μg / Vaborbactam10μg.
Device Comparison:
| Table 5.1: Similarities and differences between proposed and predicate devices. | ||
|---|---|---|
| Similarities | Thermo Scientific Oxoid | |
| Meropenem/Vaborbactam | ||
| Disc (30µg) MEV30 | Predicate Device | |
| HardyDisk | ||
| Meropenem/Vaborbactam | ||
| 20/10 µg (MEV30) | ||
| K172621 | ||
| Intended Use | Oxoid Antimicrobial | |
| Susceptibility Test Discs | ||
| are used in the semi | ||
| quantitative agar diffusion | ||
| test method for in vitro | ||
| susceptibility testing. | Same | |
| Antimicrobial Agent(s) | Meropenem/Vaborbactam | Same |
| Antimicrobial Agent | ||
| Concentration | Meropenem | |
| 20µg/Vaborbactam 10µg | Same | |
| Test Method | Semi quantitative agar | |
| diffusion test method | ||
| using antimicrobial discs | ||
| impregnated with an | ||
| antimicrobial agent. | Same | |
| Result Interpretation Method | Measurement of zone size | Same |
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| | Thermo Scientific Oxoid
Meropenem/Vaborbactam
Disc (30µg) MEV30 | Predicate Device
HardyDisk
Meropenem/Vaborbactam
20/10 µg (MEV30)
K172621 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Interpretation | Require the user to
determine categorical
interpretations (S/I/R) using
the measured zone diameter
against CLSI approved
standards M02 and M100. | Same |
| Differences | | |
| Product Name | Oxoid
Meropenem/Vaborbactam
Disc (30µg) MEV30 | HardyDisk
Meropenem/Vaborbactam
20/10 µg (MEV30) |
Substantial Equivalence Conclusion:
Devices are substantially equivalent.
Performance Data:
The performance of the disc has been assessed through a comparative study with a predicate device (Hardy Meropenem Vaborbactam disk) on clinical and challenge isolates. The study also included QC and reproducibility studies. A summary of the results is detailed in section 20. The conclusion from the studies was that the disc performance was equivalent to the predicate device. A summary of the performance characteristics is presented here:
Performance Characteristics
The Oxoid Meropenem/Vaborbactam disc (30 µg, MEV30) was compared with a cleared disk (predicate) of the same antimicrobial, mass and concentration. The study included 300 clinical and 75 challenge isolates. The category agreement (CA) with the predicate was as follows:
| Organism(s) | Total | CA (#) | CA (%) |
|---|---|---|---|
| Enterobacteriaceae 1, 2, 3 | 375 | 372 | 99.2 |
1 Including indicated organisms K. pneumoniae (184), Escherichia coli (121), and Enterobacter cloacae spp. Complex (35).
2The safety and efficacy of meropenem/vaborbactam in treating clinical infections due to Gram-Negative organisms other than Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex may or may not have been established in adequate and well-controlled clinical significance of such susceptibility
6
information in those instances is unknown.
3The performance of Oxoid Meropenem/Vaborbactam disk (30 ug) MEV30 is unknown for Enterobacteriaceae with the following resistance mechanisms: overexpression of efflux pumps and/or lower expression of porins.
Product performance is in accordance with the recommendations of the manufacturer of the antibiotic.
Limitations
The ability of the Oxoid Meropenem/vaborbactam disc to detect resistance in species other than K. pneumoniae is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing.
| Table 5.2: Susceptibility Interpretive Criteria for Meropenem/Vaborbactam Disc (30μg) |
|---|
| Pathogen | Disc Diffusion Zone
Diameter (mm) | | |
|--------------------|--------------------------------------|-------|------------|
| | S | I | R |
| Enterobacteriaceae | $\u226517$ | 14-16 | $\u226413$ |
Abbreviations: S=Susceptible; I=intermediate; R=Resistant
Quality Control testing was completed in accordance with CLSI Performance Standards For Antimicrobial Disc Susceptibility Tests; Approved Standard - Twelfth Edition M02-A12 and Performance Standards for Antimicrobial Susceptibility Testing M100 - S27.
Quality Control testing was completed each day susceptibility testing is performed or weekly if satisfactory performance can be documented according to the CLSI Standard.
Control Zone Diameter Limits (mm) for organisms recommended to be tested are:
Table 5.3: Acceptable Quality Control Ranges for Meropenem/Vaborbactam Disc (30μg) Susceptibility Testing
| Quality Control Organism | Disc Diffusion Zone
Diameter (mm) |
|--------------------------------------|--------------------------------------|
| Klebsiella pneumoniae ATCC BAA-1705* | 21-27 |
| Klebsiella pneumoniae ATCC BAA-2814* | 16-20 |
| Escherichia coli ATCC 25922 | 31-37 |
| Klebsiella pneumoniae ATCC 700603 | 29-35 |
ATCC = American Type Culture Collection
*KPC-producing K. pneumoniae included for the QC of vaborbactam activity