Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

K181975 · Oxoid Limited (Part of Thermo Fisher Scientific) · JTN · Sep 27, 2018 · Microbiology

Device Facts

• Record ID: K181975
• Device Name: Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
• Applicant: Oxoid Limited (Part of Thermo Fisher Scientific)
• Product Code: JTN · Microbiology
• Decision Date: Sep 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended 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 (30μg) MEV30 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 in vitro: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex

Device Story

Device consists of 6mm high-absorbent paper disks impregnated with 30µg Meropenem/Vaborbactam (MEV30). Used in clinical microbiology laboratories for semi-quantitative agar diffusion (Kirby-Bauer) testing. Operator inoculates agar medium with pure bacterial culture; places disk on surface. Antibiotic diffuses into agar; after incubation, user measures zone of inhibition diameter. Results compared against established interpretive criteria to categorize bacteria as susceptible, intermediate, or resistant. Output assists clinicians in selecting appropriate antimicrobial therapy for patients with infections caused by indicated Gram-negative bacteria.

Clinical Evidence

Bench testing only. Evaluated 375 isolates (300 clinical, 75 challenge) including E. coli, K. pneumoniae, and E. cloacae complex. Demonstrated 99.2% category agreement with predicate. Reproducibility study (270 data points) showed >95% agreement. QC performance >95% across multiple strains.

Technological Characteristics

6mm absorbent paper disks impregnated with 20µg Meropenem and 10µg Vaborbactam. Principle: agar diffusion. Manual reading of inhibition zones. Standardized per CLSI M02-A13 and M100-S28. No software or electronic components.

Indications for Use

Indicated for in vitro susceptibility testing of Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex using the semi-quantitative agar diffusion method.

Regulatory Classification

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.

Predicate Devices

• HardyDisk Meropenem/Vaborbactam 20/10 µg (MEV30) (K172621)

Submission Summary (Full Text)

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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

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803) 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 ([e-mail]) or phone [phone] 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)<br>MEV30 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg)<br>MEV30 |
| Applicant: | Oxoid Ltd |
| Contact: | Philip Brame<br>Regulatory Affairs Manager Oxoid Ltd.<br>Wade Road Basingstoke<br>Hampshire RG24 8PW<br>United Kingdom<br>[phone]<br>[e-mail] |
| 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. ●

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# 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<br>Meropenem/Vaborbactam<br>Disc (30µg) MEV30 | Predicate Device<br>HardyDisk<br>Meropenem/Vaborbactam<br>20/10 µg (MEV30)<br>K172621 |
| Intended Use | Oxoid Antimicrobial<br>Susceptibility Test Discs<br>are used in the semi<br>quantitative agar diffusion<br>test method for in vitro<br>susceptibility testing. | Same |
| Antimicrobial Agent(s) | Meropenem/Vaborbactam | Same |
| Antimicrobial Agent<br>Concentration | Meropenem<br>20µg/Vaborbactam 10µg | Same |
| Test Method | Semi quantitative agar<br>diffusion test method<br>using antimicrobial discs<br>impregnated with an<br>antimicrobial agent. | Same |
| Result Interpretation Method | Measurement of zone size | Same |

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| | Thermo Scientific Oxoid<br>Meropenem/Vaborbactam<br>Disc (30µg) MEV30 | Predicate Device<br>HardyDisk<br>Meropenem/Vaborbactam<br>20/10 µg (MEV30)<br>K172621 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Interpretation | Require the user to<br>determine categorical<br>interpretations (S/I/R) using<br>the measured zone diameter<br>against CLSI approved<br>standards M02 and M100. | Same |
| Differences | | |
| Product Name | Oxoid<br>Meropenem/Vaborbactam<br>Disc (30µg) MEV30 | HardyDisk<br>Meropenem/Vaborbactam<br>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

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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<br>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<br>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