BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks

K152516 · Becton, Dickinson and Company · JTN · Oct 13, 2015 · Microbiology

Device Facts

• Record ID: K152516
• Device Name: BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks
• Applicant: Becton, Dickinson and Company
• Product Code: JTN · Microbiology
• Decision Date: Oct 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

Intended Use

Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20μ.g) is intended for use in determining the susceptibility to Ceftazidime avibactam of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 206494.

Device Story

Device consists of high-quality paper discs impregnated with Ceftazidime (30µg) and Avibactam (20µg). Used in clinical microbiology laboratories for semi-quantitative in vitro susceptibility testing via agar diffusion (Bauer-Kirby method). Discs are placed on Mueller Hinton Agar plates inoculated with pure bacterial cultures. Following incubation, healthcare professionals measure zones of inhibition surrounding the discs. Measured diameters are compared against established zone size ranges from FDA-approved drug inserts and CLSI/NCCLS standards (M2, M100) to categorize organisms as susceptible, intermediate, or resistant. Results assist clinicians in selecting appropriate antimicrobial therapy for patients with cIAI or cUTI, potentially improving treatment outcomes by identifying effective antibiotics.

Clinical Evidence

No clinical data. Performance characteristics rely on interpretive criteria and quality control ranges established by the drug manufacturer and evaluated by CDER during the drug approval process (NDA 206494).

Technological Characteristics

High-quality paper discs impregnated with Ceftazidime (30µg) and Avibactam (20µg). Principle: Agar diffusion (Bauer-Kirby method). Media: Mueller Hinton Agar (or specialized variants for specific organisms). Form factor: Cartridges of 50 discs. Manual test procedure; no electronic connectivity or software components.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing of bacteria to Ceftazidime avibactam in patients with complicated intra-abdominal infections (cIAI) or complicated urinary tract infections (cUTI) including pyelonephritis, caused by specified Gram-negative microorganisms.

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

• BD BBL™ Sensi-Disc™ Ciprofloxacin 5 µg

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 13, 2015

BECTON, DICKINSON AND COMPANY LAURA STEWART REGULATORY AFFAIRS SPECIALIST 7 LOVETON CIRCLE SPARKS MD 21152-0999

Re: K152516

Trade/Device Name: BD BBL Sensi-disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks

Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: II Product Code: JTN Dated: September 1, 2015 Received: September 3, 2015

Dear Ms. Stewart:

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Ribhi Shawar -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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

| 510(k) Number (if known) | K152516 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Device Name | BD BBL ^TM Sensi-Disc ^TM Ceftazidime avibactam (30/20µg), Antimicrobial Susceptibility Test Disks |
| Indications for Use (Describe) | |

Use of BD BBL^TM Sensi-Disc^TM Ceftazidime avibactam (30/20µg) for *in vitro* agar diffusion susceptibility testing is
indicated when there is a need to determine the susceptibility of bacteria to Ceftazidime avibactam. The concentration of
30/20µg has been shown to be active *in vitro* against most strains of microorganisms listed below, as described in the
FDA approved drug insert for this antimicrobic.

**Active In Vitro and in Clinical Infections Against:**

| Complicated Intra-abdominal Infections (cIAI)<br>Gram-negative Microorganisms | Complicated Urinary Tract Infections<br>(cUTI), including Pyelonephritis<br>Gram-negative Microorganisms |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Escherichia coli | Citrobacter freundii |
| Enterobacter cloacae | Citrobacter koseri |
| Klebsiella pneumoniae | Escherichia coli |
| Klebsiella oxytoca | <i>Pseudomonas aeruginosa</i> |
| Proteus mirabilis | Enterobacter aerogenes |
| Providencia stuartii | Enterobacter cloacae |
| Pseudomonas aeruginosa | Proteus spp. |
| | Klebsiella pneumoniae |

**Active In Vitro Against:**

| Gram-negative Microorganisms | |
|------------------------------|--|
| Morganella morganii | |
| Providencia rettgeri | |
| Serratia marcescens | |

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| <div><img alt="Checked" src="checkbox_checked.png"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><img alt="Unchecked" src="checkbox_unchecked.png"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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#### 510(k) SUMMARY

| SUBMITTED BY: | Becton, Dickinson and Company<br>7 Loveton Circle<br>Sparks, MD 21152<br>Phone [phone]<br>Fax: [phone] |
|------------------------|------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Laura Stewart, Regulatory Affairs Specialist |
| DATE PREPARED: | September 1, 2015 |
| DEVICE TRADE NAME: | BD BBL™ Sensi-Disc™ Ceftazidime avibactam<br>(30/20 µg), Antimicrobial Susceptibility Test Discs |
| DEVICE COMMON NAME: | Antimicrobial Susceptibility Test Discs |
| DEVICE CLASSIFICATION: | 21 CFR§866.1620, Class II (Product Code JTN),<br>Susceptibility Test Discs, Antimicrobial |
| PREDICATE DEVICE: | Other BD BBL™ Sensi-Disc™<br>(e.g., Ciprofloxacin 5 µg, BD BBL™ Sensi-Disc™) |

#### INTENDED USE:

Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20μ.g) is intended for use in determining the susceptibility to Ceftazidime avibactam of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 206494.

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# 510(k) SUMMARY

#### Indications for Use:

Use of BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20μg) for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftazidime avibactam. The concentration of 30/20wg has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.

#### Active In Vitro and in Clinical Infections Against:

Complicated Intra-abdominal Infections (clAI) Gram-negative Microorganisms Escherichia coli Enterobacter cloacae Klebsiella pneumoniae Klebsiella oxytoca Proteus mirabilis Providencia stuartii Pseudomonas aeruginosa

#### Complicated Urinary Tract Infections (cUTI), including Pyelonephritis Gram-negative Microorganisms Citrobacter freundii Citrobacter koseri

Escherichia coli Pseudomonas aeruginosa Enterobacter aerogenes Enterobacter cloacae Proteus spp. Klebsiella pneumoniae

# Active In Vitro Against:

# Gram-negative Microorqanisms

Morganella morganii Providencia rettgeri Serratia marcescens

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# DEVICE DESCRIPTION:

BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20ug), Antimicrobial Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Ceftazidime avibactam (30/20uq) supplied by the drug manufacturer. Each Ceftazidime avibactam (30/20ug) disc is clearly marked on both sides with the agent and drug content. Ceftazidime avibactam (30/20ug) cartridges each contain 50 impregnated discs that are packed as a single cartridge in a single box. Ceftazidime avibactam (30/20μq) discs are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing. Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.

Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.

#### DEVICE PRINCIPLE:

Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Aqar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus species] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the disks are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested with the antimicrobial agent is made by comparing zone diameters to those found in the respective organism tables of the FDA drug insert and/or CLS//NCCLS Document M2 ("Performance Standards for Antimicrobial Disk Susceptibility Tests") and of CLSI/NCCLS Document M100 ("Performance Standards for Antimicrobial Susceptibility Testing").

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# DEVICE COMPARISON:

The BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20ug) is similar to the BD BBL™ Sensi-Disc™ Ciprofloxacin, 5ug in that:

- . Both methods are for antimicrobial susceptibility testing using paper discs impregnated with an antimicrobial agent.
- Both methods have the same intended use.
- Both methods provide the user with antimicrobic minimum inhibitory concentration (MIC) results based on measurements of zone diameters.
- . Both methods require the user to determine categorical interpretations (S/I/R) using the measured zone diameters against CLSI/NCCLS Approved Standards M2 and M100.
- . Both methods use pure cultures of bacterial isolates.

The BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20ug) differs from the BD BBL™ Sensi-Disc™ Ciprofloxacin. 5ug in that:

- BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20μg) is a susceptibility test that . uses discs impregnated with the antimicrobics Ceftazidime at a concentration of 30ug and Avibactam at a concentration of 20ug while the BD BBL™ Sensi-Disc™ Ciprofloxacin, 5ug is a susceptibility test that uses discs impregnated with the antimicrobic Ciprofloxacin at a concentration of 5ug.
- BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20μg) is a susceptibility test . used to test a different battery of microorganisms than the BD BBL™ Sensi-Disc™ Ciprofloxacin, 5ug.

# SUBSTANTIAL EQUIVALENCE TESTING DATA:

See the Ceftazidime avibactam drug package insert, "Microbiology". Shelf life (stability data) for the drug is being collected and will be maintained on file at BD as indicated in the guidance document.