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 30/20µg 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.

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.

AI/ML Overview

The provided text describes the BD BBL™ Sensi-Disc™ Ceftazidime avibactam (30/20ug), Antimicrobial Susceptibility Test Discs. However, it does not contain specific acceptance criteria, detailed study results, or information regarding the sample size for testing, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for the training set.

The document primarily focuses on the device's intended use, its comparison to a predicate device, and the general principle of antimicrobial susceptibility testing using agar diffusion. It explicitly states: "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." This indicates that the detailed performance data, including acceptance criteria and study results, would be found in the drug package insert, which is not provided in the given text.

Therefore, I cannot provide a complete answer with all the requested information based solely on the provided text. I can only extract what is present.

Information Extracted from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided text. The document refers to "established zone size ranges for individual antimicrobial agents" and "respective organism tables of the FDA drug insert and/or CLSI/NCCLS Document M2 ('Performance Standards for Antimicrobial Disk Susceptibility Tests') and of CLSI/NCCLS Document M100 ('Performance Standards for Antimicrobial Susceptibility Testing')." These external documents would contain the specific acceptance criteria (zone diameter ranges for Susceptible, Intermediate, Resistant categories).
Reported Device Performance: Not explicitly stated in the provided text. The document mentions "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." The actual performance data (e.g., categorical agreement, essential agreement, or specific zone diameter values for tested strains) is not included here.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified in the provided text.

4. Adjudication method for the test set:

Not specified in the provided text.

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:

Not applicable/Not mentioned. This device is an antimicrobial susceptibility test disk, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not mentioned. This device is a manual disc diffusion test that requires human interpretation of zone diameters.

7. The type of ground truth used:

The document implies that the ground truth for establishing zone interpretations would be derived from the "FDA approved drug insert for this antimicrobic" and "CLSI/NCCLS Document M2" and "CLSI/NCCLS Document M100," which set the clinical breakpoints or interpretative categories (Susceptible, Intermediate, Resistant). These are typically established based on extensive microbiological data, pharmacokinetic/pharmacodynamic studies, and clinical outcomes data related to the antimicrobial agent.

8. The sample size for the training set:

Not applicable/Not mentioned. This is not a machine learning or AI device that typically uses a training set in that context.

9. How the ground truth for the training set was established:

Not applicable/Not mentioned for the same reason as above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three human profiles forming the body of the symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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.

{1}------------------------------------------------

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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 BBLTM Sensi-DiscTM 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)Gram-negative Microorganisms	Complicated Urinary Tract Infections(cUTI), including PyelonephritisGram-negative Microorganisms
Escherichia coli	Citrobacter freundii
Enterobacter cloacae	Citrobacter koseri
Klebsiella pneumoniae	Escherichia coli
Klebsiella oxytoca	Pseudomonas aeruginosa
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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
----------------------	-------------

PSC Publishing Services (301) 443-6740 EF

ය

{3}------------------------------------------------

510(k) SUMMARY

SUBMITTED BY:	Becton, Dickinson and Company7 Loveton CircleSparks, MD 21152Phone 410-316-4435Fax: 410-316-4188
CONTACT NAME:	Laura Stewart, Regulatory Affairs Specialist
DATE PREPARED:	September 1, 2015
DEVICE TRADE NAME:	BD BBL™ Sensi-Disc™ Ceftazidime avibactam(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),Susceptibility Test Discs, Antimicrobial
PREDICATE DEVICE:	Other BD BBL™ Sensi-Disc™(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.

{4}------------------------------------------------

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

{5}------------------------------------------------

DEVICE DESCRIPTION:

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").

{6}------------------------------------------------

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.

Regulation Number and Section

§ 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).