(30 days)
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No
The device description details a traditional agar diffusion method for antimicrobial susceptibility testing using paper discs impregnated with an antibiotic. The interpretation relies on measuring zones of inhibition and comparing them to established standards, which is a manual or semi-automated process based on pre-defined thresholds, not AI/ML. There is no mention of AI, ML, or related technologies in the provided text.
No.
The device is used to determine the susceptibility of bacteria to an antimicrobial agent, but it does not directly treat or diagnose a condition in a patient. It is an in vitro diagnostic device used in a laboratory setting.
Yes
The device is used for "in vitro susceptibility testing" to determine "the susceptibility of bacteria to Meropenem," which directly aids in diagnosing and guiding treatment for bacterial infections by identifying effective antimicrobial agents. This falls under the definition of a diagnostic device as it provides information for medical diagnosis.
No
The device description clearly states it is a physical disc impregnated with a chemical agent, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the discs are used for "semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures." The term "in vitro" is a key indicator of an IVD. It also describes the purpose of the test: "determining the susceptibility of a wide range of gram-positive and gram-negative bacteria... to Meropenem." This is a diagnostic purpose, providing information about the bacteria's response to an antimicrobial agent.
- Device Description: The description details how the discs are used in a laboratory setting ("applied to the surface of Mueller Hinton Agar plates... inoculated with pure cultures of clinical isolates") to perform a test ("zones of inhibition surrounding the discs are measured and compared with established zone size ranges"). This process is characteristic of an in vitro diagnostic test.
- Regulatory References: The document mentions FDA approval (under NDA No. 50-706) and references standardized procedures from organizations like the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO), and the National Committee for Clinical Laboratory Standards (NCCLS). These are all relevant to the regulation and standardization of IVDs.
- Purpose of the Test: The ultimate goal of using these discs is to determine whether an organism is susceptible, intermediate, or resistant to Meropenem, which directly informs clinical decisions regarding antimicrobial therapy. This is a diagnostic outcome.
Therefore, based on the provided text, the Meropenem Susceptibility Test Discs are clearly intended for and used in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Meropenem Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including Streptococcus peuemoniae (excluding penicillin-resistant strains). Viridans group streptococci, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria meningitidis, Pseudomonas aeruginosa, Bacteroides fragilis, Bacteriodes thetaiotaomicron and peptostreptococcus species to Meropenem. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer. ZENECA Pharmaceuticals, and received FDA approval under NDA No. 50-706.
Use of BBL® Meropenem Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Meropenem.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Meropenem Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Meropenem supplied by the manufacturer, ZENECA Pharmaceuticals, Wilmington, Delaware, Each Meropenem disc is clearly marked on both sides with the agent and content. Meropenem discs are furnished in cartridges of 50 discs each. Meropenem cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.
Agar diffusion methods employing dried filter paper discs 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 National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A5 (12/93) and M100-S6 (12/95).
Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for H. influenzae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae1 inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs 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 determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A5 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Fifth Edition, Approved Standard", 12/93) and of NCCLS Document M100-S6 ("Performance Standards for Antimicrobial Susceptibility Testing", Sixth Informational Supplement, 12/95).
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)
See attached ZENECA Pharmaceuticals product insert section on Susceptibility testing Diffusion Techniques for Merrem® IV, (meropenem for Injection).
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.
Other BBL® Sensi-Discs® such as Imipenem, 10 mcg, Sensi-Disc®
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).
0
ATTACHMENT A
Date 9/23/96
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
Robert E. James, Director International Regulatory and Quality Development Becton Dickinson Microbiology Systems P.O. Box 243 Cockeysville, MD 21030-0243
NAME OF DEVICE:
| Trade Name: | Meropenem, 10 mcg, Sensi-Discs
Catalog Numbers 4331703, 4331704 |
|--------------------------|--------------------------------------------------------------------|
| Common Name/Description: | Antimicrobial Susceptibility Test Discs |
| Classification Name: | Antimicrobial Susceptibility Test Discs |
| EDICATE DEVICE: | Other BBL® Sensi-Discs® such as
Imipenem, 10 mcg, Sensi-Disc® |
DEVICE DESCRIPTION:
PRE
INTENDED USE:
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Meropenem Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including Streptococcus peuemoniae (excluding penicillin-resistant strains). Viridans group streptococci, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria meningitidis, Pseudomonas aeruginosa, Bacteroides fragilis, Bacteriodes thetaiotaomicron and peptostreptococcus species to Meropenem. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer. ZENECA Pharmaceuticals, and received FDA approval under NDA No. 50-706.
A-1
1
INDICATIONS FOR USE:
Use of BBL® Meropenem Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Meropenem.
PRODUCT DESCRIPTION:
Meropenem Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Meropenem supplied by the manufacturer, ZENECA Pharmaceuticals, Wilmington, Delaware, Each Meropenem disc is clearly marked on both sides with the agent and content. Meropenem discs are furnished in cartridges of 50 discs each. Meropenem cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.
Agar diffusion methods employing dried filter paper discs 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 National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A5 (12/93) and M100-S6 (12/95).
Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for H. influenzae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae1 inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs 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 determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is
A-2
2
made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A5 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Fifth Edition, Approved Standard", 12/93) and of NCCLS Document M100-S6 ("Performance Standards for Antimicrobial Susceptibility Testing", Sixth Informational Supplement, 12/95).
PERFORMANCE DATA:
See attached ZENECA Pharmaceuticals product insert section on Susceptibility testing Diffusion Techniques for Merrem® IV, (meropenem for Injection).