(10 days)
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No
The device description and intended use describe a traditional, standardized agar diffusion method for antimicrobial susceptibility testing using pre-impregnated paper discs. There is no mention of any computational analysis, pattern recognition, or learning algorithms. The interpretation relies on comparing measured zone sizes to established, static standards.
No
The device is an in vitro diagnostic (IVD) product used to determine the susceptibility of bacteria to an antimicrobial agent, which helps guide the selection of appropriate therapy but does not directly provide therapy to a patient.
Yes
The device is used for "in vitro susceptibility testing" to determine the susceptibility of bacteria to Cefepime, which is a diagnostic purpose to aid in antimicrobial therapy decisions.
No
The device description clearly states it is a physical disc impregnated with a chemical, 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 device is 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 Cefepime." This is a diagnostic purpose, providing information about the characteristics of a biological sample (bacteria).
- Device Description: The description details how the device is used in a laboratory setting with biological samples (pure cultures of clinical isolates) and a test medium (Mueller Hinton Agar). The outcome of the test (zone of inhibition) is measured and interpreted to determine the susceptibility of the organism, which is a diagnostic result (susceptible, intermediate, or resistant).
- Regulatory Context: The document references FDA approval (NDA No. 50-679) and adherence to standards from organizations like the FDA, WHO, and NCCLS. These are all relevant to the regulation and standardization of IVDs.
- Predicate Device: The mention of "Other BBL® Sensi-Discs®" as predicate devices further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
The core function of the device is to perform a test on a biological sample outside of the body to provide information for diagnostic purposes (determining bacterial susceptibility to an antibiotic). This aligns perfectly with the definition of an In Vitro Diagnostic device.
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. Cefepime Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including Enterobacter spp, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae, and Streptococcus pyogenes (Lancefield's Group A streptococci), to Cefepime. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Bristol-Myers Squibb, and received FDA approval under NDA No. 50-679.
Use of BBL® Cefepime Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to cefepime.
Product codes
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Device Description
Cefepime Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Cefepime supplied by the manufacturer, Bristol-Myers Squibb Company, Princeton, New Jersey. Each Cefepime disc is clearly marked on both sides with the agent and content (FEP-30). Cefepime discs are furnished in cartridges of 50 discs each. Cefepime cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.
Agar diffusion methods emploving 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, GC II Agar with IsoVitaleX® Enrichment for N. gonorrhoeae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae] 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 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 Bristol-Myers Squibb Company product insert for MAXIPIME®, (Cefepime Hydrochloride) 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.
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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
APR - 5 % S
Date 3/25/96
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems P.O. Box 243 Cockevsville, MD 21030-0243
NAME OF DEVICE:
| Trade Name: | Cefepime Sensi-Discs
Catalog Numbers 31695, 31696 |
|--------------------------|------------------------------------------------------------|
| Common Name/Description: | Antimicrobial Susceptibility Test Discs |
| Classification Name: | Antimicrobial Susceptibility Test Discs |
| PREDICATE DEVICE: | Other BBL® Sensi-Discs® such as
Cefmetazole Sensi-Disc® |
DEVICE DESCRIPTION:
INTENDED USE:
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Cefepime Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including Enterobacter spp, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae, and Streptococcus pyogenes (Lancefield's Group A streptococci), to Cefepime. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Bristol-Myers Squibb, and received FDA approval under NDA No. 50-679.
1
INDICATIONS FOR USE:
Use of BBL® Cefepime Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to cefepime.
PRODUCT DESCRIPTION:
Cefepime Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Cefepime supplied by the manufacturer, Bristol-Myers Squibb Company, Princeton, New Jersey. Each Cefepime disc is clearly marked on both sides with the agent and content (FEP-30). Cefepime discs are furnished in cartridges of 50 discs each. Cefepime cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.
Agar diffusion methods emploving 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, GC II Agar with IsoVitaleX® Enrichment for N. gonorrhoeae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae] 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
2
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 Bristol-Myers Squibb Company product insert for MAXIPIME®, (Cefepime Hydrochloride) for Injection.