(14 days)
Use of Telavancin 30µg BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Telavancin. The concentration of 30ug 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:
Facultative Gram-positive Microorganisms Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pvogenes Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius and S. constellatus)
Active In Vitro Against:
Facultative Gram-positive Microorganisms
Enterococcus faecium (vancomycin-susceptible isolates only) Staphylococcus haemolyticus Streptococcus dysgalactaie subsp. equisimilis Staphylococcus epidermidis
Telavancin30µg BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Telavancin supplied by the drug manufacturer. Each Telavancin disk is clearly marked on both sides with the agent and drug content. Telavancin cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Telavancin disks 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.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details based on the information given.
It's important to note that the provided text is a 510(k) summary, which often refers to predicate devices and previously established methods rather than detailing a new, comprehensive study within the document itself. The information about the study proving the device meets acceptance criteria is largely indirect or refers to external documents.
Acceptance Criteria and Device Performance for Telavancin 30µg BBL™ Sensi-Disc™
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Telavancin 30µg BBL™ Sensi-Disc™ are not explicitly stated as numerical targets within this document. Instead, the criteria are implied by adherence to established clinical and laboratory standards for antimicrobial susceptibility testing, specifically those published by the Clinical and Laboratory Standards Institute (CLSI) (formerly NCCLS). The performance is linked to the correlation of zone diameters with minimum inhibitory concentrations (MICs) and agreement with categorical interpretations (Susceptible [S], Intermediate [I], Resistant [R]).
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from Text) |
|---|---|
| Correlation with MIC values: Implied by comparison of zone diameters to established ranges in CLSI/NCCLS documents M2 and M100 to determine categorical interpretations (S/I/R). This ensures the disk test accurately reflects the organism's susceptibility. | The device provides "antimicrobic minimum inhibitory concentration (MIC) results based on measurements of zone diameters." The user determines categorical interpretations by comparing zone diameters to CLSI/NCCLS Approved Standards M2 and M100. |
| Reproducibility and Reliability: The method aims to eliminate or minimize variability in testing, as per the Bauer-Kirby method and subsequent standardized procedures. | The disk is prepared by "impregnating high quality paper with accurately determined amounts of Telavancin." The method follows "standardized reference procedures based on the Bauer-Kirby method," adopted by CLSI and "periodically updated." |
| Clinical Relevance/Antimicrobial Activity: To correctly identify organisms susceptible to Telavancin. | "The concentration of 30µg has been shown to be active in vitro against most strains of microorganisms listed," as described in the FDA approved drug insert for Telavancin. Specific microorganisms are listed as "Active In Vitro and in Clinical Infections Against" and "Active In Vitro Against." |
| Substantial Equivalence: The device should be similar enough to a predicate device in intended use, technology, and performance to ensure safety and effectiveness. | The device is deemed "substantially equivalent" to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in its method for susceptibility testing, intended use, providing MIC results based on zone diameters, requiring CLSI/NCCLS standards for interpretation, and using pure bacterial cultures. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to the Telavancin drug package insert, "Microbiology" for "SUBSTANTIAL EQUIVALENCE TESTING DATA." This indicates that the primary data supporting the device's performance, including any test set sample sizes, would be found in that external document. The 510(k) summary itself does not provide these details.
Therefore, the specific sample size, country of origin of the data, and whether it was retrospective or prospective cannot be determined from the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. Given that the testing refers to CLSI/NCCLS standards and the drug package insert, it's highly likely that ground truth would be established through reference methods overseen by qualified microbiologists or clinical laboratory professionals, but the specifics are not detailed here.
4. Adjudication Method for the Test Set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" is implicitly established by comparing the zone diameters to the "established zone size ranges for individual antimicrobial agents" found in CLSI/NCCLS documents M2 and M100. This is a direct comparison against a standard, rather than a consensus among multiple human reviewers for each case.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study, as typically understood for AI-assisted diagnostics comparing human performance with and without AI, was not done or reported in this document. This device is a measurement tool (an antimicrobial susceptibility disk) and not an AI algorithm designed to assist human readers in interpretation. Its performance is validated against established microbiological methods and standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of this device. The Telavancin 30µg BBL™ Sensi-Disc™ is a physical diagnostic tool for in vitro antimicrobial susceptibility testing, not an algorithm. Its "standalone" performance is measured by its ability to produce accurate zone diameters that correlate with MICs and subsequently lead to correct categorical interpretations when compared against established standards (CLSI/NCCLS). The output (zone diameter measurement and subsequent interpretation) requires human involvement to measure the zone and compare it to the CLSI tables, but the device itself is not an "algorithm" as typically defined in AI contexts.
7. The Type of Ground Truth Used
The ground truth used is primarily based on expert consensus embodied in standardized reference procedures and documents. Specifically:
- CLSI/NCCLS Documents M2 and M100: These documents provide the "established zone size ranges" and corresponding "categorical interpretation [S], intermediate (I), or resistant (R)" for various antimicrobial agents and organisms. This represents a consensus of expert microbiologists and clinicians.
- FDA Approved Drug Insert for Telavancin: This document describes in vitro activity and clinical efficacy against specific microorganisms, contributing to the overall understanding of Telavancin's effectiveness and thus informing the expected susceptibility patterns.
8. The Sample Size for the Training Set
The document does not provide details about a "training set" in the context of machine learning. For traditional in vitro diagnostic devices like this, development and validation involve testing against a diverse set of clinically relevant bacterial isolates to establish expected zone diameter ranges and correlations with MICs. The sample sizes for this development work would be extensive but are not specified here. The "SUBSTANTIAL EQUIVALENCE TESTING DATA" references the Telavancin drug package insert, which would contain relevant studies used to establish its microbiological activity.
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, the concept of a "training set" and its ground truth establishment, as typically understood in AI, is not directly applicable to this device. For traditional antimicrobial susceptibility test development, the "ground truth" (e.g., MIC values obtained via broth microdilution or agar dilution) would be established using reference methods (e.g., broth microdilution susceptibility testing) as defined by regulatory bodies and standards organizations like CLSI. These reference methods are considered the gold standard for determining the true susceptibility phenotype of an organism. The disk diffusion method is then correlated with these reference methods to establish interpretive criteria (zone diameter breakpoints).
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KC/00722
510(k) Submission Telavancin 30µg BBLTM Sensi-DiscTM CONFIDENTIAL AND PROPRIETARY
MAR 2 9 2010
510(k) SUMMARY
Indications for Use:
Use of Telavancin 30µg BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Telavancin. The concentration of 30ug 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:
Facultative Gram-positive Microorganisms Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pvogenes Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius and S. constellatus)
Active In Vitro Against:
Facultative Gram-positive Microorganisms
Enterococcus faecium (vancomycin-susceptible isolates only) Staphylococcus haemolyticus Streptococcus dysgalactaie subsp. equisimilis Staphylococcus epidermidis
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DEVICE DESCRIPTION:
Telavancin30µg BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Telavancin supplied by the drug manufacturer. Each Telavancin disk is clearly marked on both sides with the agent and drug content. Telavancin cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Telavancin disks 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:
Disks containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Hacmophilus Test Medium Agar 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 [S], intermediate (1), 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 CLSVNCCLS 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 BBL " Schsi-Disc" Antimicrobial Susccptibility Test Disks - Telavancin 30μg is similar to the BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:
- Both methods are for antimicrobial susceptibility testing using paper disks 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 BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Telavancin 30pg differs from the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:
- BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks Telavancin 30μg is a susceptibility test . that uses disks impregnated with the antimicrobic Telavancin at a concentration of 30μg while the BBL™ Sensi-Disc" Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg is a susceptibility test that uses disks impregnated with the antimicrobic Ciprofloxacin at a concentration of 5 µg.
- BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disk Telavancin 30 µg is a susceptibility test . used to test a different battery of microorganisms than the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk - Ciprofloxacin 5 µg.
SUBSTANTIAL EQUIVALENCE TESTING DATA:
See the Telavancin drug package insert, "Microbiology".
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Ms. Janine Matlak Spafford Becton Dickinson and Company 7 Loveton Circle. MC 614 Sparks, MD 21152
Re: K100722
Trade/Device Name: BBLTMSensi-DiscTM Telavancin 30ug Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: March 12, 2010 Received: March 15, 2010
Dear Ms. Spafford:
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
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(21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Vay artan
y A. Heivat, M.Sc., Ph.D.
Sally A. Hoivat, M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Submission Telavancin 30ug BBLTM Sensi-DiscTM
INDICATIONS FOR USE
510(k) Number (if known): K j 0 0 7 2 2
Device Name: BBL™ Sensi-Disc" Antimicrobial Susceptibility Test Disks, Telayancin30ug
Indications for Use:
Use of Telavancin 30ug, BBL" Scisi-Disc" for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Telayancin. The concentration of 30µg 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:
Facultative Gram-positive Microorganisms Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis (vancomycin-susceptible isolates only) Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius and S. constellatus)
Active In Vitro Against:
Facultative Gram-positive Microorganisms Enterococcus faecium (vancomycin-susceptible isolates only) Staphylococcus haemolyticus Streptococcus dvsgalactaie subsp. equisimilis Staphylococcus epidermidis
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie Lee Parks
frice of In Vita Diagnostic Device ivaluation and Safety
510(k) / K100727
Becton, Dickinson and Company
§ 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).