(14 days)
Not Found
No
The device description details a traditional agar diffusion susceptibility test method using impregnated paper disks, a technique developed in the 1940s. There is no mention of AI, ML, image processing, or any computational analysis of the results. The method relies on visual interpretation of inhibition zones.
No.
This device is an in vitro diagnostic (IVD) device used for susceptibility testing of bacteria to Telavancin, not for direct treatment or therapy in humans.
Yes
The device is used for in vitro agar diffusion susceptibility testing to determine the susceptibility of bacteria to Telavancin, which is a diagnostic purpose.
No
The device description clearly states it is a physical disk made of impregnated paper, which is a hardware component. The method described is a traditional agar diffusion test, not a software-based analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for in vitro agar diffusion susceptibility testing." This means the device is used to test biological samples (bacteria) outside of the body.
- Device Description: The description details how the device is used in a laboratory setting ("agar diffusion test method," "Mueller Hinton Agar," "standardized reference procedures").
- Regulatory Context: The description mentions adherence to standards from organizations like the FDA, WHO, and CLSI, which are relevant to IVD regulation.
- Predicate Device: The mention of a predicate device (BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg) further indicates that this device falls under the regulatory framework for IVDs.
The core function of the device is to determine the susceptibility of bacteria to an antimicrobial agent using a test performed in a laboratory setting, which is the definition of an in vitro diagnostic.
N/A
Intended Use / 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
Product codes
JTN
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").
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
1
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