(37 days)
Other BBL™ Sensi-Disc™ (eg, Ciprofloxacin 5 µg, BBL™ Sensi-Disc™)
Not Found
No
The device is a physical disk impregnated with an antimicrobial agent used in a standardized laboratory procedure (agar diffusion test). The description focuses on the physical properties of the disk and the historical development of the testing method, with no mention of computational analysis, algorithms, or machine learning.
No
This device is an in vitro diagnostic (IVD) device used for laboratory testing to determine the susceptibility of bacteria to an antimicrobial agent. It is not applied directly to a patient for treatment or prevention of disease.
Yes
The device, Tigecycline 15µg BBL™ Sensi-Disc™, is used for "semi-quantitative in vitro susceptibility testing" to "determine the susceptibility to Tigecycline of a wide range of bacteria." This process identifies how effective an antimicrobial agent is against specific microorganisms, which is a diagnostic purpose to inform treatment decisions.
No
The device is a physical disk impregnated with an antimicrobial agent, used in a laboratory procedure. It is not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Explicitly states "semi-quantitative in vitro susceptibility testing" and "for in vitro agar diffusion susceptibility testing".
- Device Description: Describes the device as "used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method."
- Overall Function: The device is used to test the susceptibility of bacteria to an antimicrobial agent outside of the human body, which is the core definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Tigecycline 15µg BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Tigecycline 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 21-821.
Use of Tigecycline 15µg BBL" Sensi-Disc "for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Tigecycline. The concentration of 15ug 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:
Aerobic facultative Gram-positive microorganisms
Enterococcus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus -(methicillin susceptible and resistant isolates only) Streptococcus agalactiae Streptococcus anginosus grp. -(includes S. anginosus, S. intermedius, and S. constellatus Streptococcus pyogenes
Active In Vitro Against:
Aerobic and facultative Gram-positive microorganisms
Enterococcus avium Enterococcus casseliflavus Enterococcus faecalis (vancomycin-resistant isolates) Enterococcus faecium-(vancomycin-susceptible and -resistant isolates) Enterococcus gallinarum Listeria monocytogenes Stapvlococcus epidermidis -(methicillin-susceptible and -resistant isolates) Stapylococcus haemolyticus
Aerobic and facultativeGram-negative microorganisms
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
Aerobic and facultative Gram-negative microorganisms
Acinetobacter baumannii Aeromonas hydrophila Citrobacter koseri Enterobacter aerogenes Pasteurella multocida Serratia marcescens Stenotrophomonas maltophilia
Product codes (comma separated list FDA assigned to the subject device)
JTN
Device Description
Tigecycline15ug BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Tigecycline supplied by the drug manufacturer. Each Tigecycline disk is clearly marked on both sides with the agent and drug content. Tigecycline 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. Tigecycline 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
See the Tigecycline drug package insert, "Susceptibility Tests: Diffusion Techniques" (Appendix 1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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-Disc™ (eg, Ciprofloxacin 5 µg, BBL™ 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.
Not Found
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).
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
510(k) Submission
Tigecycline 15ug BBL T4 Sensi-Disc
NOV 1 7 2005
510(k) SUMMARY
| SUBMITTED BY: | Becton Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Phone 410-316-4905
Fax: 410-316-4499 |
|------------------------|-----------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Dainelle N. Clark, Regulatory Affairs Specialist |
| DATE PREPARED: | October 10, 2005 |
| DEVICE TRADE NAME: | Tigecycline 15µg, BBL™ Sensi-Disc™ Antimicrobial
Susceptibility Test Disks |
| DEVICE COMMON NAME: | Antimicrobial Susceptibility Test Disks |
| DEVICE CLASSIFICATION: | 21 CFR§866.1620, Class II (Product Code JTN), Susceptibility
Test Disks, Antimicrobial |
| PREDICATE DEVICE: | Other BBL™ Sensi-Disc™
(eg, Ciprofloxacin 5 µg, BBL™ Sensi-Disc™) |
INTENDED USE:
Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Tigecycline 15ug BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Tigecycline 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 21-821.
1
510(k) SUMMARY
Indications for Use:
Use of Tigecycline 15µg BBL" Sensi-Disc "for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Tigecycline. The concentration of 15ug 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:
Aerobic facultative Gram-positive microorganisms
Enterococcus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus -(methicillin susceptible and resistant isolates only) Streptococcus agalactiae Streptococcus anginosus grp. -(includes S. anginosus, S. intermedius, and S. constellatus Streptococcus pyogenes
Active In Vitro Against:
Aerobic and facultative Gram-positive microorganisms
Enterococcus avium Enterococcus casseliflavus Enterococcus faecalis (vancomycin-resistant isolates) Enterococcus faecium-(vancomycin-susceptible and -resistant isolates) Enterococcus gallinarum Listeria monocytogenes Stapvlococcus epidermidis -(methicillin-susceptible and -resistant isolates) Stapylococcus haemolyticus
Aerobic and facultativeGram-negative microorganisms
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
Aerobic and facultative Gram-negative microorganisms
Acinetobacter baumannii Aeromonas hydrophila Citrobacter koseri Enterobacter aerogenes Pasteurella multocida Serratia marcescens Stenotrophomonas maltophilia
2
DEVICE DESCRIPTION:
Tigecycline15ug BBL" Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Tigecycline supplied by the drug manufacturer. Each Tigecycline disk is clearly marked on both sides with the agent and drug content. Tigecycline 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. Tigecycline 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 [or Haemophilus 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 [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 CLSVNCCLS Document M2 ("Performance Standards for Antimicrobial Disk Susceptibility Tests) and of CLSI/NCCLS Document M100 ("Performance Standards for Antimicrobial Susceptibility Testing").
3
DEVICE COMPARISON:
The BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disks - Tigercycline15ug is similar to the BBL Sensi-Disc " Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 ug 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 - Tigecycline 15ug differs from the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:
- BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks Tigecycline 15μg is a susceptibility test . that uses disks impregnated with the antimicrobic Tigecycline at a concentration of 15ug 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 ug.
- BBL " Sensi-Disc" Antimicrobial Susceptibility Test Disk Tigecycline 15 µg is a susceptibility test . used to test a different battery of microorganisms than the BBL" Sensi-Disc " Antimicrobial Susceptibility Test Disk - Ciprofloxacin 5 ug.
SUBSTANTIAL EQUIVALENCE TESTING DATA:
See the Tigecycline drug package insert, "Susceptibility Tests: Diffusion Techniques" (Appendix 1).
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with three stylized wing or feather shapes.
NOV 1 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Dainelle N. Clark Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K052853 Re: Trade/Device Name: BBL™ Sensi-Disc ™ Antimicrobial Susceptibility Test Disks, Tigecycline 15 µg Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II Product Code: JTN Dated: October 10, 2005 Received: October 11, 2005
Dear Ms. Clark:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 –
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Sally, a Hogg
Sally A. Hojvat, 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
6
INDICATIONS FOR USE
K052853 510(k) Number (if known):
Device Name: BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks, Tigecycline I Sug
Indications for Use:
Use of Tigecycline 15ug, BBL" Sensi-Disc" for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Tigecycline. The concentration of 15ug 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:
Aerobic facultative Gram-positive microorganisms
Enterococcus faecalis (vancomycin-susceptible isolates only) Staphylococcus aureus -(methicillin susceptible and resistant isolates only) Streptococcus agalactiae Streptococcus anginosus grp. -(includes S. anginosus, S. intermedius, and S. constellatus Streptococcus pyogenes
Active In Vitro Against:
Aerobic and facultative Gram-positive microorganisms
Enterococcus avium Enterococcus casseliflavus Enterococcus faecalis (vancomycin-resistant isolates) Enterococcus faecium-(vancomycin-susceptible and -resistant isolates) Enterococcus gallinarum Listeria monocytogenes Stapvlococcus epidermidis -(methicillin-susceptible and -resistant isolates) Stapylococcus haemolyticus
Aerobic and facultativeGram-negative microorganisms Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
Aerobic and facultative Gram-negative microorganisms Acinetobacter baumannii Aeromonas hydrophila Citrobacter koseri Enterobacter aerogenes
Pasteurella multocida Serratia marcescens Stenotrophomonas maltophilia
Prescription Use (Per 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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)
Freddi tu. Poole
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
3510(k) KD5.2853
Becton, Dickinson and Company