(35 days)
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No
The device description and intended use clearly describe a traditional, manual agar diffusion test method using impregnated paper disks. There is no mention of any computational analysis, image processing, or algorithmic interpretation that would suggest the use of AI or ML.
No
This device is an in vitro diagnostic (IVD) tool used for susceptibility testing of bacteria, not for treating patients.
Yes
The device is described as an "Antimicrobial Susceptibility Test Disks" used "for semi-quantitative in vitro susceptibility testing" and "determining the susceptibility to Doripenem of a wide range of bacteria." This indicates its function is to provide information for diagnosis and treatment planning by identifying how effective an antimicrobial is against a specific bacterial infection.
No
The device description explicitly states it is prepared by impregnating high-quality paper with Doripenem and is a physical disk used in an agar diffusion test method. This is a hardware component, not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The text explicitly states the device is used for "semi-quantitative in vitro susceptibility testing" and "for in vitro agar diffusion susceptibility testing". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details how the device is used in a laboratory setting with agar diffusion methods, which are standard techniques for in vitro diagnostic testing.
- Regulatory Context: The mention of FDA approval (NDA Number 22-106) and adherence to standardized procedures from organizations like the FDA, WHO, and CLSI (formerly NCCLS) further supports its classification as a regulated medical device used for diagnostic purposes.
- Predicate Device: The predicate device listed is "Other BBL™ Sensi-Disc™", which are also IVDs used for antimicrobial susceptibility testing.
Therefore, the Doripenem 10µg BBL™ Sensi-Disc™ is clearly intended for use outside of a living organism (in vitro) to provide diagnostic information about the susceptibility of bacteria to an antimicrobial agent.
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. Doripenem 10ug BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Doripenem 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 22-106.
Use of Doripenem 10µg BBL" Sensi-Disc" for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Doripenem. The concentration of 10ug has been shown to be active in viro 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 Streptococcus constellatus Streptococcus intermedius
Aerobic and facultative Gram-negative microorganisms Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
Active In Vitro Against:
Aerobic and facultative Gram-positive microorganisms Staphylococcus aureus - (methicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes
Aerobic and facultative Gram-negative microorganisms Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Serratia marcescens
Product codes
JTN
Device Description
Doripenem10µg BBL™ Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Doripenem supplied by the drug manufacturer. Each Doripenem disk is clearly marked on both sides with the agent and drug content. Doripenem 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. Doripenem 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Other BBL™ Sensi-Disc™
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
510(k) Submission
Image /page/0/Picture/1 description: The image shows the text "K080998" in a handwritten style. Below this, the text "Doripenem 10ug BBL_TM Sensi-Disc_TM" is printed in a clear font. The text appears to be related to a medical or scientific context, possibly indicating a drug name and its concentration.
510(k) SUMMARY
| SUBMITTED BY: | Becton Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Phone 410-316-4938
Fax: 410-316-4499 | MAY 12 2008 |
|------------------------|-----------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT NAME: | Janine Matlak, Regulatory Affairs Specialist | |
| DATE PREPARED: | April 4, 2008 | |
| DEVICE TRADE NAME: | Doripenem 10µg, 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. Doripenem 10ug BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Doripenem 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 22-106.
1
510(k) SUMMARY
Indications for Use:
Use of Doripenem 10µg BBL" Sensi-Disc" for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Doripenem. The concentration of 10ug has been shown to be active in viro 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 Streptococcus constellatus Streptococcus intermedius
Aerobic and facultative Gram-negative microorganisms Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
Active In Vitro Against:
Aerobic and facultative Gram-positive microorganisms Staphylococcus aureus - (methicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes
Aerobic and facultative Gram-negative microorganisms Citrobacter freundii
Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Serratia marcescens
2
DEVICE DESCRIPTION:
Doripenem10µg BBL™ Sensi-Disc" is prepared by impregnating high quality paper with accurately determined amounts of Doripenem supplied by the drug manufacturer. Each Doripenem disk is clearly marked on both sides with the agent and drug content. Doripenem 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. Doripenem 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 CLSINCCLS Document M100 ("Performance Standards for Antimicrobial Susceptibility Testing").
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DEVICE COMPARISON:
The BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks – Doripenem 10μg 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 - Doripenem 10ug differs from the BBL." Sensi-Disc " Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 ug in that:
- BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks Doripenem 10μg is a susceptibility test . that uses disks impregnated with the antimicrobic Doripenem at a concentration of 10ug 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 Doripenem 10 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 Doripenem drug package insert, "Susceptibility Test Methods: Diffusion Techniques" (Appendix l ).
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Image /page/4/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janine Matlak Regulatory Affairs Specialist BD Diagnostic System Benton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
MAY 12 2008
Re: K080998
Trade/Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk, Doripenem 10ug Regulation Number: 21 CFR § 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: II Product Code: JTN Dated: Received:
Dear Ms. Matlak:
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.
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).
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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attym
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
510(k) Number (K080998):
Device Name: BBL" Sensi-Disc" Antimicrobial Susceptibility Test Disks, Doripenem10ug
Indications for Use:
Use of Doripenem 10μg, BBL" Sensi-Disc" for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Doripenem. The concentration of 10ug 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 | Aerobic and facultative Gram-negative microorganisms |
|---|---|
| Streptococcus constellatus | Acinetobacter baumannii |
| Streptococcus intermedius | Escherichia coli |
| Klebsiella pneumoniae | |
| Proteus mirabilis | |
| Pseudomonas aeruginosa |
The safety and efficacy of doripenem in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials -
Active In Vitro Against: Aerobic and facultative Gram-positive microorganisms Staphylococcus aureus - (methicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes
Aerobic and facultative Gram-negative microorganisms Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii Serratia marcescens
Prescription Use V (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 L. Poole
DIISION.sgOff
ce of In Vitro Diagnostic Device on at Safety
SIN(2) K080998
Becton, Dickinson and Company