K Number
K980683
Device Name
TROVAFLOXACIN 10G, SENSI-DISC
Date Cleared
1998-05-01

(67 days)

Product Code
Regulation Number
866.1620
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use of BBL Trovafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Trovafloxacin has been shown to be active against most strains of microorganisms listed below, as described in the Roerig package insert for this antimicrobic.
Device Description
Trovafloxacin Susceptibility Test Discs are prepared by impregnating high guality paper with accurately determined amounts of Trovafloxacin supplied by the manufacturer, Roerig. Each Trovafloxacin disc is clearly marked on both sides with the agent and content. Trovafloxacin discs are furnished in cartridges of 50 discs each. Trovafloxacin cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. 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-A6 (1/97) and M100-S7 (1/97). Discs 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 Aqar with 5% Sheep Blood for Streptococcus 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 respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S8 ("Performance Standards for Antimicrobial Susceptibility Testing", Eighth Informational Supplement, 1/98).
More Information

Not Found

Not Found

No
The device description details a traditional agar diffusion susceptibility testing method using impregnated paper discs and manual zone size measurement compared to established standards. There is no mention of automated analysis, image processing, or any computational methods that would suggest the use of AI or ML.

No
This device is for in vitro diagnostic susceptibility testing of bacteria, not for treating patients.

Yes

The device is used for in vitro agar diffusion susceptibility testing to determine the susceptibility of bacteria to Trovafloxacin, which is a diagnostic purpose to inform antimicrobial therapy.

No

The device description clearly describes physical components (paper discs, cartridges, boxes) and a physical testing method (agar diffusion). There is no mention of software as the primary or sole component of the device.

Based on the provided text, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states the use of the discs for "in vitro agar diffusion susceptibility testing" to determine the susceptibility of bacteria to Trovafloxacin. This is a classic definition of an in vitro diagnostic test.
  • Device Description: The description details a method (agar diffusion) that is performed outside of the body (in vitro) using a sample (bacterial culture) to provide information about a patient's condition (bacterial susceptibility to an antibiotic).
  • Regulatory References: The text mentions adherence to standards from organizations like the FDA, WHO, and NCCLS, which are heavily involved in regulating IVD devices.
  • Purpose: The ultimate goal is to determine which antimicrobial agent is "most suitable for use in antimicrobial therapy," directly impacting patient treatment decisions based on the in vitro test results.

The device is used to test a sample (bacteria) outside of the body to provide information that aids in diagnosing or treating a condition (bacterial infection). 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. Trovafloxacin Sensi-Discs® are intended for use in determining the susceptibility to Trovafloxacin of a wide range of bacteria, as described under Indications For Use below. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Roerig, a Division of Pfizer Inc., and received FDA approval under NDA Nos. 20-759 and 20-760.

Use of BBL® Trovafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Trovafloxacin. Trovafloxacin has been shown to be active against most strains of microorganisms listed below, as described in the Roerig package insert for this antimicrobic.

Active In Vitro and In Clinical Infections Against:

Aerobic Gram-Positive Microorganisms
Enterococcus faecalis (many strains are only moderately susceptible Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus pyogenes Viridans group streptococci Aerobic Gram-Negative Microorganisms Escherichia coli Gardnerella vaginalis Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Neisseria gonorrhoeae Proteus mirabilis Pseudomonas aeruginosa Anaerobic Microorganisms Bacteroides fragilis Peptostreptococcus species Prevotella species Other Microorganisms: Chlamydia pneumoniae Chlamvdia trachomatis Legionella pneumophila Mycoplasma pneumoniae

Active In Vitro Only Aqainst:

Aerobic Gram-Positive Microorganisms Streptococcus pneumoniae (penicillin-resistant strains) Aerobic Gram-Negative Microorganisms Citrobacter freundii Enterobacter aerogenes Morganella morganii Proteus vulgaris Anaerobic Microorganisms Bacteroides distasonis Bacteroides ovatus Clostridium perfringens
Other Microorganisms: Mvcoplasma hominis Ureaplasma urealyticum

Product codes (comma separated list FDA assigned to the subject device)

JTN

Device Description

Trovafloxacin Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Trovafloxacin supplied by the manufacturer, Roerig. Each Trovafloxacin disc is clearly marked on both sides with the agent and content. Trovafloxacin discs are furnished in cartridges of 50 discs each. Trovafloxacin cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.

Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. 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-A6 (1/97) and M100-S7 (1/97).

Discs 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 Aqar with 5% Sheep Blood for Streptococcus 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 respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S8 ("Performance Standards for Antimicrobial Susceptibility Testing", Eighth Informational Supplement, 1/98).

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 attached Roerig product insert section on Susceptibility Tests - Diffusion Techniques for TROVAN™ Tablets (trovafloxacin mesylate tablets) and TROVAN™ I.V. (alatrofloxacin mesylate injection) for intravenous infusion.

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.

Not Found

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

K980683

1 MAY

Date 2/20/98

SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTED BY:

Virginia C. Weinknecht Requlatory Affairs Specialist Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, MD 21152-0999

NAME OF DEVICE:

Trade Name:Trovafloxacin, 10 µg, Sensi-Discs Catalog Numbers 4331715 and 4331716
Common Name/Description:Antimicrobial Susceptibility Test Discs
Classification Name:Antimicrobial Susceptibility Test Discs
INDICATE DEVICE:Other BBL® Sensi-Discs® such as Ciprofloxacin, 5 mcg, Sensi-Disc®

DEVICE DESCRIPTION:

PRE

INTENDED USE:

Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Trovafloxacin Sensi-Discs® are intended for use in determining the susceptibility to Trovafloxacin of a wide range of bacteria, as described under Indications For Use below. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Roerig, a Division of Pfizer Inc., and received FDA approval under NDA Nos. 20-759 and 20-760.

INDICATIONS FOR USE:

Use of BBL® Trovafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Trovafloxacin. Trovafloxacin has been shown to

1

be active against most strains of microorganisms listed below, as described in the Roerig package insert for this antimicrobic.

Active In Vitro and In Clinical Infections Against:

Aerobic Gram-Positive Microorganisms Enterococcus faecalis (many strains are only moderately susceptible Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus pyogenes Viridans group streptococci Aerobic Gram-Negative Microorganisms Escherichia coli Gardnerella vaginalis Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Neisseria gonorrhoeae Proteus mirabilis Pseudomonas aeruginosa Anaerobic Microorganisms Bacteroides fragilis Peptostreptococcus species Prevotella species Other Microorganisms: Chlamydia pneumoniae Chlamvdia trachomatis Legionella pneumophila Mycoplasma pneumoniae

Active In Vitro Only Aqainst:

Aerobic Gram-Positive Microorganisms Streptococcus pneumoniae (penicillin-resistant strains) Aerobic Gram-Negative Microorganisms Citrobacter freundii Enterobacter aerogenes Morganella morganii Proteus vulgaris Anaerobic Microorganisms Bacteroides distasonis Bacteroides ovatus Clostridium perfringens

2

Active In Vitro Only Against (continued): Other Microorganisms: Mvcoplasma hominis Ureaplasma urealyticum

PRODUCT DESCRIPTION:

Trovafloxacin Susceptibility Test Discs are prepared by impregnating high guality paper with accurately determined amounts of Trovafloxacin supplied by the manufacturer, Roerig. Each Trovafloxacin disc is clearly marked on both sides with the agent and content. Trovafloxacin discs are furnished in cartridges of 50 discs each. Trovafloxacin cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.

Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. 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-A6 (1/97) and M100-S7 (1/97).

Discs 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 Aqar with 5% Sheep Blood for Streptococcus 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 respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S8

3

("Performance Standards for Antimicrobial Susceptibility Testing", Eighth Informational Supplement, 1/98).

PERFORMANCE DATA:

See attached Roerig product insert section on Susceptibility Tests - Diffusion Techniques for TROVAN™ Tablets (trovafloxacin mesylate tablets) and TROVAN™ I.V. (alatrofloxacin mesylate injection) for intravenous infusion.

4

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 1998

1998

Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, Maryland 21152-0999

Re: K980683 Trade Name: Trovafloxacin 10μg, Sensi-Disc® Regulatory Class: II Product Code: JTN Dated: February 20, 1998 Received: February 23, 1998

Dear Ms. Weinknecht:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

5

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

Page 1 of 2 510(k) Number (if known):

Device Name: Trovafloxacin, 10 ug, Sensi-Disc®

Indications For Use:

Use of BBL Trovafloxacin Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Trovafloxacin has been shown to be active against most strains of microorganisms listed below, as described in the Roerig package insert for this antimicrobic.

Active In Vitro and In Clinical Infections Against:

Aerobic Gram-Positive Microorganisms

Enterococcus faecalis (many only mod. suscept.) Streptococcus agalactiae Staphylococcus aureus (meth. suscept.) Streptococcus pneumoniae (pen. suscept.) Staphylococcus epidermidis (meth. suscept.) Streptococcus pyogenes Viridans group streptococci

Aerobic Gram-Negative Microorganisms

Escherichia coliMoraxella catarrhalis
Gardnerella vaginalisNeisseria gonorrhoeae
Haemophilus influenzaeProteus mirabilis
Haemophilus parainfluenzaePseudomonas aeruginosa
Klebsiella pneumoniae
Anaerobic Microorganisms
Bacteroides fragilisPrevotella species
Peptostreptococcus species
Other Microorganisms
Chlamydia pneumoniaeLegionella pneumophila
Chlamydia trachomotisMycoplasma pneumoniae

Active In Vitro Only Against:

Aerobic Gram-Positive Microorganisms
Streptococcus pneumoniae (penicillin-resistant strains)
Aerobic Gram-Negative Microorganism
Citrobacter freundiiMorganella morganii
Enterobacter aerogenesProteus vulgaris
Anaerobic Microorganisms
Bacteroides distasonisClostridium perfringens
Bacteroides ovatus
Other Microorganisms
Mycoplasma hominisUreaplasma urealyticum

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) NumberK980683

OR

Prescription Use Per 21 CFR 801.109Over-The-Counter Use Optional Format 1-2-96
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