(42 days)
Other BBL™ Sensi-Disc™ such as Ciprofloxacin, 5 µg, BBL™ Sensi-Disc™
Not Found
No
The device is a physical disc used in a standardized agar diffusion test, which relies on manual measurement and comparison to established zone size ranges. There is no mention of any computational analysis or algorithms that would suggest the use of AI/ML.
No
This device is an in vitro diagnostic product designed to determine the susceptibility of bacteria to Synercid, not to treat a condition in a living organism.
Yes
This device determines the susceptibility of bacteria to an antibiotic, which is a diagnostic function used to guide treatment decisions.
No
The device is a physical disc impregnated with an antimicrobial agent used in a laboratory setting for susceptibility testing. It is not software.
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" and "to determine the susceptibility of bacteria to Synercid." This clearly indicates the device is used outside of the body to analyze biological samples (bacteria).
- Device Description: The description details how the device is used in a laboratory setting ("applied to the surface of Mueller Hinton Agar plates... inoculated with pure cultures of clinical isolates") to perform a diagnostic test ("determine the agent(s) most suitable for use in antimicrobial therapy").
- Regulatory References: The text mentions FDA approval and references standardized procedures from organizations like the FDA, WHO, and NCCLS, which are all relevant to the regulation and standardization of IVD devices.
- Purpose: The ultimate goal of using this device is to provide information that aids in determining the appropriate treatment for a patient by identifying which antimicrobial agents are effective against a specific bacterial infection. This is a core function of an IVD.
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. Synercid BBL® Sensi-Disc™ are intended for use in determining the susceptibility to Synercid 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, Rhone Poulenc-Rorer, and received FDA approval under NDA Nos. 50-747 and 50-748.
Use of Synercid BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Synercid. Synercid has been shown to be active against most strains of microorganisms listed below, as described in the Rhone Poulenc-Rorer labeling for this antimicrobic.
Product codes (comma separated list FDA assigned to the subject device)
JTN
Device Description
Synercid Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Synercid supplied by the manufacturer, Rhone Poulenc-Rorer. Each Synercid disc is clearly marked on both sides with the agent and content. Synercid discs are furnished in cartridges of 50 discs each. Synercid 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=S9 (1/99).
Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar 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 NCCLS Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S9 ("Performance Standards for Antimicrobial Susceptibility Testing", Ninth Informational Supplement, 1/99).
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 Rhone Poulenc-Rorer labeling on Susceptibility Testing - Diffusion Techniques for Synercid
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™ such as 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
NOV - 3 1999
993186
Date: September 22, 1999
510(k) SUMMARY
SUBMITTED BY:
Bradford M. Spring Manager, Regulatory Affairs Becton Dickinson and Company 7 Loveton Circle Sparks, MD 21152-0999
NAME OF DEVICE:
| Trade Name: | Synercid, 15 µg, BBL™ Sensi-Disc™
Catalog Numbers 4331720 and 4331721 |
|--------------------------|--------------------------------------------------------------------------|
| Common Name/Description: | Antimicrobial Susceptibility Test Discs |
| Classification Name: | Susceptibility Test Discs, Antimicrobial |
| PREDICATE DEVICE: | Other BBL™ Sensi-Disc™ such as
Ciprofloxacin, 5 µg, BBL™ Sensi-Disc™ |
DEVICE DESCRIPTION:
INTENDED USE:
Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Synercid BBL® Sensi-Disc™ are intended for use in determining the susceptibility to Synercid 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, Rhone Poulenc-Rorer, and received FDA approval under NDA Nos. 50-747 and 50-748.
1
INDICATIONS FOR USE:
Use of Synercid BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Synercid. Synercid has been shown to be active against most strains of microorganisms listed below, as described in the Rhone Poulenc-Rorer labeling for this antimicrobic.
Active In-Vitro Against:
Aerobic Gram-Positive Microorganisms
Cornyebacterium ieikeium Enterococcus faecium (Vancomycin-resistant and multi-drug resistant strains only) Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Streptococcus agalactiae Streptococcus pyogenes
PRODUCT DESCRIPTION:
Synercid Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Synercid supplied by the manufacturer, Rhone Poulenc-Rorer. Each Synercid disc is clearly marked on both sides with the agent and content. Synercid discs are furnished in cartridges of 50 discs each. Synercid 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=S9 (1/99).
2
Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates for Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar 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 NCCLS Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S9 ("Performance Standards for Antimicrobial Susceptibility Testing", Ninth Informational Supplement, 1/99).
PERFORMANCE DATA:
See Rhone Poulenc-Rorer labeling on Susceptibility Testing - Diffusion Techniques for Synercid
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Nov - 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Bradford M. Spring Manager, Regulatory Affairs Becton Dickinson and Company 7 Loveton Circle Sparks. Maryland 21152
Re: K993186 Trade Name: Synercid 15ug, BBL TM Sensi-DiscTM Regulatory Class: II Product Code: JTN Dated: September 22, 1999 Received: September 23, 1999
Dear Mr. Spring:
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 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). 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
4
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 Butman
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
5
Page 1 of 1
510(k) Numbor (if known): K993186
Device Name: Synarcid, 15 ug, BBL" Sensi-Disc"
Indications for Use:
Use of Synercid, 15 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Synercid. Synercid indication whown to be active in vito against most strains of microorganisms listed below, as described in the Rhone Poulenc-Rorer package insert for this antimicrobic.
Active In Vitro Against:
Aerobic Gram Positive Microorganisms
Enterococcus facium (Vancomycin-resistant and multi-drug resistant strains only) Staphylococcus aureus (methiclilin-susceptible strains only) Straptococcus pyoganes
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH, Office of Device Evaluation (ODE)
Woody Dubose
Division of Clinical Laboratory Devices 510(k) Number
Prescription Use
Per 21 CFR 801.109
OR
Over-The-Counter Use Optional Format 1-2-96