SYNERCID, 15 UG, BBL SENSI-DISC

K993186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · JTN · Nov 3, 1999 · Microbiology

Device Facts

• Record ID: K993186
• Device Name: SYNERCID, 15 UG, BBL SENSI-DISC
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: JTN · Microbiology
• Decision Date: Nov 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• Device Class: Class 2

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.

Device Story

Device consists of paper discs impregnated with specific concentration of antimicrobial agent Synercid; used in clinical microbiology laboratories. Principle of operation: agar diffusion (Bauer-Kirby method). Discs applied to inoculated Mueller Hinton Agar plates; incubated; zones of inhibition measured. Zone sizes compared to established NCCLS standards (M2-A6, M100-S9) to classify bacteria as susceptible, intermediate, or resistant. Output assists clinicians in selecting appropriate antimicrobial therapy for patients.

Clinical Evidence

No clinical data. Performance relies on established agar diffusion methodology and susceptibility breakpoints determined by the drug manufacturer (Rhone Poulenc-Rorer) under NDA 50-747 and 50-748.

Technological Characteristics

High-quality paper discs impregnated with 15 µg Synercid. Standardized via Bauer-Kirby agar diffusion method. Compliant with NCCLS M2-A6 and M100-S9 standards. Manual application to agar plates.

Indications for Use

Indicated for in vitro agar diffusion susceptibility testing to determine bacterial susceptibility to Synercid. Target organisms include: Enterococcus faecium (vancomycin-resistant and multi-drug resistant strains), Staphylococcus aureus (methicillin-susceptible strains), and Streptococcus pyogenes.

Regulatory Classification

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.

Predicate Devices

• Ciprofloxacin, 5 µg, BBL™ Sensi-Disc™

Submission Summary (Full Text)

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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™<br>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<br>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.

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#### 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).

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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

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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.

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

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#### 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