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

Active In Vitro and In Clinical Infections Against:
Aerobic Gram-Positive Microorganisms
Staphylococcus aureus (including ß-lactamase producing strains, but excluding methicillin-resistant staphylococci) Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pvogenes
Aerobic Gram-Neqative Microorganisms
Haemophilus influenzae (including ß-lactamase producing strains) Haemophilus parainfluenzae (including ß-lactamase producing strains) Moraxella catarrhalis (including ß-lactamase producing strains)

Active In Vitro Only Against:
Aerobic Gram-Positive Microorganisms Staphylococcus epidermidis (methicillin-susceptible strains only) Streptococcus agalactiae Viridans group streptococci Aerobic Gram Negative Microorganisms Citrobacter diversus Escherichia coli Klebsiella pneumoniae Proteus mirabilis

Device Description

Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Cefdinir Sensi-Discs® are intended for use in determining the susceptibility to Cefdinir 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, Parke-Davis, a Division of Warner-Lambert Co., and received FDA approval under NDA Nos. 50-739 and 50-749.

Cefdinir Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Cefdinir supplied by the manufacturer. Parke-Davis. Each Cefdinir disc is clearly marked on both sides with the agent and content. Cefdinir discs are furnished in cartridges of 50 discs each. Cefdinir 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-S8 (1/98).

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 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 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).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cefdinir, 5 µg, Sensi-Discs:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Performance Standard	Conformity to NCCLS standards	Demonstrated conformant performance based on interpretation of zone sizes against NCCLS M2-A6 and M100-S8.
Zone Size Interpretation	Comparison to established ranges	Zone sizes are compared with established zone size ranges for individual antimicrobial agents to determine susceptibility.
Control Organism Limits	Within defined limits	Control organism limits determined by antimicrobic manufacturer (Parke-Davis) and received FDA approval.

Note: The document itself does not explicitly list numerical acceptance criteria in a pass/fail format. Instead, it refers to industry-standardized procedures and interpretation guidelines. The "reported device performance" is essentially that the device functions according to these standards, allowing for accurate interpretation.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The document refers to "pure cultures of clinical isolates" but does not give a number.
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "clinical isolates," suggesting real-world samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not explicitly stated.
Qualifications of Experts: The ground truth for interpreting zone sizes and control organism limits was "determined by the antimicrobic manufacturer, Parke-Davis, a Division of Warner-Lambert Co., and received FDA approval" and by reference to "National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A6" and "NCCLS Document M100-S8." This implies that the standards themselves, developed by expert committees and validated by regulatory bodies, serve as the "ground truth establishment." There is no mention of individual experts reviewing the test set results.

4. Adjudication method for the test set

Adjudication Method: Not applicable in the traditional sense of human consensus for individual test results. The device's performance is adjudicated against pre-established, standardized criteria (NCCLS documents and manufacturer-defined zone sizes/control limits). Interpretation of results involves comparing measured zone sizes to these established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is an antimicrobial susceptibility test disc, a consumable used in a laboratory procedure. It does not involve AI or human "readers" in the context of image interpretation or diagnostic scanning for which MRMC studies are typically performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable in the context of an algorithm. The device itself is a physical disc. Its "standalone performance" is its ability to produce a measurable zone of inhibition when used according to standardized laboratory procedures. The interpretation of this zone into "susceptible," "intermediate," or "resistant" is a manual human step, guided by the NCCLS standards. There is no automated algorithm performing this interpretation described.

7. The type of ground truth used

Type of Ground Truth: The primary ground truth is expert consensus/standardization as defined by the National Committee for Clinical Laboratory Standards (NCCLS) documents (M2-A6 and M100-S8) and manufacturer-established (Parke-Davis) zone size interpretation guidelines and control organism limits, which received FDA approval. This is essentially a standardized, accepted reference for what constitutes "susceptible," "intermediate," or "resistant."

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a "training set." The performance is based on chemical properties and standardized biological reactions, not statistical model training.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device. The "ground truth" for the interpretation of the disc's results is established through the rigorous standardization process of the NCCLS and validation by the manufacturer and FDA.

Summary

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JUN - 9 1998

K981517

Date April 27, 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTED BY:

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

NAME OF DEVICE:

Trade Name:	Cefdinir, 5 µg, Sensi-DiscsCatalog Numbers 4331713 and 4331714
Common Name/Description:	Antimicrobial Susceptibility Test Discs
Classification Name:	Antimicrobial Susceptibility Test Discs
PREDICATE DEVICE:	Other BBL® Sensi-Discs® such asCiprofloxacin, 5 mcg, Sensi-Disc®

DEVICE DESCRIPTION:

INTENDED USE:

INDICATIONS FOR USE:

{1}------------------------------------------------

strains of microorganisms listed below, as described in the Parke-Davis package insert for this antimicrobic.

Active In Vitro and In Clinical Infections Against:

Aerobic Gram-Positive Microorganisms

Staphylococcus aureus (including ß-lactamase producing strains, but excluding methicillin-resistant staphylococci) Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pvogenes

Aerobic Gram-Neqative Microorganisms

Haemophilus influenzae (including ß-lactamase producing strains) Haemophilus parainfluenzae (including ß-lactamase producing strains) Moraxella catarrhalis (including ß-lactamase producing strains)

Active In Vitro Only Against:

Aerobic Gram-Positive Microorganisms Staphylococcus epidermidis (methicillin-susceptible strains only) Streptococcus agalactiae Viridans group streptococci Aerobic Gram Negative Microorganisms Citrobacter diversus Escherichia coli Klebsiella pneumoniae Proteus mirabilis

PRODUCT DESCRIPTION:

B-2

{2}------------------------------------------------

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-S8 (1/98).

PERFORMANCE DATA:

See attached Parke-Davis product insert section on Susceptibility Tests - Diffusion Techniques for Omnicef® capsules and Omnicef® for Oral Suspension.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

JUN - 9 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K981517 Re: Trade Name: Cefdinir, 5ug, Sensi-Disc Regulatory Class: II Product Code: JTN Dated: April 27, 1998 Received: April 28, 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 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 (QS) 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 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

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

Device Name: Cefdinir, 5 ug, Sensi-Disc®

Indications For Use:

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

Active In Vitro Against:

Aerobic Gram-Positive Microorganisms

Staphylococus aureus (including B-lactamase producing stains, but excluding methicillinresistant staphylococci) Staphylococcus epidermidis (methicillin-susceptible strains only)

Aerobic Gram-Negative Microorganisms

Haemophilus influenzae (including (3-lactamase producing strains) Haemophilus parainfluenzae (including ß-lactamase producing strains) Moraxella catarrhalis (including ß-lactamase producing stains) Escherichia coli Kiebsiella pneumoniae Proteus mirabilis

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)	Woodly Dubois
Division of Clinical Laboratory Devices
510(k) Number	K981517

Prescription Use Per 21 CFR 801.109 OR

Over-The-Counter Use _ Optional Format 1-2-96

Regulation Number and Section

§ 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).