FOSFOMYCIN, 200 MG, SENSI-DISC by BECTON DICKINSON MICROBIOLOGY SYSTEMS

Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Fosfomycin Sensi-Discs® are intended for use in determining the susceptibility to Fosfomycin of a wide range of bacteria, including Enterococcus faecalis, Enterococcus faeclum, Escherichia coli, Citrobacter diversus, Citerobacter freundii, Entercbacter aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, and Serratia marcesceus. Zone sizes used tor interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Forest Pharmaceuticals, Inc., and received FDA approval under NDA No. 50-717.

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

Active In Vitro and In Clinical Infections Against: Aerobic Gram-Positive Microorganisms Enterococcus faecalis Aerobic Gram-Negative Microorganisms Escherichia coli Active In Vitro Only Against: Aerobic Gram-Positive Microorganisms Enterococcus faeclum Aerobic Gram-Negative Microorganisms Citrobacter diversus Citerobacter freundii Enterobacter aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Serratia marcesceus

Device Description

Antimicrobial Susceptibility Test Discs

AI/ML Overview

The provided text describes a 510(k) submission for "Fosfomycin, 200 mcg, Sensi-Discs" and provides a "Summary of Safety and Effectiveness." However, it does not include detailed acceptance criteria or a study proving the device meets those criteria in the format requested. The document primarily focuses on the device's labeling, intended use, and substantial equivalence to a predicate device, rather than detailed performance study results with specific metrics.

Therefore, most of the information requested in your prompt cannot be extracted directly from the provided text.

Here's what can be gathered and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The document mentions "Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Forest Pharmaceuticals, Inc., and received FDA approval under NDA No. 50-717." This implies that the acceptance criteria for the interpretation of the device's results are based on established standards for Fosfomycin, but the performance of this specific Sensi-Disc against those criteria is not detailed.
Reported Device Performance: Not provided in a quantitative form (e.g., accuracy, sensitivity, specificity, reproducibility).

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

Sample Size for Test Set: Not specified.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

This information is not provided. The ground truth seems to be implicitly linked to the "Forest Pharmaceuticals, Inc., package insert for this antimicrobic" but how this was established in the context of the Sensi-Disc's performance is not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

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

This device is an antimicrobial susceptibility test disc (a physical laboratory consumable), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

Again, this is not an algorithm or AI device. It's a laboratory consumable. Standalone performance as an algorithm is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth is implied to be based on the established clinical breakpoints and susceptibility interpretations for Fosfomycin, as determined by the antimicrobic manufacturer (Forest Pharmaceuticals, Inc.) and FDA-approved under NDA No. 50-717. This would typically involve correlation with minimum inhibitory concentration (MIC) testing (a gold standard for antibiotic susceptibility) and clinical outcomes data from the drug's initial approval. However, the specific method for establishing ground truth for this particular Sensi-Disc performance study is not detailed.

8. The sample size for the training set

Not specified. This device is not an AI/machine learning model, so the concept of a "training set" in that context does not apply.

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

As above, not applicable in the context of AI/machine learning training.

In summary, the provided document is a regulatory approval letter and a summary of the device's intended use and relationship to a predicate device. It lacks the detailed performance study data, acceptance criteria, and methodology that would typically be found in a clinical or validation study report.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 28 1997

Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems P.O. Box 243 Cockeysville, Maryland 21030-0243

Re: K972098 Trade Name: Fosfomycin, 200 mg, Sensi-Disc® Regulatory Class: II Product Code: JTN Dated: June 2, 1997

Received: June 4, 1997

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 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 Good Manufacturing Practice for Modical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 (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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K 973098

Date 6/2/97

SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTED BY:

Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems P.O. Box 243 Cockeysville, MD 21030-0243

NAME OF DEVICE:

Trade Name:	Fosfomycin, 200 mcg, Sensi-DiscsCatalog Numbers 4331709, 4331710
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:

PRE

INTENDED USE:

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Device Name: Fosfomycin, 200 mg, Sensi-Disc®

Indications For Use:

Active In Vitro and In Clinical Infections Against: Aerobic Gram-Positive Microorganisms Enterococcus faecalis Aerobic Gram-Negative Microorganisms Escherichia coli Active In Vitro Only Against: Aerobic Gram-Positive Microorganisms Enterococcus faeclum Aerobic Gram-Negative Microorganisms Citrobacter diversus Citerobacter freundii Enterobacter aerogenes Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Serratia marcesceus

(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) Number	K972098

Prescription Use		OR	Over-The-Counter Use
Per 21 CFR 801.109			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).