Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Ertapenem 10 µg BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Ertapenem of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Merck & Co., Inc. and received FDA approval under NDA Number 21-337.

Use of Ertapenem 10 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 Ertapenem. Ertapenem has been shown to be active in vitro against most strains of microorganisms listed below, as described in the Merck & Co., Inc. package insert for this antimicrobic.

Active In Vitro and in clinical infections against:

Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pyogenes

Aerobic gram-negative microorganisms

Escherichia coli Haemophilus influenzae (beta-lactamase negative strains only) Klebsiella pneumoniae

Active In Vitro Against:

Aerobic gram-positive microorganisms Streptococcus pneumoniae (penicillin-intermediate strains only)

Aerobic gram-negative microorganisms

Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Haemophilus influenzae (beta-lactamase positive strains) Haemophilus parainfluenzae Klebsiella oxytoca (excluding ESBL producing strains) Morqanella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens

Device Description

Ertapenem 10 µg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Ertapenem supplied by the manufacturer, Merck & Co., Inc. Each Ertapenem disc is clearly marked on both sides with the agent and drug content. Ertapenem cartridges each contain 50 impregnated discs that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ertapenem discs are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

Agar diffusion susceptibility methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Ertapenem 10 µg Sensi-Disc," an antimicrobial susceptibility test disc. This type of document focuses on establishing substantial equivalence to a predicate device and outlining its intended use and general characteristics. It does not typically include detailed clinical study data with acceptance criteria, sample sizes for test/training sets, expert adjudication methods, or MRMC study results in the way a diagnostic imaging or AI-driven device submission would.

Therefore, many of the requested details are not present in the provided text. However, I can extract what is available and explain why other information is missing.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" for this device is tied more to NCCLS (now CLSI) standards for zone size interpretation and the approved drug package insert for Ertapenem, rather than specific performance metrics like sensitivity/specificity for a novel diagnostic algorithm. The acceptance criteria are implicit in the adherence to these established standards.

Table of Acceptance Criteria and Reported Device Performance:

Criterion Category	Acceptance Criteria (based on text)	Reported Device Performance (based on text)
Intended Use	"Used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures."	The device is intended for "determining the susceptibility to Ertapenem of a wide range of bacteria, as described in the 'Indications for Use' section."
Interpretation Standards	Zone sizes for interpretation, including control organism limits, determined by Merck & Co., Inc. and received FDA approval under NDA Number 21-337. Interpretations (S/I/R) made by comparing zone diameters to NCCLS Document M2-A7 and M100-S12.	The device uses "established zone size ranges for individual antimicrobial agents" and "respective organism tables of NCCLS Document M2-A7... and of NCCLS Document M100-S12" for categorical interpretation. (No explicit performance values like agreement rates are given in this summary.)
Microorganism Panel (Active In Vitro and in clinical infections)	Active against specific gram-positive (Staphylococcus aureus (methicillin-susceptible), Streptococcus agalactiae, Streptococcus pneumoniae (penicillin-susceptible), Streptococcus pyogenes) and gram-negative (Escherichia coli, Haemophilus influenzae (beta-lactamase negative), Klebsiella pneumoniae) microorganisms.	The device is indicated for use with, and shown to be active in vitro against, the specified panel of microorganisms, consistent with the Merck & Co., Inc. package insert.
Microorganism Panel (Active In Vitro Against)	Active against specific gram-positive (Streptococcus pneumoniae (penicillin-intermediate)) and gram-negative (Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Haemophilus influenzae (beta-lactamase positive), Haemophilus parainfluenzae, Klebsiella oxytoca (excluding ESBL),morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) microorganisms.	The device is indicated for use with, and shown to be active in vitro against, the specified panel of microorganisms, consistent with the Merck & Co., Inc. package insert.

The "study that proves the device meets the acceptance criteria" is referenced as "SUBSTANTIAL EQUIVALENCE TESTING DATA: See the INVANZ™ (Ertapenem for injection) Merck & Co., Inc. drug package insert, 'Susceptibility Tests: Diffusion Techniques'." This implies that the performance data justifying the zone size interpretations and efficacy against certain organisms is contained within the drug's FDA-approved package insert, not a separate study submitted with this 510(k) for the disc itself. The 510(k) leverages the existing approval of the drug and its associated susceptibility testing guidelines.

Additional Requested Information:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided 510(k) summary. The document points to the Merck & Co., Inc. drug package insert for "Susceptibility Tests: Diffusion Techniques" which would contain this information.
- Data Provenance: Not specified in the provided 510(k) summary. The original drug studies would likely have included multicenter data; however, this document does not detail it.
- Retrospective or Prospective: Not specified in the provided 510(k) summary. This information would be within the drug's package insert or associated clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For antimicrobial susceptibility testing, "ground truth" often refers to established methodologies (e.g., broth microdilution MICs) and expert consensus panels (e.g., NCCLS/CLSI) that define interpretive criteria. The development of these criteria involves extensive studies and expert review, but the specific number and qualifications of individuals are not typically detailed in product-specific 510(k) summaries for the discs.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This type of adjudication is typically for subjective diagnostic interpretations (e.g., radiology reads). For quantitative zone size measurements, the 'adjudication' is effectively the comparison to objective, predetermined zone diameter breakpoints.
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:
- Not applicable. This is not an AI-driven device or a diagnostic imaging device involving multiple human readers interpreting subjective images. It's a laboratory device for quantitative antimicrobial susceptibility testing.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an "algorithm." This device is a physical disc used in a standardized laboratory procedure that requires human action (applying disc, measuring zone) and interpretation against established guidelines.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for defining susceptibility categories (S/I/R) and associated zone diameter breakpoints is based on a combination of expert consensus (e.g., NCCLS/CLSI guidelines), clinically correlated MIC breakpoints derived from pharmacokinetic/pharmacodynamic (PK/PD) studies, and clinical outcomes data from drug trials (as referenced by the Merck & Co., Inc. package insert). For the performance of the disc itself, "ground truth" would be established by comparison to a reference method (e.g., broth microdilution or agar dilution MICs).
The sample size for the training set:
- Not specified. The 510(k) summary does not refer to a "training set" in the context of machine learning. The "training" data for establishing zone size breakpoints and their correlation to MICs would have come from extensive microbiological studies conducted by Merck & Co., Inc. during the drug's development and shared with organizations like NCCLS.
How the ground truth for the training set was established:
- For the drug Ertapenem, the ground truth for establishing susceptibility breakpoints (which the disc then leverages) would have been established through:
  - In vitro susceptibility testing: Large-scale testing of many bacterial isolates against Ertapenem to determine MIC distributions.
  - Correlation of MICs to zone diameters: Empirical studies to find correlations between disc diffusion zone sizes and MIC values.
  - Pharmacokinetic/Pharmacodynamic (PK/PD) modeling: Relating drug concentrations achievable in patients to the MICs required to inhibit bacterial growth.
  - Clinical Efficacy Data: Evidence from clinical trials showing patient outcomes with different MICs.
  - Expert Review/Consensus: National and international expert committees (like NCCLS/CLSI) then review all this data to define the official interpretive criteria (breakpoints).

In essence, this 510(k) is for a relatively simple, well-understood in vitro diagnostic device (a paper disc). The detailed "study" and "ground truth" aspects are largely deferred to the extensive work already done and approved for the antimicrobial drug itself and the established standards for antimicrobial susceptibility testing.

Summary

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K020842

MAY 1 5 2002

510(k) Submission

Ertapenem 10 µg Sensi-Disc

Date: March 13, 2002

SUBMITTED BY:

510(k) SUMMARY

Becton Dickinson and Company 7 Loveton Circle Sparks, MD 21152 410-316-4778 Phone: 410-316-4499 Fax:

Michelle B. Bandy, Regulatory Affairs Specialist CONTACT NAME:

March 13, 2002 DATE PREPARED:

Ertapenem 10 µg, BBL™ Sensi-Disc™ Antimicrobial DEVICE TRADE NAME: Susceptibility Test Discs

Antimicrobial Susceptibility Test Discs DEVICE COMMON NAME:

21 CFR§866.1620, Class II (Product Code JTN), DEVICE CLASSIFICATION: Susceptibility Test Discs, Antimicrobial

Other BBL™ Sensi-Disc™ PREDICATE DEVICE: (eg, Ciprofloxacin 5 µg, BBL™ Sensi-Disc™)

INTENDED USE:

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Ertapenem 10 ug Sensi-Disc

510(k) SUMMARY

INDICATIONS FOR USE:

Use of Ertapenem 10 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility OSe of Enaponion 10 pg, there is a need to determine the susceptibility of bacteria to testing is maloutou more has been shown to be active in vitro against most strains of microorganisms listed below, as described in the Merck & Co., Inc. package insert for this antimicrobic.

Active In Vitro and in clinical infections against:

Aerobic gram-negative microorganisms

Escherichia coli Haemophilus influenzae (beta-lactamase negative strains only) Klebsiella pneumoniae

Active In Vitro Against:

Aerobic gram-positive microorganisms Streptococcus pneumoniae (penicillin-intermediate strains only)

Aerobic gram-negative microorganisms

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DEVICE DESCRIPTION:

DEVICE PRINCIPLE:

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 species] 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 categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested with the antimicrobial agent is made by comparing zone diameters to those found in the respective organism tables of NCCLS Document M2-A7 ("Performance Standards for Antimicrobial Disk Susceptibility Tests - Seventh Edition, Approved Standard", 1/00) and of NCCLS Document M100-S12 ("Performance Standards for Antimicrobial Susceptibility Testing", Twelfth Informational Supplement, 1/02).

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DEVICE COMPARISON:

The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ertapenem 10 µg is similar to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ciprofloxacin 5 uq in that:

Both methods are for antimicrobial susceptibility testing using paper discs ● impregnated with an antimicrobial agent.
Both methods have the same intended use. .
Both methods provide the user with antimicrobic minimum inhibitory concentration . (MIC) results based on measurements of zone diameters.
Both methods require the user to determine categorical interpretations (S///R) using . the measured zone diameters against NCCLS Approved Standards M2 and M100.
Both methods use pure cultures of bacterial isolates. .

The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ertapenem 10 µg differs from the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs - Ciprofloxacin 5 uq in that:

BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs Ertapenem 10 µg is a . susceptibility test that uses discs impregnated with the antimicrobic Ertapenem at a concentration of 10 ug while the BBL"" Sensi-Disc" Antimicrobial Susceptibility Test Discs - Ciprofloxacin 5 ug is a susceptibility test that uses discs impregnated with the antimicrobic Ciprofloxacin at a concentration of 5 ug.
BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disc Ertapenem 10 µg is a . susceptibility test used to test a different battery of microorganisms than the BBL™ Sensi-Disc" Antimicrobial Susceptibility Test Disc - Ciprofloxacin 5 ug.

SUBSTANTIAL EQUIVALENCE TESTING DATA:

See the INVANZ™ (Ertapenem for injection) Merck & Co., Inc. drug package insert, "Susceptibility Tests: Diffusion Techniques".

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 5 2002

Ms. Michelle B. Bandy Regulatory Affairs Specialist BD Diagnostic Systems 7 Loveton Circle Sparks, MD 21152

K020842 Re:

Trade/Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Discs, Ertapenem 10ug Regulation Number: 21 CFR 866.1620 Regulation Name: Susceptibility Test Discs Regulatory Class: Class II Product Code: JTN Dated: March 13, 2002 Received: March 15, 2002

Dear Ms. Bandy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter in all the your ding of substantial equivalence of your device to a legally marketed nothloadon. The FD I Intelligention 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 1 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, (301) 591 1500. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufactor Internet address "http://www.fda.gov/cdrh/dsma/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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510(k) Number (if known): ___

Device Name: BBL™ Sensi-Disc" Antimicrobial Susceptibility Test Discs, Ertapenem 10ug

Indications for Use:

Use of Ertapenem 10 µg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated Use of Ertapenen 10 pg, DDC "Ochor Bloo" to " in " a chapenem. Ertapenem. Ertapenem in the March & Co when there is a need to determine the odsoophisms is active as described in the Merck & Co., Inc. package insert for this antimicrobic.

Active In Vitro and in clinical infections against:

Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus agalactiae Streptococcus pneumoniae (penicillin-susceptible strains only)

Streptococcus pyogenes

Aerobic gram-negative microorganisms

Escherichia coli Haemophilus influenzae (beta-lactamase negative strains only) Klebsiella pneumoniae

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Luddu h. Poole

(DNision Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K020840

Prescription Use
(Per 21 CFR 801.109)
✓

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).