The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates.

This 510(k) is for Plazomicin in the dilution range of 0.06-128 ug/ml for testing non-fastidious gram negative organisms on the Sensititre 18 - 24 hour MIC panel.

Plazomicin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

o Escherichia coli
o Klebsiella pneumoniae
o Proteus mirabilis
o Enterobacter cloacae

The following in vitro data are available, but their clinical significance is unknown.

Gram-negative Bacteria
o Citrobacter freundii
o Citrobacter koseri
o Klebsiella aerogenes
o Klebsiella oxytoca
o Morganella morganii
o Providencia stuartii
o Serratia marcescens
o Proteus vulgaris

Device Description

Not Found

AI/ML Overview

The provided text is related to an FDA 510(k) clearance for an antimicrobial susceptibility test system (Sensititre with Plazomicin). It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device that would require such details (e.g., performance metrics like sensitivity, specificity, or AUC, and details on ground truth, expert adjudication, or training sets).

The document is primarily focused on:

Granting 510(k) clearance for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Plazomicin.
Indicating the device's intended use for clinical susceptibility testing of non-fastidious isolates, specifically for Plazomicin against certain gram-negative organisms.
Listing the organisms against which Plazomicin has shown activity.
Regulatory information and disclaimers.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device from this document. This document pertains to a traditional in vitro diagnostic product, not an AI/ML powered medical device.

Summary

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August 8, 2018

Thermo Fisher Scientific Cynthia Knapp Director of AST/PHARMA R&D 1 Thermo Fisher Way Oakwood Village, Ohio 44014-6

Re: K181946

Trade/Device Name: Sensititre 18-24 hour MIC Breakpoint System with Plazomicin in the dilution range of 0.06-128 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY, LRG, LTT Dated: July 17, 2018 Received: July 20, 2018

Dear Ms. Knapp:

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 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) 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, fi applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ribhi Shawar -S

For Uwe Scherf. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181946

Device Name

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 us/ml

Indications for Use (Describe)

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates.

This 510(k) is for Plazomicin in the dilution range of 0.06-128 ug/ml for testing non-fastidious gram negative organisms on the Sensititre 18 - 24 hour MIC panel.

Plazomicin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

o Escherichia coli
o Klebsiella pneumoniae
o Proteus mirabilis
o Enterobacter cloacae

The following in vitro data are available, but their clinical significance is unknown.

Gram-negative Bacteria
o Citrobacter freundii
o Citrobacter koseri
o Klebsiella aerogenes
o Klebsiella oxytoca
o Morganella morganii
o Providencia stuartii
o Serratia marcescens
o Proteus vulgaris

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).