Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml

K192729 · Thermo Fisher Scientific · JWY · Nov 6, 2019 · Microbiology

Device Facts

• Record ID: K192729
• Device Name: Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
• Applicant: Thermo Fisher Scientific
• Product Code: JWY · Microbiology
• Decision Date: Nov 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre MIC and Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious gram negative isolates comprising of Enterobacteriaceae, Pseudomonas aeruginosa and other non-Enterobacteriaceae and of non-fastidious gram positive isolates, comprising of Staphylococcus spp., Enterococcus spp., and Beta-hemolytic Streptococci other than S. pneumoniae.

Device Story

Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System uses multi-well microtiter plates pre-dosed with dried, stabilized antimicrobials (Lefamulin). System functions as miniaturized broth dilution method. Clinical laboratory personnel inoculate plates with bacterial suspension; plates incubated 18-24 hours at 34–36 °C. Growth detection occurs via two methods: VIZION (digital viewing device with touch screen/video camera) or OptiRead (automated reader using fluorescence). OptiRead monitors bacterial surface enzyme activity by cleaving fluorogenic substrate; fluorescence intensity correlates to bacterial growth. MIC determined by lowest antimicrobial concentration inhibiting growth. Results assist clinicians in determining appropriate antibiotic therapy for MSSA infections. System requires Sensititre AIM for inoculation and VIZION or OptiRead for reading.

Clinical Evidence

Performance evaluated via clinical and challenge testing of 251 MSSA isolates (201 clinical, 50 challenge) across four sites. Compared against CLSI broth microdilution reference. VIZION read method: 100% Essential Agreement (EA), 100% Category Agreement (CA). OptiRead method: 99.6% EA, 100% CA. Reproducibility >95%. Quality control testing with S. aureus ATCC 29213 met acceptance criteria. No trending identified. Insufficient data for non-susceptible isolates; labeling includes limitation for reference lab confirmation.

Technological Characteristics

Multi-well plastic microtiter plates; dried, stabilized antimicrobial (Lefamulin); miniaturized broth dilution principle. Sensing via fluorescence (OptiRead) or visual digital display (VIZION). Inoculation via Sensititre AIM. Incubation 18-24 hours at 34-36 °C. Connectivity: Standalone instrument systems. No specific software algorithm class (rule-based interpretation of growth/inhibition).

Indications for Use

Indicated for in vitro diagnostic susceptibility testing of non-fastidious and fastidious bacterial isolates to determine the Minimum Inhibitory Concentration (MIC) or breakpoint susceptibility to the antimicrobial agent Lefamulin (0.008-16 ug/ml).

Regulatory Classification

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.

Predicate Devices

• Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin (K171870)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 6, 2019

Thermo Fisher Scientific Cynthia Knapp Director of AST/Pharma R&D One Thermo Fisher Way Oakwood Village, Ohio 44146

## Re: K192729

Trade/Device Name: Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16 ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG, LTT Dated: September 26, 2019 Received: September 27, 2019

## Dear Cynthia 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, and prohibitions 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

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

801 and Part 809); medical device 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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, if 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure