(51 days)
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 Sulbactam in the dilution range of 0.015/4-32/4 ug/mL for testing non-fasidious Gram negative organisms on the Sensititre 18 - 24 hour MIC panel.
Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
Acinetobacter baumannii-calcoaceticus complex
Not Found
This is a 510(k) clearance letter for an antimicrobial susceptibility test (AST) system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically seen for AI/ML-based medical devices. The document is a regulatory approval for a laboratory diagnostic product, specifically for testing the susceptibility of certain bacteria to a new antibiotic combination (Sulbactam-durlobactam).
The type of "performance" for such a device is related to its accuracy in determining minimum inhibitory concentrations (MICs) or breakpoints, and its ability to correctly classify bacteria as susceptible, intermediate, or resistant to the antibiotic.
Here's how I can address your request based on the provided text, while also noting what is not present:
A. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria or a detailed performance table for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam.
For this type of device (Antimicrobial Susceptibility Test), acceptance criteria typically involve:
- Essential Agreement (EA): The percentage of MIC values that are within ±1 doubling dilution of a reference method.
- Category Agreement (CA): The percentage of isolates that are categorized identically (Susceptible, Intermediate, or Resistant) by the test system and the reference method.
- Major Errors (ME): When the test system reports an isolate as Susceptible when the reference method reports it as Resistant.
- Very Major Errors (VME): When the test system reports an isolate as Resistant when the reference method reports it as Susceptible.
Regulatory guidance for AST devices usually sets specific thresholds for these metrics (e.g., >90% EA, >90% CA, <3% ME, <1.5% VME). However, these specifics are not in the provided document. The document is the FDA's clearance letter, not the detailed submission itself.
B. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). For an AST device, this would typically involve a collection of clinical bacterial isolates and challenge isolates tested against a reference method.
C. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not mention experts or their qualifications for establishing ground truth. For AST devices, the "ground truth" is typically established by:
- A reference AST method, such as broth microdilution, performed by trained microbiologists.
- Concordance with CDC or CLSI guidelines for interpreting MIC values.
D. Adjudication Method
The provided text does not mention an adjudication method. This is common for AST devices, as the reference method typically provides the definitive result without requiring expert adjudication in the same way as an imaging AI product.
E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are typically used for imaging AI products to assess how AI assistance impacts human reader performance (e.g., radiologists interpreting images). This device is a diagnostic test kit for antimicrobial susceptibility, not an AI imaging tool. Therefore, there is no discussion of human readers improving with or without AI assistance.
F. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The concept of a "standalone algorithm" is not directly applicable in the same way it would be for an AI/ML device. For an AST system, the "standalone performance" refers to the accuracy of the test panel itself in determining MICs or breakpoints when compared to a gold standard reference method.
The FDA clearance implies that such performance data was submitted and found acceptable, demonstrating the system's ability to accurately determine susceptibility to Sulbactam-durlobactam for the specified organisms. However, the details of this study (e.g., specific metrics like EA, CA, ME, VME) are not included in this clearance letter.
G. Type of Ground Truth Used
The ground truth for this type of device (Antimicrobial Susceptibility Test) would typically be established by a broth microdilution reference method or another CLSI-standardized AST method, along with established clinical breakpoints or interpretive criteria. The FDA drug label for Sulbactam-durlobactam would also provide essential information on activity against specific organisms. The document states: "Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label: Acinetobacter baumannii-calcoaceticus complex." This implicitly references established in-vitro and clinical data as part of the ground truth.
H. Sample Size for the Training Set
The provided text does not contain information about a "training set" sample size. This term is primarily relevant for AI/ML devices that learn from data. An AST system is a chemical and biological assay, not a machine learning model, so there isn't a "training set" in the AI sense.
I. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense for this type of device, this question is not applicable and therefore, no information is provided on how its ground truth was established.
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August 25, 2023
Thermo Fisher Scientific Cynthia Knapp Director R & D AST and Pharma One Thermo Fisher Way Oakwood Village, Ohio 44146
Re: K231994
Trade/Device Name: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactamdurlobactam in the dilution range of 0.015/4-32/4 µg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: June 30, 2023 Received: July 5, 2023
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
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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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K231994
Device Name
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 µg/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 Sulbactam in the dilution range of 0.015/4-32/4 ug/mL for testing non-fasidious Gram negative organisms on the Sensititre 18 - 24 hour MIC panel.
Sulbactam-durlobactam has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
Acinetobacter baumannii-calcoaceticus complex
X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).