(67 days)
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.
The Thermo Scientific Oxoid Sulbactam Disc (10/10 ug) SUD20 can be used to determine susceptibility to Sulbactam/Durlobactam against the following bacteria for which Sulbactam has been shown to be active both clinically and in vitro:
Acinetobacter-baumannii calcoaceticus complex
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20
The provided FDA letter and "Indications for Use" document do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets them. This type of information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.
However, I can extract what is available and indicate where information is missing.
Here's a breakdown of the information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, accuracy, or zone diameter interpretive criteria. It only describes the intended use of the device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided text. The device is an antimicrobial susceptibility test disc, so the ground truth would likely refer to established microbiological methods, not expert human interpretation in the way, for example, a radiology AI device would use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text.
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
The device is an antimicrobial susceptibility test disc, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a physical disc used in a laboratory procedure. It is not an algorithm. The "performance" refers to the accuracy of the disc's susceptibility determination against established reference methods. While it operates "standalone" in the sense that its results are read directly, it's not an algorithm in the typical AI sense. The study would test the disc's performance in determining susceptibility against reference methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For antimicrobial susceptibility testing, the ground truth is typically established by reference methods such as broth microdilution (BMD) or agar dilution, performed according to recognized standards (e.g., Clinical and Laboratory Standards Institute (CLSI) guidelines). The provided document does not explicitly state the ground truth method, but this is the standard for such devices.
8. The sample size for the training set
The concept of a "training set" is usually associated with machine learning or AI models. This device is a physical antimicrobial susceptibility test disc. Therefore, there isn't a "training set" in the conventional AI sense. The development of such discs involves extensive laboratory testing and formulation, but not a dataset to train an algorithm.
9. How the ground truth for the training set was established
As explained above, the concept of a "training set" and associated ground truth establishment for a training set is not applicable to this type of device.
Summary of Device and Indication from the Text:
- Device Name: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20
- Regulation Number: 21 CFR 866.1620
- Regulation Name: Antimicrobial susceptibility test disc
- Intended Use: To determine susceptibility to Sulbactam/Durlobactam against Acinetobacter baumannii-calcoaceticus complex using the semi-quantitative agar diffusion test method for in vitro susceptibility testing. This assists clinicians in determining potential treatment options for patients with microbial infections.
- Type of Use: Prescription Use.
To get the detailed information you are seeking, you would typically need to review the full 510(k) summary (K232276) available on the FDA's website, which often includes details about the analytical studies performed to demonstrate substantial equivalence.
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October 6, 2023
Oxoid Limited (Part of Thermo Fisher Scientific) Amie Lovatt Scientist II Team Lead AST Disc Clinical Trials Wade Road Basingstoke, Hampshire RG24 8PW United Kingdom
Re: K232276
Trade/Device Name: Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20 Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: Class II Product Code: JTN Dated: July 4, 2023 Received: July 31, 2023
Dear Amie Lovatt:
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 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 (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) K232276
Device Name
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 ug) SUD20
Indications for Use (Describe)
Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. Used in a diagnostic workflow to and clinicians in determining potential treatment options for patients suspected of having a microbial infection, these discs are intended to determine susceptibility against microorganisms for which specific drugs have been shown to be active both clinically and in vitro.
The Thermo Scientific Oxoid Sulbactam Disc (10/10 ug) SUD20 can be used to determine susceptibility to Sulbactam/Durlobactam against the following bacteria for which Sulbactam has been shown to be active both clinically and in vitro:
Acinetobacter-baumannii calcoaceticus complex
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).