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The provided FDA letter (K211672) is for an Antimicrobial Susceptibility Test Powder (MTS Piperacillin-tazobactam). This type of device is used to determine the susceptibility of microorganisms to antimicrobial agents, which is crucial for guiding antibiotic treatment. The information provided in the FDA letter and its attachments does not typically contain the detailed performance study information common for AI/ML-based medical devices or imaging analysis software.
Therefore, many of the specific details requested in your prompt (e.g., sample size for training set, number of experts for ground truth, MRMC study effect size, AI assistance) are not applicable (N/A) to this specific device/submission type, as it is a microbiology culture-based test, not an AI/ML device.
However, I can extract the relevant information regarding the acceptance criteria and performance as typically presented for such devices.
Here's the summary based on the provided documents:
1. A table of acceptance criteria and the reported device performance
For Antimicrobial Susceptibility Testing (AST) devices like this, acceptance criteria typically involve demonstrating substantial equivalence to a predicate device and achieving acceptable Essential Agreement (EA) and Category Agreement (CA) with a reference method (e.g., CLSI broth microdilution). The acceptance criteria often align with FDA guidance for AST devices.
| Acceptance Criteria Category | Specific Criteria (Typical for AST) | Reported Device Performance (Implied from Clearance) |
|---|---|---|
| Preamble Criteria | Substantial Equivalence to Predicate | Was found "substantially equivalent" for stated indications. |
| Primary Performance Endpoints | Essential Agreement (EA) ≥ 90% | Implied to have met required EA thresholds for all tested organisms/drugs. |
| Category Agreement (CA) ≥ 90% | Implied to have met required CA thresholds for all tested organisms/drugs. | |
| Secondary Performance Endpoints | Major Discrepancies (MD) rate ≤ 3% | Implied to be within acceptable limits. |
| Very Major Discrepancies (VMD) rate ≤ 1.5% | Implied to be within acceptable limits. | |
| Reproducibility/Precision | Consistent results across replicates and sites | Implied to have demonstrated acceptable reproducibility and precision. |
| No Growth/Contamination | <5% (typical) | Implied to be within acceptable limits. |
Note: The specific numerical performance values (e.g., exact EA/CA percentages, MD/VMD rates for Piperacillin-tazobactam with MTS) are not present in these documents but would be found in the 510(k) summary or full submission.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided documents. For AST devices, this typically involves a large number of clinical isolates and challenge strains. FDA guidance often recommends testing hundreds to thousands of isolates covering various resistance mechanisms for each drug/bug combination.
- Data Provenance: Not explicitly stated. For AST devices, data is usually collected prospectively from clinical laboratories or reference labs, often across multiple sites (e.g., hospitals, public health labs) within the U.S. and potentially internationally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A) in the AI/ML sense. For AST devices, "ground truth" is established by a standardized reference method, typically CLSI (Clinical and Laboratory Standards Institute) broth microdilution. The interpretation of these reference method results is based on established CLSI breakpoints, not on expert consensus in the way AI/ML models are often validated. Oversight and review of study data are performed by clinical microbiologists and statisticians.
4. Adjudication method for the test set
- Not Applicable (N/A) in the AI/ML sense. Adjudication is not typically needed for AST ground truth. Results from the reference method (e.g., CLSI broth microdilution) are considered the definitive truth. Any discrepancies between the investigational device and the reference method would be categorized (e.g., EA, CA, MD, VMD) and analyzed, but not "adjudicated" by experts in the context of resolving disagreement on the ground truth itself.
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
- No (N/A). This is an Antimicrobial Susceptibility Test Powder, not an AI-assisted diagnostic imaging or analysis device. MRMC studies are not relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A) in the AI/ML sense. This is a laboratory diagnostic reagent. Its performance is evaluated intrinsically against a reference method, independently of a human "reading" the result in the AI/ML context. While a human interprets the output of the AST test, it's not "human-in-the-loop" in the way an AI algorithm assists a human.
7. The type of ground truth used
- Reference Method: The ground truth for AST devices is established using a Clinical and Laboratory Standards Institute (CLSI) sanctioned reference method, most commonly broth microdilution, interpreted using CLSI-established breakpoints.
8. The sample size for the training set
- Not Applicable (N/A). This device is not an AI/ML algorithm that requires a "training set." It is a reagent for phenotypic susceptibility testing.
9. How the ground truth for the training set was established
- Not Applicable (N/A). As it's not an AI/ML device, there is no "training set" or ground truth establishment for it in that context.
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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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
October 26, 2021
Liofilchem S. R. L. % Laura Koeth President Laboratory Specialists, Inc. 26214 Center Ridge Road Westlake, Ohio 44145
Re: K211672
Trade/Device Name: MTS Piperacillin-tazobactam 0.016/4 - 256/4ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY
Dear Laura Koeth:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 20, 2021. Specifically, FDA is updating this SE Letter to correct a typo in the IFU form 3881 as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ribhi Shawar, Ph.D. (ABMM), General Bacteriology and Antimicrobial Susceptibility Branch, 240-506-5573, ribhi.shawar(@fda.hhs.gov.
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 and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/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.
October 20, 2021
Liofilchem s.r.l. % Laura Koeth President Laboratory Specialists, Inc. 26214 Center Ridge Road Westlake. Ohio 44145
Re: K211672
Trade/Device Name: MTS Piperacillin-tazobactam 0.016/4 - 256/4ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: May 27, 2021 Received: June 1, 2021
Dear Laura Koeth:
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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
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 and Radiological Health 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)
Device Name
Indications for Use (Describe)
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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§ 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).