(108 days)
For in vitro diagnostic use: System U3 is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation. This 510(k) application is for System U3/Piperacillin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 64 µg/ml and Resistant ≥ 128 µg/ml for use with P. aeruginosa, and Susceptible ≤ 16 µg/ml, Intermediate 32-64 µg/ml and Resistant ≥ 128 µg/ml for use with non-fastidious Gram negative aerobic bacteria.
The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.
The provided text describes a 510(k) premarket notification for the "System U3 for Piperacillin," an in vitro diagnostic device for antimicrobial susceptibility testing. The document focuses on regulatory approval rather than a detailed study report with specific acceptance criteria and performance data. Therefore, many of the requested details are not available in the provided text.
Based on the information available, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions MIC breakpoints for Piperacillin, which serve as acceptance criteria for susceptibility categories. However, it does not provide a table of the device's reported performance against these criteria.
| Acceptance Criteria (MIC Breakpoints for Piperacillin) | Reported Device Performance |
|---|---|
| For P. aeruginosa | Not provided in the text |
| - Susceptible ≤ 64 µg/ml | Not provided in the text |
| - Resistant ≥ 128 µg/ml | Not provided in the text |
| For non-fastidious Gram negative aerobic bacteria | Not provided in the text |
| - Susceptible ≤ 16 µg/ml | Not provided in the text |
| - Intermediate 32-64 µg/ml | Not provided in the text |
| - Resistant ≥ 128 µg/ml | Not provided in the text |
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 provided in the 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 provided in the text. The ground truth for antimicrobial susceptibility testing would typically be established by reference methods or expert consensus on those methods, but the specifics are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 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
This is an in vitro diagnostic device for antimicrobial susceptibility testing, which typically does not involve human "readers" in the same way as an imaging device would. Therefore, an MRMC study with human readers improving with AI assistance is not applicable to this type of device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "System U3" is a qualitative technique, not an algorithm in the AI sense. It's used to determine susceptibility categories based on an antibiotic gradient and MIC breakpoints. The performance described would inherently be "standalone" in the sense that the device itself performs the test, and the interpretation relies on direct measurement against predefined breakpoints. However, the exact experimental design for evaluating this standalone performance is not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for antimicrobial susceptibility testing is typically established using reference methods (e.g., broth microdilution, agar dilution) that are well-defined and accepted in microbiology. The document mentions "MIC break-point concentrations," implying comparison against these established standards. However, the specific ground truth method used in the study is not explicitly stated.
8. The sample size for the training set
This information is not provided in the text. For an in vitro diagnostic device of this nature, there isn't typically a "training set" in the machine learning sense. Instead, the device is developed and validated against a representative collection of bacterial isolates with known susceptibility profiles.
9. How the ground truth for the training set was established
As with point 8, the concept of a "training set" as in AI/machine learning isn't directly applicable here. If referring to the development and validation data, the ground truth would have been established by reference methods for antimicrobial susceptibility testing. The specific methods are not detailed in the provided text.
{0}------------------------------------------------
FEB 1 8 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Anne Bolmstrom President AB BIODISK North America Inc. 200 Centennial Avenue Piscataway , New Jersey 08854-3910
Re: K983890 Trade Name: System U3 for Piperacillin Regulatory Class: II Product Code: JWY Dated: February 5, 1999 Received: February 8, 1999
Dear Ms. Bolmstrom:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known):
Device Name: System U3™ for Piperacillin
Indications For Use:
For in vitro diagnostic use:
System U3 ** is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.
This 510(k) application is for System U3/Piperacillin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 64 µg/ml and Resistant ≥ 128 µg/ml for use with P. aeruginosa, and Susceptible ≤ 16 µg/ml, Intermediate 32-64 µg/ml and Resistant ≥ 128 µg/ml for use with non-fastidious Gram negative aerobic bacteria.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Woody Dubose | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K983890 |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The Counter Use |
|---|---|---|---|
| (Optional Format 1-2-96) |
§ 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).