(47 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the elimination of limitations in the sensititre technical insert. The limitation to be removed are as follows: 2.) The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually. A nitrocefin Beta lactamase test should be performed to detect B-lactamase producing strains of enterococci. 3.) The ability of the Sensititre System to detect resistance with amoxicillin/clavulanic acid with Enterococcus sp., and gentamicin (500 ug/mL) with Enterococcus faccium is unknown because too few resistant strains were available at the time of comparative testing. The addition of the following limitation in the Sensititre technical insert: The autoreader system should not be used Nitrofurantoin with Enterococcus species. Nitrofurantoin should be read manually. The ability to detect resistance with nitrofuantoin is unknown because too few resistant strains were available at the time of comparative testing.
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This document is a 510(k) premarket notification acceptance letter from the FDA for a Susceptibility Test Panel. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device. However, it does not include detailed study information, acceptance criteria tables, or performance data typically found in a clinical study report or a summary of safety and effectiveness.
Therefore,Based on the provided document, I cannot fulfill all components of your request, as the document is an FDA acceptance letter and not a detailed study report. It states what limitations are being removed and added to the device's technical insert, implying that certain studies were done to support these changes, but it does not provide the study details requested.
Here's what I can extract or infer from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The document is an FDA clearance letter, not a scientific study report. It mentions the "elimination of limitations" and "addition of a limitation" for the Sensititre system, implying that testing was conducted to support these changes, but the specific acceptance criteria and performance results are not detailed.
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 document. The text mentions "lack of performance data on emerging resistant Enterococcus sp." and "too few resistant strains were available at the time of comparative testing" for specific drug-organism combinations, suggesting that the initial testing datasets had limitations, but it does not detail the sample sizes or provenance of the data used for the re-evaluation.
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 document. For antimicrobial susceptibility testing, the "ground truth" is typically established by reference methods and expert interpretation of results, but the specifics are not included here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 not applicable to this device. The device is an "Antimicrobial Susceptibility Test" system (Susceptibility Test Panel), not an AI-assisted diagnostic imaging device that involves human readers interpreting images. The mention of "AutoReader system" refers to an automated instrument for reading the susceptibility tests, not an AI for human augmentation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described is the "Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System." The document mentions the "AutoReader system" and limitations regarding its use for certain organisms (e.g., Enterococcus sp.) and drugs (Nitrofurantoin), suggesting there is an automated component. The statement "The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually" implies that a standalone (automated) assessment for Enterococcus sp. was initially not sufficient. The subsequent removal of this limitation suggests improved standalone performance was demonstrated. However, specific standalone performance metrics are not given.
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 or agar dilution as defined by CLSI (Clinical and Laboratory Standards Institute) guidelines. This document doesn't explicitly state the ground truth method but implies the use of comparative testing against established methods.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document. As mentioned for the test set, it would likely be established using reference antimicrobial susceptibility testing methods.
In summary, this FDA letter confirms the clearance of a device based on its substantial equivalence and the resolution of previous limitations. It does not contain the detailed study results, methodologies, or specific performance metrics that would answer most of your questions. Such information would typically be found in the 510(k) submission itself or a summary of safety and effectiveness, neither of which is part of these provided pages.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol representing the human profile, depicted as three overlapping silhouettes.
Food and Drug Administration 2098 Gaither Road · Rockville MD 20850
SEP 2 5 2002
Ms. Cynthia C. Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K022775
Trade/Device Name: Susceptibility Test Panel Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: August 2, 2002 Received: August 9, 2002
Dear Ms. 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. 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 (PMA), 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 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsmaldsmamain.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
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510 (k) Number (If known): Device Name: Susceptibility Test Panel
Indications For Use:
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product
for clinical susceptibility testing of gram negative and gram positive organisms.
This 510(k) is for the climination of limitations in the sensititre technical insert. The limitation to be removed are as follows:
2.) The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually. A nitrocefin Beta lactamase test should be performed to detect B-lactamase producing strains of enterococci. 3.) The ability of the Sensititre System to detect resistance with amoxicillin/clavulanic acid with Enterococcus sp., and gentamicin (500 ug/mL) with Enterococcus faccium is unknown because too few resistant strains were available at the time of comparative testing.
The addition of the following limitation in the Sensititre technical insert:
The autoreader system should not be used Nitrofurantoin with Enterococcus species. Nitrofurantoin should be read manually. The ability to detect resistance with nitrofuantoin is unknown because too few resistant strains were available at the time of comparative testing.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
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Division of Clinical Laboratory Devices
| 510(k) Number | K022775 |
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Prescription Use W (Per 21 CFR 801.109
OR
Over-The-Counter Use
§ 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).