(109 days)
The "Sensititre® 18 - 24 hour MIC or Breakpoint Susceptibility System" is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms.
This 510(k) is for addition of Doxycycline in the dilution range of 0.03 - 16μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Doxycycline is for:
Aerobic and facultative Gram-negative and Gram-positive microorganisms:
Escherichia coli Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Streptococcus pyogenes Enterococcus spp. (faecalis and faecium) Staphylococcus aureus*
*Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.
Not Found
The provided text is a 510(k) premarket notification approval letter for the "Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System Doxycycline (0.03 -16 µg/mL) - Gram Negative and Gram Positive." This document approves the device for marketing and lists its indications for use. However, it does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the 510(k) summary or the actual study report submitted to the FDA during the review process.
Therefore, many of the requested details cannot be extracted from this document.
Here's what can be inferred or stated based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot be extracted. This document is the approval letter, not the study report itself. It does not contain the specific acceptance criteria (e.g., performance metrics, thresholds) or the detailed performance results of the device.
2. Sample size used for the test set and the data provenance:
- Cannot be extracted. The document does not specify the sample size of the test set or the provenance of the data (country of origin, retrospective/prospective).
- Likely Context: For an Antimicrobial Susceptibility Test (AST) device, the "test set" would consist of a collection of bacterial isolates tested against Doxycycline. Data provenance would typically involve controlled laboratory studies, often performed in multiple sites to ensure generalizability.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be extracted. This information is not present in the provided text.
- Likely Context: For AST devices, the "ground truth" (or reference method) is typically established using a standardized, often manually intensive, reference method suchest as broth microdilution or agar dilution as defined by clinical standards organizations (e.g., CLSI in the US). This is not typically an "expert consensus" process in the way it might be for image-based diagnostics. The "experts" would be skilled microbiologists performing the reference method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be extracted. This document does not mention an adjudication method.
- Likely Context: Adjudication methods (like 2+1) are typically used for subjective diagnostic interpretations (e.g., reading images). For AST devices, the reference method provides a more objective "ground truth," so a separate adjudication process as described is usually not applicable. Discrepancies between the device and the reference method would be analyzed, but not typically "adjudicated" by multiple readers in this manner.
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:
- Not applicable. This device is an Antimicrobial Susceptibility Testing system, not an AI-assisted diagnostic tool that aids human readers in interpreting results. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Partially applicable/inferred. The Sensititre® system determines MIC or breakpoint suscpetibility, which is essentially a "standalone" algorithmic or automated measurement process (without a human interpreting an image or complex patterns). The performance validation for such a system is, by nature, a "standalone" evaluation against a reference method. The document does not explicitly state "standalone study," but the nature of the device implies its performance is evaluated in this manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred: For an Antimicrobial Susceptibility Test (AST) device, the ground truth is established by a standardized reference method, typically a microbiological reference method like broth microdilution as defined by organizations like CLSI (Clinical and Laboratory Standards Institute). This is considered the definitive method for determining the Minimum Inhibitory Concentration (MIC) or susceptibility.
8. The sample size for the training set:
- Cannot be extracted. The document does not mention training sets.
- Likely Context: For an AST device, while there might be internal development and optimization using various isolates, the concept of a distinct "training set" in the machine learning sense is not explicitly used. The device's underlying principles are based on established microbiological methods and reagents, rather than a machine learning model trained on a large dataset in the way an AI diagnostic would be.
9. How the ground truth for the training set was established:
- Not applicable / Cannot be extracted. As mentioned above, the concept of a training set with specific ground truth establishment like in AI is generally not relevant for this type of device. The "ground truth" for evaluating the Sensititre system's performance would be the reference method results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 4 2009
Ms. Cynthia C. Knapp Director Lab Services Trek Diagnostic Systems Inc 982 Keynote Circle Suite 6 Cleveland, OH 44131
Re: K083606
Trade/Device Name: Sensitite® 18-24 hour MIC or Breakpoint Susceptibility System Doxycycline (0.03 -16 µg/mL) - Gram Negative and Gram Positive Regulation Number: 21 CFR 866.1640
Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: March 16, 2009 Received: March 17, 2009
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. Ilsting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attayma
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): t(083606
Device Name: The "Sensititre® 18 - 24 hour MIC or Breakpoint Susceptibility System" with Doxycycline (0.03 - 16μg/ml) for Gram Negative and Gram Positive's
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 positive and gram negative organisms.
This 510(k) is for addition of Doxycycline in the dilution range of 0.03 - 16μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Doxycycline is for:
Aerobic and facultative Gram-negative and Gram-positive microorganisms:
Escherichia coli Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Streptococcus pyogenes Enterococcus spp. (faecalis and faecium) Staphylococcus aureus*
*Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.
Prescription Use X (Part 21 CFR 801 Subpart D)
- September 2004. IS . Chican and the
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Fredda L. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K083601
§ 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).