(63 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic device for antimicrobial susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Moxifloxacin in the dilution range of 0.004 - 3 µgml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC panel for testing Streptococcus pneumoniae and Haemophilus Influenzae isolates.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Moxifloxacin. It confirms the substantial equivalence of the device to legally marketed predicate devices for the specified indications for use.
While the document confirms regulatory clearance based on substantial equivalence, it does not contain the detailed study results, acceptance criteria, or sample sizes related to the device's performance in the way requested. The 510(k) summary (which would include such information) is not provided in this extract.
Therefore, most of the requested information cannot be directly extracted from this document. However, based on the nature of a 510(k) submission for an antimicrobial susceptibility test, we can infer some general aspects and state what is missing.
Here's an attempt to answer the questions based on the provided text and general knowledge of such submissions:
Acceptance Criteria and Device Performance Study Information
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted directly from the provided text. The 510(k) letter confirms substantial equivalence but does not provide the specific performance data or the acceptance criteria used to demonstrate that equivalence. In a typical 510(k) for an AST device, this would involve comparing the device's Minimum Inhibitory Concentration (MIC) results and categorical agreement (Susceptible, Intermediate, Resistant) with a US FDA-approved reference method.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted directly from the provided text. The sample size for the test set (number of isolates tested) and the data provenance (e.g., country of origin, retrospective/prospective nature of the study) are not mentioned in this regulatory letter. This information would typically be detailed in the study report within the 510(k) submission.
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)
- Not applicable in this context. For antimicrobial susceptibility testing, the "ground truth" is typically established by comparing the device's results to a recognized reference method (e.g., broth microdilution according to CLSI standards) performed by trained laboratory personnel. It does not typically involve a panel of "experts" in the same way, for example, an imaging study would use radiologists. The accuracy of the reference method itself is the benchmark.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in this context. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are interpreting images or clinical data and there's a need to resolve discrepancies. For AST devices, the "adjudication" is generally based on pre-defined criteria for agreement between the test device and the reference method, and any significant discrepancies would trigger retesting or further investigation.
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 in vitro diagnostic susceptibility plate, not an AI-assisted diagnostic tool that involves human readers interpreting results in a comparative effectiveness study. Its performance is assessed on its ability to accurately determine antibiotic susceptibility.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself (the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates) is a standalone system for determining MICs. While a human is involved in performing the test and interpreting the result (e.g., reading the well for growth inhibition), the core performance assessment is of the device and its ability to provide accurate MICs and categorical interpretations (susceptible, intermediate, resistant) compared to a reference method. It's not an "algorithm-only" interpretation in the AI sense, but the device's analytical performance is evaluated independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for antimicrobial susceptibility testing is typically established by a reference method, most commonly the Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method. This method is standardized and validated, and its results are considered the gold standard for determining MIC values.
8. The sample size for the training set
- Cannot be extracted directly from the provided text. The 510(k) letter does not mention a training set. For in vitro diagnostic devices like this, the "training set" concept (as in machine learning) may not apply directly to the development of the susceptibility plate itself, but rather to the internal validation and optimization processes of the manufacturer. The regulatory submission focuses on the performance of the final device, which is evaluated against a test set (clinical isolates).
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" and its ground truth in the machine learning sense is not explicitly addressed in this type of regulatory document for an in vitro diagnostic test. If there were internal development/optimization studies, the ground truth would similarly be established by reference methods or other validated laboratory techniques.
In summary: The provided document is a regulatory clearance letter acknowledging substantial equivalence but does not contain the detailed performance study results that would typically be found in the 510(k) summary or the full submission. Therefore, most of the specific quantitative details about the study design and results are missing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of a stylized bird with three wing-like shapes, suggesting movement or flight. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 0 9 2002
Ms. Cynthia C. Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K021339
R021397
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Moxifloxacin
Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: March 6, 2002 Received: March 7, 2002
Dear Ms. Knapp:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of the enactment date of the Medical Device Amendments, or to conimered prices 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). and coometer rever (10) and the device, subject to the general controls provisions of the Act. The I ou may y are se revisions 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 If your de rise is exassinon 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 r loase of action and I Drivination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 vith 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 Of It 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/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
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510 (k) Number (If known):
Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates:
Indications For Use:
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in The Sensiture Haemophilus/Succeoceds phounting testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Moxifloxacin in the dilution range of 0.004 - 3 µgml to the This STO(K) is for the addition of Irloxinozacin in the U.C. panel for testing Streptococcus, Sensifitre Haemophilus influenzae isolates. The "Indications for Use" and clinical pheumoniae and Moxifloxacin is for: Haemophilus Influenzae
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Clinical Laboratory Devices | |
| 510(k) Number | K021339 |
| Prescription Use (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).