(44 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro quantitative and qualitative susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Clarithromycin in the dilution range of 0.016 - 16 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Clarithromycin is for: Streptococcus pneumoniae
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Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) clearance letter for a modified antimicrobial susceptibility testing plate, specifically for the addition of Clarithromycin. It does not contain a table of acceptance criteria or detailed performance data. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.
To provide an example relevant to this type of device, typical acceptance criteria for an antimicrobial susceptibility test (AST) in a 510(k) submission would involve demonstrating acceptable agreement with a reference method (e.g., broth microdilution or agar dilution). The performance metrics would generally be:
| Performance Metric | Acceptance Criteria (Example) | Reported Device Performance (Not in document, hypothetical) |
|---|---|---|
| Essential Agreement (EA) | ≥ 90% | (e.g., 96.5%) |
| Category Agreement (CA) | ≥ 90% | (e.g., 95.8%) |
| Major Discrepancies (MD) | < 3% | (e.g., 1.2%) |
| Very Major Discrepancies (VMD) | < 1.5% | (e.g., 0.8%) |
Note: The document only indicates that the FDA reviewed the information and found the device substantially equivalent. The specific performance data and acceptance criteria met for this determination would be in the full 510(k) submission, which is not included here.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given document. For an AST device, the test set would typically involve a specific number of bacterial isolates (e.g., hundreds) spanning a range of resistance mechanisms and susceptibility patterns to the antibiotic in question. The provenance would likely include diverse geographical regions to capture variability in strains.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given document. For AST, the "ground truth" is usually established by a reference method performed by trained microbiologists or laboratory personnel, not typically "experts" in the sense of clinicians or radiologists.
4. Adjudication Method for the Test Set
This information is not provided in the given document, as it's not applicable in the usual sense for AST. The reference method serves as the ground truth. Discrepancies between the investigational device and the reference method would be analyzed, but typically not "adjudicated" by a panel of experts like in imaging studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is primarily relevant for medical imaging devices where human interpretation is a critical component and the AI assists human readers. Antimicrobial susceptibility testing is a laboratory assay with a direct, quantitative output, not a human-interpreted image.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. Antimicrobial susceptibility tests, like the Sensititre plates, are inherently "standalone" in their function. The device (the plate with reagents) provides a result (MIC value) based on bacterial growth, and this result is then interpreted. There isn't typically a "human-in-the-loop" performance aspect similar to an AI algorithm assisting a radiologist. The performance evaluation focuses on the accuracy of the device itself in determining the MIC.
7. The Type of Ground Truth Used
The type of ground truth used for an antimicrobial susceptibility test like this would be results from an established and validated reference method, such as:
- Broth Microdilution (BMD): This is often considered the gold standard for MIC determination.
- Agar Dilution: Another well-established reference method.
The document itself does not explicitly state which reference method was used, but it would be one of these standard laboratory methods.
8. The Sample Size for the Training Set
This information is not provided in the given document. For an AST device, "training set" is not a typical term as it would be for a machine learning algorithm. The "training" for such a device involves developing and optimizing the reagent concentrations and interpretation algorithms (if any) using a large number of diverse isolates during the R&D phase, often distinct from the formal validation (test set).
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, the concept of a "training set" with established ground truth is generally not applied in the same way for these types of in vitro diagnostic devices as it would be for AI/ML. The development process would involve iterative testing of different plate formulations against known strains and established reference methods to ensure the device accurately determines MICs. The ground truth for this developmental work would also be derived from reference methods (e.g., BMD or agar dilution).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized caduceus-like symbol with three abstract human figures connected by flowing lines, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 2 2001
Ms. Cynthia C. Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K013580
K013360
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Clarithromycin Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: October 26, 2001 Received: October 29, 2001
Dear Ms. Knapp:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to Conniner to May 20, 1978, are cance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I vou may, morelore, mainer of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 device to such additional controls. Existing major regulations affecting your device can may or bund 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 I loase of actived that I termination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21 comps while/); 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, (201) 594-4539 - 12 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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): Kol 3580
Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
Indications For Use:
The Sensititte Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in The Sellshure Tracmopinas Busceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Clarithromycin in the dilution range of 0.016 - 16 µg/ml to This Sto(K) is for the addraon of Claricon of Clariconiae MIC panel for testing Streptococcus the Sensuite fraemophilus influenzae isolates. The "Indications for Use" and clinical significance of Clarithromycin is for: Streptococcus pneumoniae
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Luddi tu. Pocke
| (Division Sign-Off) | Division of Clinical Laboratory Devices |
|---|---|
| 510(k) Number | K01 3580 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------ | ------------------------------------------------------- | ---- | ---------------------- |
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).