(43 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic device for quantitative susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Cefotaxime in the dilution range of 0.016 - 4 µgml to the Sensititre Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Cefotaxime is for: Streptococcus pneumoniae
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The provided text is a 510(k) clearance letter for an in vitro diagnostic device, specifically for an antimicrobial susceptibility test plate to detect cefotaxime susceptibility in Streptococcus pneumoniae and Haemophilus influenzae. This type of document, while providing regulatory clearance, does not typically contain detailed study data or acceptance criteria in the format requested.
The information requested, such as specific performance metrics and study design details (sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.), would usually be found in the manufacturer's 510(k) submission itself, which is not publicly released in its entirety in this format.
Therefore, based solely on the provided text, I cannot generate the table of acceptance criteria and reported device performance, nor can I answer most of the detailed questions about the study design. The document confirms that a review was conducted and the device was deemed substantially equivalent to a predicate device, implying that appropriate studies were performed to support this claim, but the details of those studies are not present here.
Here's what can be inferred or stated from the provided text, with many questions remaining unanswered:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot be provided from the given text. The document does not contain a table of performance metrics (e.g., essential agreement, categorical agreement) or defined acceptance criteria for substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Not specified in the provided text. The document does not mention the sample size of the test set or the country of origin of the data. It also does not state whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text. This information is typically part of the detailed study protocol, which is not included in the clearance letter.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided 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:
- Not applicable. This device is an in vitro diagnostic antimicrobial susceptibility test, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study with human readers assisting AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied, but not explicitly detailed. For an in vitro diagnostic device like an antimicrobial susceptibility plate, "standalone performance" refers to the accuracy and reliability of the test itself in determining MICs, without human interpretation of complex images or data. The clearance implies that the device's performance in determining susceptibility has been evaluated, but the specifics are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but can be inferred as a reference method. For antimicrobial susceptibility testing, the typical "ground truth" or reference standard would be a well-established, validated reference method (e.g., broth microdilution or agar dilution performed according to CLSI guidelines) against which the new device's results are compared. The document doesn't explicitly name it but this is standard practice.
8. The sample size for the training set:
- Not applicable / Not specified. This device is an in vitro diagnostic test plate, not a machine learning or AI algorithm that typically has a "training set." The performance is based on the chemical and biological reactions on the plate.
9. How the ground truth for the training set was established:
- Not applicable / Not specified. As noted above, there isn't a "training set" in the context of typical machine learning for this type of device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia C. Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K013195
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefotaxime Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: LTT, JWY Dated: September 24, 2001 Received: September 25, 2001
NOV 0 7 2001
Dear Ms. Knapp:
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 to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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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/cdrb/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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NOV 0 7 2001
KD13195
510 (k) Number (If known): KO13195
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 Hacmophilas Occeptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Cefotaxime in the dilution range of 0.016 - 4 µgml to the I his 510(k) is for the adultion of Celotaxino in vie MIC panel for testing Streptococcus Sensitire Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Cefotaxime 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)
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Freddie H. Poole
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K013195 |
|---|---|
| --------------- | --------- |
| 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).