(98 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Cefdinir in the dilution range of 0.016 - 4 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 Cefdinir is for: Haemophilus Influenzae (including B-lactamase production strains)
Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefdinir 0.016-4 ug/ml
The provided text describes a 510(k) premarket notification for a medical device called "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefdinir 0.016-4 ug/ml." This device is an in vitro diagnostic product used for clinical susceptibility testing of certain bacteria to the antibiotic Cefdinir. The document confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain the detailed study information required to answer all parts of your request. Specifically, it lacks information about:
- Acceptance criteria and detailed reported device performance in a table format.
- Sample sizes used for test and training sets.
- Data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Whether MRMC or standalone studies were done, or their results/effect sizes.
- Type of ground truth used (beyond implying it's related to susceptibility testing which would typically involve laboratory reference methods).
- How ground truth for the training set was established.
The document primarily focuses on FDA's substantial equivalence determination for regulatory clearance based on the device's indications for use.
Based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a performance table. For in vitro diagnostic (IVD) devices like this, acceptance criteria typically involve demonstrating acceptable agreement (e.g., categorical agreement, essential agreement) with a predicate device or a gold standard method. The document only confirms the device's substantial equivalence to a predicate device, implying these criteria were met during the submission process.
2. Sample sized 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.
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, "ground truth" is typically established by laboratory reference methods (e.g., broth microdilution or agar dilution as per CLSI guidelines), not by expert human readers/adjudicators in the same way an imaging AI would use radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods as described (2+1, 3+1) are typically relevant for human interpretation of data, often in imaging or pathology, where human expert disagreement needs resolution. For an IVD like this, the 'ground truth' is usually an objective laboratory reference method, so human adjudication in this sense is not applicable.
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
An MRMC study is not applicable to this device. This device is an in vitro diagnostic test for antimicrobial susceptibility, not an AI or imaging device where human readers interact with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone diagnostic test (a susceptibility plate). It is not an algorithm with human-in-the-loop performance. Its "performance" would be its ability to correctly determine the susceptibility or resistance of bacteria to Cefdinir. The document states it is an "in vitro diagnostic product for clinical susceptibility testing," meaning it operates independently to provide a result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for antimicrobial susceptibility testing is typically established by reference laboratory methods, such as broth microdilution or agar dilution as defined by clinical and laboratory standards (e.g., CLSI guidelines). The document does not explicitly state which specific reference method was used, but this is the standard practice for such devices.
8. The sample size for the training set
This information is not provided in the document. IVD devices like this are not typically "trained" in the way AI algorithms are. They are developed based on known chemical reactions and bacterial physiology, and validated through extensive testing against reference methods.
9. How the ground truth for the training set was established
This information is not provided in the document, and the concept of a "training set" with ground truth in the AI sense is generally not applicable to this type of traditional IVD device. The development and validation involve testing against established microbiological reference methods.
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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
K021997 Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefdinir 0.016-4 ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: September 10, 2002 Received: September 11, 2002
Dear Ms. Knapp:
Re:
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 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 Sutman
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):
Image /page/2/Picture/1 description: The image shows a handwritten string of characters, "K021997". The characters are written in black ink on a white background. The characters are slightly uneven and have a casual, handwritten style.
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 vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae.
This 510(k) is for the addition of Cefdinir in the dilution range of 0.016 - 4 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 Cefdinir is for: Haemophilus Influenzae (including B-lactamase production strains)
(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 | K021997 |
| 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).