(83 days)
The Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates and Justone are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species from clinical specimens.
Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus pneumoniae and Streptococcus species and manually with H. influenzae. The JustOne® strip can only be read manually.
This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates on the Sensititre® (HP) MIC susceptibility system. The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for:
Aerobic facultative Gram-positive microorganisms Streptococcus pneumoniae (Penicillin susceptible stains only)
Not Found
The information provided is a 510(k) premarket notification letter from the FDA, approving the Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, Tigecycline (0.004 - 8ug/mL). This document primarily contains the regulatory approval status and indications for use. Key information about the device's performance study and acceptance criteria is not explicitly detailed in the provided text.
Specifically, the document states:
- The device is an in vitro diagnostic product for susceptibility testing.
- The 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates.
- The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for Streptococcus pneumoniae (Penicillin susceptible stains only).
To address your request, I will outline the typical information that would be found in a study report for such a device, and explicitly state what is missing from this FDA letter.
Missing Information:
The provided text does not contain any details about the acceptance criteria, the specific study conducted, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies. These details would typically be found in the 510(k) submission itself or a separate study report, which is not included here.
Therefore, the following sections will indicate where the requested information would normally be found or what typical approaches are used for such devices, and will explicitly state that the specific details are not available in the provided document.
Acceptance Criteria and Reported Device Performance
Specific data for acceptance criteria and reported device performance are NOT available in the provided text.
For an antimicrobial susceptibility test (AST) device like the Sensititre® plates, the acceptance criteria would typically focus on agreement rates with a predicate method (e.g., broth microdilution) for categorical agreement (Sensitive, Intermediate, Resistant) and essential agreement (within +/- 1 dilution).
A hypothetical table showing typical acceptance criteria and what would be reported for an AST device:
| Performance Metric | Acceptance Criteria (Typical) | Reported Device Performance (Specifics NOT in provided text) |
|---|---|---|
| Essential Agreement (EA) | ≥ 90% | Not provided in the document |
| Categorical Agreement (CA) | ≥ 90% | Not provided in the document |
| Major Discrepancies (MD) | < 3% | Not provided in the document |
| Very Major Discrepancies (VMD) | < 1.5% | Not provided in the document |
| Minor Discrepancies (mD) | < 10% | Not provided in the document |
Study Details (Information NOT in provided document)
Since the specific study details are not in the provided 510(k) letter, I will indicate typical practices for such studies.
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Sample size used for the test set and the data provenance:
- Sample Size: For an AST device for a specific drug/organism combination (like Tigecycline for S. pneumoniae), the test set would typically involve a minimum of 200-300 isolates of the target organism, with a sufficient distribution across susceptible, intermediate, and resistant categories (if applicable for the drug). This would include both challenge strains (well-characterized strains with known resistance mechanisms) and clinical isolates.
- Data Provenance: The isolates would typically come from multiple clinical laboratories within the United States (and potentially other countries like Canada or Europe) to ensure diversity. The data would be prospective or retrospective clinical isolates collected and tested according to a predefined protocol.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: For AST devices, "experts" in the traditional sense of clinicians or radiologists is less applicable for ground truth determination. Instead, the "ground truth" (reference method) is established by following standardized, well-accepted laboratory procedures (e.g., CLSI broth microdilution or agar dilution methods). The personnel performing these reference tests would be highly trained microbiologists or laboratory technicians with extensive experience in antimicrobial susceptibility testing, often adhering to Good Laboratory Practices (GLP). Sometimes, a single expert or supervisor might oversee the reference testing.
- Qualifications of Experts: Clinical microbiologists or laboratory scientists with 5+ years of experience in antimicrobial susceptibility testing according to CLSI or ISO standards.
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Adjudication method for the test set:
- Adjudication Method: For AST devices, adjudication is typically not done through multiple human readers in the same way it would be for imaging studies. Instead, discrepancies between the investigational device and the reference method are investigated by repeat testing or by using an alternative reference method. If a discrepancy persists, the isolate might be retested on both systems, or a third, highly reliable method might be used to confirm its true susceptibility profile.
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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:
- MRMC Study: Highly unlikely for this type of device. MRMC studies are primarily relevant for imaging diagnostics where human interpretation plays a significant role and AI is often used as an aid for readers. This device is an in vitro diagnostic for automated or manual reading of microbial growth, not for human interpretation of complex images. Therefore, the concept of "improving human readers with AI assistance" is not applicable here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in a way. The performance of the Sensititre® plates, whether read manually or automatically (Sensititre Autoreader and/or ARIS), is assessed against the reference method. The "algorithm" here refers to the system's ability to accurately determine MICs and categorize susceptibility based on microbial growth, independent of human interpretive bias. The study focuses on the accuracy of the device itself to produce the correct susceptibility result.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth: For AST devices, the ground truth is established by a conventional, well-established reference method, most commonly the Clinical and Laboratory Standards Institute (CLSI) broth microdilution method or agar dilution method. This is considered the "gold standard" for determining bacterial susceptibility to antimicrobials in vitro. It is not expert consensus, pathology, or outcomes data.
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The sample size for the training set:
- Training Set Sample Size: Not applicable in the typical sense for this specific device. The Sensititre® plates are a phenotypic test system, not an AI or machine learning algorithm that requires a "training set" of data to learn patterns. The "development" of the plate involves extensive in-house testing to ensure accurate dilution ranges, media composition, and stable drug concentrations, but this isn't a "training set" like in deep learning. If the auto-reader component were using AI/ML, then a training set would be relevant for that specific aspect, but the primary device (the plate itself) doesn't use one.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable as there is no "training set" for the Sensititre® plates themselves in the machine learning sense. The reference method would be used during the validation of the full system (plate + reader) and during the initial development phases to ensure the plate's inherent accuracy.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
FEB 2 5 2010
Ms. Cindy Knapp Director, Lab Services TREK Diagnostics Systems, Inc., 982 Keynote Circle, Suite 6 Cleveland, OH 44131
Re: K093741
Trade/Device Name: Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, Tigecycline (0.004 - 8ug/mL) Regulation Number: 21 CFR § 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System
Regulatory Class: II Product Code: JWY, LRG Dated: December 2, 2009 Received: December 4, 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, 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895.
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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).
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Freddie Lu. Poole
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): K09 374/
Device Name: Sensititre Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, Tigecycline (0.004 - 8μg/mL)
Indications for Use:
The Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates and Justone are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species from clinical specimens.
Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus pneumoniae and Streptococcus species and manually with H. influenzae. The JustOne® strip can only be read manually.
This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates on the Sensititre® (HP) MIC susceptibility system. The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for:
Aerobic facultative Gram-positive microorganisms Streptococcus pneumoniae (Penicillin susceptible stains only)
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Luddie L. Poolv
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
510(k) K093741
§ 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).