(56 days)
The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus species to azithromycin (0.25 - 2 ug/mL), amoxicillin/clavulanic acid (2/1 -- 16/8 ug/mL), cefotaxime (0.12 - 4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
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Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study:
Based on the provided text, the device is the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates with specific antimicrobial agents. The 510(k) submission (K062022) is for the addition of Streptococcus species to the existing indications for azithromycin, amoxicillin/clavulanic acid, and cefotaxime when used with these plates.
The document primarily focuses on the regulatory approval for an expanded indication and does not contain detailed information about a specific study proving the device meets acceptance criteria in terms of analytical performance metrics like accuracy, essential agreement, or categorical agreement against a gold standard. Instead, it refers to "in vitro data," likely meaning internal validation studies the manufacturer performed to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested fields cannot be directly populated from the provided submission. However, an attempt has been made to infer or state what information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Antimicrobial Agent: Azithromycin | Clinical Significance: | The document states "The approved primary 'indications for use' and clinical significance of azithromycin is for: Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes with activity against: Streptococci (Groups C, F, G), Viridans group streptococci." No specific performance metrics (e.g., % agreement with a reference method) are provided in this regulatory letter. The acceptance criteria would typically involve demonstrating a high level of agreement (e.g., >90-95% Essential Agreement and Categorical Agreement) with a recognized reference method like broth microdilution or agar dilution. |
| Antimicrobial Agent: Amoxicillin/clavulanic acid 2:1 ratio | Clinical Significance: | The document states "The approved primary 'indications for use' and clinical significance of amoxicillin/clavulanic acid 2:1 ratio is for: Streptococcus pneumoniae ** (non beta lactamase producing organisms), with in vitro data available for Streptococcus pyogenes ** (clinical significance unknown)." No specific performance metrics are provided. Similar to azithromycin, acceptance criteria would be based on agreement with a reference method. |
| Antimicrobial Agent: Cefotaxime | Clinical Significance: | The document states "The approved primary 'indications for use' and clinical significance of cefotaxime is for: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus spp." No specific performance metrics are provided. Similar to the other antibiotics, acceptance criteria would be based on agreement with a reference method. |
| Device Purpose: In vitro diagnostic product for clinical susceptibility testing | Successfully demonstrated substantial equivalence for expanded Streptococcus species indication. | The FDA letter grants market clearance based on substantial equivalence to a legally marketed predicate device, implying that the manufacturer's internal studies met the necessary regulatory thresholds for performance, which generally include agreement with a reference method. However, the specific acceptance thresholds and reported performance metrics are not detailed in this public regulatory letter. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided documents. The general requirement for antimicrobial susceptibility test (AST) devices during FDA clearance would typically involve a statistically significant number of isolates for each species and drug combination, often in the hundreds of isolates for clinical trials and potentially hundreds more for challenge isolates.
- Data Provenance: Not specified. It's highly likely to be prospective clinical isolates and possibly retrospective challenge isolates, often collected from various geographical locations (e.g., across the US or internationally) to ensure diversity.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not specified. For AST devices, ground truth is typically established by a reference method like broth microdilution or agar dilution, performed by trained microbiologists, rather than experts establishing a "ground truth" diagnosis. If any expert review were involved (e.g., for interpreting discordant results), their numbers and qualifications are not mentioned.
4. Adjudication Method for the Test Set
- Not specified. For AST devices, adjudication would typically involve revisiting isolates with discordant results between the investigational device and the reference method. This often involves retesting by both methods or using a third, confirmatory method. The method for resolving these discrepancies (e.g., a "2+1" rule where two out of three agree, or expert consensus) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No. This document describes an antimicrobial susceptibility test (AST) plate, which is a laboratory device for determining bacterial resistance to antibiotics. It is not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, not directly applicable in the AI sense. The device itself is a phenotypic test that produces a result (MIC value, susceptible/intermediate/resistant category). While it might be read by an automated reader, the device itself is not an "algorithm" in the context of AI. The performance evaluation would be of the device's ability to accurately determine susceptibility, not an AI algorithm's standalone performance.
7. The Type of Ground Truth Used
- Reference Method (e.g., Broth Microdilution or Agar Dilution): For antimicrobial susceptibility testing, the universally accepted "ground truth" is a standardized reference method, such as broth microdilution or agar dilution, often performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. This is the standard against which new AST devices are compared.
- Pathology/Outcomes Data: Not typically used as ground truth for AST device performance, which focuses on the in-vitro bacterial response to antibiotics.
8. The Sample Size for the Training Set
- Not specified. For AST devices, the "training set" concept is less directly applicable than in machine learning. Instead, product development involves extensive internal validation and optimization using a large collection of isolates (likely thousands) to ensure accurate growth and antimicrobial activity across different strains and concentrations. This "internal validation" serves a similar purpose to a training set in optimizing the device's design.
9. How the Ground Truth for the Training Set Was Established
- Not specified directly. Similar to the test set, the "ground truth" during the development and optimization (analogous to training) of an AST plate would be established using a standardized reference method (e.g., broth microdilution or agar dilution) on a large bank of characterized bacterial isolates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
SEP 1 1 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
K062022 Re:
Trade/Device Name: Sensititre® Haemophilus inflenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates Azithromycin (0.25-2 ug/ml), Amoxicillin/clavulanic acid 2:1 ratio (2/1-16/8 µg/ml), Cefotaxime (0.12-4 ug/ml)
Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: July 12, 2006 Received: July 17, 2006
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. 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).
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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)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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,
Sally, Watson
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): K 062022
Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Azithromycin (0.25-2μg/ml), Amoxicillin/clavulanic acid 2:1 ratio (2/1-16/8 µg/ml), Cefotaxime (0.12-4 µg/ml)
Indications For Use:
The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species.
This 510(k) is for the addition of Streptococcus species to azithromycin (0.25 - 2 ug/mL), amoxicillin/clavulanic acid (2/1 -- 16/8 ug/mL), cefotaxime (0.12 - 4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates .
The approved primary "indications for use" and clinical significance of azithromycin is for:
Streptococcus agalactiae, Streptococcus pneumoniae,
Streptococcus pyogenes
With activity against:
Streptococci (Groups C, F, G)
Viridans group streptococci.
The approved primary "indications for use" and clinical significance of amoxicillin/clavulanic acid 2:1 ratio is for:
Streptococcus pneumoniae **
The following in vitro data are available but their clinical significance is unknown:
Streptococcus pyogenes **
- **These are non beta lactamase producing organisms, and therefore are susceptible to amoxicillin alone.
The approved primary "indications for use" and clinical significance of cefotaxime is for:
Streptococcus pneumoniae Streptococcus pyogenes Streptococcus spp.
Fred Lee W. Poole
sion Sign-Or
Office of In Vitro Diagnostic Device Evaluation and Safe
510(k) K06 2022
pg. 1 of 2
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Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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 W. Cool.
ision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Satety
510(k) K062027
Pg. 2 of 2
§ 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).