(151 days)
The Sensititre HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System.
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.
This 510(k) is for the addition of Ceftaroline in the dilution range of 0.015-32μg/ml to the Sensititre HP MIC Susceptibility plate for testing Haemophilus influenzae and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.015-64μg/ml for testing gram negative isolates.
The approved primary "Indications for Use" and clinical significance of Ceftaroline is for:
Facultative Gram-negative Microorganisms:
Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Haemophilus influenzae
In vitro data, without clinical correlation is provided for:
Facultative Gram-Negative Microorganisms:
Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morganii Proteus mirabilis
Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).
Not Found
The provided text describes the 510(k) premarket notification for TREK Diagnostic Systems' Sensititre® 18-24 hour Susceptibility MIC Plates with the addition of Ceftaroline. However, the document does not contain the detailed acceptance criteria and study information typically found in a full scientific report or FDA submission.
The document primarily focuses on the FDA's clearance of the device based on substantial equivalence to a predicate device. It briefly mentions what the device is for ("clinical susceptibility testing") and lists some microorganisms, but does not provide specific performance metrics, study designs, or ground truth details.
Therefore, many of the requested details cannot be extracted from this specific document.
Below is a table summarizing the information that can be extracted, and highlighting where information is not provided in the document.
Acceptance Criteria and Device Performance for Sensititre® 18-24 hour Susceptibility MIC Plates with Ceftaroline
1. Table of Acceptance Criteria and Reported Device Performance
| Metric / Aspect | Acceptance Criteria (Not explicitly stated in this document) | Reported Device Performance (Not explicitly stated in this document in a tabular format) |
|---|---|---|
| Essential Agreement (EA) Rate | Not provided in document | Not provided in document |
| Category Agreement (CA) Rate | Not provided in document | Not provided in document |
| Major Discrepancies (MD) | Not provided in document | Not provided in document |
| Very Major Discrepancies (VMD) | Not provided in document | Not provided in document |
| Minor Discrepancies (mD) | Not provided in document | Not provided in document |
| Dilution Range | For Haemophilus influenzae: 0.015-32 μg/ml (Ceftaroline on Sensititre HP MIC Plate) For gram negative isolates: 0.015-64 μg/ml (Ceftaroline on Sensititre 18-24 hour MIC panel) | The device is intended for use with Ceftaroline in these dilution ranges. The document does not provide performance results within these ranges as compared to a reference method. |
| Microorganisms tested for resistance | Not provided in document (But lists organisms for which in vitro data without clinical correlation is provided) | Not provided in document |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document refers to "in vitro data," suggesting laboratory testing, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified in the document. The document refers to the device for "clinical susceptibility testing," implying comparison to a reference method, but no details of expert involvement or their qualifications are given.
4. Adjudication method for the test set
- Not specified in the document.
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
- No mention of an MRMC study or AI. This device is an in vitro diagnostic product for antimicrobial susceptibility testing, which typically does not involve human readers in the same way an imaging AI study would.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an in vitro diagnostic susceptibility test plate. The device itself is the "algorithm" in a sense, as it provides the results based on microbial growth. The document does not describe separate algorithm performance.
7. The type of ground truth used
- Not explicitly stated. For antimicrobial susceptibility testing (AST) devices, the "ground truth" generally refers to a recognized reference method (e.g., CLSI broth microdilution or agar dilution reference methods). The document implies the device provides "susceptibility testing," suggesting comparison to a reference standard, but the specific standard is not named nor are the results of such a comparison provided.
8. The sample size for the training set
- Not applicable as this is an in vitro diagnostic product, not an AI/ML model that requires a "training set" in the conventional computational sense. The "development" of such a test involves formulation and testing against a large number of clinical isolates, but these are not framed as a "training set."
9. How the ground truth for the training set was established
- Not applicable (see point 8).
Summary of what the document does provide:
- Device Name: Sensititre® 18-24 hour Susceptibility MIC Plates with Ceftaroline
- Intended Use: Clinical susceptibility testing of fastidious (Sensititre HP MIC Plate) and non-fastidious (Sensititre 18 - 24 hour MIC panel) isolates.
- Dilution Range for Ceftaroline: 0.015-32 μg/ml for Haemophilus influenzae (on HP plate) and 0.015-64 μg/ml for gram negative isolates (on 18-24 hour panel).
- Microorganisms for which "in vitro data, without clinical correlation is provided": Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Enterobacter aerogenes, Moraxella catarrhalis, Morganella morganii, Proteus mirabilis.
- Microorganisms for which "Approved primary 'Indications for Use' and clinical significance of Ceftaroline is for": Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Haemophilus influenzae.
- Limitations: Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
TREK Diagnostic Systems, Ltd. C/o Cindy Knapp Director of US Regulatory and Global Clinical Affairs 982 Keynote Circle, Suite 6 Cleveland OH 44131
NOV - 8 2011
Re: K111615
Trade/Device Name: Sensititre® 18-24 hour Susceptibility MIC Plates Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: November 2, 2011 Received: November 4, 2011
Dear Cindy 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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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
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Page 2 - Ms. Knapp
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jail C. Harper
Sally Hojvat 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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510(k) Number (if known):
Device Name: Sensititre® HP MIC Susceptibility Plate with Ceftaroline (0.015-32µg/ml) and The Sensititre® 18 - 24 hour MIC Susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml)
Indications for Use: The Sensititre HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System.
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates._The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.
This 510(k) is for the addition of Ceftaroline in the dilution range of 0.015-32μg/ml to the Sensititre HP MIC Susceptibility plate for testing Haemophilus influenzae and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.015-64μg/ml for testing gram negative isolates.
The approved primary "Indications for Use" and clinical significance of Ceftaroline is for:
Facultative Gram-negative Microorganisms:
Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Haemophilus influenzae
In vitro data, without clinical correlation is provided for:
Facultative Gram-Negative Microorganisms:
Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morganii Proteus mirabilis
Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).
Prescription Use X (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)
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Pole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111615
§ 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).