(83 days)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for the newly approved Oritavancin in the dilution range of 0.0005-8ug/ml to the Sensitire HP MIC Susceptibility plate for testing Streptococcus spp. The approved primary "Indications for Use" and clinical significance for Streptococus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus dysgalactia Streptococcus anginosus
The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/mL
This is a 510(k) premarket notification for "The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/ml." This device is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates, specifically for testing Streptococcus spp. The document you provided is an FDA clearance letter and an Indications for Use statement, not a detailed study report. Therefore, much of the requested information regarding the study design and acceptance criteria specifically for the device's performance is not available in these documents.
However, based on the information provided and general knowledge of FDA clearances for antimicrobial susceptibility testing (AST) devices, I can construct a partial answer.
Please note: The provided documents are limited. A full study report, often found in the 510(k) summary or detailed submission, would contain the complete information. The following response is an interpretation based on the given text and common practices for AST device clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list the acceptance criteria or reported device performance in a table format. However, for AST devices, FDA typically expects specific agreement rates between the investigational device and a reference method. The Indications for Use states that the device is for susceptibility testing of Streptococcus spp., and the clearance implies that the device met the FDA's criteria for substantial equivalence to a predicate device.
Typical Acceptance Criteria for AST Devices (Based on FDA Guidance for 510(k)s):
| Metric | Acceptance Criteria (Typical) | Reported Device Performance (Not explicitly stated in provided document) |
|---|---|---|
| Essential Agreement (EA) | ≥ 90% (Agreement between MIC values within +/- 1 two-fold dilution interval of the reference method) | (Not provided in the document) |
| Category Agreement (CA) | ≥ 90% (Agreement in categorical interpretation: Susceptible, Intermediate, Resistant) | (Not provided in the document) |
| Major Discrepancies (MD) | < 3.0% (Reference: Susceptible; Device: Resistant or Intermediate) | (Not provided in the document) |
| Very Major Discrepancies (VMD) | < 1.5% (Reference: Resistant; Device: Susceptible or Intermediate) | (Not provided in the document) |
Study Proving Acceptance Criteria:
The document states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..." This implies that Thermo Fisher Scientific submitted a study comparing the performance of the Sensititre HP MIC Susceptibility plate with Oritavancin to a recognized reference method (e.g., broth microdilution or agar dilution as described by CLSI standards) for the specified Streptococcus species. The results of this study demonstrated that the device met the FDA's acceptance criteria for Essential Agreement, Category Agreement, and acceptable rates of Major and Very Major Discrepancies.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided documents. For AST devices, FDA typically requires a significant number of isolates (e.g., hundreds) for each drug-bug combination, including a diverse representation of susceptible, intermediate, and resistant strains.
- Data Provenance: Not explicitly stated in the provided documents. Data for clinical studies for FDA clearance usually comes from multiple clinical laboratories, often in the US, to ensure representativeness. It would typically be prospective or a combination of retrospective and prospective isolates depending on the availability of strains and the clearance pathway.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this device. For AST devices, the "ground truth" (reference method) is typically a standardized laboratory method (e.g., broth microdilution or agar dilution) performed by trained microbiologists, not a panel of experts reviewing cases.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments (e.g., image interpretation). For AST, discrepancies between the investigational device and the reference method are usually resolved by re-testing or thorough investigation, not by an expert panel adjudication.
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 (IVD) antimicrobial susceptibility test, not an AI-based diagnostic tool that assists human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept doesn't directly apply. The device itself (the Sensititre plate) produces results (MIC values and categorical interpretations). The "standalone performance" is the device's accuracy in determining MICs and categories compared to the reference method. The device is standalone in the sense that its primary function is to provide an objective measurement. Clinical microbiologists then interpret these results in the context of patient care.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for AST devices is almost universally established by a standardized reference method, typically:
- Broth Microdilution (BMD): The most common reference method, performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines.
- Agar Dilution: Another recognized reference method.
These methods involve precise measurements of the minimum concentration of an antimicrobial agent that inhibits visible growth of a microorganism (Minimum Inhibitory Concentration - MIC).
8. The sample size for the training set
Not explicitly stated in the provided documents. For AST devices, "training set" doesn't apply in the common machine learning sense. Instead, product development involves extensive internal testing and optimization (sometimes called internal validation or verification) using numerous isolates before formal clinical studies for regulatory submission. The number of isolates used in this developmental phase would be considerably larger than the submission test set.
9. How the ground truth for the training set was established
Similar to the ground truth for the test set, the ground truth for any internal optimization or "training" phases would be established using standardized reference methods (e.g., Broth Microdilution) according to CLSI guidelines.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
THERMO FISHER SCIENTFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS 1 THERMO FISHER WAY OAKWOOD VILLAGE OH 44014-6
March 5, 2015
Re: K143526
Trade/Device Name: The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/mL
Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: JWY, LRG, LTT, LTW Dated: December 10, 2014 Received: December 12, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf –S for
Sally Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143526
Device Name
The Sensititre HP MIC Susceptibility plate with Oritavancin in the dilution range of 0.0005-8ug/ml
Indications for Use (Describe)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
This 510(k) is for the newly approved Oritavancin in the dilution range of 0.0005-8ug/ml to the Sensitire HP MIC Susceptibility plate for testing Streptococcus spp.
The approved primary "Indications for Use" and clinical significance for Streptococus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus dysgalactia Streptococcus anginosus
Type of Use (Select one or both, as applicable)
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).