(74 days)
The Quantra® QPlus® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra QPlus System is intended for in vitro diagnostic use.
The Quantra Hemostasis Analyzer uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation. The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a 3.2% citrated venous whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes tests with a heparin neutralizer.
The system is intended to be used by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Time Ratio (CTR).
The Quantra QPlus System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure.
Results obtained with the Quantra OPlus System should not be the sole basis for patient diagnosis.
The Quantra QPlus System is an in vitro diagnostic device designed to assess a patient's coagulation system by measuring the viscoelastic properties of a blood sample during clot formation in surgical and intensive care settings. The system consists of the Quantra Hemostasis Analyzer (instrument), QPlus Cartridge (single-use disposable cartridge) and Quantra Quality Controls (external Quality Control materials).
This document describes a Special 510(k) submission for a software modification to the Quantra QPlus System. The modification involves the implementation of an optional accessory called the Quantra Desktop Remote Viewer (QDRV) software application. The primary purpose of this submission is to demonstrate that the modified device, particularly the QDRV, does not alter the device's intended use or fundamental scientific technology and thus maintains substantial equivalence to the previously cleared Quantra QPlus System (DEN180017).
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of clinical or analytical validation for this specific Special 510(k) submission. This is because the submission is for a software modification (QDRV) that allows for remote viewing of results and doesn't change the core functionality or intended use of the Quantra QPlus System itself.
Therefore, the acceptance criterion for this submission is implicitly the demonstration of substantial equivalence to the predicate device, meaning the new software does not negatively impact the safety or effectiveness of the previously cleared system.
The reported device performance for the new QDRV software is that it allows "remote viewing of real-time (active) and historical test results created by the Quantra Hemostasis Analyzer only by authorized users. Users cannot manipulate the test data that is stored on the Quantra Hemostasis Analyzer and displayed within the QDRV software application. Users cannot input any additional clinical data into the QDRV software application or the Quantra Hemostasis Analyzer from the QDRV." This functionality is compared against the predicate device which "Not Applicable" for this remote viewing feature.
Table 1: Comparison of Modified Device (with QDRV) and Predicate Device
| Feature/Characteristic | Modified Device (with QDRV) | Predicate Device (DEN180017) |
|---|---|---|
| Intended Use | Same as predicate device | The Quantra® QPlus® System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. It is intended for in vitro diagnostic use to evaluate viscoelastic properties of whole blood in perioperative patients age 18 and older to assess hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries. |
| Fundamental Scientific Technology | Unchanged | Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. |
| Quantra Hemostasis Analyzer Software Version | v1.10.6 | v.1.6.15 |
| Quantra Desktop Remote Viewer (QDRV) | Optional software application (v2.1.15) for remote viewing of non-manipulable real-time and historical test results. | Not Applicable (This feature was not present in the predicate device.) |
| Impact on Safety/Effectiveness | No expected change as core functionality remains the same; QDRV is a viewing-only tool. | Already cleared as safe and effective. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document focuses on a software modification (QDRV) for remote viewing. Clinical or analytical performance studies with specific sample sizes from test sets are not described or required for this type of Special 510(k) submission, as the core analytical performance parameters of the Quantra QPlus System are not being altered. The submission confirms that the change "does not affect the device's intended use nor alter the device's fundamental scientific technology." Therefore, previous validation data for the predicate device would be referenced, but no new clinical or analytical study data for the QDRV itself are presented here.
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)
Not applicable. As described above, this submission is for a software accessory that enables remote viewing of existing analytical results. It does not involve new diagnostic interpretations or ground truth establishment based on expert consensus for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This submission does not involve a test set requiring expert 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. The Quantra QPlus System is a coagulation measurement device, not an AI-assisted diagnostic imaging system that would typically use MRMC studies. The QDRV is a viewing tool, not an AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an "algorithm only (standalone)" performance study as commonly understood for AI/ML devices. The Quantra QPlus System measures viscoelastic properties of blood. The QDRV is a software interface for displaying these measurements. The "performance" of the QDRV is its ability to accurately display the data generated by the Quantra Hemostasis Analyzer without allowing manipulation. This is typically verified through software validation and verification, not a standalone clinical performance study like an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The QDRV displays output from an IVD device. The accuracy of the displayed data is verified against the data stored on the Quantra Hemostasis Analyzer using software validation methods, not medical "ground truth" derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. The QDRV is a commercial software product and not an AI/ML model that requires a "training set" in the context of machine learning model development.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this software modification.
§ 864.5430 Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
(a)
Identification. A coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in perioperative patients, as an aid in the assessment of coagulopathies when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include detailed documentation of, and results from, the following:
(i) A study assessing precision using protocols determined to be acceptable by FDA, to cover the measurement range for each reported parameter (test output). Testing must include native specimens with coagulation profiles representative of the intended use population. In order to cover the measuring range, testing may include a limited number of contrived specimens, not to exceed 10 to 20 percent, or as otherwise deemed appropriate by FDA. The contrived specimens must be prepared to resemble clinical specimens. This testing must evaluate repeatability and reproducibility and provide assessments of within-run, within-day, between-run, between-day, between-reagent lot, between-instrument, between-site, and between-operator precision, as applicable to the system;
(ii) Studies that demonstrate the performance of each parameter (test output) throughout the claimed measurement range, to include linearity studies or dose-response studies, as applicable to the parameter (test output);
(iii) Potential interferent study that includes evaluation of hemolyzed and lipemic samples as potential interferents; exogenous and endogenous interferents associated with each patient population intended for use with the device, and which might be expected to affect assay performance, must be evaluated; and potential interferents that are specific for, or related to, the technology or methodology of the device. Evaluation of all potential interferents must be performed using a protocol determined to be acceptable to the FDA (
e.g., an FDA-recognized standard) and include both normal and abnormal specimens covering coagulation profiles representative of the intended use population;(iv) A study that evaluates specimen stability under the intended conditions for specimen collection, handling, and storage, using samples that cover the coagulation profiles representative of the intended use population, and using protocols determined to be acceptable by FDA;
(v) A multisite clinical study, determined to be acceptable by FDA, demonstrating performance, relative to clinically relevant and clinically validated laboratory test(s) for each parameter (test output). Further, the study must meet all of the following criteria:
(A) The study must be performed in the intended use population and include representation from all patient populations for whom the device is intended to be used. Potential endogenous and exogenous interferents for each target patient population must be evaluated or known prior to the study;
(B) The study must be conducted at a minimum of three external sites representative of the intended use setting by the intended operators;
(C) Test samples must be collected at time intervals relevant to the device's use in the intended use population;
(D) Clinical specimens, which cover coagulation profiles representative of the intended use population, must be evaluated at each of the three clinical sites in the study;
(E) Analysis of the concordance of clinical interpretation of patient coagulation status made from individual test parameter (test output) results as compared to clinical interpretation of coagulation status from a clinically relevant laboratory test or tests (
e.g., a comparative viscoelastic device or standard laboratory tests) must be conducted; and(F) Expected (reference) values for each parameter (test output) must be demonstrated by testing a statistically appropriate number of samples from apparently healthy normal individuals;
(vi) For a device with a user interface that has information that needs to be interpreted by the user in correctly using the device to achieve the intended test results or a device that does not provide a final output that is a comprehensive interpretation of all parameter (test output) results, a study evaluating the ability of device users to correctly interpret results;
(vii) For any device indicated to guide blood product use, a clinical outcome study determined to be acceptable by FDA that specifically validates the device's indicated use in guiding blood product use; and
(viii) For any device indicated to guide use of medication, a clinical outcome study determined to be acceptable by FDA that specifically validates the device's indicated use in guiding use of medication.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A summary of results from the study required by paragraph (b)(1)(i) of this section, including repeatability, reproducibility, and assessments of within-run, within-day, between-run, between-day, between-reagent lot, between-instrument, between-site, and between-operator precision, as applicable to the system.
(ii) The claimed measurement range of each parameter (test output), as supported by demonstrated performance of the parameter (test output) throughout the claimed measurement range, including studies required by paragraphs (b)(1)(i) through (iii) and (v) of this section, and, if applicable, paragraphs (b)(1)(vii) and (viii) of this section.
(iii) Identification of known interferents, including all endogenous, exogenous, technology-specific, and patient population-specific interferents, specific to each parameter (test output). The information must include the concentration(s) or level(s) at which interference was found to occur and the concentration range or levels at which interference was not found to occur.
(iv) Information regarding the multisite clinical study required by paragraph (b)(1)(v) of this section, including:
(A) Each patient population evaluated;
(B) Each intended use setting and the operators;
(C) A summary of the results, including the concordance analysis to clinically relevant laboratory test(s); and
(D) Demonstrated expected (reference) values for each parameter (test output).
(3) The labeling required under § 809.10 of this chapter must include the following:
(i) A limiting statement that the result(s) from the device is(are) not intended to be used as the sole basis for a patient diagnosis.
(ii) Unless appropriate clinical outcome studies are done in accordance with paragraph (b)(1)(vii) of this section that specifically validate an indication for the device's use in guiding blood product use, a limiting statement that the device has not been evaluated to guide blood product use.
(iii) Unless appropriate clinical outcome studies are done in accordance with paragraph (b)(1)(viii) of this section that specifically validate an indication for the device's use in guiding use of medication, a limiting statement that the device has not been evaluated to guide use of medication.