(31 days)
The Quantra® System is composed of the Quantra Hemostasis Analyzer, OPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra 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 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.
The QPlus Cartridge is a multi-channel cartridge that provides sem-quantitative indications of the coagulation state of a 3.2% citrated venous or arterial 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 QPlus Cartridge is indicated for use in cardiovascular or major orthopedic surgeries before, and following the procedure.
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous whole blood sample. The QStat Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the extrinsic pathway, and includes a test with tranexamic acid to evaluate clot lysis characteristics. The QStat Cartridge is indicated for use in trauma and liver transplantation procedures.
The Quantra System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions. Results obtained with the Quantra System should not be the sole basis for patient diagnosis.
The Quantra 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 and lysis in trauma, surgical and intensive care settings. The system consists of the Quantra Hemostasis Analyzer (instrument), single-use disposable cartridges, (OPlus and OStat cartridges) and Quantra Quality Controls (external Quality Control materials).
This document describes a Special 510(k) submission for the HemoSonics Quantra Hemostasis Analyzer. The purpose of the submission is to implement a new operating system (Microsoft Windows 10 IoT Enterprise LTSC 2019) in the device. The FDA determined that this change does not affect the device's intended use or alter its fundamental scientific technology. Therefore, the information provided focuses on the substantial equivalence to the predicate devices (Quantra System cleared under K213917 and K223433), rather than a detailed clinical study demonstrating device performance against new acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Since this 510(k) is for a software update (operating system change) that does not alter the fundamental scientific technology or intended use, traditional performance acceptance criteria in terms of clinical accuracy or diagnostic efficacy are not presented in this document. The "acceptance criteria" here refer to demonstrating that the new software version maintains the performance of the predicate device.
| Aspect of Performance | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Functionality | The device with the new operating system (W10IoT) performs the same functions as the predicate device (Windows Embedded Standard 8). | The submission asserts that the change does not affect the device's intended use or alter the device's fundamental scientific technology. All functionalities related to measuring shear modulus of whole blood during coagulation, multi-channel cartridge processing (QPlus, QStat), and quality controls are presumed to be maintained. |
| Safety | The new operating system does not introduce new safety concerns or compromise existing safety measures. | Implicitly deemed safe by the FDA's substantial equivalence determination for this software change. The FDA stated: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". |
| Effectiveness | The device's effectiveness in evaluating blood coagulation, as per its Indications for Use, is maintained. | No new clinical effectiveness data presented for this specific 510(k). The equivalence is based on the underlying technology and intended use remaining unchanged from the previously cleared predicate devices. |
| Software Version | Update to Quantra Hemostasis Analyzer Software to v2.2.16 and Embedded Windows Operating System to Microsoft Windows 10 IoT Enterprise LTSC 2019 | Achieved, as this is the subject of the submission. |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a software update (operating system change) and does not involve a new clinical study with a test set of patient data as would be typical for a de novo device or a significant change in intended use/technology. The document does not specify a "test set" in the context of clinical data. It relies on the performance data from its predicate devices (K213917 and K223433) for which clinical data would have been submitted.
Therefore:
- Sample size for test set: Not applicable (no new clinical test set for this specific software update).
- Data provenance: Not applicable for a new clinical test set. The predicate devices' data would have included (presumably) prospective or retrospective clinical data, but its details are not in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this software update submission. No new clinical ground truth establishment described here.
4. Adjudication Method for the Test Set
Not applicable for this software update submission. No new clinical adjudication described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done as this submission pertains to a software (operating system) update, not a change requiring a new clinical evaluation of human reader performance with or without AI assistance. The Quantra System is a diagnostic instrument that measures viscoelastic properties of whole blood; it is not an AI-assisted diagnostic tool for imaging interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of a software update for an in vitro diagnostic device like the Quantra System. The device performs automated measurements. Its performance is inherent to the algorithm and instrument design, which are not changing beyond the operating system.
7. The type of ground truth used
Not applicable for this software update submission. The "ground truth" for the original device clearance (K213917, K223433) would have been established through correlation with established clinical methods for assessing coagulation status (e.g., standard coagulation assays, clinical outcomes, expert clinical judgment), but details are not provided in this document.
8. The Sample Size for the Training Set
Not applicable. This submission is about updating the operating system of an already cleared device, not about training a new algorithm with a specific training set.
9. How the ground truth for the training set was established
Not applicable, as no new algorithm training or associated ground truth establishment is described in this submission.
§ 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.