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510(k) Data Aggregation
(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.
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