Quantra QPlus System

K201513 · Hemosonics, LLC · QFR · Aug 21, 2020 · Hematology

Device Facts

• Record ID: K201513
• Device Name: Quantra QPlus System
• Applicant: Hemosonics, LLC
• Product Code: QFR · Hematology
• Decision Date: Aug 21, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5430
• Device Class: Class 2

Intended Use

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 (CT), 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 QPlus System should not be the sole basis for patient diagnosis.

Device Story

Quantra QPlus System; modification adds Quantra Desktop Remote Viewer (QDRV) accessory. System analyzes whole blood viscoelastic properties; provides coagulation status. QDRV allows remote viewing of results from locations separate from analyzer. Used in clinical settings; operated by healthcare professionals. Output facilitates clinical decision-making regarding hemostasis management.

Clinical Evidence

No clinical data; substantial equivalence based on design control activities, risk analysis, and verification/validation of software modification.

Technological Characteristics

Viscoelastic coagulation analyzer; software-based remote viewing accessory (QDRV). Fundamental scientific technology unchanged from predicate. Connectivity: networked remote viewing capability.

Indications for Use

Indicated for use as a coagulation system for the measurement of whole blood viscoelastic properties.

Regulatory Classification

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.

Special Controls

The special controls for this device are:

*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.

Predicate Devices

• Quantra QPlus System (DEN180017)

Submission Summary (Full Text)

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August 21, 2020

HemoSonics, LLC Anne Zavertnik Vice President, Regulatory Affairs and Quality Systems 400 Preston Avenue, Suite 250 Charlottesville, Virginia 22903

Re: K201513

Trade/Device Name: Quantra QPlus System Regulation Number: 21 CFR 864.5430 Regulation Name: Coagulation system for the measurement of whole blood viscoelastic properties Regulatory Class: Class II Product Code: QFR Dated: June 5, 2020 Received: June 8, 2020

Dear Anne Zavertnik:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201513

Device Name Quantra QPlus System

#### Indications for Use (Describe)

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 asess 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.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the logo for Hemosonics. The logo consists of a red blood drop with sound waves emanating from the bottom left. To the right of the blood drop is the word "HEMOSONICS" in a sans-serif font.

# 510(K) SUMMARY

## A. APPLICANT INFORMATION

| Submitter Information: | HemoSonics, LLC<br>400 Preston Avenue, Suite 250<br>Charlottesville, VA 22903<br>Phone: [phone] |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Anne Zavertnik, RAC<br>Email: [e-mail]<br>Phone [phone] x100, 585-500-8427 mobile |

#### B. PROPRIETARY AND ESTABLISHED NAMES

Quantra® QPlus® System

# C. REGULATORY INFORMATION

| Trade/Device Name: | Quantra QPlus System |
|----------------------------|------------------------------------------------------------------------------------------------------------|
| Regulation Number: | 21 CFR 864.5430 |
| Regulation Name: | Coagulation system for the measurement of whole blood<br>viscoelastic properties in perioperative patients |
| Regulatory Classification: | Class II |
| Product Code: | QFR |

#### D. PURPOSE OF SUBMISSION

To implement an optional accessory to the Quantra OPlus System called the Quantra® Desktop Remote Viewer software application. This change does not affect the device's intended use nor alter the device's fundamental scientific technology.

#### E. MEASURAND

The combination of clot time and clot stiffness parameters measured from the four channels of the cartridge provides information about the functional role of coagulation factors, fibrinogen, and platelets in the sample.

#### F. TYPE OF TEST

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

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Image /page/4/Picture/0 description: The image shows the logo for Hemosonics. The logo consists of a red blood drop with sound waves emanating from it on the left, and the word "HEMOSONICS" in black text on the right. The text is in a sans-serif font.

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).

### G. INTENDED USE/INDICATIONS FOR USE

The Quantra® OPlus® System is composed of the Quantra Hemostasis Analyzer, OPlus 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 OPlus Cartridge is a multi-channel cartridge that provides semiquantitative 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 (CT), 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 QPlus System should not be the sole basis for patient diagnosis

#### H. DEVICE MODIFICATION DESCRIPTION

The Quantra QPlus System was previously cleared under DEN180017. HemoSonics is submitting this Special 510(k) to implement a software modification to the Quantra Hemostasis Analyzer that allows an optional accessory, Quantra Desktop Remote Viewer (QDRV), for viewing results from a location separate from the Quantra. The QDRV is a PC based software application that 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 ODRV software application. Users cannot input any additional clinical data into the QDRV software application or the Ouantra Hemostasis Analyzer from the ODRV.

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# I. SUBSTANTIAL EQUIVALENCE INFORMATION

Predicate Device Name: Quantra Plus System

Predicate 510(k) Number: DEN180017

Comparison with the Predicate:

Table 5-1 provides an overall comparison of the modified Quantra QPlus System with the previously cleared Quantra QPlus System.

# Table 5-1: Comparison between Quantra QPlus System (DEN180017) and Modified Quantra QPlus System

| | Modified Device | Predicate Device |
|---------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Quantra QPlus System | Quantra QPlus System |
| | (Subject of Special 510(k)) | (DEN180017) |
| Similarities | | |
| Manufacturer | Same as predicate device | HemoSonics, LLC |
| Trade Name | Same as predicate device | Quantra Hemostasis Analyzer |
| Common Name | Same as predicate device | Whole Blood Hemostasis System |
| Classification Name | Same as predicate device | Coagulation system for the measurement of<br>whole blood viscoelastic properties in<br>perioperative patients. |
| Regulation Number | Same as predicate device | 21 CFR 864.5430 |
| Product Code | Same as predicate device | QFR (DEN180017) |
| Device Class | Same as predicate device | II |
| Indications for Use | Same as predicate device | The Quantra® QPlus® System is composed of<br>the Quantra Hemostasis Analyzer, QPlus<br>Cartridge, and Quantra Quality Controls Level 1<br>and 2. The Quantra QPlus System is intended<br>for in vitro diagnostic use.<br>The Quantra Hemostasis Analyzer uses Sonic<br>Estimation of Elasticity via Resonance (SEER)<br>Sonorheometry, an ultrasound-based<br>technology, to measure the shear modulus of<br>whole blood during coagulation. The QPlus<br>Cartridge is a multi-channel cartridge that<br>provides semi-quantitative indications of the<br>coagulation state of a 3.2% citrated venous<br>whole blood sample. The QPlus Cartridge<br>includes tests to assess coagulation<br>characteristics via the intrinsic pathway, via the<br>extrinsic pathway, and includes tests with a<br>heparin neutralizer.<br>The system is intended to be used by trained<br>professionals at the point-of-care and in clinical<br>laboratories to evaluate the viscoelastic<br>properties of whole blood by means of the |

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Image /page/6/Picture/1 description: The image shows the logo for Hemosonics. The logo consists of a red blood drop with sound waves emanating from the bottom left, followed by the word "HEMOSONICS" in a sans-serif font. The logo is simple and modern, and it is likely used to represent a company or organization that is involved in the field of blood analysis or diagnostics.

| | | | | following functional parameters: Clot Time<br>(CT), Clot Time with Heparinase (CTH), Clot<br>Stiffness (CS), Fibrinogen Contribution to Clot<br>Stiffness (FCS), Platelet Contribution to Clot<br>Stiffness (PCS) and Clot Time Ratio (CTR).<br>The Quantra QPlus System is indicated for the<br>evaluation of blood coagulation in perioperative<br>patients age 18 years and older to assess possible<br>hypocoagulable and hypercoagulable conditions<br>in cardiovascular or major orthopedic surgeries<br>before, during, and following the procedure.<br>Results obtained with the Quantra QPlus System<br>should not be the sole basis for patient<br>diagnosis. |
|--------------------|--|-------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | Same as predicate device | | Same as indications for use |
| | | | | QPlus Cartridge (multichannel cartridge) |
| Disposables | | Same as predicate device | | Quantra Quality Controls (Level 1 and Level 2) |
| | | | | Quantra Hemostasis Analyzer |
| Analyzer Hardware | | Same as predicate device | | HS-002 |
| Differences | | | | |
| Quantra Hemostasis | | v1.10.6 | | v.1.6.15 |
| Analyzer Software | | | | |
| Quantra Desktop | | Optional software application | | Not Applicable |
| Remote Viewer | | v2.1.15 | | |

## Conclusion:

The data and information provided in the submission support the substantial equivalence determination for the Quantra QPlus System with optional QDRV to the Quantra QPlus System approved in DEN180017.