Citrated: K, KH, RTH, FFH

K232018 · Haemonetics Corporation · JPA · Mar 29, 2024 · Hematology

Device Facts

• Record ID: K232018
• Device Name: Citrated: K, KH, RTH, FFH
• Applicant: Haemonetics Corporation
• Product Code: JPA · Hematology
• Decision Date: Mar 29, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The TEG 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer and the Citrated: K, KH, RTH, FFH assay cartridge. The TEG 6s Hemostasis System is intended for in vitro diagnostic use with adult patients where an evaluation of their blood hemostasis properties is desired. The TEG 6s Hemostasis System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots and provides semi-quantitative results. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care. The Citrated: K, KH, RTH, FFH assay cartridge is intended to be used in patients where heparin/heparinoids may be present and who are at an increased risk of coagulopathy. Hemostasis evaluations are indicated to assess clinical conditions in cardiovascular surgery, cardiovascular procedures (e.g., minimally invasive valve replacement or repairs) and liver transplantation to assess hemorrhage or thrombosis conditions before, during and following the procedure. The Citrated: K, KH, RTH, FFH assay cartridge contains four independent assays (CK, CKH, CRTH and CFFH) and the system output consists of a table of numerical values for parameters R, MA, and LY30. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. Clotting characteristics are described by the functional parameters R (clotting time) and MA (maximum clot strength). The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests. LY30 describes fibrinolysis 30 minutes after reaching maximum clot strength. The CRTH assay monitors the hemostasis process after stimulation of both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter MA (maximum clot strength with contributions of both platelets and fibrin). The CFFH assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s Hemostasis System after blocking platelet contributions to clot strength, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter MA (fibrinogen contribution to maximum clot strength). Results from the TEG 6s analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests.

Device Story

TEG 6s Hemostasis System uses disposable cartridges with four independent measurement cells to analyze 3.2% citrated whole blood. Device uses piezoelectric actuator to vibrate measurement cells; optical sensors detect meniscus motion. System performs Fast Fourier Transform (FFT) on motion data to calculate resonant frequency and modulus of elasticity (stiffness) as sample clots. Output includes numerical values for R (clotting time), MA (maximum clot strength), and LY30 (fibrinolysis). Used in labs or point-of-care by clinicians to evaluate hemostasis, monitor heparin effects, and assess fibrinogen/platelet contributions. Results assist in managing coagulopathy, hemorrhage, or thrombosis risks during surgery. System provides semi-quantitative data to support clinical decision-making alongside patient history.

Clinical Evidence

Method comparison study across 8 clinical sites (N=617-883 samples depending on parameter) compared subject device to predicate and Clauss Fibrinogen. Primary endpoints (bias at medical decision points, slope, correlation) met acceptance criteria. Pearson correlation coefficients >0.82 for Type 1/2 parameters. Type 3 (CFFH-MA vs Clauss Fibrinogen) showed Spearman correlation of 0.79. Precision studies (repeatability/reproducibility) per CLSI EP05-A3 showed CVs <15% for R and <10% for MA. Interference testing confirmed robustness against common clinical interferents.

Technological Characteristics

Viscoelastic hemostasis analyzer using non-contact optical resonance frequency measurement. Disposable cartridge with 4 independent microfluidic channels. Reagents: Kaolin, Tissue Factor, Abciximab, Heparinase, CaCl2. Connectivity: Standalone. Software: Moderate level of concern. Standards: IEC 61010-1, IEC 61010-2-010, IEC 61010-2-101 (safety); IEC 60601-1-2, IEC/EN61326-1, IEC/EN61326-2-6 (EMC).

Indications for Use

Indicated for adult patients at increased risk of coagulopathy where heparin/heparinoids may be present. Used to assess hemorrhage or thrombosis in cardiovascular surgery, cardiovascular procedures (e.g., valve replacement/repair), and liver transplantation.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• TEG 6s with the Citrated Multichannel Cartridge (K150041)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

March 29, 2024

Haemonetics Corporation Julie Bergeman Senior Regulatory Affairs Specialist 125 Summer St Boston, Massachusetts 02110

Re: K232018

Trade/Device Name: Citrated: K, KH, RTH, FFH Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: July 6, 2023 Received: July 7, 2023

Dear Julie Bergeman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medicaldevices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

# Min Wu -S

Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics 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) K232018

Device Name Citrated: K. KH, RTH, FFH

#### Indications for Use (Describe)

The TEG 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer and the Citrated: K, KH, RTH, FFH assay cartridge. The TEG 6s Hemostasis System is intended for in vitro diagnostic use with adult patients where an evaluation of their blood hemostasis properties is desired. The TEG 6s Hemostasis System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots and provides semi-quantitative results. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.

The Citrated: K, KH, RTH, FFH assay cartridge is intended to be used in patients where heparinheparinoids may be present and who are at an increased risk of coagulopathy. Hemostasis evaluations are indicated to assess clinical conditions in cardiovascular surgery, cardiovascular procedures (e.g. minimally invasive valve replacement or repairs) and liver transplantation to assess hemorrhage or thrombosis conditions before, during and following the procedure.

The Citrated: K, KH, RTH, FFH assay cartains four independent assays (CK, CKH, CRTH and CFFH) and the system output consists of a table of numerical values for parameters R, MA, and LY30.

The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. Clotting characteristics are described by the functional parameters R (clotting time) and MA (maximum clot strength).

The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests. LY30 describes fibrinolysis 30 minutes after reaching maximum clot strength.

The CRTH assay monitors the hemostasis process after stimulation of both the intrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter MA (maximum clot strength with contributions of both platelets and fibrin).

The CFFH assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s Hemostasis System after blocking platelet contributions to clot strength, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter MA (fibrinogen contribution to maximum clot strength).

Results from the TEG 6s analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests.

For professional use only.
Type of Use (*Select one or both, as applicable*)

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary

| Submitter: | Haemonetics Corporation<br>125 Summer Street<br>Boston MA 02110 United States |
|----------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Julie Bergeman<br>Senior Regulatory Affairs Specialist<br>262-693-8368<br>[e-mail] |
| Date Prepared: | March 26, 2024 |

### 1. Device Information

| Device Trade Name: | Citrated: K, KH, RTH, FFH |
|----------------------|-------------------------------------------------------|
| Common Name: | Whole Blood Hemostasis System |
| Classification Name: | System, Multipurpose For In Vitro Coagulation Studies |
| Regulatory Class: | 2 |
| Regulation Number: | 21 CFR 864.5425 |
| Product Code: | JPA |

### 2. Legally Marketed Predicate Device

| Predicate # | Predicate Trade Name | Product Code |
|-------------|-------------------------------------------------|--------------|
| K150041 | TEG 6s with the Citrated Multichannel Cartridge | JPA |

### 3. Device Description Summary

### TEG® 6s System Description

The TEG® 6s Hemostasis System (TEG® hemostasis analyzer and TEG® 6s assay cartridges) is intended for in vitro diagnostic use to provide semi-quantitative indications of a blood sample's ability to form and maintain a clot. The TEG® 6s Hemostasis System records the kinetic changes in a sample of whole blood as the sample clots, retracts and/or lyses. The system output consists of a table of numerical values and graphs resulting from the hemostasis process over time. This information can be used by clinicians to aid in determining if a clotting dysfunction or coagulopathy is present.

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To perform a test, a disposable TEG® 6s assay cartridge is inserted into the TEG® 6s hemostasis analyzer. The instrument reads the bar code on the cartridge and identifies the type of cartridge for operator confirmation. Blood (collected in a 3.2% sodium citrate tube) or Quality Control (QC) material is added to the entry port on the cartridge and drawn into the cartridge under the TEG® 6s hemostasis analyzer control. The amount of the sample drawn into the cartridge is determined by the pre-set volume of the blood chambers in the cartridge. Once in the cartridge, the sample is metered into as many as 4 separate analysis channels, depending upon the assays being performed. Reconstitution of reagents dried within the cartridge is accomplished by moving the sample back and forth through reagent chambers, under the control of microfluidic valves and bellows (pumps) within the cartridge. After each sample has been mixed with reagent, it is delivered to a test cell where it is monitored for viscoelastic changes due to coagulation. Excess sample material is moved under microfluidic control into an enclosed waste chamber within the cartridge.

### TEG® 6s Measurement Technique

The TEG® 6s technology is based on a disposable cartridge containing up to 4 independent measurement cells. Each cell consists of a short vertically-oriented injection molded tube (ring). Detection of clotting in the TEG® 6s Hemostasis System is performed optically. A piezoelectric actuator vibrates the measurement cell(s) through a motion profile composed of summed sinusoids at different frequencies. The movement of the measurement cells will induce motion in the sample meniscus, which will be detected by a photodiode. The resulting motion of the meniscus is monitored optically and analyzed by the instrument to calculate the resonant frequency and modulus of elasticity (stiffness) of the sample. By performing a Fast Fourier Transform (FFT) on meniscus motion data, the resonant frequencies can be determined. The analyzer monitors the harmonic motion of a hanging drop of blood in response to external vibration. As the sample transitions from a liquid state to a gel-like state during clotting, the modulus of elasticity (stiffness) and therefore resonant frequency increase. The TEG® 6s hemostasis analyzer measures these variations in resonant frequency during clotting and lysis.

Resonance is the tendency of a material or structure to oscillate with greater amplitude at some frequencies than others. The exact frequencies at which resonance occurs will depend on the stiffness and mass of the sample. Stiffness, in turn, is a function of a material's modulus of elasticity and the boundary conditions to which the material is exposed, such as the geometry and materials of a test cell. By holding these boundary conditions and sample mass constant from sample to sample, the TEG® 6s Hemostasis System allows direct comparison of

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# HAEMONET

elasticity between samples. The output measurements are displayed in a table and on a graphical tracing that reflects the hemostasis profile of the clot formation.

In a typical test, blood that has been delivered to the measurement cell will not clot for several minutes. During this time the sample has no inherent stiffness except that provided by surface tension, and since this remains constant the measured resonant frequencies will not change.

Once clotting begins, however, the elastic modulus and thus the resonant frequencies increase rapidly. During fibrinolysis, the process is reversed, with elastic modulus and resonant frequencies decreasing. In tests where clotting does not occur, the resonant frequency of the sample will not change. During coagulation, however, a clot will bind to the ring contained in the cartridge and the resonant frequency will rise with increasing firmness of the clot. The TEG® 6s hemostasis analyzer collects meniscus motion data, tracks changing resonant frequencies and analyzes the frequency data to provide semi-quantitative parameters describing the clot.

The TEG® 6s Hemostasis System monitors the interaction of platelets within the fibrin mesh of the clot during clot formation and lysis, all in a whole-blood setting. The TEG® 6s Hemostasis System uses thromboelastography to provide continuous measurement of clot elasticity.

Method Comparison testing has been performed, yielding data from 8 clinical sites. These data include the applicable parameters for the tests in the Citrated: K, KH, RTH, FFH assay cartridge. Table 1 provides the definitions that apply to calculated parameters in the TEG® 6s Hemostasis System.

| TEG® 6s<br>Parameter | Definition | Parameter Relation to<br>Hemostasis |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | R | R is the time from the start of the test until initial<br>fibrin formation. This represents the enzymatic<br>portion of coagulation. |
| MA | MA, or Maximum Amplitude, represents the<br>maximum firmness of the clot during the test. | Normal / reduced / increased<br>clot elasticity/strength |
| LY30 | LY30 is a measurement of the rate of fibrinolysis<br>30 minutes after MA is reached. The LY30<br>measurement is based on the reduction of the<br>tracing area that occurs between the time that M<br>A is measured until 30 minutes after the MA is | Normal / reduced clot<br>stability; clot dissolution |

Table 1. TEG® 6s parameter definitions

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| defined. |
|----------|
|----------|

#### Citrated Assays Citrated Kaolin (CK) assay

The CK assay is a semi-quantitative in vitro diagnostic assay for monitoring the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG® 6s Hemostasis System. The CK assay consists of Kaolin which is used in the assay for activation of coagulation. It is combined with calcium chloride to neutralize the sodium citrate used to anticoagulate the blood sample.

The clotting characteristics of the CK generated hemostasis profile are described by the functional parameters Clotting Time (R) and Maximum Clot strength (MA). Since it may take an hour or more for a non-activated whole blood sample to reach maximum amplitude MA, Kaolin is essential to reduce run time and variability associated with running non-activated whole blood samples.

### Citrated Kaolin with Heparinase (CKH) assay

The CKH assay is a semi-quantitative in vitro diagnostic assay for monitoring the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG® 6s Hemostasis System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests. LY30 describes fibrinolysis 30 minutes after reaching maximum clot strength. The Kaolin with heparinase assay neutralizes the anticoagulant property of heparin. Calcium Chloride (CaCl2) is included to neutralize any sodium citrate in the blood.

The CKH assay monitors the effects of heparin, a commonly used anticoagulant in surgical procedures. Even very low concentrations of heparin, fractions of IU/mL of blood, can noticeably increase the R time and can even completely anticoagulate the blood, making it difficult if not impossible to monitor developing coagulopathies that are masked by high levels of therapeutic heparin.

### Citrated RapidTEGTM with Heparinase (CRTH) assay

The CRTH assay is a semi-quantitative in vitro diagnostic assay that monitors the hemostasis process after stimulation of both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG® 6s Hemostasis System, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter: MA (maximum clot strength with contributions of both platelets and fibrin). The CRTH assay produces an

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# HAEMONET

accelerated clotting time which allows for an earlier MA result compared to the CK assay. Therefore, in the TEG® Hemostasis System, the CRTH assay is simultaneously run along with the CK and CKH assays to provide a fast way to reach a stable value for MA (CRTH) while still measuring the time- dependent parameters (CK).

As described in the CK assay, Kaolin is used for activation of coagulation and is combined with Calcium Chloride to neutralize sodium citrate in the blood sample. The addition of Tissue Factor is used for coagulation activation that would be classically described as extrinsic. The addition of heparinase in the assay cartridge neutralizes the effects of heparin in the sample. The CRTH hemostasis profile resulting from Kaolin and Tissue Factor activation provides a measure of the strength of the clot and the breakdown of the clot, or fibrinolysis.

### Citrated Functional Fibrinogen with Heparinase (CFFH) assay

The CFFH assay is a semi-quantitative in vitro diagnostic assay for monitoring the hemostasis process after blocking platelet contributions to clot strength in 3.2 % citrated whole blood specimens, neutralizing the effect of heparin in the sample. The CFFH assay consists of Tissue Factor and abciximab. It is combined with Calcium Chloride to neutralize sodium citrate in the blood sample. The addition of heparinase in the assay cartridge neutralizes the effects of heparin in the sample. Tissue Factor is used for coagulation activation that would be classically described as extrinsic, with platelet aggregation inhibited by abciximab (a GPIIb/IIIa inhibitor), excluding its contribution to clot strength, and thereby measuring fibrinogen contribution to clot strength.

The Clotting characteristics are described by the functional parameter: MA (fibrinogen contribution to maximum clot strength) and measures the part of clot strength that is contributed by fibrinogen in the blood sample.

### 4. Intended Use/Indications for Use

The TEG 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer and the Citrated: K, KH, RTH, FFH assay cartridge. The TEG 6s Hemostasis System is intended for in vitro diagnostic use with adult patients where an evaluation of their blood hemostasis properties is desired. The TEG 6s Hemostasis System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots and provides semi-quantitative results. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.

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The Citrated: K, KH, RTH, FFH assay cartridge is intended to be used in patients where heparin/heparinoids may be present and who are at an increased risk of coagulopathy. Hemostasis evaluations are indicated to assess clinical conditions in cardiovascular surgery, cardiovascular procedures (e.g. minimally invasive valve replacement or repairs) and liver transplantation to assess hemorrhage or thrombosis conditions before, during and following the procedure.

The Citrated: K, KH, RTH, FFH assay cartridge contains four independent assays (CK, CKH, CRTH and CFFH) and the system output consists of a table of numerical values for parameters R, MA, and LY30.

The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. Clotting characteristics are described by the functional parameters R (clotting time) and MA (maximum clot strength).

The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests. LY30 describes fibrinolysis 30 minutes after reaching maximum clot strength.

The CRTH assay monitors the hemostasis process after stimulation of both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter MA (maximum clot strength with contributions of both platelets and fibrin).

The CFFH assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s Hemostasis System after blocking platelet contributions to clot strength, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter MA (fibrinogen contribution to maximum clot strength).

Results from the TEG 6s analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests.

For professional use only.

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### 5. Comparison Citrated: K, KH, RTH, FFH and predicate device

### Indications for Use Comparison

The TEG® 6s Hemostasis System consists of the TEG® 6s hemostasis analyzer including analyzer software and assay cartridges. The assay cartridges predicate device is the K 150041 TEG 6s with the Citrated Multichannel Cartridge (07-601-US). The indications for use are of the same intent with the following inclusions:

- 1. Heparinase is included in the RT and FF channels of the new assay cartridge.
- 2. Use location is defined as laboratory and point-of-care for the new assay cartridge.
- 3. Patient types are defined for the new assay to include the same population as the predicate (cardiovascular surgery, cardiology procedures) with expansion to patients undergoing liver transplant.

### Technology Comparison

Substantial equivalence is being demonstrated through a method comparison clinical study. No key design elements required changes for the cartridge including the reagent spotting technology, the microfluidic pathway, the shaker design, or the cartridge interface with the analyzer. The reagent channel order has been rearranged; however, that has been shown to not influence cartridge functionality. There is no change to the design of the cartridge and there is no change in the mechanics of how the cartridge is run on the TEG® 6s hemostasis analyzer. No additional product development of the TEG® 6s analyzer hardware and TEG® 6s software was required to add the Citrated: K. KH. RTH. FFH assay cartridge.

| Item | K150041 TEG 6s with the Citrated<br>Multichannel Cartridge (Predicate)<br>Analyzer | Citrated: K, KH, RTH, FFH |
|--------------------------|--------------------------------------------------------------------------------------------------------|---------------------------|
| Technological<br>Purpose | Monitoring the physical response of<br>a clot to low levels of applied strain<br>(resonance frequency) | Same |
| Measurement | Changes in physical clot elasticity<br>over time | Same |
| Matrix | 3.2% citrated whole blood | Same |
| Initial Warm Up<br>Time | 5 minutes | Same |

### Table-2 Summary of Technological Characteristics for Substantial Equivalence: Similarities

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| Item | K150041 TEG 6s with the Citrated<br>Multichannel Cartridge (Predicate) | Citrated: K, KH, RTH, FFH | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Analyzer-Hardware | Fully integrated<br>Thromboelastography analyzer | Same | |
| | Analyzer-Measuring<br>Technique | Non-contact optical measurement of<br>shear elasticity of a coagulating<br>sample | Same |
| Measurement Output | | Graphical tracings of resonant<br>frequency per reagent type; table of<br>parameters | Same |
| | Assay and Reagents | | |
| | Assays | CK, CKH, CRT, CFF | CK, CKH, CRTH, CFFH<br>Same with inclusion of heparinase<br>for the CRT and CFF channels |
| Assay Reagents | CK – kaolin and CaCl2<br>CKH – kaolin and CaCl2 with<br>heparinase<br>CRT – tissue factor, kaolin and<br>CaCl2<br>CFF – abciximab, tissue factor and<br>CaCl2 | Same with inclusion of heparinase<br>for the CRT and CFF channels | |
| Assay Parameters<br>Reported | CK: R, K, Angle, MA | CK: R, MA | |
| | CKH: R | CKH: R, LY30 | |
| | CRT: MA | CRTH: MA | |
| | CFF: MA, FLEV | CFFH: MA | |
| Quality Controls | Cartridge Reagent QC - Level 1<br>Cartridge Reagent QC - Level 2 | Same | |

Table-3 Summary of Technological Characteristics for Substantial Equivalence: Differences and Clinical Value Comparisons

| Item | K150041 TEG 6s with the Citrated<br>Multichannel Cartridge (Predicate) | Citrated: K, KH, RTH, FFH |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Use Location | N/A | The TEG® 6s Hemostasis System<br>with Citrated: K, KH, RTH, FFH<br>assay cartridge can be used in the<br>laboratory or at the point-of-care. |
| Patient Population<br>from Intended Use | Hemostasis evaluations are<br>commonly used to assess clinical<br>conditions in cardiovascular surgery<br>and cardiology procedures to assess<br>hemorrhage or thrombosis | The Citrated: K, KH, RTH, FFH<br>assay cartridge is intended to be<br>used in patients where<br>heparin/heparinoids may be present<br>and who are at an increased risk of<br>coagulopathy. Hemostasis |
| | conditions before, during and | evaluations are indicated to assess |
| | following the procedure. | clinical conditions in cardiovascular<br>surgery, cardiovascular procedures<br>(e.g. minimally invasive valve<br>replacement or repairs) and liver<br>transplantation to assess hemorrhage<br>or thrombosis conditions before,<br>during and following the procedure. |
| Clinical Value Comparisons | | |
| Clinical Value of<br>Citrated: Kaolin<br>(CK)<br>Parameter R (min) | Initiation phase of coagulation<br>triggered by enzymatic clotting<br>factors and culminating with the<br>initial fibrin formation. A prolonged<br>R value is indicative of slow clot<br>formation, due to coagulation factor<br>deficiencies or heparin. | Kaolin R is the time in minutes<br>elapsing between sample<br>activation and the point in time<br>where clotting provides enough<br>resistance to produce a 2 mm<br>amplitude reading on the TEG<br>analyzer tracing. The CK - R<br>parameter represents the initiation<br>phase of coagulation triggered by<br>enzymatic clotting factors and<br>culminating with the initial fibrin<br>formation. A prolonged R value is<br>indicative of slow clot formation,<br>and a shortened R value is<br>indicative of fast clot formation.<br><i>Clinical Value</i> . A prolonged R value is<br>indicative of slow clot formation, due to<br>coagulation factor deficiencies, heparin,<br>or other anticoagulants. |
| Clinical Value of<br>Citrated: Kaolin<br>(CK)<br>Parameter MA (mm) | MA, or Maximum Amplitude,<br>represents the maximum firmness of<br>the clot during the test. The MA<br>provides information about the<br>contribution of platelets/fibrin to the<br>overall strength of the clot. | The maximal strength of the clot<br>when activated with kaolin. This<br>represents the combination of the<br>contribution of fibrinogen and<br>platelets to clot strength.<br><i>Clinical Value</i> : The MA provides<br>information of platelets and fibrinogen<br>to the overall clot strength without<br>excluding the influence of heparin. A<br>decreased MA is indicative of low clot<br>strength, which could be due to<br>decreased platelet contribution or<br>decreased fibrinogen; whereas, an<br>increased MA is indicative of high clot<br>strength, which could be due to<br>increased platelet or fibrinogen<br>contribution. |
| Clinical Value of<br>Citrated: Kaolin with<br>Heparinase (CKH)<br>Parameter R (min)<br>Heparinase is<br>included in the<br>predicate and<br>subject device | Initiation phase of coagulation<br>triggered by enzymatic coagulation<br>factors and culminating with the<br>initial fibrin formation.<br>A prolonged R value is indicative of<br>slow clot formation, due to<br>coagulation factor deficiencies or<br>heparin. Inclusion of heparinase in<br>the blood chamber channel of the<br>cartridge provides ability to<br>compare R (min) without the effect<br>of heparin on the clot. | The reaction time between<br>initiation of the clot (via kaolin)<br>and the point where the tracing<br>reaches 2mm of amplitude, with<br>heparinase being used to<br>neutralize the effect of heparin.<br>Clinical Value: A prolonged R value is<br>indicative of slow clot formation, due to<br>coagulation factor deficiencies or non-<br>heparin anticoagulant. A shortening of<br>the CKH-R compared to the CK-R<br>indicates effect of heparin in the blood<br>sample. |
| Clinical Value of<br>Citrated: Kaolin with<br>Heparinase (CKH)<br>Parameter LY30 (%) | Parameter LY30 (%) is not reported<br>for the predicate device. | Clot lysis, in a sample with<br>heparinase to neutralize effects of<br>heparin, expressed as a percent<br>reduction in clot strength 30 minutes<br>after the MA is reached. Clinical<br>Value: LY30 provides information<br>about fibrinolytic activity. |
| Clinical Value of<br>Citrated: RapidTEG<br>with Heparinase<br>(CRTH) Parameter<br>MA (mm)<br>Heparinase is<br>included in the<br>subject device | RapidTEG™ MA is the point at<br>which clot strength reaches its<br>maximum and reflects the end result<br>of minimal platelet-fibrin interaction<br>via the GPIIb/IIIa receptors. Due to<br>faster coagulation activation, clot<br>strength is measured faster than<br>Citrated: Kaolin (K) activated<br>samples. Same results as CK<br>maximum amplitude (CK-MA).<br>The MA provides information about<br>the contribution of platelets/fibrin to<br>the overall strength of the clot. | RapidTEG MA is the point of<br>maximal amplitude of the TEG<br>tracing, measured in mm, and<br>reflects the maximum clot strength.<br>The strength of the clot is primarily<br>a result of platelet-fibrin interactions<br>via the GPIIb/IIIa receptors. Clinical<br>Value: The MA provides<br>information of platelets and<br>fibrinogen contribution to the overall<br>clot strength. A decreased MA is<br>indicative of low clot strength,<br>which could be due to decreased<br>platelet or decreased fibrinogen<br>contribution; whereas an increased<br>MA is indicative of high clot<br>strength, which could be due to<br>increased platelet or fibrinogen<br>contribution. |
| Clinical Value of<br>Citrated: Functional<br>Fibrinogen with<br>Heparinase (CFFFH)<br>Parameter MA (mm) | The maximum amplitude of CFF<br>provides the functional fibrinogen<br>contribution to the clot strength.<br>Provides the overall contribution of<br>functional fibrinogen to clot | The Functional Fibrinogen reagent<br>inhibits platelet aggregation via the<br>GPIIb/IIIa receptor, excluding its<br>contribution to clot strength (MA),<br>and thereby primarily measures the |
| | strength. In conjunction with CRT- | functional fibrinogen contribution to |
| Heparinase is | MA, this assay enables an | clot strength. |
| included in the | assessment of the relative | Clinical Value: CFFH - MA provides |
| subject device | contributions of functional | the fibrinogen contribution to clot |
| | fibrinogen and platelets to clot | strength by exclusion of platelet |
| | strength. Results may be valuable | aggregation. In conjunction with |
| | for guiding fibrinogen | CRTH-MA, this assay enables the |
| | supplementation or platelet | contributions of fibrin and platelets to |
| | transfusion. | clot strength to be determined. |

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# HAEMONET

### 6. Non-Clinical and/or Clinical Tests Summary & Conclusions

### Non-Clinical Performance Testing

- A. Reference Ranges
Expected values for test results are within the Reference Ranges for a reference population that were established according to CLSI EP28-A3c. Citrated whole blood from normal donors (representative of normal population distributions - age, gender, race) with no known coagulopathies and not taking any drugs that would potentially affect patient hemostasis was used. Non-parametric method for analysis was used to determine the reference range for each assay parameter. The following tables contain the reference range data for each reagent and parameter.

### CK Reference Ranges

| Citrated Blood Parameter | N | Range |
|--------------------------|-----|---------|
| R (min) | 157 | 4.6-9.1 |
| MA (mm) | 151 | 52-69 |
| CKH Reference Ranges | | |
| Citrated Blood Parameter | N | Range |
| R (min) | 155 | 4.3-8.3 |
| LY30 (%) | 148 | 0-3.2 |
| CRTH Reference Ranges | | |
| Citrated Blood Parameter | N | Range |
| MA (mm) | 162 | 53-69 |
| CFFH Reference Ranges | | |
| Citrated Blood Parameter | N | Range |
| MA (mm) | 162 | 15-34 |

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# HAEMONET

- B. Analytical Precision (Repeatability and Reproducibility)
Several studies were performed to support the Precision (Repeatability and Reproducibility) of the Citrated: K, KH, RTH, FFH assay cartridge. Studies performed with Cartridge Reagent QC Level 1 and Level 2 materials included a multi-site reproducibility study and a single-site repeatability study in accordance with the CLSI-EP05 A3 guideline, and a within lab lot to lot precision study. Two additional studies were performed with normal whole blood samples and contrived hypocoagulable, hypercoagulable and hyperfibrinolytic blood samples.

### Citrated: K, KH, RTH, FFH Cartridge Reagent QC Precision

Several test protocols were executed as part of Citrated: K, KH, RTH, FFH assay cartridge (PN 07-604-US) performance verification on the TEG® 6s Hemostasis System with Cartridge Reagent QC Level 1 and Level 2 materials:

Each data set includes evaluation of different sources of variation, these were combined to generate an assessment of the Citrated: K, KH, RTH, FFH assay cartridge combined QC precision for a worst case estimate of total precision.

| Study | Multi-site<br>TR-DIS-102653-C | Cartridge Lot to Lot<br>TR-DIS-102583-C | Operator to Operator<br>TR-DIS-102697-C | Repeatability<br>TR-DIS-102697-C |
|---------------|-------------------------------|-----------------------------------------|-----------------------------------------|----------------------------------|
| Instrument | 3 in combination per<br>site | 6 confounded with rep | 1 instrument/control I | 1 instrument/control |
| Operator | | 2 operators | 2 operators | 1 operator |
| Day | 5 days | 10 days | 10 days | 20 days |
| Cartridge Lot | 1 lot | 3 lots | 1 lot | 1 lot |
| QC Lot | 1 lot | 2 lots | 1 lot | 1 lot |
| Run | 1 run/day | 1 run/day | 2 runs | 2 runs |
| Rep | 5 reps/control/site | 1 rep | 2 reps/control | 2 reps/control |
| Total N | 75 | 120 | 80 | 80 |
| Study Design | Nested | Crossed | Nested | Nested |

Cartridge Reagent QC Precision Studies - Overview

Results of the QC precision studies demonstrate that Citrated: K, KH, RTH, FFH assay cartridge achieves repeatability, within laboratory, reproducibility and total precision requirements on all reported parameters for Cartridge Reagent OC Level 1 and Cartridge Reagent OC Level 2.

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# HAEMONE'

| Sample | Assay-Parameter | N | Mean | Repeatability | | Between<br>Run | | Between<br>Day | | Between<br>Cartridge<br>Lot | | Between<br>QC Lot | | Between Site<br>Instrument/Operat<br>or | | Total | | Pass/<br>Fail |
|---------------------------------------------------|-----------------|------|-------|---------------|------|----------------|------|----------------|------|-----------------------------|------|-------------------|------|-----------------------------------------|------|-------|-------|---------------|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| Cartridge<br>Reagent<br>QC Level<br>1<br>(07-664) | CK-R (min) | 316 | 6.16 | 0.54 | 8.9% | 0.00 | 0.0% | 0.27 | 4.4% | 0.02 | 0.4% | 0.12 | 2.0% | 0.39 | 6.3% | 0.73 | 11.9% | Pass |
| | CKH-R (min) | 316 | 4.62 | 0.41 | 8.5% | 0.09 | 2.0% | 0.14 | 3.1% | 0.12 | 2.5% | 0.25 | 5.2% | 0.26 | 5.7% | 0.58 | 12.3% | Pass |
| | CK-MA (mm) | 316 | 66.85 | 1.57 | 2.4% | 0.00 | 0.0% | 0.48 | 0.7% | 0.00 | 0.0% | 1.37 | 2.1% | 0.56 | 0.8% | 2.21 | 3.3% | Pass |
| | CRTH-MA (mm) | 316 | 59.36 | 1.81 | 3.0% | 0.00 | 0.0% | 0.95 | 1.6% | 0.00 | 0.0% | 0.00 | 0.0% | 1.76 | 2.9% | 2.70 | 4.5% | Pass |
| | CFFH-MA (mm) | 316 | 63.80 | 1.35 | 2.1% | 0.00 | 0.0% | 1.05 | 1.7% | 0.61 | 1.0% | 0.00 | 0.0% | 2.11 | 3.3% | 2.78 | 4.4% | Pass |
| | CKH LY30 (%) | 196* | 0.00 | 0.00 | n/a | 0.00 | n/a | 0.00 | n/a | 0.00 | n/a | 0.00 | n/a | 0.00 | n/a | 0.00 | n/a | Pass |
| Cartridge<br>Reagent<br>QC Level<br>2<br>(07-665) | CK-R (min) | 316 | 1.18 | 0.09 | 7.0% | 0.05 | 3.6% | 0.04 | 2.8% | 0.01 | 0.7% | 0.06 | 5.0% | 0.03 | 2.7% | 0.12 | 10.1% | Pass |
| | CKH-R (min) | 316 | 1.18 | 0.09 | 7.2% | 0.02 | 1.5% | 0.03 | 2.4% | 0.00 | 0.0% | 0.07 | 5.7% | 0.03 | 2.8% | 0.12 | 10.0% | Pass |
| | CK-MA (mm) | 313 | 27.64 | 1.51 | 5.4% | 1.01 | 3.7% | 0.84 | 3.1% | 0.23 | 0.8% | 0.72 | 2.6% | 0.51 | 1.8% | 2.20 | 8.0% | Pass |
| | CRTH-MA (mm) | 316 | 29.03 | 1.52 | 5.2% | 0.76 | 2.7% | 0.89 | 3.2% | 0.30 | 1.0% | 0.83 | 2.8% | 0.81 | 2.7% | 2.26 | 7.8% | Pass |
| | CFFH-MA (mm) | 316 | 28.69 | 1.26 | 4.5% | 0.95 | 3.4% | 0.91 | 3.3% | 0.13 | 0.5% | 0.95 | 3.3% | 0.68 | 2.3% | 2.17 | 7.7% | Pass |
| | CKH-Ly30 (%) | 316 | 92.42 | 0.46 | 0.5% | 0.40 | 0.4% | 0.12 | 0.1% | 0.04 | 0.0% | 0.10 | 0.1% | 0.00 | 0.0% | 0.63 | 0.7% | Pass |

#### CARTRIDGE REAGENT QC PRECISION – SUMMARY OF RESULTS

### Citrated: K, KH, RTH, FFH Cartridge Whole Blood Repeatability

Two studies were conducted for Whole Blood Repeatability on the Citrated: K, KH, RTH, FFH assay cartridge. Testing was conducted with normal donor whole blood and contrived hyper-coagulable, hypo-coagulable, and hyper-fibrinolytic whole blood samples. The following table summarizes the sample types evaluated:

| Sample<br>Type # | Hemostatic State | CK R | CKH R | CK MA | CRTH MA | CFFH MA | CKH<br>LY30 | Method or Additive for<br>Contriving* |
|------------------|----------------------------|------|-------|-------|---------|---------|-------------|------------------------------------------|
| 1 | Normal | x | x | x | x | x | x | None |
| 2 | Contrived Hypo-coagulable | x↑ | x↑ | x↓ | x↓ | | | Abciximab and Dabigatran |
| 3 | Contrived Hypo-coagulable | | | | | x↓ | | Dilution and /or Fibrinogen<br>depletion |
| 4 | Contrived Hyper-coagulable | | | x↑ | x↑ | | | Platelet Rich Plasma and<br>Fibrinogen |
| 5 | Contrived Hyper-coagulable | | | | | x↑ | | Fibrinogen |

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| 6 | Contrived Hyper-fibrinolytic | | | | x $ ↑ $ | tPA |
|---|------------------------------|---------|--|---------|---------|---------------|
| 7 | Contrived Hyper-coagulable | x $ ↓ $ | | x $ ↓ $ | | Tissue factor |

Whole Blood precision testing was conducted at a one (1) location, using two (2) operators, three (3) cartridge lots. For the normal whole blood samples, each operator performed 2 replicates/sample/cartridge lot on each of 2 analyzers for a total N= 12 per operator. For the contrived samples, each operator performed 1 replicate/sample simultaneously on 4 different analyzers/cartridge lot for a total N =12 per operator. Each contrived sample was prepared just prior to execution of testing.

Data collected for each sample was analyzed separately through an ANOVA for precision. Results are summarized in the tables below:

| Sample | Assay Parameter | N | Mean | Repeatability | | Between Operator | | Between Lot | | Between Device/Day | | Within Laboratory<br>( = Total Precision) | | Pass<br>/Fail |
|-----------------------------|-----------------|----|-------|---------------|-------|------------------|------|-------------|-------|--------------------|-------|-------------------------------------------|-------|---------------|
| | | | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | |
| S1 Normal Donor Whole Blood | CK R (min) | 24 | 7.50 | 0.44 | 5.9% | 0.00 | 0.0% | 0.65 | 8.7% | 0.28 | 3.8% | 0.83 | 11.2% | Pass |
| | CKH R (min) | 24 | 7.60 | 0.75 | 10.0% | 0.00 | 0.0% | 0.00 | 0.0% | 0.14 | 1.8% | 0.77 | 10.1% | Pass |
| | CK MA (mm) | 24 | 54.80 | 0.96 | 1.7% | 0.32 | 0.6% | 0.54 | 1.0% | 0.25 | 0.5% | 1.17 | 2.1% | Pass |
| | CRTH MA (mm) | 24 | 17.00 | 0.27 | 1.6% | 0.46 | 2.7% | 0.09 | 0.6% | 0.60 | 3.5% | 0.81 | 4.8% | Pass |
| | CFFH MA (mm) | 24 | 57.00 | 1.43 | 2.5% | 0.65 | 1.1% | 0.20 | 0.4% | 0.00 | 0.0% | 1.58 | 2.8% | Pass |
| | CKH LY30 (%) | 24 | 0.30 | 0.13 | 51.0% | 0.00 | 0.0% | 0.10 | 36.5% | 0.08 | 32.1% | 0.18 | 70.4% | Pass |

WHOLE BLOOD PRECISION REPEATABILITY SUMMARY - NORMAL SAMPLE

#### WHOLE BLOOD PRECISION REPEATABILITY SUMMARY - CONTRIVED ABNORMAL SAMPLES

| Sample | Assay<br>Parameter | N | Mean | Repeatability* | | Between<br>Operator | | Between Lot | | Within Laboratory<br>(= Total Precision) | | Pass<br>/Fail |
|--------------------------------------------------------|--------------------|----|-------|----------------|-------|---------------------|------|-------------|--------------------|-------------------------------------------|--------|---------------|
| | | | | SD | CV | SD | CV | SD | CV | SD | CV | |
| S2<br>Contrived<br>Hypo-<br>Coagulable<br>(R↑,<br>MA↓) | CK R (min) | 24 | 13.29 | 1.47 | 11.1% | 0.00 | 0.0% | 0.00 | 0.0% | 1.47 | 11.1% | Pass |
| | CKH R (min) | 24 | 13.09 | 1.52 | 11.6% | 0.61 | 4.6% | 0.39 | 3.0% | 1.68 | 12.8% | Pass |
| | CK MA (mm) | 24 | 52.78 | 1.04 | 2.0% | 0.00 | 0.0% | 0.89 | 1.7% | 1.37 | 2.6% | Pass |
| | CRTH MA (mm) | 24 | 58.55 | 0.51 | 0.9% | 0.00 | 0.0% | 0.35 | 0.69% | 0.62 | 1.1% | Pass |
| | CFFH MA (mm) | 24 | 18.02 | 0.17 | 1.0% | 0.03 | 0.2% | 0.12 | 0.76% | 0.21 | 1.2% | Pass |
| | CKH LY30 (%) | 24 | 1.18 | 0.19 | 16.1% | 0.00 | 0.0% | 0.00 | 0.0% | 0.19 | 16.1% | Pass |
| S3<br>Contrived…