(30 days)
The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below.
The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA).
The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests.
The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay.
The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV).
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. The indication for TEG 6s System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.
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.
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.
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 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 TEC® 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.
The provided document is a 510(k) Summary for the Haemonetics TEG® 6s Hemostasis System, specifically for the Citrated: K, KH, RT, FF Assay Cartridge. Its primary purpose is to demonstrate substantial equivalence to a predicate device (K150041). As such, it focuses on comparing the proposed device to the predicate rather than detailing a study that establishes novel acceptance criteria or proves performance against new, distinct benchmarks requiring extensive clinical trials with human-in-the-loop or standalone AI performance.
The document states: "There is no change to the technology, design of the device, reported parameters, or mechanics of how the cartridge is run on the TEG® 6s analyzer. No additional product development of the TEG® 6s system was required." The only change mentioned is an expansion of the "Use Location" from "clinical laboratory" to "clinical laboratory or at the point-of-care."
Therefore, the document does not contain the detailed information necessary to answer the prompt's request for:
- A table of acceptance criteria and reported device performance for a new device or significant modification requiring such a study. Instead, it relies on the predicate's established performance.
- Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details as these are typically required for demonstrating efficacy or superiority of a new or substantially modified device, especially AI/ML-driven ones.
The document is a submission for substantial equivalence for a minor modification (expanded use location) of an already cleared device, not a submission for a novel device or a device with a new AI/ML component that requires extensive performance validation against a defined ground truth.
Therefore, based solely on the provided text, I cannot extract the information required by your prompt, as the study described is a demonstration of substantial equivalence via comparison to a predicate, not an independent performance study of a novel device against predefined acceptance criteria for its core functionality.
The "study" described is a regulatory comparison. The "acceptance criteria" are effectively that the modified device performs equivalently to the predicate device, especially in the expanded use environment. No specific performance metrics or detailed study results are presented because the core technology and measured parameters are unchanged from the predicate.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.
January 15, 2025
Haemonetics Corporation Erica Molaro Senior Regulatory Affairs Specialist 125 Summer Street Boston, Massachusetts 02110
Re: K243858
Trade/Device Name: TEG 6s Hemostasis System Citrated: K. KH, RT, FF Assay Cartridge Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: December 12, 2024 Received: December 16, 2024
Dear Erica Molaro:
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 (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.
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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" (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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E).
For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/unique-deviceidentification-system-udi-system. 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/medical-devices/medical-devicesafety/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-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image contains the text "Min Wu-S". The text is written in a simple, sans-serif font. The letters are black, and the background is white. The text is centered in the image.
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) K243858
Device Name
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Indications for Use (Describe)
The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below.
The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA).
The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests. The CRT assay monitors the hemostasis process via both the intrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay.
The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV).
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. The indication for TEG 6s System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter: | Haemonetics Corporation125 Summer StreetBoston, MA 02110, United States |
|---|---|
| Contact: | Erica MolaroSenior Regulatory Affairs Specialist(201) 661-1493emolaro@haemonetics.com |
| Date Prepared: | January 14, 2025 |
| I. Device Information | |
| Device Trade Name: | TEG® 6s Hemostasis System: Citrated: K, KH, RT, FF Assay Cartridge |
| 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 |
II. Legally Marketed Predicate Device
| Predicate # | Predicate Trade Name | Product Code |
|---|---|---|
| K150041 | TEG 6s Hemostasis System: Citrated: K, KH, RT, FF AssayCartridge | JPA |
III. 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.
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
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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 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
{6}------------------------------------------------
cartridge and the resonant frequency will rise with increasing firmness of the Clot. The TEC® 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.
| TEG 6sParameter | Definition | Parameter Relation toHemostasis |
|---|---|---|
| R | R is the time from the start of the testuntil initial fibrin formation. Thisrepresents the enzymatic portion ofcoagulation | Clotting time – Normal / reduced/ increased speed of coagulationinitiation |
| K | K is the time after R needed to reach acertain level of clot strength. Thisrepresents clot kinetics | Normal / reduced / increasedspeed of coagulationamplification and propagation |
| Alpha α(Angle) | Alpha is the angle representing the rateof increase in the clot strength therapidity of fibrin build-up and cross-linking | Normal / reduced / increasedspeed of coagulationamplification and propagation |
| MA | MA, or Maximum Amplitude, representsthe maximum firmness of the clot duringthe test. | Normal / reduced /increased clotelasticity/strength |
| FLEV | FLEV is an estimate of the fibrinogenlevel in the blood sample. | Estimated Functional FibrinogenLevel |
Table 1: TEG® 6s Parameters for TEG® 6s Citrated: K, KH, RT, FF Assay Cartridge
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 (CaCl2) to neutralize the sodium citrate in the blood.
The clotting characteristics of the CK generated hemostasis profile are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot strength (MA). Since it may take an 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
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Hemostasis System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests. 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 RapidTEG (CRT) assay
The CRT assay is a semi-quantitative in vitro diagnostic assay for monitoring the hemostasis process after stimulation of both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the TEG® 6s Hemostasis System. The CRT assay consists of a reagent containing kaolin and tissue factor. It is combined with Calcium Chloride (CaCl2) to neutralize sodium citrate in the blood sample. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA).
The CRT assay produces an accelerated clotting time which allows for an earlier MA results compared to the CK assay. Therefore, in the TEG® Hemostasis System, the CRT assay is simultaneously run along with the CK and CKH assays to provide a fast way to reach a stable value for MA (CRT) while still measuring the time- dependent parameters (CK).
Citrated Functional Fibrinogen (CFF) assay
The CFF 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 on the TEG® 6s Hemostasis System. The CFF assay consists of tissue factor and abciximab. It is combined with Calcium Chloride (CaCl2) to neutralize sodium citrate in the blood 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. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), the Estimated Functional Fibrinogen Level (FLEV).
IV. Intended Use/Indications for Use
The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide semiquantitative indications of the hemostasis state of a venous blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below.
The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional
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parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA).
The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests.
The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay.
The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV).
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. The indication for TEG 6s System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.
- V. Comparison to Predicate Device
Indications for Use Comparison
The TEG® 6s system consists of the TEG® 6s analyzer including analyzer software and assay cartridges. The assay cartridges predicate device is the TEG® 6s Hemostasis System Citrated: K, KH, RT, FF (07-601-US, K150041). The indications for use are of the same intent with the following inclusion:
-
- Use location is defined as laboratory and point-of-care
Technology Comparison
There is no change to the technology, design of the device, reported parameters, or mechanics of how the cartridge is run on the TEG® 6s analyzer. No additional product development of the TEG® 6s system was required.
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| Table 2: Summary of Technological Characteristics for Substantial Equivalence: Similarities | ||
|---|---|---|
| TEG® 6s Citrated: K, KH, RT, FFCleared Device/Predicate [K150041] | TEG® 6s Citrated: K, KH, RT, FF Modified Device | |
| Technological Purpose | Monitoring the physical response of aclot to low levels of applied strain(resonance frequency) | Same |
| Measurement | Changes in physical clot elasticity overtime | Same |
| Matrix | 3.2% citrated venous whole blood | Same |
| Initial Warm Up Time | 5 minutes | Same |
| Analyzer Hardware | Fully integratedThromboelastography analyzer | Same |
| Analyzer Measuring Technique | Non-contact optical measurement ofshear elasticity of a coagulatingsample | Same |
| Measurement Output | Graphical tracings of resonantfrequency per reagent type; table ofparameters | Same |
| Physical Configuration Used forSample Measurement | Vertically-oriented cylindricalcontainer (ring or tube) containingsample with meniscus formed atbottom; non-conact measurement ofmeniscus amplitude of vibration | Same |
| Physical Principle UnderlyingMeasuring Technique | Clotting process causes an increase inthe modulus of elasticity, whichincreases stiffness and increases theforce of the clot within the ring wallswhen moving up and down in the ringtube against the sample's own weight.This increases the resonant frequency,which increases the clot strengthamplitude. During clot dissolution(lysis), the resonant frequencydecreases, corresponding to decreasingclot strength amplitude. | Same |
| Boundary Conditions | Physical ring tube dimensions defineboundary conditions that are helpconstant, allowing comparison of onesample to the next. | Same |
| Measuring Channel | Up to 4 | Same |
| Signal Generation | Multi-frequency harmonic oscillationof a small open-ended cylindercontaining the sample | Same |
| Signal Transducer | Optical detection (silicon photodiode)of the motion of a free surface of thesample. | Same |
| Sensitivity to Applied Strains | Applied strains are very low, resultingin minimal interference with smallchanges in clot formation. | Same |
| Temperature Control | 20° to 50°C | Same |
| Sample Volume (per channel) | 20 μl | Same |
| Total Reaction Volume (singlechannel) | 20 μl | Same |
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| TEG® 6s Citrated: K, KH, RT, FFCleared Device/Predicate [K150041] | TEG® 6s Citrated: K, KH, RT,FF Modified Device | |
|---|---|---|
| Analyzer Input Voltage | 12 volts DC, 60 watts max(power supply) | Same |
| Environment | Stable and level surface.Operating Temperature 10° to 32° CStorage Temperature: -20° to +50°C (instrument only)Relative humidity 20 to 80%(noncondensing) | Same |
| Operating Position | Level (adjustment not required) | Same |
| Sample Preparation | Performed under analyzer controlwithin the disposable cartridge | Same |
| Pipetting | Unmetered transfer pipette orsyringe; blood sample is added until itfills to a level above the line markedon the blood intake well ofthe cartridge. | Same |
| Analyzer Software | Fully integrated Thromboelastographyanalyzer | Same |
| Consumables | Carrier (acrylic plastic) withmicrofluidics laminate and test rings(acrylic plastic) | Same |
| Assay | CK, CKH, CRT, CFF | Same |
| Assay Reagents | CK - kaolin and CaCl2CKH - kaolin and CaCl2 withheparinaseCRT - tissue factor, kaolin andCaCl2CFF - abciximab (brand nameReoPro), tissue factor and CaCl2 | Same |
| Assay Parameters Reported | CK: R, K, Angle, MACKH: RCRT: MACFF: MA, FLEV | Same |
| Quality Controls | Abnormal QC | Cartridge Reagent QC - Level 1Cartridge Reagent QC - Level 2 |
Table 3: Summary of Clinical Values Comparisons: Similarities
| TEG® 6s Citrated: K, KH, RT, FFCleared Device/Predicate [K150041] | TEG® 6s Citrated: K, KH, RT,FF Modified Device | |
|---|---|---|
| Clinical Values of Citrated:Kaolin (CK) Parameter R (min) | Initiation phase of coagulationtriggered by enzymatic clotting factorsand culminating with the initial fibrinformation. A prolonged R value isindicative of slow clot formation, dueto coagulation factor deficiencies orheparin. | Same |
| Clinical Value of Citrated:Kaolin (CK) Parameter MA(mm) | MA, or Maximum Amplitude,Represents the maximum firmness ofthe clot during the test. The MAprovides information about the | Same |
| TEG® 6s Citrated: K, KH, RT, FFCleared Device/Predicate [K150041] | TEG® 6s Citrated: K, KH, RT,FF Modified Device | |
| contribution of platelets/fibrin to theoverall strength of the clot. | ||
| Clinical Value of Citrated:Kaolin with Heparinase (CKH)Parameter R (min) | Initiation phase of coagulationtriggered by enzymatic coagulationfactors and culminating with the initialfibrin formation.A prolonged R value is indicative ofslow clot formation, due tocoagulation factor deficiencies orheparin. Inclusion of heparinase in theblood chamber channel of the cartridgeprovides ability to compare R (min)without the effect of heparin on theclot. | Same |
| Clinical Value of Citrated:RapidTEG Parameter MA (mm) | RapidTEGTM MA is the point atwhich clot strength reaches itsmaximum and reflects the end result ofminimal platelet-fibrin interaction viathe GPIIb/IIIa receptors. Due to fastercoagulation activation, clot strength ismeasured faster thanCitrated: Kaolin (K) activatedsamples. Same results as CKmaximum amplitude (CK-MA).The MA provides information aboutthe contribution of platelets/fibrin tothe overall strength of the clot. | Same |
| Clinical Value of Citrated:Functional Fibrinogen ParameterMA (mm) | The maximum amplitude of CFFprovides the functional fibrinogencontribution to the clot strength.Provides the overall contribution offunctional fibrinogen to clotstrength. In conjunction with CRT-MA, this assay enables anassessment of the relativecontributions of functionalfibrinogen and platelets to clotstrength. Results may be valuable forguiding fibrinogensupplementation or platelettransfusion. | Same |
| Patient Population fromIntended Use | Hemostasis evaluations arecommonly used to assess clinicalconditions in cardiovascular surgeryand cardiology procedures to assesshemorrhage or thrombosis conditionsbefore, during and following theprocedure. | Same |
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| Table 4: Summary of Technological Characteristics for Substantial Equivalence: Differences | ||
|---|---|---|
| TEG® 6s Citrated: K, KH, RT, FFCleared Device/Predicate [K150041] | TEG® 6s Citrated: K, KH, RT,FF Modified Device | |
| Use Location | The TEG® 6s Hemostasis Systemwith TEG® 6s Citrated: K, KH, RT,FF assay can be used in the clinicallaboratory. | The TEG® 6s Hemostasis Systemwith TEG® 6s Citrated: K, KH, RT,FF assay can be used in the clinicallaboratory or at the point-of-care. |
Non-Clinical Test Summary and Conclusions
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the TEG® 6s analyzer. The system complies with IEC 61010-1, IEC 61010-2-010, IEC 61010-2-101, standards for safety and the IEC 60601-1-2, IEC/ EN61326-1, IEC/ EN61326-2-6, standards for EMC.
Conclusion
The information provided in this submission support a substantial equivalence determination for the TEG® 6s Hemostasis System: Citrated: K, KH, RT, FF and the predicate device.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.