(421 days)
The TEG 6s System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The TEG 6s System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The TEG 6s System provides specific blood modifiers, in the form of reagents dried-in-place within TEG 6s cartridges.
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 use for the TEG 6s System 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 TEG6s analyzer is a four-channel in vitro diagnostic instrument with an integrated computer module, a display touch screen for operator interaction, and a slot for inserting one TEG 6s cartridge. The TEG 6s analyzer is for use in laboratories and near patient use. It consists of an assembly of controllers, sensors, and displays, all managed and sequenced by a central processor. The embedded programming in the processor provides the necessary information for the automation of hemostasis testing. The program sequences the instrument hardware through the appropriate cycles to perform the test. Using a compressor, pressure and vacuum sensors, and a series of valves, actuators and controls, blood samples are introduced into the microfluidics of a disposable cartridge.
To perform a test, a disposable cartridge is inserted into the instrument. The instrument reads the bar code on the cartridge, identifies the type of cartridge for operator confirmation. Then, the operator adds a blood sample to the entry port on the cartridge and uses the touch screen to issue the command to the instrument to proceed with the test. The sample is then drawn into the cartridge under instrument control. The amount of the sample drawn into the cartridge is automatically determined by the volume of the reagent chambers in the cartridge.
The TEG 6s analyzer firmware provides features for and manages all functions of the instrument, including user interface (via the touch display screen) and external communications for service and installation via Service Maintenance Software (SMS). SMS is run on a separate computer connected to one or more TEG 6s analyzer(s) via the Ethernet port and a router. Its purpose is to allow additional control of analyzer functions by authorized remote users, such as administrative and service personnel.
The TEG Manager 2.0.0 is an optional accessory to Haemonetics TEG 6s Hemostasis System. TEG Manager 2.0.0 is an application that provides remote viewing of current and historical patient tracing and test results created by the TEG 6s analyzers, and administration of all connected TEG 6s devices. TEG Manager interfaces with the TEG analyzers to obtain clinical data and retrieves patient information from external Hospital Information System (HIS). Users cannot manipulate the data that is stored and displayed within TEG Manager or input any additional clinical data in the software.
The provided document is a 510(k) summary for the Haemonetics TEG® 6s Hemostasis System and TEG Manager 2.0.0. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically the TEG 6s Hemostasis System (K140893 and K150041), with the addition of TEG Manager 2.0.0 as an optional accessory.
Here's the breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the TEG Manager 2.0.0. Instead, the acceptance criterion for the software is described in a more general sense:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| TEG Manager 2.0.0 Software Functionality: The software must be thoroughly verified and validated at different levels (unit, system/integration, verification, validation, beta testing). | "The TEG Manager 2.0.0 software was thoroughly verified and validated via test standards. The overall approach to testing was to test the software at different levels, including unit, system/integration, verification, validation and beta testing." |
| Test Case Results: Acceptance criteria for verification and validation testing were identified in individual test cases as expected results. Test cases were comprised of scenarios with multiple steps along with their respective expected results. | "The acceptance criteria for verification and validation testing were identified in the individual test cases as the expected results. Test cases were comprised of scenarios with multiple steps along with their respective expected results. When all the steps were tested and the actual results matched the expected results, the test case result was passed." "Test data demonstrated that the device met all acceptance requirements, and that the subject device is as safe, as effective, and performs as well as or better than the predicate device." "The addition of TEG Manager 2.0.0 as an optional accessory to the TEG 6s Analyzer does not render the device non-substantially equivalent because non-clinical testing has demonstrated that the subject device is as safe and effective as the predicate and the results of verification and validation have not raised different questions of safety and effectiveness than the predicate." |
| Substantial Equivalence: The device, with the optional accessory, must be as safe and effective and perform as well as or better than the predicate device, without raising new questions of safety or effectiveness. | "The data and information provided in the submission support a substantial equivalence determination for the TEG 6s Analyzer and the proposed TEG 6s Analyzer with TEG Manager as an optional accessory." The document implies that the TEG Manager, being primarily a remote viewer of existing data from the predicate device, does not introduce new analytical or interpretive data and thus maintains the safety and effectiveness of the system. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for a direct performance evaluation of the TEG Manager 2.0.0 as an AI/ML device. The testing described is primarily software verification and validation (V&V). Therefore, there are no details on clinical sample size or data provenance (country of origin, retrospective/prospective) for a performance study. The focus is on ensuring the software functions as intended and accurately displays data from the TEG 6s Analyzer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since the "test set" refers to software V&V rather than clinical performance data requiring expert adjudication, there is no mention of experts establishing ground truth or their qualifications. Software testing typically relies on predefined requirements and expected outputs rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned because the V&V of the TEG Manager 2.0.0 does not involve clinical interpretation or a "ground truth" that would require expert consensus. The software's function is to accurately display data generated by the TEG 6s Analyzer.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is described. The TEG Manager 2.0.0 is an auxiliary viewing and management tool for data already generated by the TEG 6s Analyzer. It does not involve human readers interpreting images or data with and without AI assistance to assess an effect size.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The TEG Manager 2.0.0 is described as an "optional accessory" that provides "remote viewing of current and historical patient tracing and test results created by the TEG 6s analyzers, and administration of all connected TEG 6s devices." It "does not provide any additional analytical or interpretive data outside of the TEG analyzer capabilities." Therefore, its performance is intrinsically tied to the TEG 6s Analyzer, and it does not operate as a standalone diagnostic algorithm in the way an AI/ML device typically would. Its "performance" would be related to its ability to accurately reflect the analyzer's output and manage devices, which is covered by the software V&V.
7. Type of Ground Truth Used
For the TEG Manager 2.0.0, the "ground truth" for the software validation would be the expected output values and display capabilities based on the data directly produced by the TEG 6s Analyzer and the specified software requirements. It's not clinical ground truth in the sense of pathology, outcomes data, or expert consensus on a diagnosis.
8. Sample Size for the Training Set
The document does not describe any training set as would be relevant for an AI/ML model. The TEG Manager 2.0.0 is a software application for data display and management, not a learning algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, there is no discussion of how ground truth was established for such a set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, featuring three human profiles facing right, suggesting a sense of community and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2017
Haemonetics Corporation Mr. Brian Ciccariello Manager, Regulatory Affairs 400 Wood Road Braintree, MA 02184
Re: K160502
Trade/Device Name: TEG® 6s Hemostasis System; TEG Manager 2.0.0 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: April 03, 2017 Received: April 04, 2017
Dear Mr. Ciccariello:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
{1}------------------------------------------------
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Leonthena R. Carrington -S
Lea Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160502
Device Name TEG 6s Hemostasis System
Indications for Use (Describe)
The TEG 6s System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The TEG 6s System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The TEG 6s System provides specific blood modifiers, in the form of reagents dried-in-place within TEG 6s cartridges.
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 use for the TEG 6s System 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in light blue, green, gray, and red, respectively. Below the squares is the company name "HAEMONETICS" in red, followed by the tagline "THE Blood Management Company" also in red.
510(k) Summary
Submitter:
Haemonetics Corporation 400 Wood Road Braintree, MA 02184
Contact:
Brian Ciccariello Manager, Regulatory Affairs Phone: 781-348-7315 Fax: 781-356-7950 Email: brian.ciccariello@haemonetics.com
Device Information:
| Trade Name: | TEG 6s Hemostasis System |
|---|---|
| Common Name: | Whole Blood Hemostasis System |
| Classification Name: | Multipurpose System for in vitro Coagulation Studies |
| Regulation Number: | 21 CFR 864. 5425 |
| Product Code: | JPA |
| Device Class: | II |
Predicate Device
Trade Name: TEG 6s Hemostasis System 510(k) K140893 clearance Date Jan 3, 2015 TEG 6s Hemostasis System 510(k) K150041 clearance Date June 26, 2015
Device Characteristics Summary:
The TEG6s analyzer is a four-channel in vitro diagnostic instrument with an integrated computer module, a display touch screen for operator interaction, and a slot for inserting one TEG 6s cartridge. The TEG 6s analyzer is for use in laboratories and near patient use. It consists of an assembly of controllers, sensors, and displays, all managed and sequenced by a central processor. The embedded programming in the processor provides the necessary information for the automation of hemostasis testing. The program sequences the instrument hardware through the appropriate cycles to perform the test. Using a compressor, pressure and vacuum
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of four colored squares in the top left corner, followed by the company name in red, with the tagline "THE Blood Management Company" in a smaller font below. The colors of the squares are light blue, olive green, gray, and red.
sensors, and a series of valves, actuators and controls, blood samples are introduced into the microfluidics of a disposable cartridge.
To perform a test, a disposable cartridge is inserted into the instrument. The instrument reads the bar code on the cartridge, identifies the type of cartridge for operator confirmation. Then, the operator adds a blood sample to the entry port on the cartridge and uses the touch screen to issue the command to the instrument to proceed with the test. The sample is then drawn into the cartridge under instrument control. The amount of the sample drawn into the cartridge is automatically determined by the volume of the reagent chambers in the cartridge.
The TEG 6s analyzer firmware provides features for and manages all functions of the instrument, including user interface (via the touch display screen) and external communications for service and installation via Service Maintenance Software (SMS). SMS is run on a separate computer connected to one or more TEG 6s analyzer(s) via the Ethernet port and a router. Its purpose is to allow additional control of analyzer functions by authorized remote users, such as administrative and service personnel.
The TEG Manager 2.0.0 is an optional accessory to Haemonetics TEG 6s Hemostasis System. TEG Manager 2.0.0 is an application that provides remote viewing of current and historical patient tracing and test results created by the TEG 6s analyzers, and administration of all connected TEG 6s devices. TEG Manager interfaces with the TEG analyzers to obtain clinical data and retrieves patient information from external Hospital Information System (HIS). Users cannot manipulate the data that is stored and displayed within TEG Manager or input any additional clinical data in the software.
Intended Use and Indications for Use:
Please refer to the Comparison Table below for Intended Use and Indications for Use.
Non-Clinical Testing Summary:
The TEG Manager 2.0.0 software was thoroughly verified and validated via test standards. The overall approach to testing was to test the software at different levels, including unit, system/integration, verification, validation and beta testing. The acceptance criteria for verification and validation testing were identified in the individual test cases as the expected results. Test cases were comprised of scenarios with multiple steps along with their respective expected results. When all the steps were tested and the actual results matched the expected
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image displays the logo for Haemonetics, a blood management company. The logo features the company name "HAEMONETICS" in a bold, red font, with the registered trademark symbol next to it. Below the company name is the tagline "THE Blood Management Company" also in red, with another registered trademark symbol.
results, the test case result was passed. Test data demonstrated that the device met all acceptance requirements, and that the subject device is as safe, as effective, and performs as well as or better than the predicate device.
Substantial Equivalence:
TEG 6s Analyzer with TEG Manger as an optional accessory is substantially equivalent to the 510(k) cleared (K150041) TEG 6s Analyzer. TEG Manager 2.0.0 is intended to be used as an optional accessory with the TEG 6s Analyzer as a remote viewer of the data provided by the TEG 6s analyzer. TEG Manager 2.0.0 does not provide any additional analytical or interpretive data outside of the TEG analyzer capabilities.
TEG Manager 2.0.0 allows users to edit non clinical patient information data, add notes, and provide email capability that is currently on the TEG 6s analyzer, from a remote location, as long as TEG Manager 2.0.0 is connected to the analyzer. TEG Patient information edits have no impact on the hospital's HIS and do not affect clinical data. The addition of TEG Manager 2.0.0 as an optional accessory to the TEG 6s Analyzer does not render the device non-substantially equivalent because non-clinical testing has demonstrated that the subject device is as safe and effective as the predicate and the results of verification and validation have not raised different questions of safety and effectiveness than the predicate.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of the word "HAEMONETICS" in red, with the tagline "THE Blood Management Company" underneath. There are four colored squares above the company name in blue, green, gray, and red.
Table 1: Comparison of the TEG 6s Analyzer with TEG Manager to Predicate TEG 6s Analyzer
| PredicateTEG 6s Analyzer(K140893 & K150041) | Subject TEG 6sAnalyzerwith TEG Manager | |
|---|---|---|
| Manufacturer | Haemonetics Corporation | Same |
| Trade Name | TEG 6s Hemostasis System | TEG 6s Hemostasis System |
| Common Name | Whole Blood Hemostasis System | Same |
| ClassificationName | Multipurpose System for in vitro CoagulationStudies (K150041)Automated platelet aggregation system (K140893) | Same as (K150041) |
| RegulationNumber | 21 CFR 864. 5425 (K150041)21 CFR 864.5700 (K140893) | Same as (K150041) |
| Product Code | JPA (K150041)JOZ (K140893) | Same as (K150041) |
| Device Class | II | Same |
| Indications forUse | The TEG 6s System is intended for in vitrodiagnostic use to provide semi-quantitativeindications of the hemostasis state of a bloodsample. The TEG 6s System records the kineticchanges in a venous sample of 3.2% citrated wholeblood as the sample clots, and retracts in real time.The system output consists of a table of numericalvalues for parameters R, K, Angle, MA, and FLEV.The TEG 6s System provides specific bloodmodifiers, in the form of reagents dried-in-placewithin TEG 6s cartridges.Results from the TEG 6s analysis should not be thesole basis for a patient diagnosis, but should beevaluated together with the patient's medicalhistory, the clinical picture and, if necessary,further hemostasis tests.The indication for use for the TEG 6s System is withadult patients where an evaluation of their bloodhemostasis properties is desired. Hemostasisevaluations are commonly used to assess clinical | Same |
| PredicateTEG 6s Analyzer(K140893 & K150041) | Subject TEG 6sAnalyzerwith TEG Manager | |
| conditions in cardiovascular surgery and cardiologyprocedures to assess hemorrhage or thrombosisconditions before, during and following theprocedure. | ||
| Intended use | Same as Indications for Use | Same |
| Disposables | Citrated Multichannel CartridgePlateletMapping Assay CartridgesAbnormal Wet Quality Control Material | Same |
| Analyzer Software | Analyzer has fully integrated Thrombelastographysoftware | SameTEG Manager 2.0.0. is anoptional accessory to beused with the TEGSystem. TEG Managerprovides remote viewingof current and historicaltest results created by theTEG System. |
| AnalyzerHardware | Analyzer | Same |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Haemonetics, a blood management company. The logo consists of a series of colored squares in the upper left corner, followed by the company name in red, with the tagline "THE Blood Management Company" in a smaller font below. The colors of the squares are blue, green, gray, and red.
Conclusion:
The data and information provided in the submission support a substantial equivalence determination for the TEG 6s Analyzer and the proposed TEG 6s Analyzer with TEG Manager as an optional accessory.
§ 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.