(186 days)
The Thrombelastograph (TEG) Coagulation Analyzer TEG - 5000 Series is a noninvasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The TEG is indicated for use with adult patients where an evaluation of their blood coagulation properties is desired. Coagulations are commonly used to assess clinical conditions such as post-operative hemorrhage and / or thrombosis during and following cardiovascular surgery, organ transplantation, trauma, and cardiology procedures.
The TEG - 5000 Series Analyzer consists of a two-column TEG instrument, a computer interface module, software, and disposable sample cups and pins. The TEG measures the clot's physical property by the use of a special stationary cylindrical cup that holds the blood and is oscillated. A pin is suspended in the blood by a torsion wire and is monitored for motion. The torque of the rotation cup is transmitted to the immersed pin only after fibrin-platelet bonding has linked the cup and pin together. The strength of these fibrin-platelet bonds affects the magnitude of the pin motion, such that strong clots move the pin directly in phase with the cup motion. The magnitude of the output is, therefore, directly related to the strength of the formed clot. As the clot retracts or breaks apart, these bonds are broken and the transfer of cup motion is diminished.
The provided text describes the Thrombelastograph Coagulation Analyzer TEG - 5000 Series and its substantial equivalence to a predicate device (TEG - 3000S Analyzer). However, it does not contain detailed acceptance criteria or a specific study that quantifies the device's performance against such criteria in a granular manner.
The submission focuses on establishing substantial equivalence based on:
- Same intended use, principles of operation, and function.
- Minor technological differences (improved functional fibrinogen level determination, improved sample cup system, improved software menu) that do not raise new questions of safety or effectiveness.
- Comparative performance testing and software validation testing to demonstrate the device "meets established design specifications and performance requirements" and "performs as well as the predicate device."
Without specific numerical acceptance criteria and a detailed study explicitly laying out performance metrics against those criteria, it's not possible to fully complete the requested table and sections. However, based on the provided text, here's what can be inferred or stated about the study and criteria if we interpret "acceptance criteria" broadly as the demonstration of substantial equivalence and meeting design specifications:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance and Evidence in Submission |
|---|---|
| Intended Use: Device performs the same intended use as predicate. | Meets: The TEG - 5000 Series Analyzer has the same intended use: to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, and reporting coagulation parameter information. Records kinetic changes in whole blood, plasma, or platelet-rich plasma as it clots, retracts, and/or lyses. |
| Principles of Operation: Device operates on the same principles as predicate. | Meets: Same principles of operation. Measures clot's physical property using an oscillating cylindrical cup and a pin suspended by a torsion wire. Torque transmission from cup to pin is monitored, reflecting clot strength and breakdown. |
| Function: Device performs the same functions as predicate. | Meets: Same function. The described mechanism for measuring clot formation and lysis is identical to that of the predicate. |
| Safety and Effectiveness: Minor technological differences do not raise new safety or effectiveness concerns. | Meets: Differences are: 1. Software for determining functional fibrinogen level. 2. Improved sample cup placement/retrieval. 3. Improved software menu structure. The submission states "No new questions of safety or effectiveness were raised" by these changes. |
| Performance: Device meets established design specifications and performs as well as the predicate. | Meets: "Comparative performance testing and software validation testing was performed to demonstrate that the TEG - 5000 Series analyzer meets established design specifications and performance requirements. The test results confirmed that, despite differences, the TEG - 5000 Series Analyzer meets established design specifications and performs as well as the predicate device." (Specific quantitative data for "performance" is not provided in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Comparative performance testing and software validation testing was performed," but does not specify the sample size used for any test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth in the context of the performance testing. The "ground truth" for the device, being an in-vitro diagnostic, would likely be comparison against established laboratory methods or the performance of its predicate device, rather than expert consensus on patient conditions. Clinical assessments by qualified professionals are mentioned as being part of the overall patient diagnosis, in conjunction with TEG results, but not as part of establishing ground truth for the device's technical validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method as it does not detail a study involving multiple readers or complex diagnostic assessments requiring such a process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was described or implied. This device is an in-vitro diagnostic instrument measuring coagulation parameters. The concept of "human readers improve with AI vs. without AI assistance" typically applies to image-based diagnostic AI, which is not the nature of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone instrument that measures and reports coagulation parameters. Its performance testing would implicitly be "standalone" in the sense that it evaluates the instrument's ability to accurately measure these parameters. The text states it "provides a quantitative and qualitative indication" and "records kinetic changes." Therefore, a standalone performance evaluation would have been conducted to assess its accuracy and reliability in generating these readings. However, the details of this evaluation (e.g., specific metrics like accuracy, precision, linearity) are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device (Thrombelastograph), the "ground truth" for its performance testing would most likely involve comparison to established reference methods or the predicate device's measurements for various coagulation parameters using control samples, spiked samples, or clinical samples. It would not typically involve expert consensus, pathology, or direct outcomes data as the primary ground truth for the device's analytical performance. The document explicitly states that TEG results should be considered along with "other coagulation laboratory tests" and "clinical assessment," implying these other tests or assessments form a broader context for ground truth, but not for the device's intrinsic analytical performance validation in this submission.
8. The sample size for the training set
This device appears to be primarily an analytical measurement tool rather than an AI/machine learning algorithm that requires a separate "training set." While it has "software," the primary function described is physical measurement and reporting, not complex pattern recognition learned from data. Therefore, the concept of a "training set" in the context of machine learning does not seem applicable here, and no information about a training set is provided. The "software validation testing" would focus on ensuring the software correctly processes the physical measurements and reports them accurately according to its design specifications.
9. How the ground truth for the training set was established
As explained above, a "training set" as commonly understood in AI/ML is not applicable to this device based on the information provided. Therefore, this question is not relevant to the described device. If the software does contain algorithms that were "trained" in some way, the document does not elaborate on this or how any ground truth for such training would have been established.
{0}------------------------------------------------
510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Submitter's Name / Contact Person
| Eli Cohen, Ph.D.President and CEOHaemoscope Corporation7855 Gross Point Road, Unit G-4Skokie, IL 60077 | Tel: (847) 329-0001, (800) 438-2834Fax: (847) 329-0003 |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------ |
2. General Information
| Trade Name | Thrombelastograph® Coagulation Analyzer TEG® - 5000 Series |
|---|---|
| Common / Usual Name | Thrombelastograph Instrument |
| Classification Name | Multipurpose System for In Vitro Coagulation Studies |
| Identification ofEquivalent Devices | Thrombelastograph® Coagulation Analyzer – 3000S,Haemoscope Corp. (K954137) |
3. Device Description
The TEG - 5000 Series Analyzer consists of a two-column TEG instrument, a computer interface module, software, and disposable sample cups and pins. The TEG measures the clot's physical property by the use of a special stationary cylindrical cup that holds the blood and is oscillated. A pin is suspended in the blood by a torsion wire and is monitored for motion. The torque of the rotation cup is transmitted to the immersed pin only after fibrin-platelet bonding has linked the cup and pin together. The strength of these fibrin-platelet bonds affects the magnitude of the pin motion, such that strong clots move the pin directly in phase with the cup motion. The magnitude of the output is, therefore, directly related to the strength of the formed clot. As the clot retracts or breaks apart, these bonds are broken and the transfer of cup motion is diminished.
4. Intended Use
The TEG - 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG - 5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet rich-plasma as the sample clots, retracts and/or lyses (breaks apart).
Results from the TEG analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a clinical assessment of the patient's condition and other coagulation laboratory tests. For Professional Use Only.
{1}------------------------------------------------
5. Technological Characteristic Comparisons
The Thrombelastograph Coagulation Analyzer TEG - 5000 Series is substantially equivalent to the Haemoscope Corporation Thrombelastograph Coagulation Analyzer -- 3000S (K954137). Compared to the predicate device, the TEG - 5000 Series Analyzer has the same intended use, principles of operation and function as the TEG - 3000S Analyzer. There are no technological differences between the two TEG analyzer families. The TEG - 5000 Series Analyzer, a modified version of the Haemoscope TEG 3000S Analyzer, offers instructions and software for determining the functional fibrinogen level of a clot sample. In addition, the TEG - 5000 Series offers an improved sample cup placement and retrieval system, and an improved software menu structure, enhancing ease of use and user safety.
6. Summary of Studies
Comparative performance testing and software validation testing was performed to demonstrate that the TEG - 5000 Series analyzer meets established design specifications and performance requirements. The test results confirmed that, despite differences, the TEG - 5000 Series Analyzer meets established design specifications and performs as well as the predicate device. No new questions of safety or effectiveness were raised.
7. Conclusion (statement of equivalence)
The data and information provided in this submission support a substantial equivalence determination and, therefore, clearance of the 510(k) premarket notification for the Thrombelastograph Coagulation Analyzer TEG - 5000 Series.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare. The logo is rendered in black and white.
MAY - 5 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Eli Cohen, Ph.D. President and CEO Haemoscope Corporation 7855 Gross Point Road, Unit G-4 Skokie, Illinois 60077
Re: K993678
Trade Name: Thrombelastograph® Coagulation Analyzer TEG® 5000 Series Regulatory Class: II Product Code: JPA Dated: April 3, 2000 Received: April 4, 2000
Dear Dr. Cohen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonication. The I Dr initially of succion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire spoonly an invitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in the arguestions on the promotion and advertising of your device, (2017) 591-1566. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known): K993678
Device Name:
Thrombelastograph® (TEG®) Coagulation Analyzer TEG® – 5000 Series
Indications for Use:
The Thrombelastograph (TEG) Coagulation Analyzer TEG - 5000 Series is a noninvasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The TEG is indicated for use with adult patients where an evaluation of their blood coagulation properties is desired. Coagulations are commonly used to assess clinical conditions such as post-operative hemorrhage and / or thrombosis during and following cardiovascular surgery, organ transplantation, trauma, and cardiology procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription-✓
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stur E. Madim
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993678
§ 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.