(186 days)
Not Found
No
The description focuses on the mechanical measurement of clot properties and does not mention AI or ML.
No
The device is described as a "noninvasive diagnostic instrument" designed to "monitor and analyze the coagulation state of a blood sample" to "assist in the assessment of patient clinical hemostasis conditions." It does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that it 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."
No
The device description explicitly states that the TEG - 5000 Series Analyzer consists of hardware components including a two-column TEG instrument, a computer interface module, and disposable sample cups and pins, in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is designed to "monitor and analyze the coagulation state of a blood sample." This involves testing a biological sample (blood) outside of the body.
- Device Description: The description details how the device interacts with a "blood sample" in a "sample cup." This confirms that the analysis is performed on a sample taken from the patient.
- Diagnostic Purpose: The device is used to "assist in the assessment of patient clinical hemostasis conditions" and "evaluate their blood coagulation properties." This indicates a diagnostic purpose, providing information about a patient's health status.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Professional Use Only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 CEO
Haemoscope Corporation
7855 Gross Point Road, Unit G-4
Skokie, IL 60077 | Tel: (847) 329-0001, (800) 438-2834
Fax: (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 of | |
| Equivalent 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
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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