(433 days)
No
The summary describes a mechanical and optical system for measuring blood coagulation properties and processing the data with "special software". There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic assay used to monitor the coagulation process. It assesses blood coagulation properties but does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the EXTEM, FIBTEM, and APTEM assays are "semi-quantitative in vitro diagnostic assays on the ROTEM® delta Thromboelastometry System." This directly indicates its function as a diagnostic device. The text also describes its use to "monitor the coagulation process" and "assess clinical conditions," further confirming its diagnostic purpose.
No
The device description explicitly states that the ROTEM® delta Thromboelastometry System consists of a four-column instrument, integrated computer module, electronic pipette, software, reagents, quality controls, and measurement cells. This indicates it is a system with significant hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states that the EXTEM, FIBTEM, and APTEM assays are "semi-quantitative in vitro diagnostic assay[s]".
- In Vitro: The device analyzes "citrated whole blood specimens," which are biological samples taken from the body and tested outside of it (in vitro).
- Diagnostic: The purpose of the device is to "monitor the coagulation process," "monitor the clot firmness," and "evaluate their blood coagulation properties." This information is used to assess clinical conditions and aid in diagnosis and treatment decisions related to bleeding and clotting disorders.
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EXTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). Speed of clot formation time (CFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking platelet contribution to the clot firmness The fib-TEM® reagent is always used in conjunction with ex-TEM® reagent. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. The ap-TEM® reagent is always used in conjunction with ex-TEM® reagent. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). Speed of clot formation time (CFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF). The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
Product codes
JPA
Device Description
The ROTEM® delta Thromboelastometry System consists of a fourcolumn instrument (with integrated computer module, computer controlled electronic pipette, software), system reagents (in-TEM®, hep-TEM®, star-TEM®, ex-TEM®, fib-TEM® and ap-TEM®, quality controls (ROTROL N, ROTROL P) and measurement cells (Cup and Pin pro). The blood sample is filled into a cylindrical cup. A pin oscillates permanently while it is immersed in the blood holding cup. The motion of the pin is detected by an optical detection system. Data are processed and analyzed by a computer with special software. If no clotting takes place, the movement of the pin is not obstructed. When a clot forms and attaches itself to the pin and cup surfaces, the movement is obstructed. As the clot becomes firmer, the rotational movement of the pin is reduced. The rotational movement of the pin is converted into amplitude with the following definitions applying to the thromboelastogram (TEM): Amplitude of 0 mm means unobstructed oscillation, while amplitude of 100 mm can be regarded as infinite firmness and blocking of the pin by the clot. The TEM amplitude is a measure of the clot firmness.
The previously cleared (K083842) ROTEM delta Thromboelastometry system is based on thromboelastometry, an improved form of the classical thromboelastography / thrombelastography developed by Hartert in 1948. The technique was previously called rotation thrombelastography (ROTEG®), but renamed in 2003 . Thromboelastometry and thromboelastography are based on the measurement of elasticity of blood by continuous graphic logging of the firmness of a blood clot during clot formation (coagulation factors and inhibitors, platelets and fibrin) and subsequent fibrinolysis.
The patented ROTEM® technology is based on a disposable measurement cell with a fixed cup in which a pin oscillates permanently. The motion of the pin is detected by an optical detection system. Data are processed and analysed by a computer with special software. For measurement, the blood sample is filled into the 8 mm diameter cylindrical cup. This cup is placed on a 6 mm diameter pin which is attached to the lower end of a vertical axis. The centre section of the axis is guided by a ball bearing. The axis oscillates to the left and to the right by rotating through an angle of 4.75° via a s pring connector. The rotation is detected optically via a mirror plate at the upper end of the axis, a diode as light source and a light sensitive sensor (CCD (charge-coupled device) array). If no clotting takes place, the movement is not obstructed. When a clot is formed and attaches itself to the pin and cup surfaces, the movement is obstructed. The result is a balance between the torque introduced by the spring connector into the pin and the torque generated by the clot on the pin. As the clot becomes firmer, the rotational movement of the pin is reduced. The rotational movement of the pin is converted into amplitude with the following definitions applying to the ROTEM® delta analyzer: Amplitude of 0 mm means unobstructed rotation, while amplitude of 100 mm can be regarded as infinite firmness and blocking of the pin by the clot. The result displayed on screen or printed out is called a "TEMogram" or "TEM".
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Reference ranges for the ROTEM® test were estimated using the CSLI C28-A2 guideline on three clinical US reference sample groups.
Description of the test set, sample size, data source, and annotation protocol
Method comparison studies were conducted in 3 US centers on patient samples. The patients enrolled comprised patients during surgery and post surgery at the intensive care unit (ICU). In order to broaden the range of comparison, contrived samples were added.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Precision, Interference, Heparin responsiveness, Method comparison.
Sample Size: Not explicitly stated for all studies. Scatter plots for method comparison show n=100 for EXTEM CT vs. R and α vs. Angle, n=91 for EXTEM CFT vs. K, n=93 for EXTEM MCF vs. MA. For APTEM, n=84 for CT vs. R, n=73 for CFT vs. K, n=82 for α vs. Angle, n=79 for MCF vs. MA. For FIBTEM, n=88 for MCF vs. MA.
Standalone Performance:
- Precision (EXTEM/FIBTEM/APTEM):
- Within-run Precision: CT 0.8).
- EXTEM Regression Statistics:
- CT vs. R: R OLS = 0.9497, Slope Deming = 0.99, Intercept Deming = 0.29.
- CFT vs. K: R OLS = 0.9855, Slope Deming = 0.79, Intercept Deming = 0.58.
- α vs. Angle: R OLS = 0.9736, Slope Deming = 1.47, Intercept Deming = -37.05.
- MCF vs. MA: R OLS = 0.9720, Slope Deming = 0.87, Intercept Deming = 6.76.
- APTEM Regression Statistics:
- CT vs. R: R OLS = 0.934, Slope Deming = 1.02, Intercept Deming = 0.38.
- CFT vs. K: R OLS = 0.9757, Slope Deming = 0.85, Intercept Deming = 0.57.
- α vs. Angle: R OLS = 0.9777, Slope Deming = 1.51, Intercept Deming = -39.96.
- MCF vs. MA: R OLS = 0.9544, Slope Deming = 0.88, Intercept Deming = 5.84.
- FIBTEM Regression Statistics:
- MCF vs. MA: R OLS = 0.9384, Slope Deming = 1.05, Intercept Deming = -4.53.
- Reference ranges were estimated for EXTEM and FIBTEM assays.
In aggregate, the data demonstrated that the ROTEM® system and the three assays described are substantially equivalent to the predicate TEG® System and corresponding assays.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics reported are precision (CV%), linear regression statistics (Slope, Intercept, R OLS), and reference ranges (MCF, A20, CT, CFT, Alpha). Sensitivity, Specificity, PPV, NPV are not explicitly reported.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
4.0 510(k) Summary
4.1 Submitter's name / Contact Person
AUG 1 0 2011
Dr. Volker-Joachim Friemert Head of Quality Management and Regulatory Affairs Tem Innovations GmbH Martin-Kollar-Strasse 13-15 81829 Munich Germany
Contact: Office: +49-89-454295-0 Dr. Volker-Joachim Friemert: +49-89-454295-11 Fax: +49-89-454295-22 E-mail: volker-joachim.friemert@tem-innovations.de
4.2 Identification of the Product
| Trade Name: | ROTEM® delta Thromboelastometry System
ex-TEM® reagent
fib-TEM® reagent
ap-TEM® reagent |
|----------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Whole Blood Haemostasis System |
| Classification Name: | Multipurpose System for In Vitro Coagulation
Studies |
4.3 Identification of the predicate
Thrombelastograph® Coagulation Analyzer (TEG®) - 5000 Series K002177, Product Code JPA, Haemoscope Corp.
4.4 Description of the Device
The three assays are system reagents for the previously cleared (K083842) ROTEM® delta Thromboelastometry system. For clarity, the description of ROTEM® delta Thromboelastometry analyzer is provided below.
The ROTEM® delta Thromboelastometry System consists of a fourcolumn instrument (with integrated computer module, computer controlled electronic pipette, software), system reagents (in-TEM®,
1
hep-TEM®, star-TEM®, ex-TEM®, fib-TEM® and ap-TEM®, quality controls (ROTROL N, ROTROL P) and measurement cells (Cup and Pin pro). The blood sample is filled into a cylindrical cup. A pin oscillates permanently while it is immersed in the blood holding cup. The motion of the pin is detected by an optical detection system. Data are processed and analyzed by a computer with special software. If no clotting takes place, the movement of the pin is not obstructed. When a clot forms and attaches itself to the pin and cup surfaces, the movement is obstructed. As the clot becomes firmer, the rotational movement of the pin is reduced. The rotational movement of the pin is converted into amplitude with the following definitions applying to the thromboelastogram (TEM): Amplitude of 0 mm means unobstructed oscillation, while amplitude of 100 mm can be regarded as infinite firmness and blocking of the pin by the clot. The TEM amplitude is a measure of the clot firmness.
4.5 Intended Use
The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, Ll(x)). CFT and alpha (Speed of clot formation time) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).
The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking platelet contribution to the clot firmness. fib-TEM® is always used in conjunction with ex-TEM®. Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF).
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-TEM® is always used in conjunction with ex-TEM®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of clot formation time) are
- 18 -
2
complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).
CONFIDENTIAL
4.6 Summary of Technological Characteristics of the Product, Compared with the Predicate Device
| ROTEM® delta | TEG® 5000 | |
|---|---|---|
| Reagents / | ||
| Accessories: | ||
| Extrinsic Contact | ||
| Activation Reagent | ex-TEM® (Rabbit | |
| brain thromboplastin) | Commercial | |
| thromboplastin (e.g. | ||
| ex-TEM®) | ||
| Platelet Blocker | ||
| Reagent | fib-TEM® | |
| (Cytochalasin D, | ||
| CaCl2) | Reopro®,CaCl2 | |
| Antifibrinolytic drug | ap-TEM® | |
| (Aprotinin, CaCl2) | Trasylol®,CaCl2 |
*ex-TEM®, fib-TEM®, and ap-TEM® are the commercial names of the reagents used with the respective EXTEM, FIBTEM, and APTEM assays.
4.7 Executive Summary of the Study Report
The ROTEM® delta (ROTEM) Whole Blood Haemostasis System has recently been FDA cleared (K083842) using the TEG® 5000 (TEG) as a predicate device. In this study, the performance characteristics of the ex-TEM®, fib-TEM® and ap-TEM® reagents for ROTEM® delta were evaluated. For these three tests, no commercially available TEG® 5000 tests are available, but the TEG® 5000 User Manual lists on pp 11-13 recommendations on how to perform these tests using other manufacturers' reagents'.
Based on the recommendations in the TEG® manual and the study protocol the three assays (EXTEM, FIBTEM and APTEM) were run on the ROTEM® and their equivalents (as described in the TEG® manual) were run on the predicate device, the TEG® in support of a 510(k) submission.
Tissue Factor (TF) is the common activator in all three tests on both ROTEM® and on TEG®. Detailed reagent compositions are shown in Table 2.
- TEG® 5000 User's Manual. Version 4.2 Software. Remote and TEG-enabled versions. Haemoscope Corporation. Rev 02, 2006-04.
3
| ROTEM® / TEG® test | Activation Principle | Components (reagents)
ROTEM® | Components (reagents)
TEG® |
|----------------------------------|----------------------|----------------------------------------------------------------|---------------------------------------------------------------|
| EXTEM / TF activated | Tissue Factor (TF) | TF reagent ( ex-TEM®
rabbit brain
thromboplastin), CaCl2 | TF reagent (ex-TEM®
rabbit brain
thromboplastin), CaCl2 |
| FIBTEM / Platelet Blocked | Tissue Factor (TF) | Cytochalasin D, CaCl2
ex-TEM® | Reopro®, CaCl2
TF reagent (ex-TEM®), |
| APTEM / Antifibrinolytic
Drug | Tissue Factor (TF) | Aprotinin, CaCl2
ex-TEM® | Trasylol® (aprotinin),
CaCl2
TF reagent (ex-TEM®), |
Table 2. Extrinsically activated tests as nerformed in ROTEM® and TEG
ex-TEM® is the name of the TEM Innovations commercial brand of rabbit thromboplastin
The EXTEM assay run on the ROTEM® delta was compared to a "generic" tissue factor reagent run on the TEG® 5000 as recommended in the TEG® User Manual (page 12), The generic tissue factor chosen, was the ex-TEM reagent.
The FIBTEM assay (ex-TEM® reagent plus Cyochalasin D) run on the ROTEM® was compared to the TF reagent plus ReoPro run on the TEG" 5000 and used as source of TF. Cyclochalasin D and ReoPro® are both potent platelet inhibitors that inhibit platelet almost completely 3. ReoPro® is not incorporated into the FIBTEM assay because Cytochalasin D is not readily available for commercial use and is prohibitively expensive as it is an intravenous drug available by prescription only.
The APTEM assay ( ex-TEM® reagent plus aprotinin) run on the ROTEM®, was compared the TF reagent with aprotinin run on the TEG® as recommended in the TEG® 5000 User Manual (page 13) for a hyperfibrinolysis confirmation test. The ex-TEM® reagent was used as source of TF. Trasylol® (Bayer) was used on the TEG® 5000 as recommended in the manual. A generic aprotinin, rather than Trasylol® is incorporated into the APTEM assay because Trasylol® is not readily available for commercial use as it is an intravenous drug available by prescription only.
-
Khurana S, Mattson J.C, Westley S, O'Neil W.W, Timmis G.C, Safian R.D. Monitoring platelet glycoprotein IIb/Ita-fibrin interaction with tissue factor-activated thrombelastography. J. Lab Clin Med 1997; 4,:401-411
-
Lang T., Toller W. , Gütl M. , Mahla E. , Metzler H. , Rehak P. , März W. , Hallwachs-Baumann G. Different effects of abciximab and cytochalasin D on clot strength in thromboelastography. J Thromb Haemost 2004;2:147-53
4
For all three tests, the ROTEM® was shown to have good precision in its primary parameter clot firmness and adequate precision in its secondary coaqulation kinetics parameters (see 4.8.2 - 4.8.4). The main parameters and their definitions are summarized in Table 2.
The method comparison with TEG® showed equality of the clot firmness (MCF vs. MA). The kinetic parameters (CT vs. R, CFT vs. K, Alpha Angle vs. Angle) showed a linear correlation between ROTEM® and TEG® (r>0.8).
Reference ranges for the ROTEM® test were estimated using the CSLI C28-A2 guideline on three clinical US reference sample groups. The reference ranges determined showed no significant center-to-center deviations and were in accordance with the reference ranges determined in earlier studies on European reference sample groups (Table 3).
| MCF (mm) | A20 (mm) | CT (sec) | CFT (sec) | Alpha (°) ROTEM® | ||
|---|---|---|---|---|---|---|
| EXTEM | EU | 50-72 | 50-71 | 38-79 | 34-159 | 63-83 |
| US | 51.7-70.3 | 50.2-69.8 | 43.2-81.6 | 47.6-126.8 | 65.0-80.0 | |
| FIBTEM | EU | 9-25 | 8-24 | |||
| US | 7.0-24.0 | 7.0-23.8 |
Table 3: ROTEM® reference ranges from studies in Europe (EU) and US
Three interfering substances widely used in coagulation management, the antifibrinolytic drugs aprotinin, tranexamic acid and epsilon-amino caproic acid (ACA) were investigated. Dose-response curves were investigated for heparin. for dilution and for urokinase on the EXTEM model in order to verify the diagnostic principles of thromboelastometric methods on ROTEM®.
In summary, ROTEM® is a precise Whole Blood Haemostasis System with the typical performance characteristics of a thrombelastographic method (no aprotinin interference on the extrinsically activated tests, high heparin insensitivity of the tests with extrinsic activation and sensitivity to dilution and lysis induced by urokinase in-vitro). Its reference ranges are reproducible from center to center.
The method comparison with TEG® shows equality of the primary parameter clot firmness and a linear regression and good correlation in the secondary kinetic parameters.
In aggregate the data presented in this report demonstrate that the ROTEM® system and the three assays described are substantially equivalent to the predicate TEG® System and corresponding assays.
5
4.8 Performance Data
4.8.1 Acceptance Criteria for Precision
The following tables show the Acceptance Criteria for ROTEM® reagents:
EXTEM/ FIBTEM/ APTEM:
2
| Test | CT | CFT | Alpha | A20 |
|---|---|---|---|---|
| Within-run Precision1 | "TEG" and Thrombelastograph" are trademarks of Haemoscope Corp./ TEM and ROTEM® are registered trademarks of Tem Innovations GmbH |
13
For measurement, the blood sample is filled into the 8 mm diameter cylindrical cup. This cup is placed on a 6 mm diameter pin which is attached to the lower end of a vertical axis. The centre section of the axis is guided by a ball bearing. The axis oscillates to the left and to the right by rotating through an angle of 4.75° via a s pring connector.
The rotation is detected optically via a mirror plate at the upper end of the axis, a diode as light source and a light sensitive sensor (CCD (charge-coupled device) array). If no clotting takes place, the movement is not obstructed. When a clot is formed and attaches itself to the pin and cup surfaces, the movement is obstructed.
The result is a balance between the torque introduced by the spring connector into the pin and the torque generated by the clot on the pin. As the clot becomes firmer, the rotational movement of the pin is reduced. The rotational movement of the pin is converted into amplitude with the following definitions applying to the ROTEM® delta analyzer:
| ROTEM®
| Parameter | Definition | Interpretation |
|---|---|---|
| MCF | ||
| Maximum Clot | ||
| Firmness [mm] | Maximum clot firmness | |
| (maximum amplitude) of the | ||
| developed clot during the test. | Normal/reduced/increased clot | |
| firmness. | ||
| A10, A20 | ||
| Amplitude 10, 20 | ||
| [mm] | Clot firmness (amplitude) at the | |
| time points 10 and 20 minutes | ||
| after CT. | Normal/reduced/increased clot | |
| firmness. | ||
| CT | ||
| Clotting Time [s] | The time from test start until first | |
| significant level of clot firmness | ||
| (2 mm) is reached. | Normal/reduced/increased speed | |
| of coagulation initiation. | ||
| CFT | ||
| Clot Formation | ||
| Time [s] | The time from the CT/R until a | |
| clot firmness of 20 mm is | ||
| reached. | Normal/reduced/increased speed | |
| of coagulation amplification and | ||
| propagation | ||
| (complementary parameter) | ||
| α | ||
| Alpha Angle [°] | Angle between the baseline and | |
| a tangent to the clotting curve | ||
| through the 2 mm (CT/R) point. | Normal/reduced/increased speed | |
| of coagulation amplification and | ||
| propagation | ||
| (complementary parameter) |
14
Image /page/14/Figure/3 description: This image shows a graph with the title "Alpha-angle" and "MCF = Maximum Clot Firmness". The graph has an x-axis labeled with numbers 15, 30, 45, and 60. The y-axis is labeled with numbers from 20 to 60. The image also contains the text "CT = Clotting Time" and "CFT = Clot Formation Time".
The ROTEM® TEMogram and its Parameters Fig. 2)
Amplitude of 0 mm means unobstructed rotation, while amplitude of 100 mm can be regarded as infinite firmness and blocking of the pin by the clot.
The result displayed on screen or printed out is called a "TEMogram" or "TEM".
15
Image /page/15/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with a bird-like figure incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Tem Innovations GmbH c/o Dr. Volker-Joacham Friemert Manager of Quality Managment and Regulatory Affairs Martin-Kollar-Strasse 13-15 81829 Munich, Germany
AUG 1 0 2011
Re: K101533
Trade/Device Name: EXTEM® Assay, FIBTEM® Assay, APTEM® Assay for the ROTEM® delta Thromboelastometry System Regulation Number: 21 CFR §864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: September 15, 2010
Dear Dr. Friemert:
adulteration.
Received: September 21, 2010
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
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
16
Page 2 - Dr. Volker-Joacham Friemert
requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Travis M. Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
17
Indications for Use
510(k) Number: K101533
Device Name: EXTEM assay
Indications for Use
The EXTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens.
Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
Speed of clot formation time (CFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF).
The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coaqulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off |
|---|
| ------------------- |
Office of In Vitro Diagnostic
Device Evaluation and Safety
| 510(k) | K101533 |
|---|---|
| -------- | --------- |
510kl
18
Indications for Use
510(k) Number: KIOI533
Device Name: FIBTEM assay
Indications for Use
The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking platelet contribution to the clot firmness The fib-TEM® reagent is always used in conjunction with ex-TEM® reagent.
Clotting characteristics are described by the functional parameter Clot Firmness (A20/MCF).
The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K101533 |
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Indications for Use
510(k) Number: K101533
Device Name: APTEM assay
Indications for Use
The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of a citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. The ap-TEM® reagent is always used in conjunction with ex-TEM® reagent.
Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)).
Speed of clot formation time (CFT and alpha) is complementary parameter and should be used only in conjunction with the main parameters Clotting time (CT) and Clot Firmness (A20/MCF).
The indication for ROTEM® delta use is in adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations with the ROTEM® delta system are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess post-operative hemorrhage and / or thrombosis.
Prescription Use) × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Division Sign-Off |
|---|
| ------------------- |
| Office of In Vitro Diagnostic |
|---|
| Device Evaluation and Safety |
| 510(k) | K101533 |
|---|---|
| -------- | --------- |
510(k)