(190 days)
No
The description focuses on standard physiological data acquisition, display, and calculation of FFR based on user-selected waveform segments. There is no mention of AI/ML algorithms for analysis, interpretation, or prediction.
Yes
The device is described as "a hemodynamic recording and display system designed to measure, record, and display vitals signs data for patients undergoing cardiac catheterization procedures," and specifically calculates Fractional Flow Reserve (FFR) values which "provides a quantitative assessment of the functional severity of a coronary artery stenosis." While it's primarily a measurement and display system, the FFR measurement gives information that directly guides treatment decisions and diagnosis for a medical condition (coronary artery stenosis), which falls under the definition of a therapeutic device (even if it's therapeutic in an indirect way, by aiding diagnosis that leads to treatment).
Yes
The device displays and captures diagnostic quality 12 Lead resting ECG to visualize arrhythmias and ST-segment changes, and performs Fractional Flow Reserve (FFR) calculations which assess the functional severity of coronary artery stenosis, indicating the device is used for diagnostic purposes.
No
The device description explicitly states that the system is comprised of a Patient Data Module (PDM) and a Merge Hemo Monitor PC, with the PDM acquiring and calculating vital parameters. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Merge Hemo device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Merge Hemo's Function: Merge Hemo directly measures and displays physiological data from the patient's body during a procedure. It is not analyzing specimens taken from the body. It is measuring vital signs, blood pressure, and calculating FFR based on pressure measurements within the coronary artery.
Therefore, while it provides diagnostic information, it does so through direct physiological measurement rather than the analysis of in vitro specimens.
N/A
Intended Use / Indications for Use
Merge Hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure.
The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, non-invasive blood pressure (NIBP). Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture diagnostic quality 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCO2 waveform.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. The two units are connected via a serial interface.
All vital parameters are acquired and calculated in the PDM. This data is then transmitted to the Merge Hemo Monitor PC via the serial interface. All data can then be displayed on the Merge Hemo Monitor PC. The Merge Hemo system is not intended to produce alarms for out-of-range conditions.
Patient allergies and current medication information can be entered by the system. If desired and using a third party database the Hemo system can display drug to allergy interaction information.
The system is intended for use in hospital catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
Merge Hemo is a hemodynamic recording and display system designed to measure, record, and display vitals signs data for patients undergoing cardiac catheterization procedures.
The addition of a Merge Hemo software feature that provides the ability to calculate and display Fractional Flow Reserve (FFR) values is described. No hardware changes are required in order to enable or perform this functionality.
FFR provides a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization.
FFR measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.
The Merge Hemo software user interface displays the pressure waveforms from the third party FFR pressure transducers that are placed distal and proximal to the lesion. When the FFR feature is enabled, the system shows the section of each of the waveforms that is used to calculate the mean pressure.
The results of the pressure waveform recording is expressed as a fraction of the normal blood flow in the coronary artery compared to the maximum achievable blood flow in the same artery. An FFR measurement of 1.0 indicates an artery with normal blood flow. FFR measurements less than 0.80 indicate that ischemia could be caused by blood flow blockage.
The Merge Hemo software initially selects segments of the waveforms to use for FFR calculations but the user can easily change where the values are taken by using the touchscreen interface to move the segment markers along the waveforms. The FFR value recalculates accordingly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.
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)
Physiologic Simulator Test: In-house bench testing was performed using physiologic simulators, varying the input pressure values and checking the calculations generated by Merge Hemo for each set of simulated distal and proximal pressures.
Integration Test: Comparison of Merge Hemo System vs. ACIST FFR System: In-house bench testing was performed to support the validation of the FFR calculation, equivalency testing against FFR systems, and integration/compatibility testing with commercially available third party FFR pressure measurement devices that provide blood pressure data as inputs for the FFR calculation. The FFR results calculated by Merge Hemo were compared with the FFR results calculated by an FDA 510(k) cleared (K132474) FFR system used under the same conditions: ACIST RXi Rapid Exchange FFR System by ACIST Medical Systems. Both systems used the same standard pressure transducer to measure the proximal pressure. The Merge Hemo and ACIST FFR systems showed excellent correlation and met all criteria for accuracy and precision. The FFR calculations from both systems were demonstrated to be equivalent.
Integration Test: Compatibility of Different FFR Pressure Transducers: Several makes and models of FDA 510(k) cleared FFR pressure transducer devices and standard blood pressure transducers were tested in various combinations with the Merge Hemo system. The statistical analysis of the data demonstrated that various makes and models of FFR pressure transducers are compatible with Merge Hemo, including: ACIST Navvus MicroCatheter, St Jude Aeris PressureWire, Volcano Verrata Pressure Guide Wire, Volcano PrimeWire PRESTIGE® PLUS Pressure Guide Wire. The statistical analysis of the data also demonstrated that various makes and models of standard pressure transducers are compatible with Merge Hemo, including: Edwards TruWave Disposable Pressure Transducer, ICU Medical Transpac IV Disposable Pressure Transducer System, Merit Meritrans® Pressure Transducer.
FFR tests were performed without manipulating or correcting the input pressure data or the FFR ratio calculations. The standardized pressure values generated by FFR transducers are consistent and compatible with Merge Hemo's FFR calculations. All in-house bench tests passed. No issues of safety and effectiveness were raised. No clinical tests were required in order to demonstrate the proper integration of the measurements into Merge Hemo for the calculation of FFR values.
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.
GE Mac-Lab, CardioLab, ComboLab, SpecialsLab v6.9.5, K130626, HeartSuite Hemodynamics, K082421
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.
ACIST RXi Rapid Exchange FFR System by ACIST Medical Systems, K132474
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
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
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 stylized eagle or bird-like symbol with three curved lines representing the bird's head and body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2016
Merge Healthcare Incorporated Carol Nakagawa Director, Quality And Regulatory Affairs 6303 Airport Road, Suite 500 Mississauga, L4V1R8 CA
Re: K152864
Trade/Device Name: Merge Hemo Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: March 2, 2016 Received: March 4, 2016
Dear Carol Nakagawa:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/Industry/default.htm. 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 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 vours.
FDA
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Merge Hemo
Indications for Use (Describe)
Merge Hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure.
The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, non-invasive blood pressure (NIBP). Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture diagnostic quality 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCO2 waveform.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. The two units are connected via a serial interface.
All vital parameters are acquired and calculated in the PDM. This data is then transmitted to the Merge Hemo Monitor PC via the serial interface. All data can then be displayed on the Merge Hemo Monitor PC. The Merge Hemo system is not intended to produce alarms for out-of-range conditions.
Patient allergies and current medication information can be entered by the system. If desired and using a third party database the Hemo system can display drug to allergy interaction information.
The system is intended for use in hospital catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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3
Image /page/3/Picture/0 description: The image shows the word "MERGE" in a stylized logo. The letters "M", "R", "G", and "E" are in blue, while the letter "E" is represented by three horizontal orange lines. The logo is simple and modern, with a clear and easy-to-read font.
510(k) Summary
l. SUBMITTER
Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, Wisconsin 53029 U.S.A.
Tel: 262.367.0700 262.367.0717 Fax:
Contact Person: Carol Nakagawa, RAC Director, Quality & Regulatory Affairs Merge Healthcare Tel.: 905.364.8027 Fax: 905.364.8100
Date Prepared: April 1, 2016
II. DEVICE
Name of Device: Merge Hemo™ Common or Usual Name: Hemodynamic Recording and Display System Classification Name: Programmable Diagnostic Computer (21 CFR 870.1425) Requlatory Class: II Product Code: DQK
. PREDICATE DEVICE
GE Mac-Lab, CardioLab, ComboLab, SpecialsLab v6.9.5, K130626 (primary predicate) HeartSuite Hemodynamics, K082421
IV. DEVICE DESCRIPTION
Merge Hemo is a hemodynamic recording and display system designed to measure, record, and display vitals signs data for patients undergoing cardiac catheterization procedures.
4
Image /page/4/Picture/0 description: The image shows the word "MERGE" in a stylized font. The letters "M", "R", "G", and "E" are in blue, while the letter "E" is represented by three horizontal orange lines. The overall design is clean and modern.
The addition of a Merge Hemo software feature that provides the ability to calculate and display Fractional Flow Reserve (FFR) values is described. No hardware changes are required in order to enable or perform this functionality.
FFR provides a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization.
FFR measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.
The Merge Hemo software user interface displays the pressure waveforms from the third party FFR pressure transducers that are placed distal and proximal to the lesion. When the FFR feature is enabled, the system shows the section of each of the waveforms that is used to calculate the mean pressure.
The results of the pressure waveform recording is expressed as a fraction of the normal blood flow in the coronary artery compared to the maximum achievable blood flow in the same artery. An FFR measurement of 1.0 indicates an artery with normal blood flow. FFR measurements less than 0.80 indicate that ischemia could be caused by blood flow blockage.
The Merge Hemo software initially selects segments of the waveforms to use for FFR calculations but the user can easily change where the values are taken by using the touchscreen interface to move the segment markers along the waveforms. The FFR value recalculates accordingly.
V. INTENDED USE
Merge Hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure.
The Hemo System can visualize and capture vital sign values including ECG. impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture diagnostic quality 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCO2 waveform.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. The two units are connected via a serial interface.
5
Image /page/5/Picture/0 description: The image shows the word "MERGE" in a stylized font. The letters "M", "R", and "G" are in blue, while the letters "E" are in orange. The letters are bold and sans-serif.
All vital parameters are acquired and calculated in the PDM. This data is then transmitted to the Merge Hemo Monitor PC via a serial interface. All data can then be displayed on the Merge Hemo Monitor PC. The Merge Hemo system is not intended to produce alarms for out-of-range conditions.
Patient allergies and current medication information can be entered by the user and displayed by the system. If desired and using a third party database the Hemo system can display drug to drug or drug to allergy interaction information.
The system is intended for use in hospital cardiac catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.
COMPARISON WITH PREDICATE VI.
Merge Hemo and the primary predicate device GE Mac-Lab are hemodynamic recording and display systems that are capable of performing Fractional Flow Reserve (FFR) calculations. The calculation of the FFR ratio is relatively simple and is well known, based on blood pressure measurement values generated by third party FFR wires and transducers. There should be no significant differences in how Merge Hemo and the predicate device calculate the FFR value.
NON-CLINICAL TESTS VII.
Physiologic Simulator Test
In-house bench testing was performed using physiologic simulators, varying the input pressure values and checking the calculations generated by Merge Hemo for each set of simulated distal and proximal pressures.
Integration Test: Comparison of Merge Hemo System vs. ACIST FFR System In-house bench testing was performed to support the validation of the FFR calculation, equivalency testing against FFR systems, and integration/compatibility testing with commercially available third party FFR pressure measurement devices that provide blood pressure data as inputs for the FFR calculation.
The FFR results calculated by Merge Hemo were compared with the FFR results calculated by an FDA 510(k) cleared (K132474) FFR system used under the same conditions: ACIST RXi Rapid Exchange FFR System by ACIST Medical Systems. The ACIST Navvus MicroCatheter fiber optic pressure transducer was used in both systems to measure the distal pressure. Both systems used the same standard pressure transducer to measure the proximal pressure. The Merge Hemo and ACIST FFR svstems showed excellent correlation and met all criteria for accuracy and precision. The FFR calculations from both systems were demonstrated to be equivalent.
6
Image /page/6/Picture/0 description: The image shows the word "MERGE" in a stylized font. The letters "M", "R", "G", and "E" are in blue, while the letter "E" is in orange. The orange "E" is made up of three horizontal lines instead of a solid shape. The overall design is clean and modern.
Integration Test: Compatibility of Different FFR Pressure Transducers
Several makes and models of FDA 510(k) cleared FFR pressure transducer devices and standard blood pressure transducers were tested in various combinations with the Merge Hemo system.
The statistical analysis of the data demonstrated that various makes and models of FFR pressure transducers are compatible with Merge Hemo, including:
- ACIST Navvus MicroCatheter ●
- . St Jude Aeris PressureWire
- . Volcano Verrata Pressure Guide Wire
- . Volcano PrimeWire PRESTIGE® PLUS Pressure Guide Wire
The statistical analysis of the data also demonstrated that various makes and models of standard pressure transducers are compatible with Merge Hemo, including:
- Edwards TruWave Disposable Pressure Transducer ●
- . ICU Medical Transpac IV Disposable Pressure Transducer System
- . Merit Meritrans® Pressure Transducer
FFR tests were performed without manipulating or correcting the input pressure data or the FFR ratio calculations. The standardized pressure values generated by FFR transducers are consistent and compatible with Merge Hemo's FFR calculations.
All in-house bench tests passed. No issues of safety and effectiveness were raised.
No clinical tests were required in order to demonstrate the proper integration of the measurements into Merge Hemo for the calculation of FFR values.