(117 days)
Not Found
No
The summary describes a standard physiological monitoring system that measures and records vital parameters. There is no mention of AI, ML, or any advanced analytical techniques beyond basic calculations and evaluations of standard physiological signals. The performance studies focus on functional testing with simulators and data integrity, not on the performance of any AI/ML algorithms.
No
The device is described as a "Monitoring System" that "monitors, measures, and records physiologic data." It focuses on vital signs and evaluations, but does not state that it provides any form of therapy or treatment.
Yes
The device "monitors, measures, and records physiologic data" and is used for "evaluation of resting ECG, arrhythmias, ST-segments and cardiac output." This process of measuring and evaluating physiological data to gain insights into a patient's health aligns with the definition of a diagnostic device.
No
The device description explicitly states that the system comprises a "Patient Data Module" and a "HeartSuite Hemodynamics Hemo Monitor PC," which are hardware components. The Patient Data Module also uses an internal battery and external power input.
Based on the provided information, the HeartSuite Hemodynamics device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The HeartSuite Hemodynamics device directly monitors and measures physiological data from the patient's body (ECG, SpO2, blood pressure, temperature, CO2).
- The intended use and device description clearly state that it monitors, measures, and records physiologic data from a patient. This is in vivo monitoring, not in vitro analysis of samples.
- The performance studies describe testing with physiologic simulators and verifying measurements of vital parameters. This aligns with the testing of a patient monitoring device, not an IVD.
Therefore, the HeartSuite Hemodynamics device falls under the category of a patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2.
The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC.
The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/110V.
The system is intended for use in hospital cardiac catheterization laboratories.
The Monitoring System (comprising the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC) is a medical product of the Class IIa (RL 93/42/EWG, Appendix IX).
Product codes (comma separated list FDA assigned to the subject device)
DOK
Device Description
HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2.
The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC.
The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/110V.
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
Not Found
Intended User / Care Setting
hospital cardiac catheterization laboratories.
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)
In order to ensure that the HeartSuite Hemodynamics software performs safely and efficiently, the HeartSuite Hemodynamics software was tested using physiologic simulators. Various types of ECG aberrations, rates, amplitudes, and deviations were used for validation of R-Wave detection for the rate meter and timing measurements related to pressure analysis. Multiple pressures were simulated under various conditions to validate the pressure and valve analyses. Multiple oxygen saturations were entered to validate hemodynamic calculations. End tidal CO2 was validated through Schiller and verified through tests run using SimMan. Multiple erroneous and/or incongruous entries were made in data entry locations to validate data entry restrictions. Multiple cases were created and exported to validate data integrity. All command buttons were tested for their appropriate responses. Multiple reports were generated to validate the report generation functions. The software responded appropriately in the tests described. After assembly is completed each unit undergoes final products testing. Patient isolation and leakage current tests are to be performed on each unit prior to packaging for shipment.
In addition to functional testing, a risk analysis, requirements review and design review was performed.
No clinical performance data has been used to support the substantial equivalence claim.
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 (K061741)
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
§ 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
| 510(k) Summary | K082421 | DEC 1 7 2008 |
|---|---|---|
| Date Prepared: | June 27, 2008 | |
| Contact Person: | Inger Hanson | |
| Executive Director, Quality Systems and Regulatory Affairs, | ||
| Management Representative, CPO | ||
| Emageon, Inc. | ||
| Phone: 262-369-3379 | ||
| Fax: 262-367-0728 |
Device Trade Name: HeartSuite Hemodynamics
Common Name: Programmable Diagnostic Computer
Classification Name: 21 CFR 870.1425, Cardiovascular
Predicate Substantially Equivalent Devices: GE Mac-Lab (K061741)
Device Description: HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2.
The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC.
The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/110V.
The system is intended for use in hospital cardiac catheterization laboratories.
The Monitoring System (comprising the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC) is a medical product of the Class IIa (RL 93/42/EWG, Appendix IX).
l
1
Intended Use: HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature. NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2.
The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC.
The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/110V.
The system is intended for use in hospital cardiac catheterization laboratories.
The Monitoring System (comprising the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC) is a medical product of the Class IIa (RL 93/42/EWG, Appendix IX).
Performance Data: In order to ensure that the HeartSuite Hemodynamics software performs safely and efficiently, the HeartSuite Hemodynamics software was tested using physiologic simulators. Various types of ECG aberrations, rates, amplitudes, and deviations were used for validation of R-Wave detection for the rate meter and timing measurements related to pressure analysis. Multiple pressures were simulated under various conditions to validate the pressure and valve analyses. Multiple oxygen saturations were entered to validate hemodynamic calculations. End tidal CO2 was validated through Schiller and verified through tests run using SimMan. Multiple erroneous and/or incongruous entries were made in data entry locations to validate data entry restrictions. Multiple cases were created and exported to validate data integrity. All command buttons were tested for their appropriate responses. Multiple reports were generated to validate the report generation functions. The software responded appropriately in the tests described. After assembly is completed each unit undergoes final products testing. Patient isolation and leakage current tests are to be performed on each unit prior to packaging for shipment.
In addition to functional testing, a risk analysis, requirements review and design review was performed.
2
No clinical performance data has been used to support the substantial equivalence claim.
Substantial equivalence summary: The Emageon HeartSuite Hemodynamics system is a comparable type and substantially equivalent to a legally marketed predicate device. The intended use of the Emageon HeartSuite Hemodynamics system is the same as that of the predicate device Mac-Lab, marketed by GE Healthcare. No new safety or effectiveness issues are raised with the Emageon HeartSuite Hemodynamics system. The subject device has substantially equivalent technological characteristics, features, specifications, materials, modes of operation and intended uses as a legally marketed predicate device.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2008
Emageon, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 53313
Re: K082421
Trade/Device Name: HeartSuite Hemodynamics Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (Two) Product Code: DOK Dated: November 25, 2008 Received: November 28, 2008
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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
4
Page 2 - Mr. Mark Job
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) prematket 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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
07 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082421
Device Name: HeartSuite Hemodynamics
Indications for Use:
HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2.
The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC.
The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/110V.
The system is intended for use in hospital cardiac catheterization laboratories.
The Monitoring System (comprising the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC) is a medical product of the Class IIa (RL 93/42/EWG, Appendix IX).
| 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
OF NEEDED)
for B Zuckerman
| (Division Sign/off) | 12/16/08 |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K082421 |