HEARTSUITE HEMODYNAMICS 7.10 by EMAGEON INC.

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).

Device Description

HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.

The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.

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).

AI/ML Overview

The HeartSuite Hemodynamics device is a system that monitors, measures, and records physiological data from patients during cardiac catheterization procedures. The provided documentation does not explicitly list acceptance criteria in a quantitative format, but rather describes the types of tests conducted to ensure the software performs safely and efficiently.

Here's an attempt to structure the information based on the provided text, recognizing that specific numerical acceptance criteria are not detailed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Accurate R-Wave detection for rate meter and timing measurements related to pressure analysis.	Software responded appropriately to validation using various ECG aberrations, rates, amplitudes, and deviations for R-Wave detection and timing measurements.
Accurate pressure and valve analyses.	Software responded appropriately to validation using multiple simulated pressures under various conditions for pressure and valve analyses.
Accurate hemodynamic calculations based on oxygen saturation.	Software responded appropriately to validation using multiple oxygen saturations for hemodynamic calculations.
Accurate End Tidal CO2 measurements.	End Tidal CO2 was validated through Schiller and verified through tests run using SimMan, with appropriate responses.
Robust data entry restrictions.	Software responded appropriately to validation using multiple erroneous and/or incongruous entries in data entry locations.
Data integrity during export.	Software responded appropriately to validation by creating and exporting multiple cases.
Appropriate response of all command buttons.	All command buttons were tested, and the software responded appropriately.
Correct report generation.	Multiple reports were generated, and the software responded appropriately, validating the report generation functions.
Patient isolation and leakage current within specifications.	These tests are to be performed on each unit after assembly and prior to shipment. (Implied successful completion for market release).
Device functions safely and efficiently.	In addition to functional testing, a risk analysis, requirements review, and design review were performed. The software responded appropriately in all described tests, ensuring safe and efficient performance. No new safety or effectiveness issues were raised compared to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The documentation does not provide specific numerical sample sizes for the test sets (e.g., number of ECG waveforms, pressure simulations, or cases). The descriptions use terms like "various types of ECG aberrations," "multiple pressures," "multiple oxygen saturations," and "multiple erroneous and/or incongruous entries," and "multiple cases."

The data provenance is from simulated physiologic data, not actual patient data. The tests were conducted using "physiologic simulators," "Schiller," and "SimMan." This indicates that the data was not obtained retrospectively or prospectively from human patients, nor does it specify a country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of human experts to establish ground truth for the test set. The validation seems to rely on the known parameters of the "physiologic simulators," "Schiller," and "SimMan," which inherently provide the "ground truth" for the simulated scenarios.

4. Adjudication Method for the Test Set

Not applicable, as no human experts were used for establishing ground truth for the test set. The device's output was compared against the known parameters of the simulators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The documentation explicitly states, "No clinical performance data has been used to support the substantial equivalence claim." The testing focused on the device's functional performance against simulated data, not on its impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the described testing is exclusively a standalone performance evaluation. The device (HeartSuite Hemodynamics software) was "tested using physiologic simulators" to assess its ability to monitor, measure, and record data and perform calculations independently. There is no mention of a "human-in-the-loop" component in the described performance testing.

7. The Type of Ground Truth Used

The ground truth used was based on the known, predefined parameters and outputs of physiologic simulators (including Schiller and SimMan). This is akin to a "synthetic ground truth" or a "simulated ground truth."

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI components that would require one. The system appears to be based on pre-programmed logic for monitoring, measuring, and calculating physiological data, rather than a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned or implied by the device's description and testing methodology.

Summary

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510(k) Summary	K082421	DEC 1 7 2008
Date Prepared:	June 27, 2008
Contact Person:	Inger HansonExecutive Director, Quality Systems and Regulatory Affairs,Management Representative, CPOEmageon, Inc.Phone: 262-369-3379Fax: 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 system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.

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).

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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.

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.

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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.

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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

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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

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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 system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.

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)
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(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

Regulation Number and Section

§ 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).