(266 days)
Merge Hemo displays, measures, and records physiological data from patients undergoing invasive catheter-based diagnostic and interventional procedures.
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 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 EtCQ2 waveforms. The system can also perform specified calculations from captured or manually entered values.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC.
All vital parameters are acquired in the PDM. This data is then transmitted to the Merge Hemo Monitor PC. All data can then be displayed on the Merge Hemo Monitor PC. User-adjustable visual alarms available in the system alert the operator to anomalous occurrences and facilitate timely responses.
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 or drug-to-allergy interaction information.
The Merge Hemodynamic system is intended for use in invasive catheter-based diagnostic and interventional procedure laboratories and in pre- and post-procedure care areas in professional health care facilities. The Merge Hemo system is intended for use under the close supervision of qualified medical personnel. The system is not intended patient monitoring or in situations where arrhythmia detection is required. This system is used in the diagnosis and treatment of cardiovascular, peripheral vascular, and cardiac diseases. The system is designed for patients of Infant to Adult ages. The system is to be used in invasive procedural laboratories under the direct supervision of physicians, nurses, and technicians.
The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.
The device consists of off-the-shelf computer hardware such as personal computers and servers, a Patient Data Module (PDM) that acquires patient vitals received from accessories such as ECG electrodes, invasive catheters/pressure transducers, and temperature probes, and transmits them to the Merge Hemo Monitor.
The Merge Hemo system includes a Record Station with options to add a Procedure Room Hemo Monitor or a Remote Operators Terminal (ROT). The Record Station Workstation for Merge Hemo, Model RCSV2 is made up of medical grade Hemo Client and Hemo Monitor All-in-One computers with built-in display monitors.
The new PDM component, the ARGUS PB-3000 manufactured by Schiller AG, acquires the following patient vitals: ECG, Invasive Blood Pressure, SpO2, Non-Invasive Blood Pressure, Temperature, Cardiac Output, and CO2, digitizes the signals, and transmits them to the Hemo Monitor in the Record Station. The Client side of the Record Station is responsible for the documentation, display, storage, and distribution of the data acquired during the procedure.
The provided text does not contain typical acceptance criteria and a study proving device performance as might be found in a clinical trial summary. Instead, it describes a 510(k) premarket notification for a medical device (Merge Hemo, Model RCSV2) and outlines the regulatory process and the types of non-clinical performance data submitted to demonstrate substantial equivalence to a predicate device.
The "acceptance criteria" here refer to compliance with various electrical safety, electromagnetic compatibility, usability, and software development standards, rather than specific performance metrics like sensitivity or specificity for a diagnostic device. The "study" is a compilation of non-clinical tests demonstrating adherence to these standards.
Here's the breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Compliance Statement) |
|---|---|
| Electrical Safety: IEC 60601-1 Ed 3.2 2020-08 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | The system complies with the current editions of applicable standards. |
| Electromagnetic Compatibility (EMC): IEC 60601-1-2 Ed 4.1 2020-09 (General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) | The system complies with the current editions of applicable standards. |
| Usability: IEC 60601-1-6 Ed 3.2 2020-07 (General requirements for basic safety and essential performance - Collateral standard: Usability) | Demonstrated through usability testing. |
| Alarm Systems: IEC 60601-1-8 Ed 2.2 2020-07 (General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| EM immunity (Guidance): IEC TR 60601-4-2 Ed 1.0 2016-05 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Electrocardiographic monitoring equipment: IEC 60601-2-27 Ed 3.0 2011-03 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Automated non-invasive sphygmomanometers: IEC 80601-2-30 Ed 2.0 2018-03 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Invasive blood pressure monitoring equipment: IEC 60601-2-34 Ed 3.0 2011-05 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Respiratory gas monitors: ISO 80601-2-55 Ed 2.0 2018-02 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Clinical thermometers for body temperature measurement: ISO 80601-2-56 Ed 2.0 2017-03 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Pulse oximeter equipment: ISO 80601-2-61 Ed 2.0 2017-12 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Multifunction patient monitoring equipment (as applicable to the system integrator): IEC 80601-2-49:2018 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Application of usability engineering to medical devices: IEC 62366-1 Ed 1.1 2020-06 | Demonstrated through usability testing. |
| Application of risk management to medical devices: ISO 14971 Ed 3.0 2019-12 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Symbols to be used with information to be supplied by the manufacturer: ISO 15223-1 Ed 4.0 2021-07 | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Radio-frequency disturbance characteristics: CISPR 11:2015/A1:2016/A2:2019, Group 1, Class A | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Quality management systems: ISO 13485:2016 MDSAP | Not explicitly stated "complies" for this specific standard, but it's listed under "Particular and Additional Standards" and implied by overall compliance. |
| Software life cycle processes: IEC 62304 Ed 1.1 2015-06 | Formal software development processes that comply with the requirements of IEC 62304 for medical device software life cycles are followed. Verification and validation testing demonstrated that the software meets its design requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of patient data for evaluating diagnostic performance. The testing described is primarily non-clinical, focusing on hardware and software compliance with regulatory standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable/provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/provided as no clinical ground truth establishment using experts is described for diagnostic performance evaluation. The "ground truth" for the non-clinical tests would be the specifications and requirements of the various standards the device is tested against.
4. Adjudication Method
This information is not applicable/provided as no clinical study requiring adjudication of expert interpretations is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The application is for a hemodynamic monitoring system, not a diagnostic imaging AI system that typically undergoes MRMC studies. The document states: "Clinical testing was not required to demonstrate the safety and effectiveness of Merge Hemo, Model RCSV2." Therefore, the effect size of human readers with/without AI assistance is not applicable/provided.
6. Standalone (Algorithm Only) Performance Study
The document describes the device as a "hemodynamics recording computer system" and lists various vital parameters it monitors, measures, displays, and records. It also mentions "specified calculations from captured or manually entered values" and "same software algorithms" for physiological parameters.
While software verification and validation are mentioned, there is no separate "standalone performance study" of an algorithm without human involvement in the sense of a diagnostic AI product. The system is designed to acquire and display physiological data for qualified medical personnel to use in diagnosis and treatment. The performance evaluation focuses on the system's ability to accurately acquire, process, and display data in compliance with medical device standards, rather than an autonomous diagnostic algorithm's accuracy.
7. Type of Ground Truth Used
The "ground truth" for the described performance evaluation (electrical safety, EMC, software V&V, usability) is the requirements and specifications outlined in the applicable international and national standards (e.g., IEC 60601 series, ISO 14971, IEC 62304). The device is tested to ensure it operates within the defined limits and behaviors stipulated by these standards.
8. Sample Size for the Training Set
This information is not applicable/provided. As explained, the "study" is a non-clinical evaluation of compliance with regulatory standards, not a machine learning model training and testing process involving patient data in the typical sense for AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reason stated above.
§ 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).