(144 days)
Xper Flex Cardio Physiomonitoring System-The physiomonitoring system is intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing. and analytical assessment. The system is indicated for use in the cardiac catheterization, following areas: cardiology, electrophysiology, radiology, invasive radiology and other areas where cardiac monitoring may be required. The system is not intended to be used in the proximity of magnetic resonance imaging. The data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.
User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required.
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device.
Xper Information Management- The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data. such as physiologic/ hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multichannel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.
The system is indicated for use in the following areas: cardiology, cardiac catheterization. electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed.
The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system.
The system is capable of receiving and displaying user-adjustable alarms (both visual and audible) available in the system, which alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required.
The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device.
The Xper Flex Cardio physiomonitoring system and Xper Information Management systems are enhancements of the cleared Xper Information Management system (K063840).
The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, SpO2 (pulse oximetry), end tidal CO2 (ETCO2) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status. The Xper Flex Cardio physiomonitoring system is not intended for use in the proximity of magnetic resonance imaging.
The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices.
The provided 510(k) summary for the "Xper Flex Cardio Physiomonitoring System" and "Xper Information Management System" does not describe acceptance criteria for specific performance metrics or a study that rigorously proves the device meets those criteria in terms of clinical accuracy or effectiveness.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:
- Technological Characteristics: Highlighting similarities in intended use, components, and functionalities with existing cleared devices.
- Performance Testing (Compliance to Standards): Showing the device complies with relevant international electrotechnical commission (IEC) safety and electromagnetic compatibility (EMC) standards. This is a common method for medical devices to show basic safety and performance in their specific operating environment.
Here's an breakdown based on your requested information, with the understanding that the provided document does not contain the level of detail you might expect for an AI-centric device's performance study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (from document) |
|---|---|
| Clinical Performance | Not explicitly stated in terms of specific clinical metrics (e.g., sensitivity, specificity, accuracy). The document emphasizes: |
- "The results of the safety and performance testing demonstrate that the Xper Flex Cardio physiomonitoring system and the Xper Information Management System are as safe and effective as the predicate device(s) and perform as well as the predicate device(s)."
- Compliance with voluntary standards (IEC 60601 series). |
| Safety & EMC | Compliance with the following voluntary standards: - IEC 60601-1 (General Requirements for Safety)
- IEC 60601-1-1
- EN 60601-1-2
- IEC 60601-2-30
- IEC 60601-2-49 |
| System Functionality | The device is capable of:
- Displaying and analyzing surface ECG, respiration, invasive pressure, SpO2, ETCO2, NIBP, surface body temperature, thermal cardiac output curves. - Processing/analyzing multi-channel ECG signals, displaying graphical ST segment maps.
- Acquiring, displaying, trending, storing, and transmitting various types of data (physiologic/hemodynamic, clinical, medical image).
- Creating reports.
- Receiving and displaying user-adjustable visual and audible alarms.
- Transmitting patient data files for storage, viewing, and analysis. |
| Substantial Equivalence | Demonstrated by comparing the device's technological characteristics, intended use, and performance testing results to several predicate devices (Xper Information Management System K063840, GE MacLab/CardioLab EP/ComboLab System K050093, Poise DataEngine K040969, Siemens AXIOM Sensis K020440, Alliance Instruments Integrity Patient Monitor K980688). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "Performance Testing" and "hazard analysis" which implies testing was conducted, but details on sample size (e.g., number of patients, number of data points) are absent.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
- Number of Experts: Not applicable. The submission does not describe a study involving expert review for ground truth establishment.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? The document refers to the introduction of a "Philips ECG algorithm (individually cleared in K073376)". While this indicates an algorithm is part of the system, the provided 510(k) for the current device does not detail a standalone performance study for this specific algorithm or any other algorithms within the system in this submission. Its prior clearance implies a study was done for that specific component at that time.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated as expert consensus, pathology, or outcomes data for the overall system. The performance testing is primarily focused on compliance with safety and electrical standards and demonstrating functionality, rather than establishing a clinical ground truth for diagnostic accuracy in a patient cohort.
8. Sample Size for the Training Set
- Sample Size: Not applicable. The document does not describe a training set in the context of machine learning or AI model development for the device as a whole. While an ECG algorithm is mentioned, its training details are not part of this submission.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth was Established: Not applicable. As no training set is described for the device in this submission, the method for establishing its ground truth is not mentioned.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).