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510(k) Data Aggregation
(26 days)
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
• By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital
• To view the near real-time waveforms remotely
• To remotely review other standard or critical near real-time patient data from the monitored system
• To provide a request for remote consultation regarding a patient's waveform or other data
The AirStrip RPM software can display the following the physiologic data captured by other medical devices:
• ECG Waveform
• Heart Rate Monitored
• Respiratory Rate
• Oxygen Saturation
• Intracranial Pressure
• Central Venous Pressure
• Pulmonary Capillary Wedge Pressure
• Cardiac Index
• Cardiac Output
• Cerebral Perfusion Pressure
• Urine Output
• Urine/Stool Mix Output
• Systolic Blood Pressure Invasive
• Mean Arterial Pressure Invasive
• Diastolic Blood Pressure Invasive
• Systolic Blood Pressure Cuff
• Mean Arterial Pressure Cuff
• Diastolic Blood Pressure Cuff
• Vasoactive Infusions
• Antiarrhythmics
• Sedation
• Paralytics
• Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
• Allergies
• Medications
Contraindications
AirStrip RPM software is intended for installation on cellular telephones and other wireless devices, and is not intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use by clinicians when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.
The AirStrip RPM InvisionHeart Adapter is a software application that interfaces with the InvisionECG System in hospitals to allow health care professionals the ability to view near real-time patient data remotely. AirStrip RPM works by retrieving patient data from the InvisionECG System monitoring system and providing that data to the end user's device via Wi-Fi or cellular modem over the Internet.
The AirStrip RPM InvisionHeart Adapter is a software application that interfaces with the InvisionECG System to display near real-time patient data remotely to healthcare professionals.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Specification | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Purpose | Provides ability to view patient physiological waveforms and other data remotely through interface with InvisionECG. | "Provides ability to view patient physiological waveforms and other data remotely through interface with InvisionECG." (Directly stated as matching the predicate device's purpose). |
| Function – Indications for Use | Smart Client application that allows users at remote locations (anywhere there is internet access) to view patient information in near real time including physiological data, waveforms and other EMR related data. | "Smart Client application that allows users at remote locations (anywhere there is internet access) to view patient information in near real time including physiological data, waveforms and other EMR related data." (Directly stated as matching the predicate device's function and indications for use). |
| Target Population | Clinicians (users); Clinical patients using a monitoring device for cardio. The device should not differentiate between patient groups (e.g., elderly, pediatric). | "Clinicians (users) Target population (clinical patients) are anyone using a monitoring device for cardio... The Electrocardiogram cannot and does not differentiate between patient groups, therefore, the monitoring of any patient... is within the scope of this device. Therefore Airstrip... cannot differentiate between patient populations." (Claimed to match the predicate device which does not differentiate patient groups). |
| Materials | Software application and configured PDA/wireless device. | "Software application and configured PDA" (Directly stated as matching the predicate device). |
| Internet Communication | Secure Sockets Layer (SSL) via HTTPS. | "Secure Sockets Layer (SSL) via HTTPS" (Directly stated as matching the predicate device). |
| Communication Methods | Cellular Modem, Wi-Fi. | "Cellular Modem, Wi-Fi" (Directly stated as matching the predicate device). |
| Data Source Location | Hospital. | "Hospital" (Directly stated as matching the predicate device). |
| System Technology | File Based Service (and the capability to parse and transmit the information). | "File Based Service... mechanism for capturing the snapshot to be used by AirStrip RPM. Once captured by AirStrip RPM, the information is treated the same and the data in the file is parsed for the information required. There is no dependency on the method of capture for how the data is parsed." (Stated to effectively operate like the predicate device's file-based and web-based services). |
| Security Administration | Yes. | "Yes" (Directly stated as matching the predicate device). |
| Operating Environment | Anywhere the clinician has remote Internet access for iOS or Android device and use is not prohibited; Hospital data center for server. | "Anywhere the clinician has remote Internet access for iOS or Android device and use is not prohibited; Hospital data center for server" (Directly stated as matching the predicate device). |
| Programming Languages | Apple Objective C and Swift on client, Android Java and Kotlin, Microsoft Windows .NET on server. | "Apple Objective C and Swift on client, Android Java and Kotlin, Microsoft Windows .NET on server" (Matches/updates the predicate device's languages, implying compatibility). |
| Operating Systems | Apple iPhone OS on client, Android OS on client, Microsoft Windows Server on servers. | "Apple iPhone OS on client, Android OS on client, Microsoft Windows Server on servers" (Directly stated as matching the predicate device). |
| Database System | Microsoft SQL Server. | "Microsoft SQL Server" (Directly stated as matching the predicate device). |
| Hardware Platform | Apple iPhone OS devices for client, Android OS devices for client, Microsoft Windows Server compatible server computers. | "Apple iPhone OS devices for client, Android OS devices for client, Microsoft Windows Server compatible server computers" (Directly stated as matching the predicate device). |
| Presentation of Data | Smart Client. | "Smart Client" (Directly stated as matching the predicate device). |
| Ability to view near Real-time Data | Yes. | "Yes" (Directly stated as matching the predicate device). |
| DICOM Compliance | Compliance with DICOM SOP 1.2.840.10008.5.1.4.1.1.9.1.1 12-lead ECG Waveform Storage. | "The InvisionHeart Adapter accepts and transmits as a viewer the DICOM file information compliant with DICOM SOP 1.2.840.10008.5.1.4.1.1.9.1.1 12-lead ECG Waveform Storage." (Explicitly stated). |
| Risk Management | Adherence to ISO 14971:2007. | "ISO 14971:2007 Medical devices – Applications of risk management to medical devices" (Stated as followed). |
| Software Validation/V&V | Designed and developed adhering to in-house processes; underwent verification and validation testing, integration/system testing, and regression testing. Compliance with FDA guidance documents. | "The software was designed and developed adhering to in-house design and development process. The software underwent verification and validation testing and was in the form of combined integration and system testing as well as final regression testing." "Test results indicate that the InvisionHeart Adapter Software complies with its predetermined specifications and the applicable guidance documents." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for a test set in terms of patient data or clinical cases. The performance evaluation primarily focuses on demonstrating substantial equivalence through non-clinical testing of the software's functionality, interoperability, and adherence to standards.
The data provenance for any internal testing is not explicitly mentioned, but the system is designed to interface with the InvisionECG System, which handles patient data. The context implies that the testing involves how the adapter processes and displays data originating from the InvisionECG System, which in turn acquires data from actual patients in a hospital setting. The study is retrospective in the sense that it evaluates the software's ability to display data that has already been generated by other medical devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Given that no formal clinical study with human interpretation of results is detailed, there's no mention of experts establishing ground truth for a test set. The evaluation is focused on the technical performance of the software in accurately displaying information from the source system.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human-centric test set requiring adjudication. The evaluation centers on software verification and validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission explicitly. The device's purpose is to display data to clinicians, not to perform interpretations or make diagnoses itself. Therefore, a study to measure human reader improvement with AI assistance (as the device is a medical device data system, not an AI diagnostic tool) is not relevant to its stated function or the type of evaluation presented.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The evaluation conducted is essentially a standalone (algorithm only) performance assessment, though not in the typical sense of a diagnostic algorithm. The device itself is software that transmits and displays data. The "performance" tested is its adherence to technical specifications, cybersecurity, risk management, and the accurate rendering of data (ECG waveforms, other physiological parameters) from a source system. The "algorithm" here refers to the software's logic for data capture, processing, and presentation, rather than a diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests appears to be the predetermined specifications of the software and the expected output or behavior when interfacing with the InvisionECG System, as well as adherence to relevant standards (e.g., DICOM, ISO 14971). For example, the ground truth for DICOM compliance is the DICOM standard itself. For accurate waveform display, the ground truth would be the waveform as generated by the InvisionECG System.
8. The Sample Size for the Training Set
The document does not mention a training set as this device is a data display and communication system, not a machine learning or AI model that typically requires training data. Its functionality is based on established software engineering principles and interoperability standards.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of medical device data system, this point is not applicable.
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