(106 days)
The Intelesens Aingeal Activity is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.
This re-usable device is intended to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.
The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.
The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device also detects and records respiration, skin temperature and activity. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach).
The Aingeal Activity System is a modification of the Intelesens Aingeal (VS200) 510(k) cleared under 510(k) K110015. Details of the modifications can be found in Section 11.
The Aingeal Activity system includes the following components:
- Aingeal Activity Monitor a wireless (Wi-Fi) monitoring device with a rechargeable lithium polymer battery
- Adherent electrode array
- Battery charger
- Compatible monitoring software such as CPC Bernoulli (FDA 510(k) clearance # K130208)
The Aingeal Activity device is battery powered. The battery is removed from the device prior to charging in the standalone battery charger station. Charging does not occur when the Aingeal Activity device is connected to a patient. Aingeal Activity is a reusable, nonsterile device to be used with a single use disposable electrode.
The battery is charged in a separate charger, charging does not / cannot occur when the Aingeal Activity Device is connected to a patient
The Aingeal Activity monitor clips on the adherent electrode array and is worn on-body. In conjunction with the array it collects, stores and transmits user physiological data. The electrode array and device, when enabled and applied to the user's torso will measure ECG, heart rate, respiration rate, skin temperature and activity levels with on board software algorithms. This data is transmitted periodically to the compatible third party server for display such as the CPC Bernoulli software (server). ECG signals recorded by the electrode array and device will also be transmitted on a heart rate trigger basis with thresholds adjustable by the user, or arrhythmia. Respiration signals recorded by the electrode array and device will also be transmitted on a respiration rate trigger basis with thresholds adjustable by the user. Skin temperature is recorded by the electrode array and device will also be transmitted on a temperature level trigger basis with thresholds adjustable by the user. The ECG, respiration signals, skin temperature value and activity metrics are also transmitted periodically and can be displayed via the server.
The device also contains on-board ECG arrhythmia recognition to automatically record and send ECG data on detection of one or more of the following arrhythmias:
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- asystole,
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- ventricular fibrillation, (VF)
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- bradycardia
- tachycardia (Ventricular or Supraventricular 4.
The provided text describes the Intelesens Aingeal Activity System, which is a physiological patient monitor, and its 510(k) submission to the FDA. The document primarily focuses on establishing substantial equivalence to a predicate device (Intelesens Aingeal (VS-200) K110015).
Based on the provided information, the device is considered a physiological patient monitor with on-board ECG arrhythmia detection algorithms. However, the document does not contain the detailed acceptance criteria for the arrhythmia detection algorithm's performance, nor does it present the study results for proving these criteria.
Instead, the document emphasizes bench testing and compliance with various electrical safety and performance standards. It explicitly states:
- "No human clinical testing was performed" (page 10).
- "No animal testing was performed" (page 10).
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for the arrhythmia detection algorithm's accuracy, as this specific information is not present in the provided text. The document focuses on regulatory compliance and substantial equivalence based on design, technology, and general performance specifications, not on a detailed clinical performance study of the arrhythmia detection itself.
Here's an analysis of what can be extracted and what is missing:
Information Present:
- Device Name: Aingeal Activity System
- Intended Use: Monitoring and transmitting physiological data (ECG, respiration, heart rate, skin temperature, activity levels) to a remote application for display or analysis by a clinician. It has on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if arrhythmia is suspected.
- Detected Arrhythmias (on-board): Asystole, ventricular fibrillation (VF), bradycardia, tachycardia (Ventricular or Supraventricular).
- Predicate Device: Intelesens Aingeal (VS-200) K110015.
- Type of Testing: Bench testing for compliance with various standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-27, AAMI EC 57 for cardiac rhythm and ST-segment measurement algorithms).
- Ground Truth for Manufacturing/Bench Testing: Compliance with standards indicates that the device was tested against simulated or standardized signals with known characteristics.
- Test Set Data Provenance (for bench): Not explicitly stated, but implied to be generated in a lab setting to meet standard requirements.
- Training Set Sample Size/Ground Truth: Not mentioned.
Information NOT Present (and thus, cannot be provided as requested):
- A table of acceptance criteria and the reported device performance for arrhythmia detection: The document lists standards like AAMI EC 57:2012 ("Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms"), indicating that performance aspects related to arrhythmia detection were considered during bench testing. However, the specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for each arrhythmia type) and the actual numerical results achieved by the device are not provided in this summary.
- Sample size used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective) for arrhythmia detection: Since no human clinical testing was performed, there's no clinical test set in the traditional sense for arrhythmia detection performance. Bench testing would use test signals/databases, but their size and origin are not detailed.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no human clinical testing or expert ground-truthing on a patient test set was conducted for algorithm performance.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted or reported.
- Stand-alone (algorithm only without human-in-the-loop performance) study: While the device has on-board algorithms, the document does not detail a specific study demonstrating the performance metrics of these algorithms against defined ground truth, beyond stating compliance with standards.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for assessing arrhythmia detection: For the "on-board ECG arrhythmia detection algorithms," the ground truth for the bench testing would likely be standardized ECG waveforms or databases that include known arrhythmias, used to verify compliance with standards like AAMI EC 57. However, no details on such a dataset are provided.
- The sample size for the training set: Not mentioned in this document.
- How the ground truth for the training set was established: Not mentioned in this document.
In summary, this 510(k) pertains to a device whose arrhythmia detection capabilities are primarily validated through bench testing against recognized industry standards (e.g., AAMI EC 57), rather than through a human clinical performance study with defined performance metrics for arrhythmia detection. The document asserts "substantial equivalence" based on design, technology, specifications, and compliance with various safety and performance standards for medical electrical equipment.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.