(126 days)
The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.
The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer the Electrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi. TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended for pediatric use. Examples of applications are:
- Cardiology
- Pulmonary Care
- Home Care
- General Practitioners
The basic operation of the TeleSense platform is to collect and store multiple channels of ECG data. The TeleSense platform was developed to be used as basic platform for 4 different variants on the product, hereafter called "modes". The electronic platform of the different versions is identical but the different modes have some features added or removed from the electronic platform. The differences are related to features. All versions have the same intended use, intended users and intended environment. The different versions are described below.
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Basic Mode (Remote cardiac monitor)
TeleSense's Basic Mode is the basic version of the product. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer the Electrocardiogram (ECG) in mobile patients, as well as cardiac event data. The device only uses non-invasive sensors. The available integrated data transfer methods are USB and Wi-Fi. -
Event Mode
TeleSense's Event Mode operates as a traditional event recorder. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer manually indicated or automatically detected cardiac events in mobile patients. The device only uses non-invasive sensors. The available integrated data transfer methods are Wi-Fi and USB. -
Holter Mode
TeleSense's Holter Mode operates as a traditional Holter recorder. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer the electrocardiogram (ECG) in mobile patients. The device only uses non-invasive sensors. The available integrated data transfer methods are Wi-Fi and USB. In this version, there is no automatic cardiac event detection.
The provided text describes the 510(k) Summary for the TeleSense device and its comparison to a predicate device, the ScottCare TeleSentry. Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Important Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than explicitly detailing a study to prove acceptance criteria for novel performance claims. The "testing results summary" primarily discusses adherence to established safety, electrical, and performance standards and internal tests with simulated signals. It does not provide detailed performance metrics for arrhythmia detection or a traditional clinical study with human subjects.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity for arrhythmia detection). Instead, it compares specific features and technical specifications to a predicate device, arguing that differences do not adversely impact safety and effectiveness. The "Testing Results Summary" states: "The TeleSense meets the safety, mechanical, electrical, and performance requirements requirements of IEC 60601-1, the emissions requirements of IEC 60601-1-2:2007, and the safety, electrical, and performance requirements of IEC 60601-2-47 Part2."
The key performance statement related to the device's diagnostic function is: "In all tests, the TeleSense produced consistent and acceptable results." This refers to internal tests conducted with simulated ECG signals.
Here's an adaptation based on the provided technical specifications and the comparison with the predicate:
| Feature/Criterion (derived from comparison) | Predicate Device Performance (TeleSentry) | TeleSense Performance | Acceptance Rationale (Implicit) |
|---|---|---|---|
| Diagnostic Features | |||
| Continuous Monitoring | Yes | Yes | Equivalent functionality |
| Automatic Event Detection | Yes (Bradycardia, Tachycardia, AFib) | Yes (Bradycardia, Tachycardia, AFib) | Equivalent functionality |
| Manual Event Activation | Yes | Yes | Equivalent functionality |
| Connectivity | |||
| Transmission Mode | Radio Frequency (Bluetooth 2.0 SPP Profile) | Radio Frequency (Wi-Fi 802.11 b/g/n) | Wi-Fi is more favorable; no adverse impact on diagnostic use. |
| RF Transmission Range | 100 meters open space (Bluetooth) | 100 meters open space (Wi-Fi) | Equivalent range. |
| Firmware Update/Configuration | Bluetooth | USB | Equivalent functionality; no adverse impact. |
| Technical Specifications | |||
| Patient Cable Leads | 3, 5, 12 | 3 | 3-lead provides adequate diagnostic information (tachy, brady, pause, afib) for intended use. |
| Channel Recording | 3, 5, 12 | 3 | 3 channels provide adequate diagnostic information (tachy, brady, pause, afib) for intended use. |
| Bandwidth | 0.5 - 100 Hz | 0.5 - 40 Hz | Exceeds AAMI/ANSI EC38 standard (>30Hz); no adverse impact. |
| Differential Input | +/- 1mV p-p | +/- 5mV p-p | Meets EC38 and IEC 60601-2-47 standards; no adverse impact. |
| Differential Input Range | DC ± 100mV | DC ± 300mV | Meets EC38 and IEC 60601-2-47 standards; no adverse impact. |
| Common Mode Rejection (CMR) | 92 dB | 80 dB | Exceeds AAMI/ANSI EC38 and IEC 60601-2-47 standards; no adverse impact. |
| Battery Life | 24-36 hours before recharge | 50 hours before recharge | Exceeds predicate; no adverse impact on safety/effectiveness. |
| Sampling Rate (SPS) | 100, 200, 1000 | 128, 256 | Adequate for capturing sufficient information (exceeds EC38 40Hz bandwidth); no adverse impact. |
| Bits | 12 bits | 8, 10, 12 bits | Meets or exceeds predicate; no adverse impact. |
| Lead Off Detection | Yes | Yes | Equivalent functionality. |
| Unintentional Erase Data Protection | Yes | Yes | Equivalent functionality. |
| Power Loss Data Protection | Yes | Yes | Equivalent functionality. |
| Recording Period | 30 days | 30 days | Equivalent functionality. |
| Input Impedance | >20 ΜΩ | >20 ΜΩ | Equivalent functionality. |
| Compliance | |||
| Safety, Electrical, Performance | IEC 60601-1, IEC 60601-1-2:2007, IEC 60601-2-47 Part2 | IEC 60601-1, IEC 60601-1-2:2007, IEC 60601-2-47 Part2 | Meets specified standards. |
| Consistent & Acceptable Results (Internal Tests) | Not specified for predicate in this context | Yes (with simulated ECG) | Confirmatory internal testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention human patient data for the test set. The performance testing was conducted using "simulated normal ECG signals and simulated paced ECG signal tests." Therefore, there is no specific "sample size" of real-world patient data or data provenance (country of origin, retrospective/prospective) for a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Since the testing involved simulated ECG signals, no human experts were used to establish ground truth for this performance "test set." The ground truth was inherent in the simulated signals themselves (e.g., a simulated tachycardia signal would be known ground truth as tachycardia).
4. Adjudication Method for the Test Set
Given that the test set consisted of simulated ECG signals and the ground truth was inherent to these signals, an adjudication method for human review was not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or appears not to have been done for the TeleSense device. The submission focuses on the performance of the device itself relative to technical standards and a predicate, not on how it impacts human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, a form of standalone performance assessment was conducted for the arrhythmia detection algorithm. The "Internal tests" section states: "Data recorded was loaded and analyzed in the HolterCare (K042463) and EventCare (K061780) software. In all tests, the TeleSense produced consistent and acceptable results." This indicates that the device's automatic detection capability with simulated signals was tested without direct human intervention in the detection process itself (though humans would typically review the output).
7. The Type of Ground Truth Used
The ground truth used for the performance testing was based on simulated normal ECG signals and simulated paced ECG signals. This means the "truth" of the arrhythmia or normal rhythm was pre-defined by the simulation parameters.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. This type of detail is usually associated with machine learning models that require training. The TeleSense device's arrhythmia detection algorithm appears to be based on established algorithms for which specific training data may not have been detailed in this regulatory filing, or it may use more traditional signal processing methods.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is not provided in the document.
§ 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.