(129 days)
The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. VitalPatch device can be used on patients with pacemakers that comply with ISO 14117:2012 and ANSVAAMI PC69:2000 without deviations. Heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate are not intended for patients with pacemakers. The device is not intended for use on critical care patients.
VitalPatch is a wearable biosensor designed to measure a patient's vital signs, including heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). VitalPatch was most recently cleared in K190916.
There are three device modifications included in this 510(k) pre-submission:
- removal of the pacemaker contraindication from the VitalPatch instructions for use,
- heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate are not intended for patients with pacemakers.
- the patch setup procedure interface was modified to select whether the patient has a pacemaker; the response inhibits as appropriate the functions not intended for patients with pacemaker. If pacemaker is indicated as present, the device will not transmit or store heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate.
The document provided describes a 510(k) premarket notification for the VitalConnect Biosensor, specifically addressing modifications to allow its use with patients who have pacemakers. The primary study presented focuses on ensuring that the device's functionality does not interfere with pacemakers and that certain physiological measurements are appropriately suppressed when a pacemaker is detected.
Here's an analysis of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document doesn't present a single, concise table of acceptance criteria and reported device performance in the format requested. Instead, it discusses performance characteristics and verification activities related to specific aspects of the device, particularly regarding its functionality with pacemakers.
Based on the "Performance Data" section, two key areas with implied acceptance criteria and reported performance are:
Table 1: Implied Acceptance Criteria and Reported Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| EMI Interference on Pacemaker | EMI interference on the pacemaker by the VitalPatch Biosensor is within allowable limits for pacemakers complying with ISO 14117:2012 and ANSI/AAMI PC69:2000. | "Testing was performed to show that EMI interference on the pacemaker by the VitalPatch Biosensor is within allowable limits for pacemakers that comply with ISO 14117:2012 and ANSI/AAMI PC69:2000." (No detailed results or specific limit values provided in this summary.) |
| Pacemaker Status Check & Functionality | If a pacemaker is indicated as present, the device will not transmit or store heart rate, ECG, heart rate variability, R-R interval, and respiratory rate. When a pacemaker is indicated as absent, these functions are correctly displayed/transmitted/stored. | "Testing shows that if pacemaker is indicated as present, the device will not transmit or store heart rate, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate. Moreover, electrocardiography (ECG), heart rate variability, R-R interval, and respiratory rate are correctly displayed/transmitted/stored when pacemaker is indicated as absent." (No specific metrics like accuracy or reliability percentages are provided in this summary, only a statement of positive performance.) |
| Heart Rate Performance (non-pacemaker) | Satisfies clinical acceptance criteria in non-pacemaker subjects after bug fixes. | "Testing shows the Heart Rate after modifications satisfies the clinical acceptance criteria in non-pacemaker subjects." (No specific clinical acceptance criteria are detailed in this summary.) |
| Battery Current Draw (Predicate vs. Subject) | Subject device draws the same amount of current as the predicate device under the same operating scenario. | "When tested under the same operating scenario, the predicate and subject device draw same amount of current. Hence, the battery current consumption between the predicate and subject device is substantially equivalent." |
Study Information:
The document describes several verification and validation activities rather than a single, comprehensive "study" with a traditional design for evaluating a diagnostic algorithm.
1. Sample size used for the test set and the data provenance:
- EMI Interference Testing: Not specified.
- Pacemaker Status Check Test: Not specified.
- Heart Rate Performance (non-pacemaker subjects): Not specified.
- Clinical Studies: "Clinical testing was performed in non-pacemaker human subjects to demonstrate substantial equivalence in heart rate and respiratory rate of the subject device." The number of subjects is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The mention of "non-pacemaker human subjects" for clinical studies implies prospective data collection, but details are lacking.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The described tests are primarily performance evaluations of device functionality and safety, not diagnostic accuracy requiring expert ground truth for interpretation.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study requiring adjudication of expert interpretations for a test set.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The document focuses on device performance and safety, particularly concerning pacemaker compatibility, not on human reader performance with or without AI assistance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the tests described are primarily standalone performance evaluations of the device's firmware and hardware functionalities, independent of human interpretation or assistance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- EMI Interference: Ground truth would be established by regulatory standards (ISO 14117:2012 and ANSI/AAMI PC69:2000) and possibly measurements from calibrated equipment.
- Pacemaker Status Check Test: Ground truth for pacemaker presence would be the actual state of the patient (e.g., presence of a pacemaker) and the expected device response (suppression of certain measurements).
- Heart Rate Performance (non-pacemaker subjects): For heart rate and respiratory rate, ground truth would likely come from a reference standard device or method, although not explicitly stated.
- Battery Current Draw: Ground truth is measured current consumption.
7. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense for learning patterns from data to make predictions or classifications. The "firmware" being modified refers to programmed logic, not a learned model.
8. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned for an AI/ML algorithm.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).