(330 days)
The BioHarness is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace and alternate care settings. The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including heart rate, respiration rate, thoracic skin temperature, body orientation and activity.
The BioHarness collects and transmits measurements captured during both sedentary as well as rigorous activity for Heart Rate, Skin Temperature, Posture and Activity. Breathing rate values are accurately transmitted only during sedentary periods.
The BioHarness is indicated for use as a general patient monitor to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.
The BioHarness is a compact physiological monitor that consists of two components:
- A chest strap with conductive fabric skin electrodes and a thoracic expansion sensor.
- A battery-powered electronics module that attaches to the chest strap.
The device provides both storage and real-time transmission of the user's Heart Rate, Respiration Rate, Temperature, Posture and Activity Level. The device uses heart electrical activity signals and respiratory breathing frequency inferred from thoracic movement to derive the Heart Rate and Respiration Rate respectively.
An accessory cradle is provided to recharge the internal battery and transfer internally stored data to a computer.
The transmitted data provided by the device over Bluetooth may be integrated into third party monitoring applications. A simple software utility that displays vital sign data is provided. Users may transmit vital sign data from the BioHarness to the application on a PC via Bluetooth using the Bluetooth adapter.
The Zephyr BioHarness device is a physiological monitoring telemetry device intended for monitoring of adults in the home, workplace, and alternate care settings. It measures heart rate, respiration rate, thoracic skin temperature, body orientation, and activity.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for each physiological measure. Instead, it relies on demonstrating compliance with recognized performance standards and substantial equivalence to predicate devices. The device's performance is described in terms of its ability to meet these standards and its functional characteristics.
| Physiological Measure | Acceptance Criteria (Implicit from Standards/Predicate) | Reported Device Performance |
|---|---|---|
| Heart Rate | * Compliance with relevant sections of ANSI/AAMI EC13:2002/(R) 2007 (Cardiac monitors, heart rate meters, and alarms). |
- Substantial equivalence to predicate devices like Hidalgo Equivital EQ-10 (K061993) and Respironics Actiheart (K052489) in heart rate sensing and derivation. | * Monitors electrical signals from the heart via a chest strap with conductive fabric electrodes (V4 lead position).
- Derives heart rate based on proprietary analysis of the QRS complex.
- A single-ended ECG circuit is used to detect QRS complexes, incorporating ESD protection, filtering, and ADC.
- Proprietary digital filtering and signal analysis are performed to derive heart rate.
- The device provides function as a heart rate meter, but is not indicated for use as an ECG monitor.
- Collects and transmits measurements during both sedentary and rigorous activity. |
| Respiration Rate | * Substantial equivalence to predicate devices like Hidalgo Equivital EQ-10 (K061993) and VivoMetrics LifeShirt Real Time (K043604) in respiration rate sensing and derivation. | * Inferred from thoracic movement sensed by a chest strap containing a proprietary capacitive sensor. - Sensor capacitance changes due to thoracic expansion/contraction, driving changes in impedance and signal amplitude.
- Detects, filters, and amplifies this change to produce a varying voltage signal representing thoracic movement.
- Signal passed to ADC, proprietary digital filtering, and signal analysis to derive respiration rate.
- Breathing rate values are accurately transmitted only during sedentary periods. |
| Skin Temperature | * Compliance with relevant requirements of ASTM E1965 - 98(2009) (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). - Substantial equivalence to predicate device Hidalgo Equivital EQ-10 (K061993) for skin surface temperature measurement. Both methods (infrared vs. thermistor) provide "similar accuracy." | * Measurement of skin temperature on the chest performed with an integrated infrared thermometer.
- Infrared thermometer is mounted internally but has a viewing window facing the user's chest.
- Collects and transmits measurements during both sedentary and rigorous activity. |
| Activity/Body Orientation | * Substantial equivalence to predicate devices like Hidalgo Equivital EQ-10 (K061993) and Respironics Actiheart (K052489) for activity and motion detection using tri-axis accelerometers. | * Derives activity and body orientation from signals from an internal tri-axis accelerometer (Analog Devices ADXL330). - Proprietary algorithms analyze acceleration values.
- Provides a measure of user posture (upright, supine) in degrees from vertical.
- Provides activity level in Vector Magnitude Units (VMU).
- Collects and transmits measurements during both sedentary and rigorous activity. |
| Basic Safety & Performance | * Compliance with ANSI/AAMI ES60601-1:2005 (General requirements for basic safety and essential performance). - Compliance with ANSI/AAMI/IEC 60601-1-2:2007 (EMC).
- Compliance with ANSI/AAMI/ISO 10993-1:2003 (Biocompatibility). | * Tested and shown compliant with these standards through reviews and tests for electrical safety, mechanical safety, radiation hazards, temperature/other safety concerns, accuracy of controls, hazardous situations/fault conditions, construction, electromagnetic compatibility, and biocompatibility. |
| Software | * Compliance with IEC 60601-1-4:1996/(R)2005 (Collateral Standard: Programmable electrical medical systems). | * Developed using a structured software development process that meets the requirements of IEC 60601-1-4. |
Study Details
The provided document describes the premarket notification and focuses on establishing substantial equivalence to legally marketed predicate devices and compliance with recognized standards. It does not present a specific comparative clinical study (e.g., an MRMC study) or a standalone performance study with detailed numerical results for the device's accuracy in measuring physiological parameters against a gold standard.
Instead, the "studies" primarily consist of:
- Reviews and comparisons to predicate devices' technological characteristics and intended use.
- Testing for compliance with recognized consensus standards (e.g., electrical safety, EMC, biocompatibility, heart rate meter performance, infrared thermometry).
- Development testing at the bench level and under simulated field conditions for general functionality.
However, based on the information provided, we can infer some aspects and highlight what is not present:
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "reviews and tests" and "development testing... at the bench level and under simulated field conditions (i.e. field trials)." This suggests internal verification and validation testing, but no specific human subject sample size for a formal clinical test set is provided.
- Data Provenance: Implied to be internal Zephyr Technology development and testing. "Simulated field conditions (i.e. field trials)" suggests some limited real-world testing, but no details on country of origin or whether it was retrospective/prospective are given for a formal performance study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The document describes compliance with standards and comparison to predicate devices, not the establishment of a ground truth by human experts for a specific performance evaluation of its measurements. Ground truth for compliance testing typically refers to the reference methods defined within the standards themselves (e.g., electrical safety test equipment, calibrated thermometers, etc.).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. Adjudication methods are typically used in studies where human readers interpret data, and their interpretations are compared against an expert-adjudicated ground truth. This type of study is not described.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The BioHarness is a physiological sensor, not an AI-assisted diagnostic tool that aids human readers. The document focuses on the accuracy and safety of the device's measurements themselves, not on improving human interpretation of those measurements.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the primary "performance studies" described are standalone. The evaluations of the BioHarness against various standards (electrical safety, EMC, biocompatibility, heart rate metering accuracy, infrared thermometry accuracy, software lifecycle) are all evaluations of the device's inherent performance as an algorithm-driven sensor, without a human "in the loop" for the measurement process itself. The software lifecycle development meeting IEC 60601-1-4 confirms this focus on the algorithm's integrity.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Reference standards and calibrated equipment. For electrical safety, the ground truth is compliance with the limits specified in ANSI/AAMI ES60601-1. For heart rate, the ground truth would be a clinically accepted reference ECG/heart rate monitor as specified in ANSI/AAMI EC13. For infrared thermometry, the ground truth would be a highly accurate reference thermometer as per ASTM E1965. For biocompatibility, it's about material properties and tests defined in ISO 10993-1. In essence, the "ground truth" for these tests comes from the rigorous definitions and test methodologies embedded within the referenced industry standards.
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The sample size for the training set:
- Not applicable/Not mentioned. The BioHarness is described as using "proprietary analysis of the QRS complex" for heart rate, "proprietary digital filtering and signal analysis" for respiration rate, and "proprietary analysis of acceleration values" for body orientation and activity. This suggests algorithms likely developed using internal data and signal processing expertise, but there's no mention of a distinct "training set" in the context of machine learning for a regulatory submission of this nature. The device's algorithms are likely based on established physiological principles and signal processing techniques rather than large-scale data-driven machine learning in the contemporary sense.
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How the ground truth for the training set was established:
- Not applicable/Not mentioned for the reasons stated above (no explicit "training set" for machine learning is described). For the development of its proprietary algorithms, the ground truth would have been established through physiological experiments, engineering validation, and comparison to known physiological responses measured by established reference methods.
§ 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.