(271 days)
The Wireless Vital Signs Monitor Professional (WVSM Pro) series monitors are intended to be used as continuous or spot check monitors and indicated as single or multi-parameter vital signs monitors. There are two monitor configurations WVSM Pro and TVSM (Tactical Vital Signs Monitor):
WVSM Pro is indicated to monitor electrocardiogram (ECG) 5- or 12-lead waveforms and heart rate (HR); temperature; noninvasive blood pressure (NIBP); Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI); and capnography including end-tidal CO2 (ETCO2), fractional inspired CO2 (FiCO2) and respiration rate (RR).
TVSM is indicated to monitor noninvasive blood pressure (NIBP) and Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI), The monitors use wireless communications to transmit vital signs data to a PC, laptop, or mobile device. Patient population: neonate/infant, pediatric and adult patients.
The monitors may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications.
The monitor is intended to be used by trained healthcare providers.
Wireless Vital Signs Monitor Professional (WVSM Pro) and Tactical Vital Sign Monitor (TVSM) are part of the WVSM Pro Series monitors. The WVSM® Pro series monitors are small, rugged, and highly mobile medical devices intended to be used as an adult, pediatric, and neonate patient vital signs monitor for spot-checking or continuous applications. The monitors are small enough to stay with the patient from point of injury through the triage and treatment process. It is designed as a single or multi-parameter vital signs monitor. The WVSM Pro is capable of acquiring the following physiological parameters: electrocardiogram (ECG) 5- or 12-lead waveforms and heart rate (HR); temperature; noninvasive blood pressure (NIBP); Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI); and capnography including end-tidal CO2 (ETCO2), fractional inspired CO2 (FiCO2) and respiration rate (RR). The TVSM is capable of acquiring the following physiological parameters: noninvasive blood pressure (NIBP) and Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI). Both models can be used as a standalone device or can transmit data via wireless communications to a PC, laptop, or mobile device (tablet or smartphone).
WVSM Pro series monitors are intended for use in pre-hospital, emergency room, inpatient care facilities, healthcare facilities, emergency medical applications, during transport, outpatient care, and other related healthcare scenarios. The WVSM Pro is intended to be used by trained healthcare providers by prescription only.
The basic principles of operation of the WVSM® Pro Series monitors include:
ECG: 5- or 12-lead waveforms generated via skin electrodes with right-leg drive. Note: The device does NOT include the following functions: Automated Waveform Measurements, Arrhythmia Detection, or Alarms for these functions.
Capnography: Infrared (IR) Spectroscopy is used to detect CO2 concentrations in expired air via mainstream or sidestream methods
Pulse oximetry: The plethysmography waveform from Red and IR LEDs are used to calculate functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI)
Temperature: YSI 400 compatible thermistor sensors
Non-invasive blood pressure (NIBP): Oscillometric method
The WVSM® Pro Series patient monitor enclosures are primarily plastic and is not intended to contact the patient. The applied parts are OEM accessories that are FDA cleared and meet the biocompatibility requirements for intact skin contact.
This document, K233354, is a 510(k) premarket notification review from the FDA for the Athena GTX, Inc. WVSM Pro (Series) vital signs monitors. It establishes substantial equivalence to a predicate device (ZOLL Power M, K202275) without the need for new clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific performance metrics for the WVSM Pro (Series) monitor. Instead, it states that "performance data were provided in support of substantial equivalence determination" and lists various non-clinical tests and compliance with recognized standards.
The primary "acceptance criterion" for this 510(k) submission appears to be substantial equivalence to the predicate device (ZOLL Power M, K202275) across indications for use, technology, and intended use, without raising new questions of safety and effectiveness.
The document implicitly refers to performance by stating:
- "The device was evaluated and found to be in compliance with the standards identified below" (a list of IEC, ISO, and AAMI standards). These standards contain their own performance requirements and acceptance criteria for vital signs monitoring devices.
- "The device uses OEM modules for parameters that would normally require clinical testing, NIBP and Pulse Oximetry. These modules have had clinical testing performed and have been used in previously cleared devices." This implies that the performance of these modules, for which the predicate also relies on similar technology, is accepted based on prior clearances and clinical data.
Therefore, a table with specific acceptance values and corresponding WVSM Pro performance from this document cannot be constructed directly. The "device performance" is primarily demonstrated through compliance with recognized standards for safety and performance (e.g., IEC 60601 series, ISO 80601 series, AAMI ANSI EC53) and the use of previously validated OEM modules for certain functions.
2. Sample Size Used for the Test Set and Data Provenance
Since no new clinical studies were conducted for the WVSM Pro (Series) device, there is no new test set sample size or data provenance explicitly described for this 510(k) application.
The clinical data that supports the performance of the NIBP and Pulse Oximetry modules, which were incorporated from OEM parts, would have originated from the studies conducted for those original modules. The document does not specify the sample sizes or provenance of these prior studies.
The non-clinical testing (software, safety, usability, cybersecurity) does not typically involve patient "test sets" in the same way clinical trials do.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no new clinical testing was performed on the WVSM Pro (Series) that required establishing a ground truth with human experts, this information is not applicable and not provided in the document. The performance of the OEM modules is presumed to be based on the ground truth established in their original clinical validations.
4. Adjudication Method for the Test Set
Since no new clinical test set requiring human expert adjudication was created for this device, the adjudication method is not applicable and not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical testing was not necessary to show substantial equivalence." The device is intended to be used by trained healthcare providers, but its performance is not being compared to human readers or an AI-assisted human workflow in this submission.
6. Standalone Performance Study
No new standalone (algorithm only without human-in-the-loop performance) study was done for the WVSM Pro (Series). The device itself is a vital signs monitor, not typically an AI algorithm in the context of standalone performance a typical AI/CADe device would require.
The document does mention software verification and validation, ensuring the product works as designed, but this is not an "algorithm-only" performance study in the context of diagnostic AI.
7. Type of Ground Truth Used
For the WVSM Pro (Series) submission, the "ground truth" for demonstrating substantial equivalence relies on:
- Compliance with recognized performance standards: These standards (e.g., IEC, ISO, AAMI) establish the gold standard for performance expectations of vital signs monitors.
- Prior clinical validation and clearance of OEM modules: For NIBP and Pulse Oximetry, the ground truth was established during the original clinical testing of the commercially available OEM modules. This would typically involve comparison to reference clinical measurements from calibrated devices. The document does not provide details on the specific type of ground truth used in those prior studies (e.g., invasive arterial line for NIBP, co-oximetry for SpO2).
8. Sample Size for the Training Set
The WVSM Pro (Series) is a vital signs monitor and not described as an AI/Machine Learning device that requires a "training set" in the conventional sense for a standalone algorithm. Therefore, no training set sample size is provided or applicable in this context. The "software verification and validation" refers to traditional software engineering testing.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for an AI/ML algorithm within the WVSM Pro (Series), this information is not applicable.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).