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The HemoSphere Nano™ Monitor when used with a compatible non-invasive finger cuff is indicated for adult patients (≥ 18 years of age) in whom cardiac function parameters need to be evaluated as part of a patient's assessment. The HemoSphere Nano™ Monitor and compatible finger cuffs non-invasively measure blood pressure and associated hemodynamic parameters.

The HemoSphere Nano Monitor is a hand-held monitoring device that measures the arterial pressure waveform collected from a connected non-invasive finger cuff and displays blood pressure and derived hemodynamic parameters. These parameters are continuously displayed for up to a period of 10 minutes, serving as a series of spot-check or point-in-time measurements. As such, the device does not feature any physiological alarms. It is compatible for use with the single use Acumen IQ Plus finger cuff (AIQCA2; cleared via K243781).

The HemoSphere Nano Monitor utilizes the same principle of operation, algorithms, and mechanism for non-invasive monitoring hemodynamic parameters as the primary predicate, HemoSphere Advanced Monitoring Platform (K243781). When compared to the primary predicate, the subject device introduces a new hardware configuration with a smaller form factor. This new hardware configuration is powered by a rechargeable battery and features a smaller display to enable the product to be hand-held. Contrary to the predicate which incorporates a modular approach, the subject integrates all existing non-invasive technology (i.e., the ClearSight Module and Pressure Controller) into the HemoSphere Nano Monitor body itself to provide a unified and compact solution for non-invasive hemodynamic monitoring.

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This product is indicated for measuring blood pressure and pulse rate in patients older than 12 years. It is not suitable for neonates, pregnant individuals, or patients with pre-eclampsia. The device can be used at home or in a healthcare facility.

YUWELL® Blood Pressure Monitor (Model: YE650AR) is a rechargeable lithium battery-powered, automatic, noninvasive, upper-arm blood pressure measurement system intended for use by adults. The YE650AR is designed for upper arm circumference ranging from 22 cm to 32cm (8.7 in to 12.5 in) or 22 cm to 45 cm (8.7 in to 17.7 in). The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During deflation, the cuff pressure is monitored, and pulse waveform data is captured. The pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.

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The Wrist Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of person older than twelve (12) years via non-invasive oscillometric technique in medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

Wrist Blood Pressure Monitor, model: BPM-W1VL is a Noninvasive Blood Pressure Measurement System that is intended to measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited.

It measures blood pressure and pulse rate through inflating cuff which rounding the wrist of patients. The BPM-W1VL is small, portable and used at home or in medical facilities environment.

The Wrist Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-W1VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD.

Principle of operation: This product uses the Oscillometric Measuring method to detect blood pressure. When the cuff is fully inflated to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate. And Wrist circumference is 13.5-21.5 cm.

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The Wearable Ambulatory Blood Pressure Monitor, model WBP-02A is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to measure systolic and diastolic pressure in individuals aged 12 years and older. The collected data can be transmitted to a PC via USB for healthcare professionals to review and analyze. This device is not intended for diabetic patients, pregnant women, or patients with arrhythmia. It is intended for prescription use only.

The WBP-02A Ambulatory Blood Pressure Monitor from Hingmed Medical comprises a main unit, a cuff, a USB data cable, and PC analysis software. This compact and portable device is worn comfortably on the patient's upper arm. The cuff inflates to occlude the brachial artery and then gradually deflates. The device employs the oscillometric method to measure blood pressure and pulse parameters during the deflation phase, capturing the transition from blood flow occlusion to restoration. The main unit's internal memory can store up to 300 measurement records. Upon completion of the monitoring period, the data is transferred via the USB cable to a computer for comprehensive statistical analysis using the dedicated software.

The ambulatory blood pressure monitor software has two components: embedded software and PC software.

The embedded software runs on the main control unit, directing the monitor to take measurements and collect blood pressure data, which it sends to the PC software via USB. The PC software analyzes the data, generates charts for medical review, and can also configure the device—such as setting measurement intervals—and initiate readings.

The PC software operates offline and does not replace any tasks performed by healthcare professionals.

The device firmware does not include the calculation function for Mean Arterial Pressure (MAP), and the OLED screen on the host device does not display MAP values. The accompanying PC software can display the hourly average MAP value and its trend graph. MAP is calculated using the standard equivalent formula, as follows:

Calculation Formula: MAP = (SBP + 2 x DBP) / 3
Alternative expression: MAP = DBP + (1/3) x PP

Where:

• SBP = Systolic Blood Pressure
• DBP = Diastolic Blood Pressure
• PP = Pulse Pressure (SBP – DBP)

Note on the Formula:
The expression "MAP = (SBP + 2 x DBP) / 3" is mathematically equivalent to the standard MAP formula "DBP + 1/3 x (SBP – DBP)".

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The Perin Health Platform is a wireless remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in healthcare and home settings for long-term monitoring. The Perin Health Patch can monitor auscultation data of heart and lung sounds, photoplethysmography waveforms (PPG), oxygen saturation (%SpO2), heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity detection (including step count), and posture (body position relative to gravity including fall).

The Perin Health System is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. In home-use environments, the Perin Health Platform is able to integrate with optional third-party devices for blood pressure, and weight data collection via the mobile application. The mobile application transmits data from the Health Patch and third party devices to the cloud and web-based portal for storage, analysis, and review by healthcare professionals. The Perin Health Platform can include the ability to notify healthcare professionals when physiological data falls outside set limits or manual trigger by the patient.

The device is intended to provide physiological information for non-critical, adult population.

The Perin Health System is a wireless remote patient monitoring platform that enables healthcare professionals to perform spot-checking and retrospective monitoring of physiological data from adult patients. The Perin Health System is designed for use in hospitals, clinics, long-term care facilities, physician offices, and home environments.

The Perin Health System comprises the following components:

1. Perin Health Patch wearable device
2. Perin Health Patient Mobile Application
3. Perin Health Cloud
4. Perin Health Provider Portal
5. Perin Health Inpatient Application

1. The Perin Health Patch
The Perin Health Patch is a chest-worn wearable device that performs scheduled spot-check measurements of multiple physiological parameters. Unlike continuous monitoring systems, the Perin Health Patch captures measurements at predetermined intervals configured by healthcare providers based on clinical need.

The device integrates six primary sensing modalities:

• Auscultation (heart and lung sounds)
• Electrocardiography (1-channel ECG)
• Pulse oximetry via photoplethysmography (PPG)
• Bioimpedance (BioZ) for respiratory monitoring
• Temperature sensing (skin)
• Motion and orientation detection via accelerometer

The combination of these modalities in a small, low-power wearable form allows for the spot-checking of primary vital signs:

• Heart rate and R-R intervals
• Heart rate variability (HRV) parameters
• ECG waveform data
• Auscultation sound data (heart and lung sounds)
• Respiratory rate
• Pulse (PPG) waveform
• Oxygen saturation (SpO2%)
• Skin temperature
• Fall detection events
• Body posture
• Activity level and step count

The device adheres to the patient's upper left chest at the second intercostal space with a medical-grade long-term wear adhesive. The adhesive is placed on the patient-facing side of the wearable, with cutouts for the sensors to make direct contact with the skin. The wearable device is lightweight and semi-flexible, allowing for the device to conform to the natural curvature of the chest. It is water resistant, allowing for bathing and normal activities while the patient is wearing the system.

The wearable communicates to the receiving unit (mobile phone) via an encrypted Bluetooth Low Energy connection. Measurements, all notifications and control commands, and software updates are transmitted over the BLE connection. The wearable uses Near Field Communication (NFC) to facilitate the Bluetooth pairing process with the mobile phone by simply having to tap their phone to the device to initiate a Bluetooth connection. The wearable device also contains on-board memory that can store over two weeks of spot-check data. When measurements are taken and no receiving unit is present, the wearable can store recordings in the onboard memory. Recordings are stored in a stack, such that at the next connection possibility between the wearable and the receiving unit, the most recent data will be transmitted first followed by other measurements in reverse chronological order.

Other key features of the wearable include:

• Customizable recording schedule set by the healthcare provider in their care program
• Replaceable battery
• Patient-triggered recordings via double-tap
• Signal quality indicators for measurement validation and identification of noisy measurements

2. The Patient Mobile Application
The Patient Mobile Application, available on iOS or Android platforms, is intended exclusively for use in home environments by patients under healthcare provider supervision. The application serves as a data relay and display interface, allowing the patient to complete key tasks, including onboarding, device setup, device communication, and patient-reported data.

The application serves as the primary interface between the Perin Health Patch and the cloud infrastructure, receiving spot-check measurements from the device and uploading them for provider review. The application establishes and manages secured BLE communication with the Health Patch. Given that the Health Patch operates on provider-configured recording schedules, the application manages data transfer in the background with minimal patient interaction required. When internet connectivity is unavailable, the application stores measurements locally until transmission becomes possible. The system also manages firmware updates for the Perin Health Patch.

The application integrates with FDA-cleared third-party blood pressure cuff and scale using BLE and transfers the data to the Cloud System. Healthcare providers determine which patients require the additional third-party device monitoring as part of their individualized care programs. The system also allows users to optionally enter manual data for blood pressure and weight if no third-party device is connected.

Patients are able to review their historical measurement data taken throughout their monitoring program and their goals and thresholds set by their providers. The patient can view metrics assigned within their care program:

• Heart Rate and Heart Rate Variability
• Respiratory Rate
• Oxygen Saturation
• Step Count
• Temperature
• Blood Pressure
• Weight

Patients can also select audio segments captured by the device for playback (no visualization).

The application provides comprehensive patient engagement features. Patients can complete customized questionnaires with up to 20 questions in various formats, review educational content delivered through their care programs, and submit non-critical medical reports to their care team. The reporting feature includes anatomical body mapping for location-specific symptoms, severity scaling, and photo attachment capabilities. The application supports secure messaging with care providers, virtual appointment attendance with waiting room functionality, and comprehensive offline operation with automatic synchronization upon connectivity restoration.

3. The Perin Health Cloud
The Perin Health Cloud infrastructure serves as the central hub for data management and processing. The cloud system receives encrypted spot-check data from relay systems and manages raw data processing (for Health Patch data only), storage, and retrieval of physiological measurements for retrospective clinical review. Algorithms are run in the cloud to process measurements from the Health Patch and generate Signal Quality Index, Heart Rate, Heart Rate Variability, Respiratory Rate, Oxygen Saturation, and Posture.

The alert and notification system enables healthcare professionals to configure multi-level alerts based on clinical parameters, technical issues, or manual patient triggers. Clinical alerts are based on provider-configured thresholds that are set in during the enrollment of a patient in a care program. The system supports complex notification rules including threshold exceedances, percentage changes, trending patterns, and consecutive violations. Alerts are displayed to providers for the purpose of highlighting data during their retrospective review and are not intended to support real-time patient monitoring or urgent care provider action.

The cloud infrastructure includes comprehensive audit logging of all user actions, data access, and system events. The system provides API access for integration with electronic health records with HL7 v2.x, HL7 FHIR R4, and other standard protocols, enabling bidirectional data exchange with major EHR systems.

4. The web-based Provider Portal
The web-based Provider Portal enables healthcare professionals to access and manage patient data and alert statuses remotely through any compatible web browser. Through the portal, providers can review spot-check measurements and historical trends, playback audio recordings of auscultation sounds captured by the Patch, configure individualized care programs, set measurement schedules and alert thresholds, and communicate with patients through various modalities.

Through the portal, providers can review spot-check measurements with customizable vital sign charts displaying trends over days, weeks, or months. Advanced visualization includes waveform analysis for ECG and PPG signals, audio playback for auscultation recordings, and comprehensive annotation tools. The portal displays signal quality indicators and out-of-range values with appropriate visual highlighting based on configured thresholds. The portal also displays patient severity levels (Low/Medium/High) based on the NEWS2 scoring methodology. Additional clinical measures, such blood pressure and weight, that are manually input into the EHR can be read into the Perin Health System and viewed in the Provider Portal using the EHR interface.

The system employs a structured care program architecture that ensures appropriate clinical oversight throughout the monitoring process. Healthcare organizations create standardized care program templates for common conditions. Individual providers can then select from these approved templates and customize them for specific patient needs, prescribing the specific devices needed, measurement frequencies appropriate to the condition, and recording schedules tailored to clinical requirements.

The portal includes comprehensive communication capabilities supporting both patient and care team interactions. Providers can conduct virtual appointments with integrated video calling, AI-powered real-time transcription using AWS HealthScribe, and automated clinical note generation structured into standard sections. The messaging system supports secure text communication with file attachments, while the task management system enables care coordination across team members. Providers can create and deploy customized questionnaires with various response types and scoring algorithms, manage educational content delivery, and review patient-submitted reports with collaborative response capabilities.

Additional portal features include appointment scheduling with EHR integration, comprehensive alert management with acknowledgment workflows, administrative functions for user and device management, and organization hierarchy configuration. The portal provides detailed audit trails, performance analytics, and compliance reporting to support quality improvement initiatives.

5. The Perin Health Inpatient Module
The Perin Health Inpatient Module provides a monitoring dashboard for monitoring capabilities in healthcare facility environments. The modules leverage the existing architectures for the Mobile Application and Provider Portal but offer unique interfaces for inpatient spot-check measurements.

The web-based monitoring dashboard, a page accessible through the Provider Portal, displays vital signs for up to 50 concurrent patients in a grid layout. Each patient card shows the latest values for heart rate, respiratory rate, oxygen saturation, temperature, and device status, with automatic sorting by alert priority and visual indicators for threshold violations. The dashboard refreshes every second, updating as new spot-check recordings are captured from patients across the unit.

The bedside Inpatient Application is built on top of the Android architecture of the Patient Mobile app and operates in kiosk mode. The Beside app only interfaces with the Perin Health Patch and relays information to the Cloud to provide clinicians with access to recent measurements in the Provider Portal Inpatient view. The application also maintains local data storage for backup operation and automatically synchronizes with the cloud upon connectivity restoration. Providers are unable to manually input clinical data (e.g., blood pressure measurements) directly into the bedside Inpatient Application but manual data input into the EHR can be read into and visualized in the Provider Portal over the EHR interface.

The Perin Health System supports monitoring in hospitals and out-of-hospital patient care settings where care is administered by healthcare professionals. Visual alarm indicators highlight parameter exceedances according to configured thresholds. High-priority alerts display prominently with appropriate color coding, though all clinical responses and acknowledgments must be performed through the Provider Portal to maintain proper documentation and workflow management.

The Perin Health System facilitates comprehensive spot-checking and retrospective monitoring across the continuum of care. Data flows from the wearable patch and third-party devices through the patient mobile application to the central cloud infrastructure, where processing algorithms derive clinical insights. Healthcare providers access this information through the web portal or inpatient displays for clinical review and analysis, enabling healthcare providers to track patient progress, adjust treatment plans based on measurements, and identify patients requiring intervention based on retrospective data trends.

Here's a breakdown of the acceptance criteria and the study details for the Perin Health System (PHD80060-2), based on the provided FDA 510(k) clearance documentation:

Acceptance Criteria and Device Performance Study (Perin Health System PHD80060-2)

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance for key physiological parameters are summarized below:

Note: For several parameters (Skin Temperature, Posture, Body Motion, Fall Detection, Step Count, Auscultation data), the document states they were "verified by using bench testing as per the acceptance criteria" or "in accordance with acceptance criteria," implying they met the specified thresholds without explicitly re-stating the achieved performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

• SpO2% (Induced Hypoxia Study):

  • Sample Size: 12 healthy adults (5 female, 7 male)
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be prospective clinical validation conducted for this submission.

• Respiratory Rate (Clinical Validation):

  • Sample Size: 35 participants (17 males, 18 females)
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be prospective clinical validation conducted for this submission.

• ECG, Heart Rate, R-R Interval, and Heart Rate Variability (Clinical Validation):

  • Sample Size: 243 participants
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be prospective clinical validation conducted for this submission.

• Wear-life Performance (Internal Clinical Wear Life Evaluation):

  • Sample Size: 26 participants
  • Data Provenance: Across 3 clinical sites. Implied to be prospective clinical evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical test sets. However, it references:

• SpO2%: "arterial blood samples analyzed by a laboratory co-oximeter" as the gold standard. This implies specialized laboratory personnel for analysis, but their number and specific qualifications are not detailed.
• Respiratory Rate: "manually counted end-tidal CO2" as the gold standard. This would typically be performed by trained clinical staff, but their number and qualifications are not specified.
• ECG, HR, HRV: "standard Holter monitor" as the reference for comparison. Interpretation of Holter data would involve cardiologists or trained technicians, but the document doesn't specify if this was used as "ground truth" to establish the Holter reference itself or if it refers to the Holter output as the reference measurement.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test sets. The studies compare the device's measurements directly to a "gold standard" or "reference monitor" without mentioning a multi-reader adjudication process for discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done to evaluate how much human readers improve with AI vs. without AI assistance. The document focuses on the standalone performance of the device's measurements against established standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, standalone performance was done for several key parameters. The clinical validation studies directly assess the Perin Health System's ability to measure physiological data (SpO2%, Respiratory Rate, ECG/HR/HRV) against a specified gold standard or reference device. These studies inherently evaluate the algorithm's performance without direct human interpretation influencing the measurement output. For example:

• SpO2% accuracy is measured against arterial blood samples.
• Respiratory rate accuracy is measured against manually counted end-tidal CO2.
• ECG, HR, HRV performance is validated against a standard Holter monitor.

7. Type of Ground Truth Used

The types of ground truth used for the clinical validation studies include:

• Laboratory Standard / Direct Measurement: For SpO2%, the ground truth was "arterial blood samples analyzed by a laboratory co-oximeter."
• Clinical Gold Standard: For Respiratory Rate, the ground truth was "manually counted end-tidal CO2."
• Reference Clinical Device: For ECG, Heart Rate, R-R Interval, and Heart Rate Variability, the ground truth/reference was a "standard Holter monitor."

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. This information is typically proprietary to the manufacturer and not usually disclosed in 510(k) summaries unless specifically relevant to a novel AI/ML algorithm requiring such details for FDA review.

9. How the Ground Truth for the Training Set Was Established

Since no information about the training set or its sample size is provided, there is no information available on how the ground truth for the training set was established.

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This device is a digital monitor intended for use in measuring blood pressure(SYS and DIA) and pulse rate ,and the physician reference the result to diagnose.

Environments of use: Hospital and other medical establishment(contraindicate the home as an environment of use).

Patient population: Adult (exclude pregnant women ).

Clinical Automatic blood pressure monitor have two type that is DBP-20 and DBP-20i,The Clinical Automatic blood pressure monitor is used to measure the blood pressure of adult in hospital or other medical establishment. It's contain of main body、power adapter.The device can show the time and measure result .There is a difference DBP-20 and DBP -20i. The difference is the function with voice broadcast . DBP-20i have the function which broadcast the measure result.and DBP-20 have not the broadcasting function.

Clinical Automatic Blood Pressure Monitor is intended to be used for arms range from 17 to 42cm in circumference. The cuff cover can be replace easily. The device intended use at medical center .

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