Search Results

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.

Ask a specific question about this device

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 .

N/A

Ask a specific question about this device

The Arm blood pressure monitor is for home use for measuring blood pressure and pulse rate. It is suitable for adult, not for neonate or pregnancy.

The subject device, Arm Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by dry batteries. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.

The proposed device consists of the main body and the arm belt, suitable for home use for measuring blood pressure and pulse rate.

This blood pressure monitor has the memory function of 60 groups of measuring data of two people, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results.

This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

No operation for 1 minute the device will shut down automatically.

The subject device includes model MJ1DS/MJ1D/MJ3D/MJ5D/MJ6D/MJ8D/RN3D/MJ4D/RN1D/RN2D. These models are identical in terms of software design, cuff type, measurement range and function, principle, the core algorithm of the software, the key components. The schematic circuit diagrams are identical in all models. The PCB layout are identical in all models because of different appearance such as structure, buttons layout.

N/A

Ask a specific question about this device

The Arm Blood Pressure Monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.

The subject device, Arm Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy.

The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.

The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x60 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement.

This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips.

No operation for 1 minute the device will shut down automatically.

N/A

Ask a specific question about this device

HemoSphere Alta™ Advanced Monitoring Platform with Swan-Ganz™ Technology

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere Alta Swan-Ganz™ Patient Cable and Swan-Ganz™ Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Swan-Ganz™ Catheter and Swan-Ganz Jr™ Catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz™ Catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

When used in combination with a Swan-Ganz™ Catheter connected to a pressure cable and pressure transducer, the Smart Wedge™ Algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressure measurement. The Smart Wedge™ Algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge™ Algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge™ Algorithm parameters.

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Oximetry Cable

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Oximetry Cable and oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor - Pressure Cable

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the FloTrac™ Sensor, FloTrac Jr™ Sensor, Acumen IQ™ Sensor, and TruWave™ Disposable Pressure Transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used.

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI™ Feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ Feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index™ Parameter.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Right Ventricular Pressure (RVP) parameters.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Cardiac Output (RVCO) feature provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVCO algorithm is intended for use in surgical or non-surgical patients over 18 years of age that require advanced hemodynamic monitoring. The Right Ventricular Cardiac Output provides a continuous cardiac output and derived parameters.

The Cerebral Autoregulation Index (CAI) algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere™ Pressure Cable and StO2 is acquired by the ForeSight™ Oximeter Cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) algorithm.

HemoSphere Alta Advanced Monitoring Platform with ForeSight™ Oximeter Cable

The non-invasive ForeSight™ Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The ForeSight™ Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight™ Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere Alta™ Advanced Monitoring Platform.

• When used with large sensors, the ForeSight™ Oximeter Cable is indicated for use on adults and transitional adolescents ≥40 kg.
• When used with medium sensors, the ForeSight™ Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
• When used with small sensors, the ForeSight™ Oximeter Cable is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

The algorithm for measurement of blood hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight™ Oximeter Cable and noninvasive ForeSight IQ™ Sensors in cerebral locations.

HemoSphere Alta™ Advanced Monitoring Platform with Non-invasive technology

The HemoSphere Alta™ Monitor when used with the pressure controller and a compatible finger cuff are indicated for adult and pediatric patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere Alta™ Advanced Monitor and compatible finger cuffs non-invasively measures blood pressure and associated hemodynamic parameters. Refer to the non-invasive finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI™ Feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ Feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index™ Parameter.

HemoSphere Alta Advanced Monitoring Platform with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor

The Acumen assisted fluid management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the assisted fluid management suggestions.

The HemoSphere Alta Advanced Monitoring Platform is the next-generation platform that provides a means to interact with and visualize hemodynamic and volumetric data on a screen. It incorporates a comprehensive view of patient hemodynamic parameters with an intuitive and easy user interface. The HemoSphere Alta Advanced Monitoring Platform is designed to provide monitoring of cardiac flow with various core technologies coupled with other technologies-based features such as Algorithms and Interactions. It integrates existing hemodynamic monitoring technologies into a unified platform.

The HemoSphere Alta Advanced Monitoring Platform's FDA 510(k) clearance letter and associated 510(k) summary (K252533) primarily focus on software modifications and the integration of previously cleared hardware components to an existing platform (K242451). The document states that no new clinical testing was performed in support of the subject 510(k). Therefore, the information provided mainly pertains to performance verification studies rather than standalone clinical performance studies involving ground truth establishment by experts for a novel algorithm.

However, based on the provided text, we can infer the acceptance criteria and study information as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several verification activities without providing specific numerical acceptance criteria for each, except implicitly stating "All tests passed" or "All acceptance criteria were met."

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

• For Usability Study: The document mentions "the intended users." It does not specify the numerical sample size of users or the provenance of the data (e.g., retrospective or prospective, country of origin).
• For Non-Clinical Performance (Bench Simulation): "Measured and derived parameters were tested using a bench simulation." No sample size in terms of patient data or data provenance is applicable here, as it's a bench test.
• For Software Verification: "Extensive software verification testing was conducted." No specific sample size of test cases or data provenance is provided.
• For Clinical Performance: "No new clinical testing was performed in support of the subject 510(k)." This indicates no patient-level test set data was used for this specific submission. The algorithms within the device (e.g., GHI, Smart Wedge, HPI, CAI, RVP, RVCO, AFM) likely had clinical performance studies for their initial clearances, but those details are not provided in this 510(k) for the HemoSphere Alta platform updates.

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

• As "no new clinical testing was performed" for this 510(k) submission, there is no mention of experts establishing ground truth for a new clinical test set.
• For the Usability Study, "intended users" participated, implying clinical professionals, but their specific qualifications or their role in establishing "ground truth" (beyond identifying usability issues) are not detailed.

4. Adjudication Method for the Test Set

• Since no new clinical test set data with expert adjudication is described in this submission, no adjudication method is mentioned.

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

• The document does not mention any MRMC comparative effectiveness study comparing human readers with and without AI assistance for this 510(k) submission.

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

• While the device contains various algorithms (e.g., GHI, HPI, Smart Wedge, CAI, RVP, RVCO, AFM), this 510(k) primarily addresses software updates and hardware integration to an existing platform. It doesn't detail standalone performance studies for these specific algorithms within this document. The description of these algorithms (e.g., "additional information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions") implies a non-standalone, assistive role, but explicit standalone performance studies are not part of this submission's provided information.

7. Type of Ground Truth Used

• "No new clinical testing was performed." Therefore, for this specific 510(k) submission, no new patient-level ground truth (expert consensus, pathology, outcomes data, etc.) was established for performance evaluation of new algorithms or features. The verification activities relied on bench simulations and usability testing, not clinical ground truth.

8. Sample Size for the Training Set

• The document pertains to the clearance of a device (HemoSphere Alta Advanced Monitoring Platform) with software modifications and hardware integration, not the development or training of new AI algorithms. Therefore, no information on the sample size of a training set is provided. The algorithms included in the HemoSphere Alta system (e.g., GHI, HPI, CAI) would have been developed and trained using data sets prior to their initial clearance. This current 510(k) does not detail those previous training sets.

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

• Similar to the training set sample size, this information is not provided in this 510(k) document, as it focuses on software updates and hardware integration to an already cleared platform, not the initial development and training of novel algorithms.

Ask a specific question about this device

The N10, N12, N15, N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2). The N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are also intended for monitoring, displaying, reviewing, storing, alarming and transferring of physiological parameters including Masimo Rainbow SpO2, Anesthesia gas (AG), oxygen (O2) respiratory gas monitoring, Bispectral Index (BIS), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). All the parameters can be monitored on single adult, pediatric, and neonatal patient except for the following:

• Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
• NIBP measurement continual mode is not applicable to neonates.
• When using COMEN SpO2, the monitor is intended to be used on adult patient only.
• PAWP is intended for adult and pediatric patients only.
• C.O. measurement is intended for adult patients only.
• BIS monitoring is intended for adult patients only.
• RM is intended for adult and pediatric patients only.
• NMT monitoring is intended for adult and pediatric patients only.

The monitors are to be used in healthcare facilities by healthcare professionals or under their guidance.

The Multi-parameter Patient monitors are not intended for emergency and transport use, aircraft environment or home use.

The monitors are not intend for use as apnea monitors.

The monitors are not intended for use in MRI or CT environments.

The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

There are six (6) models under evaluation, namely N10, N12, N15, N10MPro, N12MPro, N15MPro. All models share the same intended condition of use, the same intended patient population and operator profile, biological safety characteristic and principle of operation. All these models are the same on electric and electrical circuit and components, mechanical construction, software and alarm system. The only difference lies on the screen and configuration of with/without plug-in module slot and the number of battery packs.

N/A

Ask a specific question about this device

The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the arm cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use.

The blood pressure monitor is a fully automatic, non-invasive upper arm measurement device using oscillometric methodology to measure systolic pressure, diastolic pressure and pulse rate. The device features an inflatable cuff that wraps around the arm, with a built-in pressure sensor and transducer that analyze arterial pulsations to determine blood pressure values. Measurement results are clearly displayed on the LCD screen.

N/A

Ask a specific question about this device

The HemoSphere Stream™ Module when used with a Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor. The device is designed for use in clinical environments requiring continuous assessment of blood pressure waveform morphology, without the need for an invasive catheter.

The HemoSphere Stream™ Module when used with the Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor.

N/A

Ask a specific question about this device

The wrist automatic blood pressure monitor LD-735,LD-752,LD-753 is intended for the non-invasive measurement of systolic and diastolic arterial blood pressure and pulse rate in adults (aged 15 and above).

The Wrist Automatic Blood Pressure Monitor is an automatic, non-invasive, blood pressure measurement device that is intended to measure the systolic and diastolic arterial blood pressure and pulse rate. The systolic and diastolic pressure are determined using the oscillometric method, where the cuff is inflated with a pump and deflates via an automatic electronic valve. During the inflation measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the sensor to determine systolic pressure and diastolic pressure.

The Wrist Automatic Blood Pressure Monitor consists of two parts: main unit and the wrist cuff. The main unit is mainly composed of pump, valve, PCB, enclosure and LCD. The cuff, which is applicable to wrist circumference approximately between 12.5 and 20.5cm, includes the inflatable bladder and the nylon shell.

This device adopts the oscillometric technology with Fuzzy Algorithm to measure the arterial blood pressure and pulse rate. The cuff is wrapped around the arm and automatically inflated by the air pump. The sensor of the device catches weak fluctuation of the pressure in the cuff produced by extension and contraction of the artery of the arm in response to each heartbeat. The amplitude of the pressure waves is measured, converted in millimeters of the mercury column, and is displayed by digital value.

This FDA 510(k) clearance letter pertains to three models of wrist automatic blood pressure monitors (LD-735, LD-752, LD-753) submitted by HONSUN (Nantong) Co.,Ltd. The clearance is based on the substantial equivalence of these devices to a legally marketed predicate device, the Wrist Automatic Blood Pressure Monitor LD-737 (K131463).

The primary focus of the submission and the FDA's review is on demonstrating that the new devices do not raise new issues of safety or effectiveness compared to the predicate. The document thoroughly compares the technical characteristics and functions of the subject devices to the predicate.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantitative set of thresholds for clinical performance that the device must meet in a specific study. Instead, the "acceptance criteria" appear to be implicit in the compliance with recognized standards and the declared measuring accuracy specification. The study performed is a non-clinical bench testing comparison to the predicate device and compliance with relevant safety and performance standards.

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

The document explicitly states that "bench testing" was conducted. However, it does not provide any details on the sample size used for this testing or the specific data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is primarily related to compliance with various electrical, EMC, and environmental standards, as well as biocompatibility. For measuring accuracy, the statement merely re-iterates the specification as being the same as the predicate, suggesting that this specification was verified during the "bench testing" rather than proven with a new clinical study.

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

The document does not mention any human experts establishing ground truth for the "test set." The evaluation appears to be based on engineering and laboratory testing for compliance with technical standards and comparison to the predicate device's specifications. This is a blood pressure monitor, not an AI/imaging diagnostic device that would typically require expert ground truth labeling.

4. Adjudication Method for the Test Set

Since no human experts were involved in establishing ground truth for a test set in the traditional sense (e.g., for diagnostic accuracy), there was no adjudication method described.

5. 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 MRMC comparative effectiveness study was done or is applicable to this device. This is a standalone medical device (blood pressure monitor), not an AI-based diagnostic tool intended to assist human readers or clinicians.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document outlines an assessment of non-clinical testing which included electrical safety, EMC, biocompatibility, and software verification/validation. The device itself is an "automatic blood pressure monitor," meaning its core function is to autonomously measure blood pressure. Therefore, the "bench testing" and compliance with standards like ISO 80601-2-30 (Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers) serve as the standalone performance evaluation for the device's accuracy and safety, without human intervention in the measurement process itself. The document states: "The performance tests demonstrate that the wrist automatic blood pressure monitor performs comparably to the predicate device that is currently marketed for the same intended use." This indicates a standalone performance assessment against established benchmarks (the predicate and relevant standards).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the primary function of blood pressure measurement accuracy, the ground truth is implicitly defined by the measurement standards provided in ISO 80601-2-30, which typically refers to reference measurements from a calibrated clinical-grade sphygmomanometer (e.g., mercury sphygmomanometer). For other aspects, the ground truth for compliance is the relevant international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC).

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This device is a hardware-based blood pressure monitor using an "oscillometric method with Fuzzy Algorithm." While a "Fuzzy Algorithm" implies some form of computational processing, the document does not indicate that it is a machine learning or AI algorithm that requires a "training set" in the modern sense of deep learning or complex predictive modeling. The algorithm is a fixed part of the device's operation.

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

Not applicable/Not mentioned for the same reasons as #8. If the "Fuzzy Algorithm" involved a "training" or calibration phase during its development, the details are not provided in this regulatory document.

Ask a specific question about this device

Upper Arm Electronic Blood Pressure Monitor, Models FC-BP107, FC-BP123, FC-BP125, FC-BP126,FC-BP127, FC-BP116 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries / 4×AAA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.

The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.

The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than the measurement values. The unit also calculates an average reading based on the values of the latest 3 times measurement.

This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.

This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.

During blood pressure measurement, if the body moves excessively, the body motion detection icon will appear on the display.

Sleeve with self-check: Detects whether the cuff is worn correctly. If the pressure can exceed 30mmHg within 15 seconds, this Sleeve with self-check icon will light up.

During the blood pressure measurement decrease process, if a pulse wave is detected, this Pulse Detected Icon will flash at the same frequency as the peak of the pulse wave appears.

The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.

The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device(except model FC-BP107).

There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically.

No operation for 2 minute the device will shut down automatically.

The device includes model FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116. Model FC-BP107 and FC-BP116 can be powered by internal battery (4×AA batteries, 6.0V DC) or Type-C port 5VDC 1A, other models can be powered by internal battery (4×AAA batteries, 6.0V DC) or Type-C port 5VDC 1A.

All models have same MCU, Air pump, Solenoid valve and blood pressure core algorithm except for PCB layout, Display screen, function of the Button, dimension and power supply.

The subject devices (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) and the predicate devices (FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112) share the same schematic, circuitry, critical components, and measurement algorithm.

For the differences between the subject device models, the differences are PCB layout difference (physical board shape and/or component arrangement differences), Display screen, function of the Button, dimension, and power supply.

These changes are mainly cosmetic and do not affect the electrical design, safety, or essential performance of the devices.

N/A

Ask a specific question about this device