(204 days)
The Dyna-Vision Telemontoring System is a wreless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and respiration effort Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™ system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment.
The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients.
The Dyna-Vision system is a wireless multi-parameter data collection systems that monitors physiological data such as: Electrocardiography (EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort.
The system consist of:
• A body-worn unit with sensor input modules for the near real time acquisition of the physiological data with built-in wireless communication for data transmission.
• A telemetry server to receive the physiological data and transmit the physiological data to
• A workstation installed on a central server (or PC) equipped with software with which the physician can process the physiological data and create reports regarding the transmitted data, and read and configure alerts/notifications when a threshold value is exceeded. The alert function is an adjunct to and not intended to replace vital sign monitoring.
The software includes algorithms for Heart Rate, Heart Rate variability (R-R interval) and rate of respiratory effort.
The device is intended to be used by clinicians and medically qualified personnel in healthcare facilities. The body-worn unit for data acquisition, is a transportable battery-operated unit to record Electrocardiograph (ECG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort to be also used by the patient in the home setting and anywhere where WIFI or cell communication is available.
The Dyna-Vision system works with 3rd party 510(k) cleared SpO2 module (Nonin OEM III, K092101), and ECG patient lead (Scottcare K092947).
The device is intended for use on general care patients aged 18 years or more.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dyna-Vision Telemonitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format with corresponding performance metrics like a typical validation study report. Instead, the "Substantial Equivalence Comparison Table" (Pages 7-10) compares the Dyna-Vision system's features and specifications against multiple predicate devices. The "acceptance criteria" are implied by the features and performance characteristics of the predicate devices. The non-clinical tests section (Page 5) lists the characteristics tested.
Based on the provided information, I can infer the "acceptance criteria" through the comparison with predicate devices and the performance "reported" by the Dyna-Vision system's specifications.
| Feature / Acceptance Criteria (Inferred from Predicate Performance & Device Specifications) | Reported Dyna-Vision Performance |
|---|---|
| ECG Monitoring | |
| Method | ECG lead wires attached to disposable electrodes to the skin |
| Resolution | 24 bit |
| Input Impedance | > 20 Mohm |
| Common Mode Rejection | -80dB - 100dB |
| Sampling Frequency | 1,000, 800, 400 and 200 Hz |
| Channels | 3, 5 and 12 channels |
| QRS Detection / AF Detection Accuracy | Yes - 99.8% |
| Heart Rate Monitoring | |
| Method | QRS detection |
| Range | 25-300 bpm |
| Accuracy | ± 2 bpm |
| Respiration Monitoring | |
| Method | Impedancy Pneumography |
| Impedance dynamic range | >20 ohms |
| Resolution | 5 seconds |
| Range | 2 - 150 breaths/min |
| Skin Temperature Monitoring | |
| Method | Skin thermistor |
| Range | 0° to +50°C |
| Accuracy | >10°C to +50°C: ±0.1°C; >50° to +122°F: ±0.2°F |
| Oxygen Saturation (SpO2) Monitoring | |
| Method | Photoplethysmogram on finger |
| Infrared | 910 nanometers @ 1.2 mW maximum average |
| Red | 660 nanometers @ 0.8 mW maximum average |
| Range | 0-100% |
| Accuracy | ± 2 digits (from 70-100%) |
| Alert/Notification Functionality | System can be configured to notify healthcare professionals when physiological data falls outside selected parameters. |
| Communication, Data Transmission & Storage | Wireless (Wi-Fi, Cellular), USB, 4 GB SD card memory, 60 days recording period. Central monitoring & data sent to central server. |
| Reliability (QoS) Wireless Quality of Service | Bench testing completed |
| Electromagnetic compatibility (EMC) | Meets IEC 60601-1-2 requirements |
| Electrical safety testing | Meets IEC 60601-1 requirements |
| Wireless Coexistence Wi-Fi testing | Bench testing completed |
| Software verification and validation testing | Bench testing completed |
| Biocompatibility verification | Bench testing completed |
| Usability testing | Usability validation is part of the Clinical Performance data |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and Clinical Performance effectiveness data." This indicates that no patient-based "test set" in the traditional sense was used for clinical performance evaluation. The evaluation was based on non-clinical (bench) testing and substantial equivalence to predicate devices. Therefore, sample size and data provenance (country of origin, retrospective/prospective) for a test set of patient data are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical studies or patient-based test sets were used, there were no experts establishing ground truth for such a set. The "ground truth" for the non-clinical tests would have been established by the standards and methodologies used in the bench testing.
4. Adjudication Method for the Test Set
As no clinical test set was used, no adjudication method was employed.
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
The document does not mention any MRMC comparative effectiveness study. The device is a "Telemonitoring System," not an AI diagnostic tool designed to assist human readers in interpreting medical images or complex data in an MRMC study context. Its purpose is continuous collection of physiological data and alerting based on parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document details extensive standalone (algorithm only/device only) performance testing through "Bench testing" and adherence to "Referenced Standards and Performance Testing." This includes:
- Electrocardiograph (ECG)
- Heart rate variability (R-R interval)
- Heart rate
- SpO2
- Skin Temperature
- ECG impedance for Rate of respiratory effort
- Notification (alert function)
- Measurement accuracy
- Communication, data transmission and storage
- Reliability (QoS) Wireless Quality of Service
- Electromagnetic compatibility (EMC)
- Electrical safety testing
- Wireless Coexistence Wi-Fi testing
- Software verification and validation testing
- Biocompatibility verification
The device's algorithms for Heart Rate, Heart Rate variability (R-R interval), and rate of respiratory effort were also implicitly tested in this standalone context against the performance claims.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench testing, the ground truth would have been established by:
- Reference measurement equipment/systems: Calibrated medical devices or simulators that provide known, accurate physiological signals for comparison.
- Established engineering and medical standards: The device was tested against standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-47, AAMI/ANSI EC38, AAMI/ANSI EC57, ISO 80601-2-61, and IEC 80601-2-59. These standards define the acceptable performance limits and test methodologies for medical electrical equipment, including physiological monitors.
8. The sample size for the training set
The document explicitly states "No clinical studies were utilized for the purpose of obtaining safety and Clinical Performance effectiveness data." This implies that patient data was likely not used for training any machine learning or AI models in a traditional sense. The device appears to rely on established signal processing algorithms for its physiological measurements rather than complex, data-trained AI. Therefore, a "training set" in the context of machine learning is not discussed or implied.
9. How the ground truth for the training set was established
Since no clinical training set is mentioned or implied, the question of how its ground truth was established is not applicable. The algorithms for Heart Rate, Heart Rate variability, and respiratory effort are likely based on well-understood physiological principles and signal processing techniques, rather than being "trained" on a large dataset with annotated ground truth.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Techmedic Development International B.V. % Patsy Trisler Regulatory Consultant, Oserve Group, Inc Qserve Group Us Inc. P.O Box 940 Charlestown. New Hampshire 03603
Re: K152973
Trade/Device Name: Dyna-Vision Telemonitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, MWI, DRG, DSI, DRT, FLL, DQA Dated: March 22, 2016 Received: March 29, 2016
Dear Patsy Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152973
Device Name Dyna-Vision Telemonitoring System
Indications for Use (Describe)
The Dyna-Vision Telemontoring System is a wreless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological
data recorded include: Electrocardiography (EGG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and respiration effort Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™
system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment.
The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitter Name: | Techmedic Development International B.V. |
|---|---|
| Submitter Address: | Broeker Werf 61721 PC Broek op LangedijkNetherlands |
| Phone Number: | +31(0)226 342044 |
| Fax Number: | +31(0)226 341446 |
| Contact Person: | Rutger Brest van Kempen |
| Date Prepared: | 22-08-2015 |
| Device Trade Name: | Dyna-Vision |
| Common Name | Patient Telemonitoring Sytem |
| Classification Name,Number &Product Code: | Monitor, physiological, patient (with arrhythmia detection or alarms)870.1025 (ΜΗΧ);Transmitters and Receivers, Physiological Signal, Radiofrequency870.2910 (DRG)Monitor, Cardiac (including cardiotachometer and rate alarm, 870.2300(DRT);Thermometer, electronic, clinical, 880.2910 (FLL); andOximeter, 870.2700 (DQA) |
| Classification Panel: | Cardiology |
| Predicate Devices: | Vitalconnect platform, K 141167TeleSentry Wireless Ambulatory ECO Arrhythmia Monitor, K092947Model 7500 Digital Pulse Oximeter, K080255Disposable Temperature Probes, K070339Propaq CS, K012451 |
| Device Description: | The Dyna-Vision system is a wireless multi-parameter data collectionsystems that monitors physiological data such as: Electrocardiography(EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheralcapillary Oxygen saturation (SpO2), Skin Temperature and Rate ofrespiratory effort.The system consist of: |
| • A body-worn unit with sensor input modules for the near realtime acquisition of the physiological data with built-in wireless |
.
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| communication for data transmission.A telemetry server to receive the physiological data and transmit the physiological data toA workstation installed on a central server (or PC) equipped with software with which the physician can process the physiological data and create reports regarding the transmitted data, and read and configure alerts/notifications when a threshold value is exceeded. The alert function is an adjunct to and not intended to replace vital sign monitoring. | |
|---|---|
| The software includes algorithms for Heart Rate, Heart Rate variability (R-R interval) and rate of respiratory effort. | |
| The device is intended to be used by clinicians and medically qualified personnel in healthcare facilities. The body-worn unit for data acquisition, is a transportable battery-operated unit to record Electrocardiograph (ECG), Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and Rate of respiratory effort to be also used by the patient in the home setting and anywhere where WIFI or cell communication is available. | |
| The Dyna-Vision system works with 3rd party 510(k) cleared SpO2 module (Nonin OEM III, K092101), and ECG patient lead (Scottcare K092947). | |
| The device is intended for use on general care patients aged 18 years or more. | |
| Physical Description: | Dyna-Vision Unit dimensions: 118 x 65 x 33 mm, Weight +/- 260 gram, Power Internal battery 3.7 V |
| Statement of Indication for Use: | The Dyna-Vision Telemonitoring System is a wireless monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings and for normal daily activities. Physiological data recorded include: Electrocardiography (EGG), Heart Rate, Heart Rate variability (R-R interval), Peripheral capillary Oxygen saturation (SpO2), Skin Temperature and respiration effort. |
| Data is transmitted wirelessly in near real time to a central location where it is stored for analysis. The Dyna-Vision™ system can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. Data from the Dyna-Vision™ system is intended to be used by healthcare professionals as an aid to diagnosis and treatment. | |
| The device is intended for use on general care patients aged 18 years or more, as a general patient monitor, to provide physiological information. It is not intended for use on critical care patients. | |
| Summary of Technological Characteristics | The Dyna-Vision system offers near real time full-disclosure streaming ECG/SpO2/temperature from anywhere using the cellular network and a telemetry service offering tele-monitoring solutions to remote locations. The Dyna-Vision unit is connected to a patient and switched on. The device automatically connects to the local cellular network to send the |
II
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data in near real time to the Dyna-Vision Server from where it can be retrieved using the Dyna-Vision software on a workstation. The collected data can be reviewed and reports can be created for sending to a cardiologist or family physician.
Bench testing was carried out on the following characteristics: Non-Clinical Tests:
- Electrocardiograph (EGG) ●
- Heart rate variability (R-R interval)
- . Heart rate
- SpO2 ●
- Skin Temperature ●
- ECG impedance for Rate of respiratory effort ●
- . Notification
- . Measurement accuracy
- . Communication, data transmission and storage
- Reliability (QoS) Wireless Quality of Service
- Electromagnetic compatibility (EMC)
- . Electrical safety testing
- Wireless Coexistence Wi-Fi testing
- Software verification and validation testing ●
- . Biocompatibility verification
In addition to the above, usability testing was also conducted.
Referenced Standards and Performance Testing:
The Dyna-Vision device was tested and meets the requirements of following performance Standards and is in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm.
- IEC 60601-1- Medical Electrical Equipment Part 1: Basic safety ● and essential performance Ed3.1 2005+A1:2012
- . IEC 60601-1-2 - Medical electrical equipment-basic safety and essential performance-EMC-Edition 3: 2007-03
- . IEC 60601-1-11 - Medical electrical equipment-basic safety and essential performance-used in the home healthcare-Ed. 1: 2010-04
- IEC 60601-2-47 - Basic safety and essential performance of ambulatory electrocardiographic systems 2012
- . AAM1/ANSI EC38
- . AAMI I ANSI EC57 - Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms 2012
- . ISO 80601-2-61 - Basic safety and essential performance of pulse oximeter equipment 2011
- IEC 80601-2-59 Basic safety and essential performance of screening thermographs for human febrile temperature screening 2008
No clinical studies were utilized for the purpose of obtaining safety and Clinical Performance effectiveness data. Usability validation is part of the Clinical Performance Data: data.
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The comparison tabulated below demonstrates that the Dyna-Vision Conclusion device is substantially equivalent to the predicate devices. The nonclinical data support the safety of the device and the hardware and software verification and validation demonstrate that the Dyna-Vision device should perform as intended in the specified use conditions.
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Substantial Equivalence Comparison Table
| Feature | Dyna-Vision | Predicate #1(Indications forUse/Technology) | Predicate #2(Technology) | Predicate #3(Add on) | Predicate #4(Add on) | Predicate #5(Add on) | |
|---|---|---|---|---|---|---|---|
| 510(k) Number | K # | K 141167 | K092947 | K080255 | K070339 | K012451 | |
| Trade name | Dyna-VisionTelemonitoringSystem | VitalConnect Platform, | TeleSentry WirelessAmbulatory ECOArrhythmia Monitor, | Model 7500 DigitalPulse Oximeter | DisposableTemperature Probes& Skin TemperatureSensor | Propaq 200 SeriesMonitors | |
| Manufacturer | TechmedicDevelopmentInternational BV | VitalConnect Inc | Scottcare Inc | Nonin Medical Inc | Cincinnati Sub-ZeroProducts Inc | Welch Allyn protocol,inc. | |
| Devicedescriptionsummary | Dyna-VisionTelemonitoringSystem relies on anambulant, wirelessdevice, which usessensors to collect,transmit andremotely assessECG andphysiologicalparameters in nearreal time. Thesystem includesalerts triggered byparametersexceeding presetlimits. | The VitalConnectPlatform is a wirelessdata collection systemthat monitorsphysiological data.The VitalConnectPlatform and thepredicate devicecontains smallambulatory monitoringsensors that measureECG, heart rate,respiration rate,activity, bodyorientation, body/skintemperature. | TeleSentry is abattery poweredambulatory ECGmonitor, whichanalyzes anelectrocardiographicsignal. | The Nonin® Model7500 Digital PulseOximeter is aportable, table topdevice indicated foruse in measuring,displaying, andrecording functionaloxygen saturation ofarterial hemoglobin(SPO2) and pulserate of adult,pediatric, infant, andneonatal patients. | To detecthypo/hyperthermia,the body temperatureis continuouslymonitored usingdisposabletemperature sensorsor probes. The basiccomponent of thesesensors is aresistance chip,which is sensitive tochanges intemperature. Thechip is in the form of"400" seriesthermistor connectedto a lead wire andencapsulated in aPVC cup. At the endof the lead wires aninsert moldedconnector orstandard phoneconnector providesfor the | The Propaq 200 Seriesmonitors are small,lightweight, portable,multi-parameter patientmonitors equipped witheither a monochromeor color display. Themonitors provide realtime monitoring anddisplay of ECG,respiration, invasiveblood pressure, non-invasive bloodpressure, temperature,CO2 and SpO2. | |
| Regulation &Product Code | 21 CFR 870.2910,DRGTransmitters andReceivers,Physiological Signal,Radiofrequency | 21 CFR 870.1025,DSIArrhythmia detectorand alarm (includingST-segmentmeasurement andalarm).DRGTransmitters andReceivers,Physiological Signal,Radiofrequency | 21 CFR 870.2700,DQAOximeter | interconnection withthe instrument cable. | 21 CFR 880.2910,FLLClinical electronicthermometer | 21 CFR 870.2300,DRTMonitor, cardiac (incl.cardiotachometer &rate alarm) | |
| Intended Use | The Dyna-VisionTelemonitoringSystem is a wirelessmonitoring systemintended for use byhealthcareprofessionals forcontinuous collectionof physiological datain home andhealthcare settingsand for normal dailyactivities.Physiological datarecorded include:Electrocardiography(EGG), Heart Rate,Heart Rate variability(R-R interval) | 21 CFR 870.2910,DRG21 CFR 880.2910,FLL21 CFR 870.1025,MHX21 CFR 870.2300,DRT21 CFR 870.2700,DQA | 21 CFR 870.1025,DSIArrhythmia detectionand alarm (includingST-segmentmeasurement andalarm)MHXMonitor, physiological,patient (witharrhythmia detectionor alarm) | The TeleSentrydevice is intended fordiagnostic evaluationof patients whoexperience transientsymptoms orasymptomatic eventsthat may suggestnon-lethal cardiacarrhythmia. Thedevice continuouslymonitors and recordsthe data,automatically recordsalarm eventstriggered by anarrhythmia detectionalgorithm or manuallyby the patient and | The Nonin® Model7500 Digital PulseOximeter is aportable,for Use tabletopdevice indicated foruse in measuring,displaying, andrecording functionaloxygen saturation ofarterial hemoglobin(SpO2) and pulserate of adult,pediatric, infant, andneonatalpatients. It isindicated for spot-checking and / orcontinuous | Skin TemperatureSensor (487M and499B): The CSZ skintemperature sensor isintended foruse in routinecontinuousmonitoring skintemperature whenthe other sensorswhich might betterreflect core bodytemperature are notindicated clinically.The sensor isdesigned forplacement on thesurface of the skin. | The Propaq monitor isintended to be used byskilled clinicians formultiparameter vitalsigns monitoring ofneonatal, pediatric, andadult patients in healthcare facility bedsideapplications. It is alsointended for intra-facility transport.The ECG channel isintended for five-leador three-lead ECGmonitoring.The Respiration(RESP) channel is |
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| Peripheral capillaryOxygen saturation(SpO2), SkinTemperature andrespiration effort. | to gravity includingfall). | automaticallytransmits therecorded eventactivity associatedwith these symptomsfor review by alicensed physician. | monitoring of patientsduring both motionand non-motionconditions, and forpatients who are wellor poorly perfused. | Instrument Cables(4872MS and4900B): The intendeduse of the instrumentcable is tointerconnect thedisposabletemperaturesensor/probe with thetemperaturemonitoringinstrument. | intended to detect therate or absence ofrespiratory effort,deriving the signal bymeasuring the acimpedance betweenselected terminals ofECG electrodes. |
|---|---|---|---|---|---|
| Data is transmittedwirelessly in nearreal time to a centrallocation where it isstored for analysis.The Dyna-Vision™system can beconfigured byAuthorized Personsto notify healthcareprofessionals whenphysiological datafalls outside selectedparameters. Datafrom the Dyna-Vision™ system isintended to be usedby healthcareprofessionals as anaid to diagnosis andtreatment.The device isintended for use ongeneral care patientsaged 18 years ormore, as a generalpatient monitor, toprovide physiologicalinformation. It is notintended for use oncritical care patients. | Data is transmittedwirelessly to a centrallocation where it isstored for analysis.The Vital ConnectPlatform can beconfigured byAuthorized Personsto notify healthcareprofessionals whenphysiological data fallsoutside selectedparameters.The device is intendedfor use on generalcare patients who are18 years of age orolder as a generalpatient monitor, toprovide physiologicalinformation.The data from theVitalConnect Platformis intended for use byhealthcareprofessionals as anaid to diagnosis andtreatment. It is notintended for use oncritical care patients. | Contraindications:a. Patients withpotentially life-threateningarrhythmias whorequire inpatientmonitoring.b. Patients who theattending physicianthinks should behospitalized. | |||
| General specifications |
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| Dimensions | 118 x 65 x 33 mm | 115 x 40 x 7 mm(sensor + patchwithout transmitter) | 110 x 6 x 2.6 | Approximately 219mm x 92 x 142 mm | N/A | N/A |
|---|---|---|---|---|---|---|
| Weight | 260 gram withbattery | --- | 280 gram with battery | Approximately900grams (2 lbs) withbattery | N/A | N/A |
| Interface | Foil with buttons andLCD display | --- | Foil with buttons, nodisplay | --- | N/A | Foil with buttons andLCD display |
| Energy source | Battery | Battery | Battery | N/A | N/A | Battery/Mains |
| Type | 3.7V lithium polymerrechargeable | Disposable zinc airbattery | 3.7V lithium polymerrechargeable | 7.2 volt NiMH batterypack | N/A | N/A |
| Autonomy onsingle charge | 22 hrs 3G streaming36 hrs Wi-Fistreaming | 3 days with ECG and4 days without ECGfor the patch. Noinformation about thetransmitter autonomy | 2-3 days withoutstreaming. 6 hourswith streaming | 16 hours minimum | N/A | N/A |
| Communication | ||||||
| Wi-Fi | Yes2,4 GHz | Bluetooth | No | N/A | N/A | N/A |
| Cellular | Yes3G module | N/A | Yes2G module | N/A | N/A | N/A |
| USB | Yes2.0 | No | Yes | N/A | N/A | N/A |
| Memory | Yes4 GB SD card | --- | Yes4 GB SD card | N/A | N/A | N/A |
| Recording period | 60 days | --- | 60 days | N/A | N/A | N/A |
| Centralmonitoring ofremotelytransmittedpatient data | Yes | Yes | Yes | N/A | N/A | Yes |
| Data sent tocentral server | Yes | Yes | Yes | N/A | N/A | Yes |
| Physiological parameters | ||||||
| PROGRAMMABLE ALERTSETTINGS ANDLIMITS | Yes | Yes | Yes | N/A | N/A | Yes |
| MONITORSECG | Yes | Yes | Yes | N/A | N/A | Yes |
| Method | ECG lead wiresattached todisposableelectrodes to the skin | Patch on the skin tomeasure single leadECG. | ECG lead wiresattached todisposable electrodesto the skin | N/A | N/A | ECG lead wiresattached to disposableelectrodes to the skin |
| Resolution | 24 bit | --- | 12 bit | N/A | N/A | N/A |
| Input impedance | > 20 Mohm | --- | > 20 Mohm | N/A | N/A | N/A |
| Common moderejection | -80dB - 100dB | --- | 92 dB | N/A | N/A | N/A |
| Samplingfrequency | 1,000, 800, 400 and200 Hz | --- | 1,000, 200, 100 | N/A | N/A | N/A |
| Channels | 3, 5 and 12 channels | 1 channel | 3, 5 and 12 channels | N/A | N/A | N/A |
| QRS detectionAF detection | Yes - 99.8% | --- | Yes > 99% | N/A | N/A | N/A |
| MONITORSHEART RATE | Yes | Yes | Yes | N/A | N/A | Yes |
| Method | QRS detection | QRS detection | QRS detection | N/A | N/A | QRS detection |
| Range | 25-300 bpm | Not specified | Not specified | N/A | N/A | 25-300 bpm |
| Accuracy | ± 2 bpm | ± 2 bpm | ± 2 bpm | N/A | N/A | ± 2 bpm |
| MONITORSRESPIRATION | Yes | Yes | No | N/A | N/A | Yes |
| Method | ImpedancyPneumography | … | N/A | N/A | N/A | ImpedancePneumography |
| Impedancedynamic range | >20 ohms | … | N/A | N/A | N/A | 20 ohms |
| Resolution | 5 seconds | … | N/A | N/A | N/A | 5 seconds |
| Range | 2 - 150 breaths/min | … | N/A | N/A | N/A | 2 to 150 breaths/min |
| MONITORSSKINTEMPERATURE | Yes | Yes | No | N/A | Yes | Yes |
| Method | Skin thermistor | … | N/A | N/A | Skin thermistor | NA |
| Range | 0° to +50 | … | N/A | N/A | 0° to +50 | NA |
| Accuracy | >10°C to +50°C:±0.1°C>50° to +122°F:±0.2°F | … | N/A | N/A | >10°C to +50°C:±0.1°C>50° to +122°F:±0.2°F | NA |
| MONITORSOXYGENSATURATION | Yes | No | No | Yes | N/A | Yes |
| Method | Photoplethysmogramon finger.Infrared: 910nanometers @ 1.2mW maximumaverage | N/A | N/A | Photoplethysmogramon finger.Infrared: 910nanometers @ 1.2mW maximumaverage | N/A | NA |
| Red: 660nanometers @ 0.8mW maximumaverage | Red: 660 nanometers@ 0.8 mW maximumaverage | |||||
| Range | 0-100% | N/A | N/A | 0-100% | N/A | NA |
| Accuracy | $\pm$ 2 digits(from 70-100%) | N/A | N/A | $\pm$ 2 digits(from 70-100%) | N/A | NA |
| USE IN HOMEANDHEALTHCARESETTINGS | Yes | Yes | Yes/No (not exactlyspecified) | Yes | N/A | Healthcare settings |
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§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.