(117 days)
The ViSI Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (TEMP), posture tracking and basic arthythmia (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation) analysis and alarm in hospital-based facilities including general medical-surgical floors, intermediate care floors, and emergency departments.
Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation. The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older; it has not been evaluated on pediatric patients.
The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.
The Visl Mobile Insight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSI Mobile patient-worn device.
The ViSi Mobile Monitoring System is a patient worn, portable, battery operated, continuous physiological monitoring device intended for the monitoring of ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (SKIN TEMP), posture tracking and alarms, basic arrhythmia analysis (ventricular fibrillation, ventricular tachycardia, asystole, atrial fibrillation) and alarms.
The ViSi Mobile Monitoring System consists of the patient worn devices, disposables, backup battery, patient data server and remote viewer.
This document (K180472) is a 510(k) premarket notification for the ViSi Mobile Monitoring System. The focus of the provided text is to demonstrate substantial equivalence to a predicate device, primarily by highlighting changes and comparing technical characteristics and performance, especially concerning arrhythmia detection.
Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" in the traditional sense for the acceptance of the device as a whole. Instead, it presents performance metrics against recognized standards (ANSI/AAMI EC57: 2012) for its arrhythmia detection algorithm, comparing the improved "Proposed Device" (Subject Device) with a "Reference Device A" (K142827), which is a previously cleared version of the ViSi Mobile Monitoring System.
Here's a table derived from the provided "C. Atrial Fibrillation Comparison" and "E. ALARM TEST COMPARISON" sections, focusing on the arrhythmia detection performance:
| Metric | Acceptance Criteria (Implicitly, the performance of the Reference Device K142827 or general industry standards like ANSI/AAMI EC57:2012) | Reported Device Performance (Proposed Device K180472) | Commentary (from document) |
|---|---|---|---|
| AF Episode Sensitivity (%) | RA (Reference Device A - K142827): | S (Subject Device - K180472): | |
| NST | 0‡ | - | Null result (test done, but statistic cannot be calculated due to absence of test or reference annotation) |
| MIT-BIH Gross | 90 | 87 | Same or Better |
| MIT-BIH Average | 92 | 87 | |
| AF Episode Positive Predictivity (%) | RA (Reference Device A - K142827): | S (Subject Device - K180472): | |
| NST | 0‡ | - | Null result |
| MIT-BIH Gross | 100 | 65 | Same or Better |
| MIT-BIH Average | 100 | 99 | |
| AF Duration Sensitivity (%) | RA (Reference Device A - K142827): | S (Subject Device - K180472): | |
| NST | ‡ | - | Null result |
| MIT-BIH Gross | 75 | 80 | Same or Better |
| MIT-BIH Average | 71 | 84 | |
| AF Duration Positive Predictivity (%) | RA (Reference Device A - K142827): | S (Subject Device - K180472): | |
| NST | 0‡ | 0 | Same or Better |
| MIT-BIH Gross | 0 | 75 | |
| MIT-BIH Average | 0 | 40 | |
| AF False Positive Report | RA (Reference Device A - K142827): | S (Subject Device - K180472): | |
| NST | 1‡ | 0 | Same or Better |
| MIT-BIH Gross | 0 | 137 | |
| MIT-BIH Average | 0 | ||
| AF False Negative Report | RA (Reference Device A - K142827): | S (Subject Device - K180472): | |
| NST | 0‡ | 0 | Same or Better |
| MT-BIH Gross | 0 | 10 | |
| MIT-BIH Average | 0 | ||
| AF Time to Detection (sec) | RA (Reference Device A - K142827): | S (Subject Device - K180472): | |
| NST | - | - | Null result |
| MIT-BIH Gross | 00:20.94 | 0:06.4 | Same or Better |
| MIT-BIH Average | |||
| VF/VT Sensitivity (%) | Reference Device A (K142827) | Subject Device (K180472) | |
| AHA | 90 | 91 | |
| MIT | 100 | 100 | |
| CU | 94 | 97 | |
| VF/VT Positive Predictivity (%) | Reference Device A (K142827) | Subject Device (K180472) | |
| AHA | 60 | 100 | |
| MIT | 67 | 100 | |
| CU | 46 | 94 | |
| AFIB Sensitivity (%) | Reference Device A (K142827) | Subject Device (K180472) | |
| MIT | 97 | 90 | |
| AFIB Positive Predictivity (%) | Reference Device A (K142827) | Subject Device (K180472) | |
| MIT | 65 | 100 |
The study that proves the device meets the acceptance criteria is primarily non-clinical, using established databases.
2. Sample size used for the test set and the data provenance
The test set utilizes publicly available, established databases:
- AHA (American Heart Association)
- MIT-BIH (Massachusetts Institute of Technology - Beth Israel Hospital Arrhythmia Database)
- CU (Creighton University Ventricular Tachyarrhythmia Database)
- NST
The specific sample sizes (e.g., number of ECG recordings or patients) from these databases are not explicitly stated in the provided text. The provenance is from these known databases, which are widely accepted for arrhythmia algorithm testing. The data within these databases is retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states: "The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282), which has been adapted for real time analysis in the ViSi System. The ViSi Monitoring System arrhythmia analysis has been validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012."
The ground truth for these databases (AHA, MIT-BIH, CU, NST) was established by experts, typically cardiologists or electrophysiologists, during the creation of the databases. The specific number and qualifications of these experts are not detailed within this 510(k) document but are inherent to the accepted nature of these standard databases.
4. Adjudication method for the test set
The document does not describe an adjudication method for the test set data itself. The ground truth for the test sets (AHA, MIT-BIH, CU, NST databases) was established independently by the creators of those databases.
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. A multi-reader multi-case (MRMC) comparative effectiveness study involving human readers is not described in this document. The study focuses purely on the algorithm's performance against established gold-standard databases, comparing an updated algorithm to a previous version and recognized standards. The device is not presented as an AI-assistance tool for human readers but rather as a standalone monitoring system with an integrated arrhythmia detection algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes. The performance evaluation presented is a standalone (algorithm only) performance assessment. The tables show the algorithm's sensitivity and positive predictivity for various arrhythmia events (VF/VT, AFIB) when processing the specified ECG databases. The context further reinforces this, stating "Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention," indicating it acts as an aid rather than requiring human modification of its output for the test.
7. The type of ground truth used
The ground truth used for the performance testing is expert consensus from established, recognized ECG databases (AHA, MIT-BIH, CU, NST). These databases contain expert-annotated ECG waveforms, which serve as the gold standard for evaluating arrhythmia detection algorithms.
8. The sample size for the training set
The document does not explicitly state the sample size of the training set used to develop or refine the arrhythmia detection algorithm. It mentions that "The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282)," which implies that the training might have occurred prior to this submission (or the core technology was pre-trained).
9. How the ground truth for the training set was established
The document does not explicitly detail how the ground truth for the training set was established. Given that the algorithm is based on (or an adaptation of) the Monebo Technologies, Inc Arrhythmia library, it's highly probable that the training also utilized similar expert-annotated ECG datasets or proprietary clinical data. The document does state that the arrhythmia algorithm was "Rewritten to improve specificity and detection metrics" and later "New arrhythmia detection algorithm to improve arrhythmia detection accuracy and positive predictivity," implying development and testing that would have involved ground truth data.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 19, 2018
Sotera Wireless, Inc. Frank Pokrop Senior Director, Regulatory Affairs and Quality 10020 Huenneckens Street San Diego, California 92121
Re: K180472
Trade/Device Name: ViSi Mobile Monitoring 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, DSI, DRT, DXN, DQA, FLL Dated: May 16, 2018 Received: May 17, 2018
Dear Frank Pokrop:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Hillemann
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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Indications for Use
510(k) Number (if known) K180472
Device Name ViSi Mobile Monitoring System
Indications for Use (Describe)
The ViSI Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (TEMP), posture tracking and basic arthythmia (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation) analysis and alarm in hospital-based facilities including general medical-surgical floors, intermediate care floors, and emergency departments.
Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation. The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older; it has not been evaluated on pediatric patients.
The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.
The Visl Mobile Insight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSI Mobile patient-worn device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 5.
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for the ViSi Mobile Monitoring System is provided below:
Submitter Information
| Date prepared | June 15, 2018 |
|---|---|
| Name | Sotera Wireless, Inc. |
| 10020 Huennekens Street | |
| San Diego, CA 92121 | |
| Contact Person | Frank Pokrop |
| Sr. Director, Regulatory Affairs and Quality | |
| Device Identification | |
| Trade name | ViSi Mobile Monitoring System |
| Common name | Vital signs monitor |
| Regulation Name | Monitor, physiological, patient (with arrhythmia detectionor alarms) |
| Classification number | 21 CFR 870.1025 |
| Product code | MHX, DSI, DRT, DXN, DQA, FLL |
| Regulatory class | II |
| Predicate devices | ViSi Mobile Monitoring System; K152341 |
| Reference devices | ViSi Mobile Monitoring System; K142827, K150361 |
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Description
The ViSi Mobile Monitoring System is a patient worn, portable, battery operated, continuous physiological monitoring device intended for the monitoring of ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (SKIN TEMP), posture tracking and alarms, basic arrhythmia analysis (ventricular fibrillation, ventricular tachycardia, asystole, atrial fibrillation) and alarms.
The ViSi Mobile Monitoring System consists of the patient worn devices, disposables, backup battery, patient data server and remote viewer.
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Image /page/5/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features a stylized blue heart with three curved lines emanating from the top, resembling radio waves. Below the heart is the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath.
Intended Use
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (TEMP), posture tracking and alarms, and basic arrhythmia (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation) analysis and alarm in hospitalbased facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.
Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation.
The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older; it has not been evaluated on pediatric patients.
The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.
The ViSi Mobile InSight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSi Mobile patient worn device.
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Comparison with the Predicate Device [21CFR807.92(a)(6)] table below demonstrates that the proposed ViSi Mobile Monitoring System is comparable with and substantially equivalent to the predicate device, cleared under 510(k) #: K152341.
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Technical Characteristics Comparison:
The basic and main technical features of the modified ViSi Mobile Monitoring System are the predicate device including Design, Operation Control, Display Modes, and Performance Results.
1. Table #1. General Comparison
| Characteristic | Comparison or Comment | ViSi Mobile Monitoring System (TBD)Proposed Device | ViSi Mobile Monitoring System (K152341)Predicate Device |
|---|---|---|---|
| Manufacturer | Same | Sotera Wireless, Inc. | Sotera Wireless, Inc. |
| Product Codes | Same | MHX, DSI, DRT, DXN, DQA, FLL | MHX, DSI, DRT, DXN, DQA, FLL |
| Classification | Same | 2 | 2 |
| Classification Regulation | Same | 870.1025 | 870.1025 |
| Intended Use | Same and SimilarProposed device containsarrhythmia analysis | The ViSi Mobile Monitoring System isintended for use by clinicians andmedically qualified personnel for singleor multi-parameter vital signsmonitoring of adult patients (18 years orolder).It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate | The ViSi Mobile Monitoring System isintended for use by clinicians andmedically qualified personnel for singleor multi-parameter vital signsmonitoring of adult patients (18 years orolder).It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate |
| Characteristic | Comparison orComment | ViSi Mobile Monitoring System(TBD) | ViSi Mobile Monitoring System(K152341) |
| Proposed Device | Predicate Device | ||
| (HR), non-invasive blood pressure(NIBP), continuous non-invasive bloodpressure (cNIBP), non-invasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2), pulse rate (PR), and skintemperature (TEMP), posture trackingand alarms, skin temperature (TEMP)and basic arrhythmia (VentricularTachycardia, Ventricular Fibrillation,Asystole, Atrial Fibrillation)analysis/alarm in hospital-basedfacilities; including, general medical-surgical floors, intermediate care floors,and emergency departments.Continuous non-invasive blood pressure(cNIBP) measurements have not beenevaluated on patients duringambulation.The arrhythmia analysis feature isintended for use by healthcareprofessionals trained in theidentification and treatment of | (HR), non-invasive blood pressure(NIBP), continuous non-invasive bloodpressure (cNIBP), non-invasivemonitoring of functional oxygensaturation of arterial hemoglobin(SpO2), pulse rate (PR), and skintemperature (TEMP) in hospital-basedfacilities; including, general medical-surgical floors, intermediate care floors,and emergency departments. | ||
| Characteristic | Comparison orComment | ViSi Mobile Monitoring System(TBD) | ViSi Mobile Monitoring System(K152341) |
| Proposed Device | Predicate Device | ||
| arrhythmia events.Automated arrhythmia analysis is anadjunct to clinical assessment; clinicianreview of the analysis should precedeany therapeutic intervention. | |||
| Use of ViSiMobile Insight | Same | The ViSi Mobile InSight is an optionalsecondary notification system thatcommunicates alarms directly to anassigned caregiver. It is intended tosupplement the primary alarmingdevices which originate in the ViSiMobile patient worn device. | The ViSi Mobile InSight is an optionalsecondary notification system thatcommunicates alarms directly to anassigned caregiver. It is intended tosupplement the primary alarmingdevices which originate in the ViSiMobile patient worn device. |
| Remote Viewing | Same | The ViSi Mobile Monitoring Systemmay be used as standalone devices ornetworked to ViSi Mobile RemoteViewers through wireless 802.11communication. | The ViSi Mobile Monitoring Systemmay be used as standalone devices ornetworked to ViSi Mobile RemoteViewers through wireless 802.11communication. |
| Patient Population | Same | 18 years or older | 18 years or older |
| Environment of Use | Same | Hospital-based facilities; includinggeneral medical-surgical floors,intermediate care floors, and emergency | Hospital-based facilities; includinggeneral medical-surgical floors,intermediate care floors, and emergency |
| Characteristic | Comparison orComment | ViSi Mobile Monitoring System(TBD) | ViSi Mobile Monitoring System(K152341) |
| Proposed Device | Predicate Device | ||
| departments | departments | ||
| Auto Set Feature | Similar | Auto Set features are enabled for BPMAP parameter. | Auto Set Feature present in K152341and earlier models |
| Expanded | Heart Rate and Pulse Rate defaultpatient limits were changed to Low 30,High 150 | Heart Rate and Pulse Rate defaultpatient limits were Low: 40, High 140 | |
| Patient Postures | Expanded | Patient Walking – previously part ofprior products now an individually setfeature. Recline left and recline rightadded. | Patient Walking – previously includedin undesirable posture features. Clearedin reference device, 510(k) #:K150361. |
| Arrhythmia DetectionAlgorithm | Similar | Rewritten to improve specificity anddetection metrics | Cleared in reference device, 510(k) #:K14827. |
| (1) Software Changes -General | Expanded | Software was enhanced and expandedcovering both normal refinements andspecific additions and improvements. | 510(k) #: K152341 included varioussoftware features as shown in thesubmission and indications for use. |
| (2) Software Changes -Specific | Expanded asShown Below: | Additional Project-Specific Features are Detailed Below - Apollo Project(Software Version 3.x.x) | |
| a) ViSi Access | Ability to access "Vital Sign" displayon the Monitor without entering a PinCode | Not present - or improved | |
| Characteristic | Comparison orComment | ViSi Mobile Monitoring System(TBD) | ViSi Mobile Monitoring System(K152341) |
| Proposed Device | Predicate Device | ||
| b) SessionManagement including achange tothe DeviceSwapMethod | Improved Pause / Stop MonitoringFlows to eliminate the need tocomplete a physical Bump forDevice Swap when the Monitorbattery is low Ability to Assign and confirm thepatient demographics for anew/resumed monitoring sessiondirectly from the Wrist Monitor | Not present – or improved | |
| c) cNIBPUpdates | cNIBP calibration alert was dividedinto three different, moreinformative alerts cNIBP calibration and data carry-over after device swap within 10minutes of device pause and resume | Not present – or improved | |
| d) MultipleCare Units | Ability to display/configure multipleCare Units from the same server(PDS) Ability to assign a Care unit fromthe Wrist Monitor when starting anew monitoring session Ability to transfer the patient fromone care unit to another using thesame Monitor | Not present – or improved | |
| Characteristic | Comparison orComment | ViSi Mobile Monitoring System(TBD)Proposed Device | ViSi Mobile Monitoring System(K152341)Predicate Device |
| Ability to associate room/bed locations from multiple care units to Remote Viewer Care Unit Room/bed locations can either be “pinned” to a specific placeholder on the RVD or remain “unpinned” and allow the clinician to place the active session in any desired location. | |||
| e) RemoteViewerGraphicUserInterface(GUI)Enhancements | Updated GUI for the patient workspace header to be consistent across all screens Improved vital sign alarm limits data entry Enhanced Current Waveforms display Enhanced Graphical Trends display Enhanced List Trends display Devices workspace which displays current battery life of all active Monitors Ability to print patient list trends in specific date/time ranges. | Not present – or improved | |
| f) Miscellaneo | Improved handling of alarms/alerts | Not present – or improved | |
| Characteristic | Comparison orComment | ViSi Mobile Monitoring System(TBD)Proposed Device | ViSi Mobile Monitoring System(K152341)Predicate Device |
| (3) Software Changes –Specific | usEnhancements | when the device goes in and out ofnetwork Improved Power Pack indicators(when connected to Wrist Monitor) Updated icon for “Battery Too Hot” Alarm acknowledgement timeincreased from 2 minutes to 10minutes Extended annunciation delay for“Network Lost” alert Added ability to set-up “Read-only”RVDs which reduce the amount ofvisible patient health informationand do not allow interactions otherthan viewing patient sessions | |
| Expanded asShown Below: | Additional Project-Specific Features are Detailed Below - Bacchus Project(Software Version 4.0.x) | ||
| a) ArrhythmiaAnalysisAlgorithmb) PatientPosture | New arrhythmia detection algorithmto improve arrhythmia detectionaccuracy and positive predictivity Add two new postures (reclinedright-side and reclined left-side), andicons to display“Immobility/Reclined Right Side” | Not present – or improvedNot present – or improved | |
| Characteristic | Comparison orComment | ViSi Mobile Monitoring System(TBD) | ViSi Mobile Monitoring System(K152341) |
| Proposed Device | Predicate Device | ||
| and Immobility/Reclined Left Side”posture status, and alert icons“Undesired + Immobility)/ReclinedRight Side” and “Undesired +Immobility)/Reclined Left Side”“Undesired/Walking” alert textchanged to “PATIENT WALKING”Alert | |||
| c) OtherChanges | Updated the algorithm that generatesa “Check Thumb Sensor” alert toidentify non-functioning thumbsensors and added new alert text(“Swap Thumb Sensor”) to signifywhen this occurs. “Check ThumbSensor” will remain to indicate thatthe sensor is either off the patient ornot positioned properly. SW Versioning check and alert toconvey that the accessory (i.e., ECGCable, NIBP Module or Power Pack)is not compatible with the WristMonitor | Not present – or improved | |
| Hardware Changes andEnhancements | Changed andImproved | Li-ion power pack NIBP cuffs NIBP cuff adapters | Not present – or improved |
| Characteristic | Comparison orComment | ViSi Mobile Monitoring System(TBD)Proposed Device | ViSi Mobile Monitoring System(K152341)Predicate Device |
| Thumb tape 5GHz band for dual band wireless radio |
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Image /page/8/Picture/1 description: The image shows the logo for Sotera Wireless. The logo consists of a blue heart-shaped icon with three curved lines emanating from it, resembling radio waves. Below the icon is the word "Sotera" in a bold, sans-serif font, and below that is the word "WIRELESS" in a smaller, sans-serif font.
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Image /page/9/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in bold, black letters, with the word "WIRELESS" in smaller, light blue letters underneath. Above the word "Sotera" is a light blue graphic that resembles a heart with radio waves emanating from it. The logo is simple and modern, and the use of blue and black gives it a professional look.
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Image /page/10/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, black font, with the word "WIRELESS" in a smaller, light blue font underneath. Above the word "Sotera" is a light blue graphic that resembles a heart with radio waves emanating from it.
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Image /page/11/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the company name in bold, black font, with the word "Sotera" stacked above the word "Wireless". Above the company name is a blue graphic that resembles a heart with radio waves emanating from it. The logo is simple and modern, and the colors are clean and professional.
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Image /page/12/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. Above the word "Sotera" is a blue icon that resembles a heart with radio waves emanating from it. The logo is simple and modern, and the use of blue suggests a connection to technology and communication.
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Image /page/13/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. Above the word "Sotera" is a blue heart-shaped icon with three curved lines emanating from it, resembling radio waves. The logo is simple and modern, and the use of blue and black gives it a professional look.
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Image /page/14/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. Above the word "Sotera" is a blue icon that resembles a heart with three curved lines emanating from the top, suggesting a wireless signal. The logo is clean and modern, conveying a sense of technology and connectivity.
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Image /page/15/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in bold, black font, with the word "WIRELESS" in a smaller, light blue font underneath. Above the word "Sotera" is a light blue graphic that resembles a heart with radio waves emanating from it.
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Image /page/16/Picture/0 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in bold, black font, with a registered trademark symbol to the right of the word. Above the word "Sotera" is a blue heart-shaped symbol with radio waves emanating from it. Below the word "Sotera" is the word "WIRELESS" in a smaller, light blue font.
II. Table #2. Comparison of Technical Performance Features
| ---- Technical Performance Features --- | |||
|---|---|---|---|
| Characteristic | Comment andComparison | ViSi Mobile Monitoring System (TBD)Proposed Device | ViSi Mobile Monitoring System(K152341)Predicate Device |
| Waveform Data | Same | ECG, SpO2, Respiration, cNIBP | ECG, SpO2, Respiration, cNIBP |
| Wrist Monitor Connectivity | Same | Standalone or Wireless | Standalone or Wireless |
| Network Connectivity | Same | 802.11a/b/g/n | 802.11a/b/g/n |
| Wrist Monitor Display | Same | Internal OLED Display | Internal OLED Display |
| Energy Type and Source | Same | Lithium ion battery | Lithium ion battery |
| EMC Compliance | Same | IEC 60601-1-2 | IEC 60601-1-2 |
| Product Safety | Same | IEC 60601-1 | IEC 60601-1 |
| Operating Temperature | Same | 0 - 50°C | 0 - 50°C |
| Operation Humidity | Same | 15 - 95% non-condensing | 15 - 95% non-condensing |
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Image /page/17/Picture/1 description: The image shows the logo for Sotera Wireless. The word "Sotera" is written in a bold, black font. Below that, the word "WIRELESS" is written in a smaller, blue font. Above the word "Sotera" is a blue heart with three curved lines emanating from it, resembling radio waves.
| --- Technical Performance Features --- | |||
|---|---|---|---|
| Characteristic | Comment and Comparison | ViSi Mobile Monitoring System (TBD)Proposed Device | ViSi Mobile Monitoring System (K152341)Predicate Device |
| Operating Pressure | Same | 106 kPa – 70 kPa | 106 kPa – 70 kPa |
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Image /page/18/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, black font, with the word "WIRELESS" in a smaller, light blue font underneath. Above the word "Sotera" is a light blue heart shape with three curved lines emanating from the top, resembling radio waves.
Table #3. Discussion and Comparison of Predicate and Reference Devices III.
| ---- Discussion and Comparison of Predicate and Reference Devices==== | |||||
|---|---|---|---|---|---|
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| Same | Manufacturer | Sotera Wireless, Inc. | Sotera Wireless, Inc. | Sotera Wireless, Inc. | Sotera Wireless, Inc. |
| Same | Product Codes | MHX, DSI, DRT, DXN,DQA, FLL | MHX, DSI, DRT, DXN,DQA, FLL | MHX, DSI, DRT, DXN,DQA, FLL | MHX, DSI, DRT, DXN,DQA, FLL |
| Same | Classification | 2 | 2 | 2 | 2 |
| Same | ClassificationRegulation | 870.1025 | 870.1025 | 870.2300 | 870.1025 |
| Same | Auto Set Feature -Presence | Same | Same | Same | Same |
| Expanded | Auto Set FeatureExpanded Limits | Expanded Limits | Present | Present | Present |
| Same | Patient Population | 18 years or older | Same | Same | Same |
| Same | Technical OperatingPrinciples and Uses | Same | Same | Same | Same |
| ---- Discussion and Comparison of Predicate and Reference Devices --- | |||||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| Environments asDescribed in theTable Above | |||||
| Expanded | Communications | Dual Band | Single Band | Single Band | Single Band |
| Same or similar | Patient Postures | Enhanced | N/A | N/A | Present |
| Same or similar | Arrythmia | Enhanced | Present | ||
| Expanded | Components | Allows for the use ofcompetitive components | Components required but exclusive to Sotera | ||
| Same | Use EnvironmentHospital-basedfacilities; includinggeneral medical-surgical floors,intermediate carefloors, and emergencydepartments | Same | Same | Same | Same |
| ---- Discussion and Comparison of Predicate and Reference Devices --- | |||||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| Same and SimilarBut ExpandedOver Time | Indications for Use | The ViSI MobileMonitoring System isintended for use byclinicians and medicallyqualified personnel forsingle or multi-parametervital signs monitoring ofadult patients (18 yearsor older). It is indicatedfor ECG (3 or 5 lead-wire), respiration rate(RESP), heart rate (HR),noninvasive bloodpressure (NIBP).continuous noninvasiveblood pressure (cNIBP),noninvasive monitoringof functional oxygensaturation of arterial | The ViSi MobileMonitoring System isintended for use byclinicians and medicallyqualified personnel forsingle or multi-parametervital signs monitoring ofadult patients (18 yearsor older). It is indicatedfor ECG (3 or 5 lead-wire), respiration rate(RESP), heart rate (HR),noninvasive bloodpressure (NIBP),continuous noninvasiveblood pressure (cNIBP),noninvasive monitoringof functional oxygensaturation of arterial | The ViSi MobileMonitoring System isintended for use byclinicians and medicallyqualified personnel forsingle or multi-parametervital signs monitoring ofadult patients (18 yearsor older). It is indicatedfor ECG (3 or 5 lead-wire), respiration rate(RESP), heart rate (HR),noninvasive bloodpressure (NIBP),continuous noninvasiveblood pressure (cNIBP),noninvasive monitoringof functional oxygensaturation of arterial | The ViSi MobileMonitoring System isintended for use byclinicians andmedically qualifiedpersonnel for single ormulti-parameter vital signsmonitoringof adult patients (18 yearsor older). It is indicated forECG (3 or 5 lead wire),arrhythmia analysis,respiration rate, heart rate,non-invasive bloodpressure(NIBP), continuous non-invasive blood pressure(cNIBP), non-invasivemonitoring of functionaloxygen saturation ofarterial hemoglobin(SpO2), pulserate, and skin temperaturein hospital-based facilities;including generalmedicalsurgicalfloors, intermediate carefloors, and emergencydepartments. |
| ---- Discussion and Comparison of Predicate and Reference Devices --- | |||||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| hemoglobin (SpO2),pulse rate (PR), skintemperature (TEMP),posture tracking andalarms, and basicarrhythmia (VentricularTachycardia, VentricularFibrillation, Asystole,Atrial Fibrillation)analysis and alarm inhospital-based facilitiesincluding generalmedical-surgical floors,intermediate care floors,and emergencydepartments.Continuous non-invasive | hemoglobin (SpO2),pulse rate (PR), and skintemperature (TEMP) inhospital-based facilities;including, generalmedical-surgical floors,intermediate care floors,and emergencydepartments.The ViSi MobileMonitoring System maybe used as standalonedevices or networked toViSi Mobile RemoteViewers throughwireless 802.11communication. | hemoglobin (SpO2),pulse rate (PR), and skintemperature (TEMP) inhospital-based facilities;including, generalmedical-surgical floors,intermediate care floors,and emergencydepartments.The ViSi MobileMonitoring System maybe used as standalonedevices or networked toViSi Mobile RemoteViewers throughwireless 802.11communication. | The ViSi MobileMonitoring System may beused as standalone devicesornetworked to a centralstation through wireless802.11 communication.Continuous non-invasiveblood pressure (cNIBP)measurements have notbeenevaluated on patientsduring ambulation.Page 14The arrhythmia analysisfeature is intended for useby healthcare professionalstrained in the identificationand treatment ofarrhythmia events.Automatedarrhythmia analysis is anadjunct to clinicalassessment; clinicianreview of theanalysis should precedeany therapeutic | ||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| blood pressure (cNIBP)measurements have notbeen evaluated onpatients duringambulation. The basicarrhythmia analysisfeature is intended foruse on patients 18 yearsof age and older; it hasnot been evaluated onpediatric patients.The arrhythmia analysisfeature is intended foruse by healthcareprofessionals trained inthe identification andtreatment of arrhythmia | The ViSi Mobile InSightis an optional secondarynotification system thatcommunicates alarmsdirectly to an assignedcaregiver. It is intendedto supplement theprimary alarming deviceswhich originate in theViSi Mobile patient worndevice. | intervention. | |||
| ---- Discussion and Comparison of Predicate and Reference Devices --- | |||||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| events. Automatedarrhythmia analysis is anadjunct to clinicalassessment; clinicianreview of the analysisshould precede anytherapeutic intervention. | |||||
| The ViSi MobileMonitoring System maybe used as standalonedevices or networked toViSi Mobile RemoteViewers through wireless802.11 communication. | |||||
| The VisI Mobile Insightis an optional secondary | |||||
| ---- Discussion and Comparison of Predicate and Reference Devices --- | |||||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| notification system thatcommunicates alarmsdirectly to an assignedcaregiver. It is intendedto supplement theprimary alarming deviceswhich originate in theViSI Mobile patient-worndevice. | |||||
| Commentary:The Use ofSubstantialEquivalence,Clinical andBench Testing andthe Use ofConsensusStandards | SubstantialEquivalence and theEvolution of Design | 1. Like many other devices the ViSi device has evolved since it was first cleared in 2012. The ViSi MobileMonitoring system has changed incrementally over time and uses technologies cleared in other devices and istested against relevant standards as described below.The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, IncArrhythmia library (K062282), which has been adapted for real time analysis in the ViSi System. The ViSiMonitoring System arrhythmia analysis has been validated by comparison to the AHA, MIT-BIH,CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012.The safety and effectiveness of the design elements implemented into the ViSi System have been confirmed bycompliance to Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28,2003). | |||
| --- Discussion and Comparison of Predicate and Reference Devices --- | |||||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| The ViSi System has successfully undergone database and functional testing to demonstrate equivalence to thepredicate devices. The following quality assurance measures were applied to the device: risk analysis,requirements review, code inspections, verification and validation, and bench testing.The ViSi System has been tested and found to comply with special control guidance and recognized consensusstandards for medical devices. The results of all the testing demonstrate that the ViSi System is safe, effective,complies with the appropriate medical device standards, and is substantially equivalent to the predicate devices.2. Use of predicate devices. The ViSi system was originally drawn from as many as 14 similar devices as cited inthe original 510k #: 112478, cleared on March 22, 2012The arrhythmia function is reviewed based on customer feedback and was originally cleared in these devices:- Automated ECG Analysis and Interpretation Analysis Software Library (K062282)- Acuity Central Monitoring Station, (K052160)3. Posture Alarms. Posture related alarms were originally cleared in 510(k) #: 150361.The previously cleared (K143751) ViSi Mobile Monitoring System ("ViSi System") has been modified to includea posture alarms feature set that can alert medical personnel to undesirable patient positions, patient immobility,and patient falls as well display if the patient is walking.The added functionality has been built upon the previously cleared (K143751) system's ability to display whetherthe patient is upright (stationary), reclined or lying-down. | |||||
| ---- Discussion and Comparison of Predicate and Reference Devices --- | |||||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| The risk analysis determined that the risk for the ViSi System is not appreciably altered by the implementation ofthe additional features and is intended to provide medical personnel with information that will have a positiveeffect on patient safety. The risk analysis concluded that the benefits in overall patient safety outweighed therisks and therefore the implementation of the additional posture features is worthwhile.The device design, technology, materials, processes, etc. have not been changed with this application. Themodification is only to add the aforementioned posture features; therefore the ViSi Mobile Monitoring System asdescribed in this submission is substantially equivalent to the predicate ViSi System device. | |||||
| 4. Proposed Device- Philosophy of Design and Supporting ChangesThe proposed device combines the above technologies and FDA clearances from Sotera into a single device.When combined, this series of changes provides an increased level of patient safety and care and allows healthcare practitioners to: remotely monitor more than a single patient, configure alarms to broader range to minimizefatigue, allow components to be substituted from other manufactures and communicate across two differentranges of radio frequencies. These incremental changes when combined allow the ViSi system to monitorpatients more completely and more robustly while still maintaining its original configuration. | |||||
| 5. The proposed device draws from specific Sotera clearances and has been tested against these standards:a. IEC 60601-2-27:2011 Medical Electrical Equipment, Part 2-27: Particular Requirements for The Safety,Including Essential Performance of ECG Monitoring Equipmentb. AAMI ANSI EC57:2012 Testing and Reporting Performance and Results of Cardiac Rhythm and STSegment Measurement Algorithms | |||||
| ---- Discussion and Comparison of Predicate and Reference Devices --- | |||||
| Comment andComparison | Characteristic | Proposed Device | Predicate Device510(k) #: 152341 | Reference Device510k#: 150361 | Reference Device510k#: 142827 |
| c. | IEC 60601-2-49:2011 Particular Requirements for The Safety of Multifunction Patient MonitoringEquipment | ||||
| d. | IEC 80601-2-30:2009 Medical Electrical Equipment – Part 2-30: Particular Requirements for TheSafety, Including Essential Performance, Of Automatic Cycling Non-Invasive Blood PressureMonitoring Equipment | ||||
| e. | ISO 80601-2-61:2011 Particular Requirements for Basic Safety and Essential Performance of PulseOximeter Equipment | ||||
| 6. Clinical Testing | Section Twenty of the original submission covers the details surrounding the testing of the ViSisystem and in conjunction with cuffs from GE and Welch Allyn | ||||
| Clinical studies have performed to evaluate the accuracy of non-invasive blood pressure (NIBP) measurementaccording to ISO 80601-2-30. | |||||
| 7. Non-clinical Testing | The following bench testing have been performed for substantial comparison: | ||||
| 8. Performance testing | |||||
| 9. Safety testing | |||||
| 10. Risk analysis | |||||
| 11. Software testing |
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Image /page/19/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. Above the word "Sotera" is a blue graphic that resembles a heart with radio waves emanating from it. The logo is simple and modern, and the use of blue suggests a connection to technology and communication.
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Image /page/20/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, black font. Above the word "Sotera" is a blue heart with three curved lines emanating from it, resembling radio waves. Below "Sotera" is the word "WIRELESS" in a smaller, blue font.
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Image /page/21/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller, lighter font underneath. Above the word "Sotera" is a blue heart with three curved lines emanating from it, resembling radio waves. The logo is clean and modern, with a focus on the company's name and its wireless technology.
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Image /page/22/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features a blue heart-shaped icon with three curved lines emanating from it, resembling radio waves. Below the icon is the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. The logo is clean and modern, suggesting a company focused on wireless technology related to health or well-being.
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Image /page/23/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller, lighter font underneath. Above the word "Sotera" is a stylized heart shape with three curved lines emanating from it, suggesting wireless signals. The heart and the word "WIRELESS" are in a light blue color, while the word "Sotera" is in black.
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Image /page/24/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. Above the word "Sotera" is a blue heart with three curved lines emanating from it, resembling radio waves. The logo is simple and modern, and the use of blue and black gives it a professional look.
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Image /page/25/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the company name in a bold, sans-serif font, with the word "Sotera" in a larger size than "WIRELESS". Above the company name is a stylized heart shape with three curved lines emanating from it, resembling radio waves. The heart and the word "WIRELESS" are in a light blue color, while "Sotera" is in black.
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Image /page/26/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, black font. Above the word "Sotera" is a blue heart-shaped icon with three curved lines emanating from the top, resembling radio waves. Below "Sotera" is the word "WIRELESS" in a smaller, blue font.
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Image /page/27/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. Above the word "Sotera" is a blue graphic that resembles a heart with radio waves emanating from it. The logo is simple and modern, and the blue and black color scheme is professional and trustworthy.
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Image /page/28/Picture/0 description: The image shows the logo for Sotera Wireless. The logo features a blue heart-shaped icon with three curved lines emanating from the bottom, resembling radio waves. Below the icon is the word "Sotera" in a bold, sans-serif font, and below that is the word "WIRELESS" in a smaller, lighter font.
IV. Table #4. Discussion: 510(k) #: 142827, Arrhythmia and the Proposed Device
| a) GENERAL COMPARISON | |||
|---|---|---|---|
| Comment andComparison | Characteristic | Proposed DeviceViSi Mobile Monitoring System510(k) #: K180472 | ViSi Mobile Monitoring System510(k) #: K142827 |
| Same | Manufacturer | Sotera Wireless, Inc. | Sotera Wireless, Inc. |
| Same | Patient Population | 18 years or older | 18 years or older |
| Same | ElectrodeConfiguration | 3-wire: II5-wire: I, II, III, AVL, AVR, AVF, V | 3-wire: II5-wire: I, II, III, AVL, AVR, AVF, V |
| Same | CommonArrhythmiasDetected | Ventricular Tachycardia, VentricularFibrillation, Asystole | Ventricular Tachycardia, VentricularFibrillation, Asystole |
| Same | AdditionalArrhythmiasDetected | Atrial fibrillation and Atrial Flutter | Atrial fibrillation and Atrial Flutter |
| Same | Environment ofUse | Hospital-based facilities; including generalmedical-surgical floors, intermediate care | Hospital-based facilities; including generalmedical-surgical floors, intermediate care |
| a) GENERAL COMPARISON | |||
| Comment andComparison | Characteristic | Proposed DeviceViSi Mobile Monitoring System510(k) #: K180472 | ViSi Mobile Monitoring System510(k) #: K142827 |
| floors, and emergency departments | floors, and emergency departments | ||
| Same | ArrhythmiaAnalog or Digital | Digital | Digital |
| Same | Common ModeRejection Range | > 85 dB | > 85 dB |
| Different | QRS DetectionSensitivity | AHA: 99.40; MIT 99.50; NST: 95.98Different | AHA 99.40; MIT 99.46, 79.00 |
| Same | Pacemaker PulseRejection | The monitor detects and rejects pacemakerimpulses in accordance with IEC 60601-2-27 | The monitor detects and rejects pacemakerimpulses in accordance with IEC 60601-2-27 |
| Same | Samples PerSecond - BitResolution | 500 samples/sec, 19 bits | 500 samples/sec, 19 bits |
| Same | AlarmLevels/Management Standalone | Vital signs, Arrhythmia | Vital signs, Arrhythmia |
| Same | Alarm | Vital signs, Arrhythmia | Vital signs, Arrhythmia |
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Image /page/29/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. Above the word "Sotera" is a blue heart-shaped icon with three curved lines emanating from it, resembling radio waves. The logo is clean and modern, suggesting a company focused on wireless technology in the healthcare or medical field.
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Image /page/30/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, black font. Above the word "Sotera" is a blue heart with three curved lines emanating from it, resembling radio waves. Below "Sotera" is the word "WIRELESS" in a smaller, blue font.
| a) GENERAL COMPARISON | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Comment andComparison | Characteristic | Proposed DeviceViSi Mobile Monitoring System510(k) #: K180472 | ViSi Mobile Monitoring System510(k) #: K142827 | ||||||
| Levels/ManagementConnected/Linked |
| B) ARRHYTHMIA DETECTION METHOD COMPARISON | |||
|---|---|---|---|
| Comment andComparison | Characteristic | Proposed DeviceViSi Mobile Monitoring System510(k) #: K180472 | ViSi Mobile Monitoring System510(k) #: K142827 |
| Enhanced in theProposed DeviceBased on BestAvailableTechnology | Asystole | Absence of heat beats for a pre-defined adjustableperiod between 4 - 15 seconds | Absence of any ‘QRS’ complexes for at least 4 seconds |
| VentricularFibrillation | Adaboost multi decision tree classifier and 4 ECGderived features | A rhythm with rapid irregular waves and nodistinguishable ‘P’ waves or ‘QRS’ complexes | |
| VentricularTachycardia | A sequence of at least 10 consecutive wide ‘QRS’complexes (PVCs) at a rate of ≥150 bpm | ||
| Atrial Fibrillation | Two features based on RR interval and higherthan user predetermined heart rate (Section) | An irregular rhythm with the absence of "p"waves (Afib) or the dissociation of "p" waves toQRS waves persisting for ≥15 seconds |
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Image /page/31/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features a stylized blue heart with three curved lines emanating from it, resembling radio waves. Below the heart is the word "Sotera" in a bold, sans-serif font. Underneath "Sotera" is the word "WIRELESS" in a smaller, lighter font.
| B) ARRHYTHMIA DETECTION METHOD COMPARISON | |||
|---|---|---|---|
| Comment andComparison | Characteristic | Proposed DeviceViSi Mobile Monitoring System510(k) #: K180472 | ViSi Mobile Monitoring System510(k) #: K142827 |
| Atrial Flutter | None | ||
| Artifact / NoisySignal | None | Spikes, or other 'noise' seen on the ECG tracedue to motion, electrical interference, etc. thatinterfere with heart rate and rhythm analysis forat least 2 seconds. | |
| UnclassifiedRhythm | None | A rhythm or 'QRS' complex that cannot beidentified, and is not artifact for at least 2seconds. |
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Image /page/32/Picture/0 description: The image shows the text "K180472". The text is in a sans-serif font and is black. The background is white.
Image /page/32/Picture/1 description: The image shows the logo for Sotera Wireless. The logo features the company name in bold, black letters, with the word "Sotera" on top and "WIRELESS" in smaller, blue letters below. Above the company name is a blue heart shape with three curved lines emanating from the top, resembling radio waves.
C. Atrial Fibrillation Comparison
S: Subject Device RA: Reference Device A : Found in R-00167 (26 Sept 2014)
'-' : null result (test was done, but statistic cannot be calculated due to absence of test or reference annotation)
| Database | AF Episode Sensitivity (%) | AF Episode Positive Predictivity (%) | AF Duration Sensitivity (%) | AF duration positive predictivity (%) | AF false positive report | AF False Negative Report | AF time to detection (sec) | Same or Different | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S | RA | S | RA | S | RA | S | RA | S | RA | S | RA | S | RA | |||
| NST | - | -‡ | - | 0‡ | - | -‡ | 0 | 0‡ | 0 | 1‡ | 0 | 0‡ | - | - | Same or Better | |
| MIT-BIH | Gross | 90 | 87 | 100 | 65 | 99 | 80 | 75 | 75 | 0 | 137 | 0 | 10 | 00:20.94 | 0:06.4 | Same or Better |
| Average | 92 | 87 | 100 | 37 | 96 | 84 | 71 | 40 |
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Image /page/33/Picture/0 description: The image shows the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with the word "WIRELESS" in a smaller font underneath. Above the word "Sotera" is a blue heart-shaped icon with three curved lines emanating from it, suggesting a wireless signal. The logo is clean and modern, conveying a sense of technology and healthcare.
D. ARRHYTHMIA ALARM COMPARISON
S: Subject Device RA: Reference Device A
| Display Message | Alarm Symbol | Basic Arrhythmia Event | Alarm Type | Same orDifferent | ||||
|---|---|---|---|---|---|---|---|---|
| S | RA | S | RA | S | RA | S | RA | |
| ASYSTOLE | ASYSTOLE | Image: Alarm Symbol | Image: Alarm Symbol | Asystole | Asystole | Life Threatening | Life Threatening | Same |
| VTACH/VFIB | SUSTAINED V-TACH | Image: Alarm Symbol | Image: Alarm Symbol | VentricularTachycardia | VentricularTachycardia | Life Threatening | Life Threatening | Same |
| VFIB | Image: Alarm Symbol | Image: Alarm Symbol | VentricularFibrillation | VentricularFibrillation | Life Threatening | Life Threatening | Same | |
| AFIB RVR | AFIB/AFLU | Image: Alarm Symbol | Image: Alarm Symbol | Atrial Fibrillationwith specified heartrate above the setlimit | AtrialFibrillation | High Severity | High Severity | Same |
| AFIB | Image: Alarm Symbol | Image: Alarm Symbol | Atrial Fibrillationwith specified heartrate below the setlimit | AtrialFibrillation | General Non-LifeThreatening | High Severity | Different |
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E. ALARM TEST COMPARISON
Units are %
- VF Ventricular Fibrillation
- VT Ventricular Tachycardia
AFIB – Atrial Fibrillation
| Call | Database | Subject Device | Reference Device A (K142827) | ||
|---|---|---|---|---|---|
| Sensitivity | Positive Predictivity | Sensitivity | Positive Predictivity | ||
| AHA | 91 | 100 | 90 | 60 | |
| VF/VT | MIT | 100 | 100 | 100 | 67 |
| CU | 97 | 94 | 94 | 46 | |
| AFIB | MIT | 90 | 100 | 97 | 65 |
§ 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.