ViSi Mobile Monitoring System

K180472 · Sotera Wireless, Inc. · MHX · Jun 19, 2018 · Cardiovascular

Device Facts

• Record ID: K180472
• Device Name: ViSi Mobile Monitoring System
• Applicant: Sotera Wireless, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: AI/ML

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), 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 arrhythmia (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.

Device Story

ViSi Mobile Monitoring System is a patient-worn, battery-operated, wireless device for continuous physiological monitoring. It collects ECG, respiration, heart rate, NIBP, cNIBP, SpO2, pulse rate, skin temperature, and posture data. The system processes these inputs to provide real-time vital signs and basic arrhythmia analysis (VT, VF, Asystole, AFib). It operates in hospital environments, used by clinicians and medically qualified personnel. Data is displayed on the wrist-worn monitor or transmitted via 802.11 wireless to a Remote Viewer. An optional secondary notification system (ViSi Mobile InSight) alerts caregivers. The device aids clinical assessment by providing automated analysis and alarms; clinicians must review analysis before therapeutic intervention. Benefits include continuous patient monitoring, improved patient safety through posture and arrhythmia detection, and flexible, remote patient observation.

Clinical Evidence

No clinical prospective/retrospective studies were performed. Evidence consists of bench testing and database validation. Arrhythmia detection performance was validated using AHA, MIT-BIH, CU, and NST databases per ANSI/AAMI EC57:2012. NIBP accuracy was evaluated per ISO 80601-2-30. Performance metrics (sensitivity, positive predictivity) for AFib and VF/VT were reported across multiple databases, showing comparable or improved performance over the reference device.

Technological Characteristics

Patient-worn, battery-operated monitor. Materials: Li-ion battery, NIBP cuffs, thumb sensors. Sensing: ECG (3/5 lead), SpO2, NIBP/cNIBP, temperature, accelerometer for posture. Connectivity: 802.11a/b/g/n (dual-band). Software: Arrhythmia detection algorithm (Adaboost multi-decision tree classifier). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-49, IEC 80601-2-30, ISO 80601-2-61, ANSI/AAMI EC57:2012.

Indications for Use

Indicated for adult patients (18+ years) in hospital settings (medical-surgical, intermediate care, emergency departments) for monitoring ECG, respiration, heart rate, NIBP, cNIBP, SpO2, pulse rate, skin temperature, posture, and basic arrhythmia (VT, VF, Asystole, AFib). Not for pediatric patients. cNIBP not evaluated during ambulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ViSi Mobile Monitoring System (K152341)

Reference Devices

• ViSi Mobile Monitoring System (K142827)
• ViSi Mobile Monitoring System (K150361)
• Monebo Technologies, Inc. Arrhythmia library (K062282)
• Acuity Central Monitoring Station (K052160)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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Image /page/3/Picture/2 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 bold, black font. Underneath "Sotera" is the word "WIRELESS" in a smaller, lighter font.

# 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 detection<br>or 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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Image /page/4/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 blue and black color scheme is professional and trustworthy.

# 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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Image /page/6/Picture/1 description: The image shows the logo for Sotera Wireless. The logo consists of the word "Sotera" in a bold, sans-serif font, with a small, stylized blue icon above the word. The icon appears to be a stylized heart with radio waves emanating from it. Below the word "Sotera" is the word "WIRELESS" in a smaller, sans-serif font, also in blue.

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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Image /page/7/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, resembling radio waves. The logo is clean and modern, with a focus on the company's name and wireless technology.

# 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.

K180472

#### 1. Table #1. General Comparison

| Characteristic | Comparison or Comment | ViSi Mobile Monitoring System (TBD)<br>Proposed Device | ViSi Mobile Monitoring System (K152341)<br>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 Similar<br>Proposed device contains<br>arrhythmia analysis | The ViSi Mobile Monitoring System is<br>intended for use by clinicians and<br>medically qualified personnel for single<br>or multi-parameter vital signs<br>monitoring of adult patients (18 years or<br>older).<br>It is indicated for ECG (3 or 5 lead-<br>wire), respiration rate (RESP), heart rate | The ViSi Mobile Monitoring System is<br>intended for use by clinicians and<br>medically qualified personnel for single<br>or multi-parameter vital signs<br>monitoring of adult patients (18 years or<br>older).<br>It is indicated for ECG (3 or 5 lead-<br>wire), respiration rate (RESP), heart rate |
| Characteristic | Comparison or<br>Comment | ViSi Mobile Monitoring System<br>(TBD) | ViSi Mobile Monitoring System<br>(K152341) |
| | | Proposed Device | Predicate Device |
| | | (HR), non-invasive blood pressure<br>(NIBP), continuous non-invasive blood<br>pressure (cNIBP), non-invasive<br>monitoring of functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2), pulse rate (PR), and skin<br>temperature (TEMP), posture tracking<br>and alarms, skin temperature (TEMP)<br>and basic arrhythmia (Ventricular<br>Tachycardia, Ventricular Fibrillation,<br>Asystole, Atrial Fibrillation)<br>analysis/alarm in hospital-based<br>facilities; including, general medical-<br>surgical floors, intermediate care floors,<br>and emergency departments.<br>Continuous non-invasive blood pressure<br>(cNIBP) measurements have not been<br>evaluated on patients during<br>ambulation.<br>The arrhythmia analysis feature is<br>intended for use by healthcare<br>professionals trained in the<br>identification and treatment of | (HR), non-invasive blood pressure<br>(NIBP), continuous non-invasive blood<br>pressure (cNIBP), non-invasive<br>monitoring of functional oxygen<br>saturation of arterial hemoglobin<br>(SpO2), pulse rate (PR), and skin<br>temperature (TEMP) in hospital-based<br>facilities; including, general medical-<br>surgical floors, intermediate care floors,<br>and emergency departments. |
| Characteristic | Comparison or<br>Comment | ViSi Mobile Monitoring System<br>(TBD) | ViSi Mobile Monitoring System<br>(K152341) |
| | | Proposed Device | Predicate Device |
| | | arrhythmia events.<br>Automated arrhythmia analysis is an<br>adjunct to clinical assessment; clinician<br>review of the analysis should precede<br>any therapeutic intervention. | |
| Use of ViSi<br>Mobile Insight | Same | The ViSi Mobile InSight is an optional<br>secondary notification system that<br>communicates alarms directly to an<br>assigned caregiver. It is intended to<br>supplement the primary alarming<br>devices which originate in the ViSi<br>Mobile patient worn device. | The ViSi Mobile InSight is an optional<br>secondary notification system that<br>communicates alarms directly to an<br>assigned caregiver. It is intended to<br>supplement the primary alarming<br>devices which originate in the ViSi<br>Mobile patient worn device. |
| Remote Viewing | Same | The ViSi Mobile Monitoring System<br>may be used as standalone devices or<br>networked to ViSi Mobile Remote<br>Viewers through wireless 802.11<br>communication. | The ViSi Mobile Monitoring System<br>may be used as standalone devices or<br>networked to ViSi Mobile Remote<br>Viewers through wireless 802.11<br>communication. |
| Patient Population | Same | 18 years or older | 18 years or older |
| Environment of Use | Same | Hospital-based facilities; including<br>general medical-surgical floors,<br>intermediate care floors, and emergency | Hospital-based facilities; including<br>general medical-surgical floors,<br>intermediate care floors, and emergency |
| Characteristic | Comparison or<br>Comment | ViSi Mobile Monitoring System<br>(TBD) | ViSi Mobile Monitoring System<br>(K152341) |
| | | Proposed Device | Predicate Device |
| | | departments | departments |
| Auto Set Feature | Similar | Auto Set features are enabled for BP<br>MAP parameter. | Auto Set Feature present in K152341<br>and earlier models |
| | Expanded | Heart Rate and Pulse Rate default<br>patient limits were changed to Low 30,<br>High 150 | Heart Rate and Pulse Rate default<br>patient limits were Low: 40, High 140 |
| Patient Postures | Expanded | Patient Walking – previously part of<br>prior products now an individually set<br>feature. Recline left and recline right<br>added. | Patient Walking – previously included<br>in undesirable posture features. Cleared<br>in reference device, 510(k) #:<br>K150361. |
| Arrhythmia Detection<br>Algorithm | Similar | Rewritten to improve specificity and<br>detection metrics | Cleared in reference device, 510(k) #:<br>K14827. |
| (1) Software Changes -<br>General | Expanded | Software was enhanced and expanded<br>covering both normal refinements and<br>specific additions and improvements. | 510(k) #: K152341 included various<br>software features as shown in the<br>submission and indications for use. |
| (2) Software Changes -<br>Specific | Expanded as<br>Shown Below: | Additional Project-Specific Features are Detailed Below - Apollo Project<br>(Software Version 3.x.x) | |
| | a) ViSi Access | Ability to access "Vital Sign" display<br>on the Monitor without entering a Pin<br>Code | Not present - or improved |
| Characteristic | Comparison or<br>Comment | ViSi Mobile Monitoring System<br>(TBD) | ViSi Mobile Monitoring System<br>(K152341) |
| | Proposed Device | Predicate Device | |
| | b) Session<br>Managemen<br>t including a<br>change to<br>the Device<br>Swap<br>Method | Improved Pause / Stop Monitoring<br>Flows to eliminate the need to<br>complete a physical *Bump* for<br>Device Swap when the Monitor<br>battery is low Ability to Assign and confirm the<br>patient demographics for a<br>new/resumed monitoring session<br>directly from the Wrist Monitor | Not present – or improved |
| | c) cNIBP<br>Updates | cNIBP calibration alert was divided<br>into three different, more<br>informative alerts cNIBP calibration and data carry-<br>over after device swap within 10<br>minutes of device pause and resume | Not present – or improved |
| | d) Multiple<br>Care Units | Ability to display/configure multiple<br>Care Units from the same server<br>(PDS) Ability to assign a Care unit from<br>the Wrist Monitor when starting a<br>new monitoring session Ability to transfer the patient from<br>one care unit to another using the<br>same Monitor | Not present – or improved |
| Characteristic | Comparison or<br>Comment | ViSi Mobile Monitoring System<br>(TBD)<br>Proposed Device | ViSi Mobile Monitoring System<br>(K152341)<br>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) Remote<br>Viewer<br>Graphic<br>User<br>Interface<br>(GUI)<br>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 or<br>Comment | ViSi Mobile Monitoring System<br>(TBD)<br>Proposed Device | ViSi Mobile Monitoring System<br>(K152341)<br>Predicate Device |
| (3) Software Changes –<br>Specific | us<br>Enhanceme<br>nts | when the device goes in and out of<br>network Improved Power Pack indicators<br>(when connected to Wrist Monitor) Updated icon for “Battery Too Hot” Alarm acknowledgement time<br>increased from 2 minutes to 10<br>minutes Extended annunciation delay for<br>“Network Lost” alert Added ability to set-up “Read-only”<br>RVDs which reduce the amount of<br>visible patient health information<br>and do not allow interactions other<br>than viewing patient sessions | |
| | Expanded as<br>Shown Below: | Additional Project-Specific Features are Detailed Below - Bacchus Project<br>(Software Version 4.0.x) | |
| | a) Arrhythmia<br>Analysis<br>Algorithm<br><br>b) Patient<br>Posture | New arrhythmia detection algorithm<br>to improve arrhythmia detection<br>accuracy and positive predictivity Add two new postures (reclined<br>right-side and reclined left-side), and<br>icons to display<br>“Immobility/Reclined Right Side” | Not present – or improved<br><br>Not present – or improved |
| Characteristic | Comparison or<br>Comment | ViSi Mobile Monitoring System<br>(TBD) | ViSi Mobile Monitoring System<br>(K152341) |
| | | Proposed Device | Predicate Device |
| | | and Immobility/Reclined Left Side”<br>posture status, and alert icons<br>“Undesired + Immobility)/Reclined<br>Right Side” and “Undesired +<br>Immobility)/Reclined Left Side”<br>“Undesired/Walking” alert text<br>changed to “PATIENT WALKING”<br>Alert | |
| | c) Other<br>Changes | Updated the algorithm that generates<br>a “Check Thumb Sensor” alert to<br>identify non-functioning thumb<br>sensors and added new alert text<br>(“Swap Thumb Sensor”) to signify<br>when this occurs. “Check Thumb<br>Sensor” will remain to indicate that<br>the sensor is either off the patient or<br>not positioned properly. SW Versioning check and alert to<br>convey that the accessory (i.e., ECG<br>Cable, NIBP Module or Power Pack)<br>is not compatible with the Wrist<br>Monitor | Not present – or improved |
| Hardware Changes and<br>Enhancements | Changed and<br>Improved | Li-ion power pack NIBP cuffs NIBP cuff adapters | Not present – or improved |
| Characteristic | Comparison or<br>Comment | ViSi Mobile Monitoring System<br>(TBD)<br>Proposed Device | ViSi Mobile Monitoring System<br>(K152341)<br>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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