Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The document explicitly mentions the use of an "Adaboost multi decision tree classifier" for arrhythmia analysis, which is a machine learning algorithm.

Therapeutic

No.
The device is intended for vital sign monitoring and basic arrhythmia analysis, which are diagnostic and monitoring functions, not therapeutic interventions.

Diagnostic

Yes

Explanation: The device performs "basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation) and alarm," which involves analyzing physiological data to identify specific medical conditions. This classification of arrhythmias is a form of diagnosis, even though it's considered "basic" and requires clinician review.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of "patient worn devices, disposables, backup battery, patient data server and remote viewer," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the ViSI Mobile Monitoring System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
ViSI Mobile Monitoring System Function: The ViSI Mobile Monitoring System is a patient-worn device that directly monitors physiological parameters on the patient's body (in vivo). It measures things like ECG, blood pressure, oxygen saturation, temperature, and posture.
Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens.

Therefore, the ViSI Mobile Monitoring System falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a PCCP for this specific device.

Overview

Intended Use / Indications for 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 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.

Product codes (comma separated list FDA assigned to the subject device)

MHX, DSI, DRT, DXN, DQA, FLL

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

18 years or older

Intended User / Care Setting

clinicians and medically qualified personnel / hospital-based facilities including general medical-surgical floors, intermediate care floors, and emergency departments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Clinical Testing:
Clinical studies have been performed to evaluate the accuracy of non-invasive blood pressure (NIBP) measurement according to ISO 80601-2-30.

Non-clinical Testing:
Bench testing has been performed for substantial comparison.

Performance Testing: Not Found
Safety Testing: Not Found
Risk Analysis: Not Found
Software Testing: Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

QRS Detection Sensitivity:

AHA: 99.40
MIT: 99.50
NST: 95.98

Atrial Fibrillation Episode Sensitivity:

NST: -
MIT-BIH: Gross 90, Average 92

Atrial Fibrillation Episode Positive Predictivity (%):

NST: -
MIT-BIH: Gross 87, Average 87

AF Duration Sensitivity (%):

NST: -
MIT-BIH: 99 (Gross), 96 (Average)

AF duration positive predictivity (%):

NST: 0
MIT-BIH: 80 (Gross), 84 (Average)

AF false positive report:

NST: 0
MIT-BIH: 75 (Gross), 40 (Average)

AF False Negative Report:

NST: 0
MIT-BIH: 137 (Gross), (Not Specified) (Average)

AF time to detection (sec):

NST: -
MIT-BIH: 10 (Gross), (Not Specified) (Average)

ALARM TEST COMPARISON (VF/VT) Sensitivity:

AHA: 91
MIT: 100
CU: 97

ALARM TEST COMPARISON (VF/VT) Positive Predictivity:

AHA: 100
MIT: 100
CU: 94

ALARM TEST COMPARISON (AFIB) Sensitivity:

MIT: 90

ALARM TEST COMPARISON (AFIB) Positive Predictivity:

MIT: 100

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152341

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K142827, K150361

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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.

1

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

2

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
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)
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 Similar
Proposed device contains
arrhythmia analysis | 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 | 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 |
| Characteristic | Comparison or
Comment | ViSi Mobile Monitoring System
(TBD) | ViSi Mobile Monitoring System
(K152341) |
| | | Proposed Device | Predicate Device |
| | | (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), and skin
temperature (TEMP), posture tracking
and alarms, skin temperature (TEMP)
and basic arrhythmia (Ventricular
Tachycardia, Ventricular Fibrillation,
Asystole, Atrial Fibrillation)
analysis/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 arrhythmia analysis feature is
intended for use by healthcare
professionals trained in the
identification and treatment of | (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), and skin
temperature (TEMP) in hospital-based
facilities; including, general medical-
surgical floors, intermediate care floors,
and emergency departments. |
| Characteristic | Comparison or
Comment | ViSi Mobile Monitoring System
(TBD) | ViSi Mobile Monitoring System
(K152341) |
| | | Proposed Device | Predicate Device |
| | | arrhythmia events.
Automated arrhythmia analysis is an
adjunct to clinical assessment; clinician
review of the analysis should precede
any therapeutic intervention. | |
| Use of ViSi
Mobile Insight | Same | 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. | 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. |
| Remote Viewing | Same | 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 Monitoring System
may be used as standalone devices or
networked to ViSi Mobile Remote
Viewers through wireless 802.11
communication. |
| Patient Population | Same | 18 years or older | 18 years or older |
| Environment of Use | Same | Hospital-based facilities; including
general medical-surgical floors,
intermediate care floors, and emergency | Hospital-based facilities; including
general medical-surgical floors,
intermediate care floors, and emergency |
| Characteristic | Comparison or
Comment | 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 BP
MAP parameter. | Auto Set Feature present in K152341
and earlier models |
| | Expanded | Heart Rate and Pulse Rate default
patient limits were changed to Low 30,
High 150 | Heart Rate and Pulse Rate default
patient limits were Low: 40, High 140 |
| Patient Postures | Expanded | Patient Walking – previously part of
prior products now an individually set
feature. Recline left and recline right
added. | Patient Walking – previously included
in undesirable posture features. Cleared
in reference device, 510(k) #:
K150361. |
| Arrhythmia Detection
Algorithm | Similar | Rewritten to improve specificity and
detection metrics | Cleared in reference device, 510(k) #:
K14827. |
| (1) Software Changes -
General | Expanded | Software was enhanced and expanded
covering both normal refinements and
specific additions and improvements. | 510(k) #: K152341 included various
software features as shown in the
submission and indications for use. |
| (2) Software Changes -
Specific | Expanded as
Shown Below: | Additional Project-Specific Features are Detailed Below - Apollo Project
(Software Version 3.x.x) | |
| | a) ViSi Access | Ability to access "Vital Sign" display
on the Monitor without entering a Pin
Code | Not present - or improved |
| Characteristic | Comparison or
Comment | ViSi Mobile Monitoring System
(TBD) | ViSi Mobile Monitoring System
(K152341) |
| | Proposed Device | Predicate Device | |
| | b) Session
Managemen
t including a
change to
the Device
Swap
Method | Improved Pause / Stop Monitoring
Flows to eliminate the need to
complete a physical Bump for
Device Swap when the Monitor
battery is low Ability to Assign and confirm the
patient demographics for a
new/resumed monitoring session
directly from the Wrist Monitor | Not present – or improved |
| | c) cNIBP
Updates | cNIBP calibration alert was divided
into three different, more
informative alerts cNIBP calibration and data carry-
over after device swap within 10
minutes of device pause and resume | Not present – or improved |
| | d) Multiple
Care Units | Ability to display/configure multiple
Care Units from the same server
(PDS) Ability to assign a Care unit from
the Wrist Monitor when starting a
new monitoring session Ability to transfer the patient from
one care unit to another using the
same Monitor | Not present – or improved |
| Characteristic | Comparison or
Comment | 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) Remote
Viewer
Graphic
User
Interface
(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 or
Comment | ViSi Mobile Monitoring System
(TBD)
Proposed Device | ViSi Mobile Monitoring System
(K152341)
Predicate Device |
| (3) Software Changes –
Specific | us
Enhanceme
nts | when the device goes in and out of
network Improved Power Pack indicators
(when connected to Wrist Monitor) Updated icon for “Battery Too Hot” Alarm acknowledgement time
increased from 2 minutes to 10
minutes Extended annunciation delay for
“Network Lost” alert Added ability to set-up “Read-only”
RVDs which reduce the amount of
visible patient health information
and do not allow interactions other
than viewing patient sessions | |
| | Expanded as
Shown Below: | Additional Project-Specific Features are Detailed Below - Bacchus Project
(Software Version 4.0.x) | |
| | a) Arrhythmia
Analysis
Algorithm

b) Patient
Posture | New arrhythmia detection algorithm
to improve arrhythmia detection
accuracy and positive predictivity Add two new postures (reclined
right-side and reclined left-side), and
icons to display
“Immobility/Reclined Right Side” | Not present – or improved

Not present – or improved |
| Characteristic | Comparison or
Comment | 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)/Reclined
Right Side” and “Undesired +
Immobility)/Reclined Left Side”
“Undesired/Walking” alert text
changed to “PATIENT WALKING”
Alert | |
| | c) Other
Changes | Updated the algorithm that generates
a “Check Thumb Sensor” alert to
identify non-functioning thumb
sensors and added new alert text
(“Swap Thumb Sensor”) to signify
when this occurs. “Check Thumb
Sensor” will remain to indicate that
the sensor is either off the patient or
not positioned properly. SW Versioning check and alert to
convey that the accessory (i.e., ECG
Cable, NIBP Module or Power Pack)
is not compatible with the Wrist
Monitor | Not present – or improved |
| Hardware Changes and
Enhancements | Changed and
Improved | Li-ion power pack NIBP cuffs NIBP cuff adapters | Not present – or improved |
| Characteristic | Comparison or
Comment | 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/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.

16

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 and
Comparison	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

K180472

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17

K180472

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.

WWW.SOTERAWIRELESS.COM

--- 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

18

K180472

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 and
Comparison	Characteristic	Proposed Device	Predicate Device
510(k) #: 152341	Reference Device
510k#: 150361	Reference Device
510k#: 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	Classification
Regulation	870.1025	870.1025	870.2300	870.1025
Same	Auto Set Feature -
Presence	Same	Same	Same	Same
Expanded	Auto Set Feature
Expanded Limits	Expanded Limits	Present	Present	Present
Same	Patient Population	18 years or older	Same	Same	Same
Same	Technical Operating
Principles and Uses	Same	Same	Same	Same
---- Discussion and Comparison of Predicate and Reference Devices ---
Comment and
Comparison	Characteristic	Proposed Device	Predicate Device
510(k) #: 152341	Reference Device
510k#: 150361	Reference Device
510k#: 142827
	Environments as
Described in the
Table 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 of
competitive components		Components required but exclusive to Sotera
Same	Use Environment
Hospital-based
facilities; including
general medical-
surgical floors,
intermediate care
floors, and emergency
departments	Same	Same	Same	Same
---- Discussion and Comparison of Predicate and Reference Devices ---
Comment and
Comparison	Characteristic	Proposed Device	Predicate Device
510(k) #: 152341	Reference Device
510k#: 150361	Reference Device
510k#: 142827
Same and Similar
But Expanded
Over Time	Indications for 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	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	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	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),
arrhythmia analysis,
respiration rate, heart rate,
non-invasive blood
pressure
(NIBP), continuous non-
invasive blood pressure
(cNIBP), non-invasive
monitoring of functional
oxygen saturation of
arterial hemoglobin
(SpO2), pulse
rate, and skin temperature
in hospital-based facilities;
including general
medicalsurgical
floors, intermediate care
floors, and emergency
departments.
---- Discussion and Comparison of Predicate and Reference Devices ---
Comment and
Comparison	Characteristic	Proposed Device	Predicate Device
510(k) #: 152341	Reference Device
510k#: 150361	Reference Device
510k#: 142827
		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
hospital-based facilities
including general
medical-surgical floors,
intermediate care floors,
and emergency
departments.
Continuous non-invasive	hemoglobin (SpO2),
pulse rate (PR), and skin
temperature (TEMP) in
hospital-based facilities;
including, general
medical-surgical floors,
intermediate care floors,
and emergency
departments.
The ViSi Mobile
Monitoring System may
be used as standalone
devices or networked to
ViSi Mobile Remote
Viewers through
wireless 802.11
communication.	hemoglobin (SpO2),
pulse rate (PR), and skin
temperature (TEMP) in
hospital-based facilities;
including, general
medical-surgical floors,
intermediate care floors,
and emergency
departments.
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
Monitoring System may be
used as standalone devices
or
networked to a central
station through wireless
802.11 communication.
Continuous non-invasive
blood pressure (cNIBP)
measurements have not
been
evaluated on patients
during ambulation.
Page 14
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
Comment and
Comparison	Characteristic	Proposed Device	Predicate Device
510(k) #: 152341	Reference Device
510k#: 150361	Reference Device
510k#: 142827
		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 | 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. | | intervention. |
| ---- Discussion and Comparison of Predicate and Reference Devices --- | | | | | |
| Comment and
Comparison | Characteristic | Proposed Device | Predicate Device
510(k) #: 152341 | Reference Device
510k#: 150361 | Reference Device
510k#: 142827 |
| | | 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 | | | |
| ---- Discussion and Comparison of Predicate and Reference Devices --- | | | | | |
| Comment and
Comparison | Characteristic | Proposed Device | Predicate Device
510(k) #: 152341 | Reference Device
510k#: 150361 | Reference Device
510k#: 142827 |
| | | 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. | | | |
| Commentary:
The Use of
Substantial
Equivalence,
Clinical and
Bench Testing and
the Use of
Consensus
Standards | Substantial
Equivalence and the
Evolution of Design | 1. Like many other devices the ViSi device has evolved since it was first cleared in 2012. The ViSi Mobile
Monitoring system has changed incrementally over time and uses technologies cleared in other devices and is
tested against relevant standards as described below.

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 safety and effectiveness of the design elements implemented into the ViSi System have been confirmed by
compliance to Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28,
2003). | | | |
| --- Discussion and Comparison of Predicate and Reference Devices --- | | | | | |
| Comment and
Comparison | Characteristic | Proposed Device | Predicate Device
510(k) #: 152341 | Reference Device
510k#: 150361 | Reference Device
510k#: 142827 |
| | | The ViSi System has successfully undergone database and functional testing to demonstrate equivalence to the
predicate 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 consensus
standards 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.

Use of predicate devices. The ViSi system was originally drawn from as many as 14 similar devices as cited in
the original 510k #: 112478, cleared on March 22, 2012

The 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)

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 include
a 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 whether
the patient is upright (stationary), reclined or lying-down. | | | |
| ---- Discussion and Comparison of Predicate and Reference Devices --- | | | | | |
| Comment and
Comparison | Characteristic | Proposed Device | Predicate Device
510(k) #: 152341 | Reference Device
510k#: 150361 | Reference Device
510k#: 142827 |
| | | The risk analysis determined that the risk for the ViSi System is not appreciably altered by the implementation of
the additional features and is intended to provide medical personnel with information that will have a positive
effect on patient safety. The risk analysis concluded that the benefits in overall patient safety outweighed the
risks 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. The
modification is only to add the aforementioned posture features; therefore the ViSi Mobile Monitoring System as
described in this submission is substantially equivalent to the predicate ViSi System device. | | | |
| | | 4. Proposed Device- Philosophy of Design and Supporting Changes

The 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 health
care practitioners to: remotely monitor more than a single patient, configure alarms to broader range to minimize
fatigue, allow components to be substituted from other manufactures and communicate across two different
ranges of radio frequencies. These incremental changes when combined allow the ViSi system to monitor
patients 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 Equipment

b. AAMI ANSI EC57:2012 Testing and Reporting Performance and Results of Cardiac Rhythm and ST
Segment Measurement Algorithms | | | |
| ---- Discussion and Comparison of Predicate and Reference Devices --- | | | | | |
| Comment and
Comparison | Characteristic | Proposed Device | Predicate Device
510(k) #: 152341 | Reference Device
510k#: 150361 | Reference Device
510k#: 142827 |
| c. | | IEC 60601-2-49:2011 Particular Requirements for The Safety of Multifunction Patient Monitoring
Equipment | | | |
| d. | | IEC 80601-2-30:2009 Medical Electrical Equipment – Part 2-30: Particular Requirements for The
Safety, Including Essential Performance, Of Automatic Cycling Non-Invasive Blood Pressure
Monitoring Equipment | | | |
| e. | | ISO 80601-2-61:2011 Particular Requirements for Basic Safety and Essential Performance of Pulse
Oximeter Equipment | | | |
| 6. Clinical Testing | | Section Twenty of the original submission covers the details surrounding the testing of the ViSi
system and in conjunction with cuffs from GE and Welch Allyn | | | |
| | | Clinical studies have performed to evaluate the accuracy of non-invasive blood pressure (NIBP) measurement
according 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.

22

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.

23

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.

27

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.

28

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 and
Comparison	Characteristic	Proposed Device
ViSi Mobile Monitoring System
510(k) #: K180472	ViSi Mobile Monitoring System
510(k) #: K142827
Same	Manufacturer	Sotera Wireless, Inc.	Sotera Wireless, Inc.
Same	Patient Population	18 years or older	18 years or older
Same	Electrode
Configuration	3-wire: II
5-wire: I, II, III, AVL, AVR, AVF, V	3-wire: II
5-wire: I, II, III, AVL, AVR, AVF, V
Same	Common
Arrhythmias
Detected	Ventricular Tachycardia, Ventricular
Fibrillation, Asystole	Ventricular Tachycardia, Ventricular
Fibrillation, Asystole
Same	Additional
Arrhythmias
Detected	Atrial fibrillation and Atrial Flutter	Atrial fibrillation and Atrial Flutter
Same	Environment of
Use	Hospital-based facilities; including general
medical-surgical floors, intermediate care	Hospital-based facilities; including general
medical-surgical floors, intermediate care
a) GENERAL COMPARISON
Comment and
Comparison	Characteristic	Proposed Device
ViSi Mobile Monitoring System
510(k) #: K180472	ViSi Mobile Monitoring System
510(k) #: K142827
		floors, and emergency departments	floors, and emergency departments
Same	Arrhythmia
Analog or Digital	Digital	Digital
Same	Common Mode
Rejection Range	> 85 dB	> 85 dB
Different	QRS Detection
Sensitivity	AHA: 99.40; MIT 99.50; NST: 95.98
Different	AHA 99.40; MIT 99.46, 79.00
Same	Pacemaker Pulse
Rejection	The monitor detects and rejects pacemaker
impulses in accordance with IEC 60601-2-27	The monitor detects and rejects pacemaker
impulses in accordance with IEC 60601-2-27
Same	Samples Per
Second - Bit
Resolution	500 samples/sec, 19 bits	500 samples/sec, 19 bits
Same	Alarm
Levels/Manageme
nt 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.

30

K180472

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.

WWW.SOTERAWIRELESS.COM

a) GENERAL COMPARISON
Comment and
Comparison	Characteristic	Proposed Device
ViSi Mobile Monitoring System
510(k) #: K180472	ViSi Mobile Monitoring System
510(k) #: K142827
	Levels/Manageme
nt
Connected/Linked

B) ARRHYTHMIA DETECTION METHOD COMPARISON
Comment and
Comparison	Characteristic	Proposed Device
ViSi Mobile Monitoring System
510(k) #: K180472	ViSi Mobile Monitoring System
510(k) #: K142827
Enhanced in the
Proposed Device
Based on Best
Available
Technology	Asystole	Absence of heat beats for a pre-defined adjustable
period between 4 - 15 seconds	Absence of any ‘QRS’ complexes for at least 4 seconds
	Ventricular
Fibrillation	Adaboost multi decision tree classifier and 4 ECG
derived features	A rhythm with rapid irregular waves and no
distinguishable ‘P’ waves or ‘QRS’ complexes
	Ventricular
Tachycardia		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 higher
than user predetermined heart rate (Section)	An irregular rhythm with the absence of "p"
waves (Afib) or the dissociation of "p" waves to
QRS 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.

www.soterawireless.com

B) ARRHYTHMIA DETECTION METHOD COMPARISON
Comment and
Comparison	Characteristic	Proposed Device
ViSi Mobile Monitoring System
510(k) #: K180472	ViSi Mobile Monitoring System
510(k) #: K142827
	Atrial Flutter	None
	Artifact / Noisy
Signal	None	Spikes, or other 'noise' seen on the ECG trace
due to motion, electrical interference, etc. that
interfere with heart rate and rhythm analysis for
at least 2 seconds.
	Unclassified
Rhythm	None	A rhythm or 'QRS' complex that cannot be
identified, and is not artifact for at least 2
seconds.

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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

33

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.

K180472

D. ARRHYTHMIA ALARM COMPARISON

S: Subject Device RA: Reference Device A

| Display Message | | Alarm Symbol | | Basic Arrhythmia Event | | Alarm Type | | Same or
Different |
|-----------------|----------------------|---------------------|---------------------|----------------------------------------------------------------------------|-----------------------------|---------------------------------|------------------|----------------------|
| 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 | Ventricular
Tachycardia | Ventricular
Tachycardia | Life Threatening | Life Threatening | Same |
| | VFIB | Image: Alarm Symbol | Image: Alarm Symbol | Ventricular
Fibrillation | Ventricular
Fibrillation | Life Threatening | Life Threatening | Same |
| AFIB RVR | AFIB/AFLU | Image: Alarm Symbol | Image: Alarm Symbol | Atrial Fibrillation
with specified heart
rate above the set
limit | Atrial
Fibrillation | High Severity | High Severity | Same |
| AFIB | | Image: Alarm Symbol | Image: Alarm Symbol | Atrial Fibrillation
with specified heart
rate below the set
limit | Atrial
Fibrillation | General Non-Life
Threatening | High Severity | Different |

34

K180472

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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