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), 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.

Device Description

The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.

AI/ML Overview

This document describes the ViSi Mobile Monitoring System, a vital signs monitor. However, the provided text does not contain the detailed study information required to fully answer all aspects of your request regarding acceptance criteria and performance study specifics. Specifically, it lacks quantitative performance data, sample sizes for test sets, details on expert panels, adjudication methods, or MRMC study results.

Based on the available information, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document mentions that acceptance criteria were met, but it does not provide specific numerical criteria or reported device performance metrics in a table format. It states: "The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set, nor does it provide information on data provenance (country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers, so such a study would likely not be applicable in this context. The modifications are related to posture tracking and associated alarms.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document implies that standalone performance testing of the algorithms was conducted, specifically:

"SVT-000061 - Walking Algorithm Software Verification"
"SVT-000062 Undesirable Posture, Immobility and Fall Detection . Software verification"
"TP-670 – Undesirable Posture Alarms Validation"
"TP-671 Immobility Alarms Validation"
"TP-672 Patient Fall Alarm Validation"
". TP-673 - Posture Definitions and Walking Validation"

These tests suggest evaluating the algorithms' accuracy in detecting posture, immobility, and falls. However, the specific metrics or acceptance criteria for these standalone tests are not provided in the summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for the posture, immobility, and fall detection features. Given the nature of these features, ground truth would likely involve:

Direct observation: Human observers physically verifying the patient's posture, movement, or fall event.
Reference sensors/equipment: Other validated sensors (e.g., accelerometers, video analysis) used as a gold standard to establish true states.

8. The sample size for the training set

The document does not provide any information regarding the sample size for the training set.

9. How the ground truth for the training set was established

The document does not provide any information on how the ground truth for the training set was established.

Summary of available information regarding acceptance criteria and performance study:

The device under review is the ViSi Mobile Monitoring System, which added new posture alarm features (undesirable posture, immobility, patient fall) and the ability to display if a patient is walking.

Acceptance Criteria and Reported Performance:

Acceptance Criteria for new features: The document generally states that "all acceptance criteria were met." However, the specific, quantitative acceptance criteria for each new feature (undesirable posture alarm, immobility alarm, patient fall alarm, walking detection) are not detailed.
Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for these features within this document. The statement is qualitative: "The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use."

Study Information (Inferred/Partial):

Type of Study: Non-clinical performance (verification and validation) testing.
Test Set Sample Size: Not specified.
Data Provenance: Not specified.
Experts for Ground Truth: Not specified.
Adjudication Method: Not specified.
MRMC Study: Not applicable/not performed for this type of device modification.
Standalone Performance: Yes, algorithm-only performance was evaluated through various software verification and validation tests related to walking, undesirable posture, immobility, and fall detection.
Ground Truth Type: Not explicitly stated but likely involved direct observation or comparison with reference sensors for posture and movement.
Training Set Sample Size: Not specified.
Training Set Ground Truth Establishment: Not specified.

In conclusion, while the document confirms that verification and validation testing was conducted and acceptance criteria were met for the new posture features, it lacks the granular detail about the studies themselves, including specific performance metrics, sample sizes, and ground truth methodologies.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 30, 2015

Sotera Wireless, Inc. Carson Krupp Product Risk Assurance Engineer 10020 Huennekens Street San Diego, California 92121

Re: K150361

Trade/Device Name: ViSi Mobile Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DRT, DXN, FLL, DQA Dated: April 1, 2015 Received: April 2, 2015

Dear Carson Krupp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

heerely yours,

forBram 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) K150361

Device Name ViSi Mobile Monitoring System

Indications for Use (Describe)

The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.

Type of Use (Select one or both, as applicable)
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X 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/1 description: The image shows the logo for Sotera Wireless. The word "Sotera" is written in a bold, black font. Above the word "Sotera" is a blue heart with a wireless signal coming from it. Below the word "Sotera" is a blue line, and below that is the word "WIRELESS" in a smaller, blue font.

510(K) SUMMARY 7

Date prepared	March 25, 2015
Name	Sotera Wireless, Inc.10020 Huennekens StSan Diego, CA 92121T. 858.427.4620; F. 858.999.2487
Trade name	ViSi Mobile Monitoring System
Common name	Vital signs monitor
Regulation Name	Cardiac Monitor Including Cardiotachometer and Rate Alarm
Classification number	21 CFR 870.2300
Product code	MWI, DRT, DXN, DQA, FLL
Regulatory class	II
Predicate devices	ViSi Mobile Monitoring System; K143751 (Clearance: 01/23/2015)
Description	The ViSi Mobile Monitoring System is a lightweight, body-worn vital signsmonitor featuring a high resolution, full color touch screen display, with visualand audible alarms and alerts. The ViSi Mobile Monitor is designed tocontinuously non-invasively measure ECG, heart rate, SpO2, blood pressure,pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respirationwaveforms are viewable on demand. The ViSi Mobile Monitoring System iscapable of one-time and continuous NIBP measurements.
Indications for use	The ViSi Mobile Monitoring System is intended for use by clinicians andmedically qualified personnel for single or multi-parameter vital signs monitoringof 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 offunctional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), andskin 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 ornetworked to ViSi Mobile Remote Viewers through wireless 802.11communication.

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Device	Modified ViSi System w/PostureFeature Set [510(k) TBD]	ViSi SystemPredicate (K143751)
Manufacturer	Same as ViSi System (Predicate)	Sotera Wireless, Inc.
Intended Use	Same as ViSi System (Predicate)	The ViSi Mobile Monitoring System isintended for use by clinicians and medicallyqualified personnel for single or multi-parameter vital signs monitoring of adultpatients (18 years or older). It is indicated forECG (3 or 5 lead-wire), respiration rate(RESP), heart rate (HR), noninvasive bloodpressure (NIBP), continuous noninvasiveblood pressure (cNIBP), noninvasivemonitoring of functional oxygen saturation ofarterial hemoglobin (SpO2), pulse rate (PR),and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, andemergency departments.The ViSi Mobile Monitoring System may beused as standalone devices or networked toViSi Mobile Remote Viewers through wireless802.11 communication.
Parameters monitored anddisplayed	Same as ViSi System (Predicate)	Electrocardiogram (ECG), respiration rate,blood oxygen saturation (SpO2), non-invasiveblood pressure (NIBP), continuousnoninvasive blood pressure (cNIBP), pulserate, heart rate, temperature
Posture Tracking	Posture (standing/sitting-up, reclined,supine) is displayed on the RVD /PWD and required to set-up cNIBP.Patient Walking can be displayed.Alarm features annunciate onundesirable postures, immobility andpatient falls.	Posture (standing/sitting-up, reclined, supine)is displayed on the RVD / PWD and requiredto set-up cNIBP.
Patient population	Same as ViSi System (Predicate)	Adults ≥ 18 years
Environment of Use	Same as ViSi System (Predicate)	Hospital-based facility including emergencydepartments, general medical-surgical andintermediate care floors.
System Design	Same as ViSi System (Predicate)	Patient monitor displays vital signs andwaveforms. Communicates to server viawireless access point.Server is hardwired to display PC.
ECG Leads	Same as ViSi System (Predicate)	3-wire: II5-wire: I, II, III, AVL, AVR, AVF, V
Radio Frequency Telemetry	Same as ViSi System (Predicate)	802.11
Alarm Annunciation	Same as ViSi System (Predicate)	Monitor, Central Station (server-connectedPC)
Alarm levels/mgmt.connected/linked	Same as ViSi System (Predicate)	Vital Signs

Substantial Equivalence Table

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Summary of substantial equivalence

The device design, technology, materials, processes, etc. have not been changed with this application. The modifications were to add the following posture alarm features: (1) undesirable posture technical alarm, (2) patient immobility technical alarm, and (3) patient fall alarm. (4) The last modification allows the system to display if the patient is walking along with the already existing ability to display if a patient is upright, reclined or lying-down. This modification is purely a visual icon and has no associated alarms. All four modifications were implemented to provide clinicians with information that will increase patient safety.

Non-clinical performance (verification and validation) testing of the aforementioned features was completed to confirm that the features, as implemented, met all requirements. Verification testing included code reviews, static testing and algorithm monitoring to ensure it performed as intended. Design validation testing consisted of the following tests:

Code Reviews, Static Testing, Unit Testing
SVT-000061 - Walking Algorithm Software Verification
SVT-000062 Undesirable Posture, Immobility and Fall Detection . Software verification
TP-670 – Undesirable Posture Alarms Validation
TP-671 Immobility Alarms Validation ●
TP-672 Patient Fall Alarm Validation ●
. TP-673 - Posture Definitions and Walking Validation

The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use.

Therefore the ViSi Mobile Monitoring System is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).