ViSi Mobile Monitoring System

K150361 · Sotera Wireless, Inc. · MWI · Apr 30, 2015 · Cardiovascular

Device Facts

• Record ID: K150361
• Device Name: ViSi Mobile Monitoring System
• Applicant: Sotera Wireless, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Apr 30, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

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), 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 Story

Body-worn vital signs monitor; measures ECG, HR, SpO2, NIBP, cNIBP, respiration, and temperature. Features high-resolution touch screen; provides visual/audible alarms. System includes posture tracking (standing, sitting, reclined, supine, walking) and fall/immobility detection. Used in hospital settings by clinicians; data transmitted via 802.11 wireless to remote viewers/central stations. Output informs clinical decision-making regarding patient status and safety. Benefits include continuous monitoring and automated alerts for undesirable postures or falls.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included code reviews, static testing, unit testing, and specific software verification/validation protocols for posture, immobility, and fall detection algorithms (SVT-000061, SVT-000062, TP-670, TP-671, TP-672, TP-673). All acceptance criteria were met.

Technological Characteristics

Body-worn monitor with touch screen display. Connectivity via 802.11 wireless. Parameters: ECG (3/5 lead), SpO2, NIBP/cNIBP, respiration, temperature. Software-based posture tracking and alarm management. No changes to core materials or energy source from predicate.

Indications for Use

Indicated for adult patients (≥18 years) in hospital settings (general medical-surgical, intermediate care, emergency departments) requiring monitoring of ECG, respiration rate, heart rate, NIBP, cNIBP, SpO2, pulse rate, and skin temperature.

Regulatory Classification

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.

Predicate Devices

• ViSi Mobile Monitoring System (K143751)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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.<br>10020 Huennekens St<br>San Diego, CA 92121<br>T. 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 signs<br>monitor featuring a high resolution, full color touch screen display, with visual<br>and audible alarms and alerts. The ViSi Mobile Monitor is designed to<br>continuously non-invasively measure ECG, heart rate, SpO2, blood pressure,<br>pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration<br>waveforms are viewable on demand. The ViSi Mobile Monitoring System is<br>capable of one-time and continuous NIBP measurements. |
| Indications for use | The ViSi Mobile Monitoring System is intended for use by clinicians and<br>medically qualified personnel for single or multi-parameter vital signs monitoring<br>of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire),<br>respiration rate (RESP), heart rate (HR), noninvasive blood pressure (NIBP),<br>continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of<br>functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and<br>skin temperature (TEMP) in hospital-based facilities; including, general medical-<br>surgical floors, intermediate care floors, and emergency departments.<br>The ViSi Mobile Monitoring System may be used as standalone devices or<br>networked to ViSi Mobile Remote Viewers through wireless 802.11<br>communication. |

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| Device | Modified ViSi System w/Posture<br>Feature Set [510(k) TBD] | ViSi System<br>Predicate (K143751) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Same as ViSi System (Predicate) | Sotera Wireless, Inc. |
| Intended Use | Same as ViSi System (Predicate) | The ViSi Mobile Monitoring System is<br>intended for use by clinicians and medically<br>qualified personnel for single or multi-<br>parameter vital signs monitoring of adult<br>patients (18 years or older). It is indicated for<br>ECG (3 or 5 lead-wire), respiration rate<br>(RESP), heart rate (HR), noninvasive blood<br>pressure (NIBP), continuous noninvasive<br>blood pressure (cNIBP), noninvasive<br>monitoring of functional oxygen saturation of<br>arterial hemoglobin (SpO2), pulse rate (PR),<br>and skin temperature (TEMP) in hospital-<br>based facilities; including, general medical-<br>surgical floors, intermediate care floors, and<br>emergency departments.<br>The ViSi Mobile Monitoring System may be<br>used as standalone devices or networked to<br>ViSi Mobile Remote Viewers through wireless<br>802.11 communication. |
| Parameters monitored and<br>displayed | Same as ViSi System (Predicate) | Electrocardiogram (ECG), respiration rate,<br>blood oxygen saturation (SpO2), non-invasive<br>blood pressure (NIBP), continuous<br>noninvasive blood pressure (cNIBP), pulse<br>rate, heart rate, temperature |
| Posture Tracking | Posture (standing/sitting-up, reclined,<br>supine) is displayed on the RVD /<br>PWD and required to set-up cNIBP.<br>Patient Walking can be displayed.<br>Alarm features annunciate on<br>undesirable postures, immobility and<br>patient falls. | Posture (standing/sitting-up, reclined, supine)<br>is displayed on the RVD / PWD and required<br>to 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 emergency<br>departments, general medical-surgical and<br>intermediate care floors. |
| System Design | Same as ViSi System (Predicate) | Patient monitor displays vital signs and<br>waveforms. Communicates to server via<br>wireless access point.<br>Server is hardwired to display PC. |
| ECG Leads | Same as ViSi System (Predicate) | 3-wire: II<br>5-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-connected<br>PC) |
| Alarm levels/mgmt.<br>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.