VISI MOBILE MONITORING SYSTEM
Device Facts
| Record ID | K130709 |
|---|---|
| Device Name | VISI MOBILE MONITORING SYSTEM |
| Applicant | Sotera Wireless, Inc. |
| Product Code | MWI · Cardiovascular |
| Decision Date | Oct 7, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
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 (18 years or older) patients. It is indicated for ECG (3 or 5 leadwire), 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 medical-surgical floors, intermediate care floors, and emergency departments. Continuous non-invasive blood pressure (cNIBP) testing has not been conducted on ambulatory patients.
Device Story
ViSi Mobile Monitoring System is a body-worn, lightweight vital signs monitor with a high-resolution touch screen. It continuously measures ECG, heart rate, SpO2, blood pressure (NIBP and cNIBP), pulse rate, respiration rate, and skin temperature. Operated by clinicians in hospital settings, it provides visual and audible alarms. The device transforms physiological signals into real-time waveforms and numerical vital sign data. Clinicians use the display to monitor patient status, facilitating clinical decision-making through continuous surveillance. The system benefits patients by enabling non-invasive, continuous monitoring of critical parameters, potentially allowing for earlier intervention. The device supports both one-time and continuous NIBP measurements.
Clinical Evidence
Clinical performance validation was conducted to assess the accuracy of intermittent NIBP MAP and cNIBP measurements. The study compared device performance against an intra-arterial reference standard. Results demonstrated compliance with ISO 81060-2 requirements, achieving a mean error of ≤ ± 5 mmHg and a standard deviation of ≤ 8 mmHg, consistent with consensus standards for automated non-invasive blood pressure monitors.
Technological Characteristics
Body-worn monitor with touch screen display. Measures ECG, SpO2, NIBP/cNIBP, respiration, pulse, and temperature. Complies with IEC 60601-1-8 (alarms), IEC 80601-2-30 (blood pressure), IEC 62304 (software lifecycle), ISO 81060-2 (NIBP accuracy), and IEC 62366 (usability).
Indications for Use
Indicated for adult patients (18+ years) in hospital settings (general medical-surgical, intermediate care, emergency departments) for monitoring ECG, respiration, heart rate, NIBP, cNIBP, SpO2, pulse rate, and skin temperature. cNIBP is contraindicated for ambulatory patients.
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
Submission Summary (Full Text)
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WIRELESS
## 5 510(K) SUMMARY
| Date prepared | June 11, 2013 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Sotera Wireless, Inc.<br>9444 Waples Street, Suite 280<br>San Diego, CA 92121<br>T. 858.373.4841; F. 858.427.4639<br>OCT 07 2013 |
| Contact person | Eben Gordon<br>Senior Director, Regulatory |
| 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; K112478 (Clearance: 3/27/2012)<br>CNAP Monitor 500i, 500at; K082599 (Clearance: 10/17/2008) |
| 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 (18 years or older) patients. It is indicated for ECG (3 or 5 leadwire),<br>respiration rate, heart rate, non-invasive blood pressure (NIBP), continuous non-<br>invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen<br>saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature in<br>hospital-based facilities; including general medical-surgical floors, intermediate<br>care floors, and emergency departments. |
| | Continuous non-invasive blood pressure (cNIBP) testing has not been conducted<br>on ambulatory patients. |
| Summary of<br>substantial equivalence | The ViSi System has the following similarities and differences with the indicated<br>predicate devices: |
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- . Intended use - The ViSi System has the same vital sign monitoring intended use as the ViSi System and CNAP Monitors. The cNIBP measurement of the ViSi System is the same as the CNAP Monitor.
- . Device Performance - The modified ViSi System with intermittent NIBP MAP and cNIBP measurements have been clinically validated to meet the same performance requirements (mean error ≤ ± 5 mmHg; standard deviation ≤ 8 mmHg) as outlined in the consensus standards for automated non-invasive blood pressure monitors.
- . Technology - The ViSi System is unchanged from it predicate submission except for the display of intermittent NIBP MAP readings and the continuous non-invasive blood pressure (cNIBP) measurements.
The intermittent NIBP MAP measurement is based on the same technology as is currently in the cleared ViSi System and is equivalent to the CNAP Monitor. The ViSi's MAP measurement has been validated by comparison to an intra-arterial reference and meets the performance requirements of ISO 81060-2.
The ViSi's cNIBP measurement has a different principle of operation from that of the CNAP Monitor predicate device. Both methods are similar in that pressure is determined on a beat-to -beat basis and are joint solutions employing automatic calibration to NIBP measurements.
The question of effectiveness of the cNIBP measurement has been addressed by the clinical performance validation to the requirements of ISO 81060-2, an equivalent consensus standard to which the CNAP Monitor meets (i.e. AAMVANSI SP10).
The safety and effectiveness of the design elements implemented into the ViSi System have been confirmed by their compliance to the prevailing standards. The ViSi System has demonstrated compliance with the following consensus standards: IEC 60601-1-8, IEC 80601-2-30, IEC 62304, ISO 81060-2, and IEC 62366.
General Safety and Effectiveness Concerns - The instructions for use for the ViSi System contains the necessary cautions and warnings to provide for safe and effective use of the device.
The ViSi System has successfully undergone 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, Bench testing, and Clinical performance testing.
The ViSi System have been tested and found to comply with recognized performance 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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 7, 2013
Sotera Wireless, Inc. Attn: Mr. Eben Gordon Sr. Director, Regulatory Affairs 9444 Waples St., Suite 280 San Diego, CA 92121
Re: K130709
Trade/Device Name: Visi Mobile Monitoring System, Model 92-10010 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (Two) Product Code: MWI, DRT, DXN, DQA and FLL Dated: September 30, 2013 Received: October 1, 2013
Dear Mr. Gordon:
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.
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## Page 2 – Mr. Eben Gordon
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 (reporting of medical device-related 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 go to http://www.ida.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
## Owen P. Faris -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4 INDICATIONS FOR USE
510(k) Number (if known): K130709_
ViSi Mobile Monitoring System __ Device Name:
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 ( 18 years or older) patients. It is indicated for ECG (3 or 5 leadwire), respiration rate, non-invasive blood pressure (NIBP), continuous noninvasive 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 medical-surgical floors, intermediate care floors, and emergency departments.
Continuous non-invasive blood pressure (cNIBP) testing has not been conducted on ambulatory patients.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over the Counter Use __
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by
Owen P. Faris -S
Date: 2013.10.07
15:13:05 -04'00'
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