VISI MOBILE MONITORING SYSTEM

K122036 · Sotera Wireless, Inc. · MWI · Aug 15, 2012 · Cardiovascular

Device Facts

• Record ID: K122036
• Device Name: VISI MOBILE MONITORING SYSTEM
• Applicant: Sotera Wireless, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Aug 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), 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. The ViSi Mobile Monitoring System may be used as standalone devices or networked to central station through wireless 802.11 communication.

Device Story

Body-worn, portable vital signs monitor; measures ECG, heart rate, SpO2, pulse rate, respiration rate, temperature, and NIBP. Inputs: physiological signals via sensors; NIBP via automated or manual intervals. Outputs: waveforms and vital sign data on high-resolution touch screen; visual/audible alarms. Used by clinicians/medically qualified personnel in hospital environments (med-surg, intermediate care, ED). Standalone or networked via 802.11 wireless to central station. Facilitates continuous patient monitoring; enables timely clinical intervention based on real-time data.

Clinical Evidence

Bench testing only. The device was evaluated for performance, safety, and electromagnetic compatibility against recognized standards. Wireless connectivity was validated per FDA draft guidance.

Technological Characteristics

Body-worn monitor with high-resolution touch screen. Measures ECG (3/5 lead), SpO2, respiration, heart rate, NIBP, and temperature. Connectivity via 802.11 wireless. Standalone or networked operation.

Indications for Use

Indicated for adult patients in hospital settings (general medical-surgical, intermediate care, emergency departments) requiring monitoring of ECG, respiration rate, heart rate, NIBP, 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 (K112478)
• Propaq LT VSM, Model 802 Series (K033378)
• Micropaq VSM, Models 402, 404 (K002725)
• Acuity Central Monitoring Station Predicate (K022453)

Submission Summary (Full Text)

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Sotera

WIRELES

# 510(k) Summary

AUG 1 5 2012

www.soterawireless.com

| Date prepared | May 30, 2012 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Sotera Wireless, Inc.<br>9444 Waples Street, Suite 280<br>San Diego, CA 92121<br>T. 858.373.4841; F. 858.427.4639 |
| Contact person | Eben Gordon<br>Senior Director, Regulatory |
| Trade name | ViSi Mobile Monitoring System |
| Common name | Vital signs monitor |
| Classification name | Cardiac monitor (including cardiotachometer and rate alarm) |
| Classification regulation | 21 CFR 870.2300 |
| Product code | MWI, DRT, DXN, DQA and FLL |
| Predicate device | ViSi Mobile Monitoring System (K112478)<br>Propaq LT VSM, Model 802 Series (K033378)<br>Micropaq VSM, Models 402, 404 (K002725)<br>Acuity Central Monitoring Station Predicate (K022453) |
| Description | The ViSi Mobile Monitoring System is a lightweight, portable patient vital<br>signs monitor featuring a high resolution, full color touch screen display,<br>with visual and audible alarms and alerts. The ViSi Mobile Monitor is<br>body-worn and designed to continuously measure ECG, heart rate, SpO2,<br>pulse rate, respiration rate, and temperature. The ECG, SpO2, and<br>Respiration waveforms are viewable on demand. NIBP can be measured as<br>a onetime measurement, or it can be measured automatically at predefined<br>intervals. |
| 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<br>monitoring of adult patients. It is indicated for ECG (3 or 5 leadwire),<br>respiration rate, heart rate, non-invasive blood pressure, non-invasive<br>monitoring of functional oxygen saturation of arterial hemoglobin, pulse<br>rate, and skin temperature in hospital-based facilities; including general<br>medical-surgical floors, intermediate care floors, and emergency<br>departments.<br>The ViSi Mobile Monitoring System may be used as standalone devices or<br>networked to a central station through wireless 802.11 communication. |
| Summary of substantial<br>equivalence | The ViSi System has been tested and complies with recognized<br>performance, safety, and electromagnetic compatibility standards for<br>medical devices. The verification and validation activities performed based |

k122036

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122036 page 2/

the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection. These results demonstrate that the ViSi System is safe, as effective, and based on the similarities with the predicate devices, substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.

### Public Health Service

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

AUG 15 2012

Sotera Wireless, Inc c/o Mr. Mark Job Third Party Reviewer: Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K122036

Trade Name: ViSi Mobile Monitoring System Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Including Cardiotachometer and Rate Alarm Regulatory Class: II (two) Product Code: MWI, DRT, DXN, DQA, FLL Dated: July 30, 2012 Received: July 31, 2012

Dear Mr. Job:

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

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Page 2 - Mr. Job

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 (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.fda.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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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## k122036

Sotera Wireless, Inc. ViSi Mobile Monitoring System Traditional 510(k)

#### INDICATIONS FOR USE 4

510(k) Number (if known): _KI2Zo36

Device Name: ________________________________ ViSi Mobile Monitoring System _

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. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), 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.

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

Prescription Use . X

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) Page __ of ___________________________________________________________________________________________________________________________________________________________________ (Division Sigh-Off) Division of Cardiovascular Devices 510||k) Number

5/31/2012

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