Vios Monitoring System

K150992 · Vios Medical, Inc. · DRT · Dec 16, 2015 · Cardiovascular

Device Facts

• Record ID: K150992
• Device Name: Vios Monitoring System
• Applicant: Vios Medical, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Dec 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological and vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of ECG, heart rate, pulse rate, functional oxygen saturation of arterial hemoglobin, and axillary temperature. VMS allows for the input of non-invasive blood pressure and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.

Device Story

Vios Monitoring System (VMS) monitors adult patients in healthcare facilities; operated by medically qualified personnel. System receives physiological data (ECG, heart rate, pulse rate, SpO2, axillary temperature, non-invasive blood pressure) from sensors and peripheral devices. Software processes and displays vitals; generates alerts for rate-based cardiac arrhythmias or out-of-range physiological parameters. Operates in stand-alone or networked modes using standard IT equipment/protocols. Enables clinician oversight of patient status; facilitates timely clinical intervention based on real-time monitoring and alarm notifications.

Clinical Evidence

Bench testing only. Verification and validation included standards compliance (IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-27, 60601-2-49), formative and summative usability testing, reliability/performance testing, and transportation simulation.

Technological Characteristics

System components include bedside monitor software running on commercial IT equipment. Supports stand-alone or networked operation via standard protocols. Conforms to IEC 60601 series (safety/EMC), ISO 14971 (risk), IEC 62304 (software lifecycle), IEC 62366 (usability), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for physiological and vital signs monitoring of adult (18+) patients in healthcare facilities. Monitors ECG, heart rate, pulse rate, SpO2, and axillary temperature; allows input of non-invasive blood pressure and peripheral device data.

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)
• VitalConnect Platform (K141167)

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

December 16, 2015

Vios Medical, Inc. Megan Graham Quality And Regulatory Advisor 7300 Hudson Blvd N. Ste 140 St. Paul, Minnesota 55128

Re: K150992

Trade/Device Name: Vios Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: DRT, DRG, FLL Dated: November 16, 2015 Received: November 17, 2015

Dear Megan Graham:

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 of medical devicerelated 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.

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,

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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#### Page 1 of 1

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K150992

Device Name Vios Monitoring System

### Indications for Use (Describe)

The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological and vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of ECG, hear rals, pull si rate, functional oxygen saturation of arterial hemoglobin, and axillary temperature. VMS allews for your and invasive blood pressure and can display data from peripheral devices. VMS can generate alserts when on notiac arrhythmias are detected and when physiological vital signs fall outside of selected paramaters.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 7. 510(k) Summary

| Submitter: | Vios Medical, Inc.<br>7300 Hudson Rd Blvd N<br>Suite 140<br>St. Paul, MN 55128 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Megan Graham<br>Quality and Regulatory Advisor<br>[e-mail]<br>Office: 651-764-8467<br>Fax: [phone] |
| Date Prepared: | April 28, 2015 |
| Trade Name: | Vios Monitoring System™ |
| Common Name: | Vitals signs monitor |
| Regulation<br>Classification: | 21 CFR 870.2300 Cardiac Monitor including Cardiotachometer<br>& Rate Alarm (Class II, Cardiovascular) 21 CFR 890.2910 Transmitters And Receivers, Physiological<br>Signal, Radiofrequency (Class II, Cardiovascular) 21 CFR 880.2910 Clinical Electronic Thermometer (Class II<br>exempt, General Hospital) |
| Review Panel: | Cardiovascular |
| Product Codes: | DRT, DRG, FLL |
| Predicate<br>Devices: | ViSi Mobile Monitoring System (K143751) for vitals monitoring<br>and temperature VitalConnect Platform (K141167) for physiological data<br>transmission and receipt |
| Device<br>Description: | The Vios Monitoring System includes the following components:<br>Bedside Monitor Software (BSM SW): Medical device software<br>that analyzes and/or displays vitals data received via standard<br>communication protocols from one or more compatible sensors<br>or peripheral devices. The software runs on standard<br>commercial IT equipment and can operate in stand-alone mode<br>or networked mode using standard networking protocols. In<br>networked mode, it can share its display with one or more |
| Indications for<br>Use: | The Vios Monitoring System (VMS) is intended for use by<br>medically qualified personnel for physiological and vital signs<br>monitoring of adult (18+) patients in healthcare facilities. It is<br>indicated for use in monitoring of ECG, heart rate, pulse rate,<br>functional oxygen saturation of arterial hemoglobin, and axillary<br>temperature. VMS allows for the input of non-invasive blood<br>pressure and can display data from peripheral devices. VMS can<br>generate alerts when rate-based cardiac arrhythmias are detected<br>and when physiological vital signs fall outside of selected<br>parameters. |
| Summary of<br>Substantial<br>Equivalence: | The Vios Monitoring System is substantially equivalent to the<br>predicate devices with respect to vitals signs monitoring in a<br>healthcare facility (product codes DRT, DRG, and FLL). Both the<br>VMS and its predicates are wireless vitals monitoring systems that<br>can operate in stand-alone or networked mode. Additional<br>functionality of the predicate devices is outside the scope of the<br>Vios Monitoring System.<br><br>The safety and effectiveness of the Vios Monitoring System design<br>have been confirmed through non-clinical testing and conformance<br>to vital signs monitoring, electrical safety (60601), electromagnetic<br>compatibility (60601), usability (62366), risk management (14971),<br>software development lifecycle (62304), and biocompatibility<br>standards (10993). |
| Non-Clinical<br>Testing: | The following bench testing was conducted to demonstrate safety<br>and efficacy of the Vios Monitoring System:<br>Design Verification and Validation Standards Compliance Testing (60601-1, 60601-1-2,<br>60601-1-8, 60601-2-27, and 60601-2-49) Usability Testing (Formative and Summative) Reliability and Performance Testing Transportation Simulation Testing |
| Conclusion: | Vios Medical considers the Vios Monitoring System to be safe,<br>effective, and substantially equivalent to the legally marketed<br>predicate devices. |

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