Vios Central Station Monitor Software, Vios Central Server Software

K173107 · Vios Medical, Inc. · DXJ · Jul 26, 2018 · Cardiovascular

Device Facts

• Record ID: K173107
• Device Name: Vios Central Station Monitor Software, Vios Central Server Software
• Applicant: Vios Medical, Inc.
• Product Code: DXJ · Cardiovascular
• Decision Date: Jul 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2450
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Vios CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM/CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.

Device Story

Vios Central Station Monitor/Central Server Software (Model 2050) functions as a centralized monitoring system within healthcare facilities. It receives, stores, manages, and displays patient physiological data, waveforms, and alarms generated by Vios proprietary vitals monitoring software. The system operates in a networked mode on commercial IT equipment. The Central Server Software acts as a communications hub, transmitting data to remote viewing software without modification. The Central Station Monitor software allows visualization of up to 16 devices on a single screen. Operated by healthcare professionals, the system facilitates clinical oversight of patient status, enabling timely response to alarms and physiological changes. It benefits patients by providing continuous, centralized monitoring capabilities.

Clinical Evidence

No clinical data. Performance evaluated through non-clinical bench testing, including software development life cycle (IEC 62304), design verification and validation testing, and risk management (ISO 14971).

Technological Characteristics

Software-based central monitoring system running on commercial IT hardware. Functions as a communications hub and remote viewing interface. Supports display of up to 16 devices. Complies with IEC 62304 for software development and ISO 14971 for risk management.

Indications for Use

Indicated for healthcare professionals to perform centralized monitoring of patient physiological data, waveforms, and alarms within a healthcare facility.

Regulatory Classification

Identification

A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

Predicate Devices

• GE Healthcare CARESCAPE Central Station v2 (K162012)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 26, 2018

Vios Medical, Inc. Megan Graham Quality Regulatory Adviser 7300 Hudson Blvd N St. Paul, Minnesota 55128

Re: K173107

Trade/Device Name: Vios Central Station Monitor/Vios Central Server Software 2050 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: September 28, 2017 Received: September 29, 2017

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 Part 807); labeling (21 CFR Part 801); medical device 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);

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# Page 2 - Megan Graham

1000-1050.

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Arielle Drummond -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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# Indications for Use

510(k) Number (if known) K173107

#### Device Name

Vios Central Station Monitor/Central Server Software Model 2050

Indications for Use (Describe)

The Vios CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM/CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.

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

| <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 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: | September 28, 2017 |
| Trade Name: | Vios Central Station Monitor/Central Server Software Model 2050 |
| Common Name: | Central monitoring software |
| Regulation: | 21 CFR Part 870.2450 Medical cathode-ray tube display |
| Classification: | Class II |
| Review Panels: | Cardiovascular |
| Product Codes: | DXJ |
| Predicate Device: | GE Healthcare CARESCAPE Central Station v2 (reference K162012) |
| Device Description: | The Vios CS SW enables the Vios Monitoring System to be used in networked<br>mode within a healthcare IT network and runs on commercial IT equipment. |
| | The Vios CS SW operates as a communications hub that can pass the data<br>generated by Vios proprietary vitals monitoring software to one or more<br>remote viewing software applications, without modifying the data. |
| | The Vios CSM SW is the remote viewing software of the Model 2050 system.<br>It allows up to 16 devices to be displayed on one screen and runs on a<br>commercial IT device that satisfies defined Vios-defined technical<br>specifications. |
| Indications for Use: | The Vios CSM/CS Software is indicated for use by healthcare professionals<br>for the purpose of centralized monitoring of patient data within a healthcare<br>facility. The Vios CSM/CS SW receives, stores, manages, and displays patient<br>physiological and waveform data and alarms generated by Vios proprietary<br>patient vitals monitoring software. |
| Summary of<br>Substantial<br>Equivalence: | The Vios CSM/CS SW Model 2050 is substantially equivalent to the predicate<br>device with respect to central station monitoring in a healthcare facility<br>(product code DXJ). Both the Vios CSM/CS SW Model 2050 and its<br>predicates meet the same standards of safety and efficacy. Risk analysis of<br>Vios CSM/CS SW Model 2050 demonstrates that no additional risks are<br>introduced. Additional functionality of the predicates is outside the scope of<br>the Vios CSM/CS SW Model 2050. |
| Non-Clinical<br>Testing: | The performance of the Vios CSM/CS SW Model 2050 has been evaluated<br>through non-clinical testing and analysis: |
| | System and Subsystem Software Development Life Cycle (62304) System and Subsystem Design Verification and Validation Testing System and Subsystem Risk Management (14971) |
| Conclusion: | Vios Medical considers the Vios CSM/CS Software Model 2050 to<br>substantially equivalent to the legally marketed predicate device. |

K173107
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