The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when rate-based carthythmias are detected and when physiological vital signs fall outside of selected parameters.

Device Description

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. VMS includes Vios-proprietary monitoring software and a Vios-proprietary vitals sensor with two Vios-proprietary adapters. It is compatible with a medical grade, Bluetooth™-enabled NIBP cuff. The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices. The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile, multiple use, and rechargeable sensor that acquires 3-channel ECG, bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data. The sensor contains signal acquisition firmware (embedded software) and wirelessly communicates acquired data via standard communication protocols (Bluetooth™) to the BSM SW for analysis and display. The Chest Sensor has a button that, when pressed, sends a patient call alert to the BSM SW. VMS Chest Sensor Adapter Models L2050E (Pulse Ox Ear Adapter) and L2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn, multiple use pulse oxygenation sensors that connect to the Vios Chest Sensor and are secured to the patient via medical grade ECG electrodes.

AI/ML Overview

The provided text is a 510(k) Summary for the Vios Monitoring System™ Model 2050. This document outlines the device's intended use, regulatory information, and a summary of the testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain specific details about acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection), the sample size of a test set, the number and qualifications of experts for ground truth establishment, adjudication methods, or effects of AI assistance on human readers.

The text focuses on hardware and software description, regulatory compliance, and general types of testing conducted (electrical safety, biocompatibility, usability, software development lifecycle, specific clinical testing for pulse oximetry and respiratory rate). It mentions that "VMS can generate alerts when rate-based cardiac arrhythmias are detected," but does not provide performance metrics for this specific function in the context of acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The information required for your questions (especially points 1-7, and 9) is not present in this 510(k) Summary.

Here's an overview of what is mentioned in relation to testing, which is very high-level:

Summary of Non-Clinical, Clinical, and Conformance Testing:
The document states that "The safety, effectiveness, and substantial equivalency of the VMS Model 2050 have been confirmed through the following non-clinical, clinical, and conformance testing:"

Non-clinical:
- Electrical safety, EMC, and vitals sign monitoring standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-49, EC53)
- Biocompatibility standards (ISO 10993)
- Usability and human factors standards (EN 62366)
- Transportation Simulation testing (ASTM D4169-16)
- Software development life cycle (EN 62304)
- Risk Management (ISO 14971)
Clinical:
- Pulse oximetry clinical testing (IEC 80601-2-61)
- Respiratory Rate clinical testing

Missing Information:

Acceptance Criteria Table & Reported Performance: Not provided for any specific vital sign or arrhythmia detection.
Sample size (test set) & Data Provenance: Not detailed. It only mentions "clinical testing."
Number & Qualifications of Experts, Adjudication Method: Not specified for any ground truth establishment.
MRMC Study / AI Assistance: Not mentioned. The device generates alerts for rate-based arrhythmias, but there's no comparative study with human readers described or any 'AI' effect size.
Standalone Performance: While the device has an algorithm for arrhythmia detection, the specific performance metrics (sensitivity, specificity) are not reported here.
Type of Ground Truth: For pulse oximetry and respiratory rate clinical testing, it's implied that a reference standard was used as per relevant IEC standards, but the exact method (e.g., expert consensus on ECG, pathology) for arrhythmia detection is not disclosed.
Training Set Sample Size: Not mentioned, as this document focuses on substantial equivalence testing rather than algorithm development.
Ground Truth for Training Set: Not mentioned.

In summary, while the document indicates that various tests were performed to support substantial equivalence, it does not provide the granular detail needed to answer your questions regarding acceptance criteria and performance metrics for the device's diagnostic or alerting capabilities.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a blue square.

June 22, 2018

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

Re: K172586

Trade/Device Name: Vios Monitoring System™ Model 2050 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: DRT, DQA, DPZ, DRG Dated: May 22, 2018 Received: May 23, 2018

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 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

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Dlorali Castillo

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) K172586

Device Name Vios Monitoring System™ Model 2050

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:	Vios Medical, Inc.700 Commerce Dr.Suite 190Woodbury, MN 55125
Contact Person:	Megan GrahamDirector, Quality and Compliancemegan@viosmedical.comOffice: 651-764-8467Fax: 651-237-7003
Date Prepared:	June 22, 2018
Trade Name:	Vios Monitoring System™ Model 2050
Common Name:	Vitals signs monitor
Primary Regulation:	21 CFR 870.2300 Cardiac Monitor including Cardiotachometer & Rate Alarm
Other Regulation:	21 CFR 890.2910 Transmitters And Receivers, Physiological Signal,Radiofrequency21 CFR 870.2710 Ear oximeter21 CFR 870.2700 Oximeter
Classification:	Class II
Review Panels:	Cardiovascular, Anesthesiology
Product Codes:	Primary: DRTOther: DQA, DPZ, DRG
Predicate Devices:	VMS Model 1000 (reference K150992)VisiMobile Monitoring System (reference K152341)Nonin Pulse Ox Model 6100C (reference K092101).
Device Description:	The Vios Monitoring System (VMS) Model 2050 is a wireless mobilemedical device platform that allows caregivers in healthcare settings tomonitor patient vitals.VMS includes Vios-proprietary monitoring software and a Vios-proprietary vitals sensor with two Vios-proprietary adapters. It iscompatible with a medical grade, Bluetooth™-enabled NIBP cuff.The VMS BSM SW Model B2050 is stand-alone software that can receive,analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). Itruns on a commercial IT platform and is intended to be used inconjunction with the Vios Chest Sensor and Vios Lead Adapters and cansupport peripheral, medical grade, Bluetooth™-enabled devices.
	The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile,multiple use, and rechargeable sensor that acquires 3-channel ECG,bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data.The sensor contains signal acquisition firmware (embedded software) andwirelessly communicates acquired data via standard communicationprotocols (Bluetooth™) to the BSM SW for analysis and display. The ChestSensor has a button that, when pressed, sends a patient call alert to theBSM SW.VMS Chest Sensor Adapter Models L2050E (Pulse Ox Ear Adapter) andL2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn,multiple use pulse oxygenation sensors that connect to the Vios ChestSensor and are secured to the patient via medical grade ECG electrodes.
Indications for Use:	The Vios Monitoring System (VMS) is intended for use by medicallyqualified personnel for physiological vital signs monitoring of adult (18+)patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, respiratory rate, pulse rate, functional oxygensaturation of arterial hemoglobin, non-invasive blood pressure, andpatient posture and activity. VMS allows for the input of bodytemperature, and can display data from peripheral devices. VMS cangenerate alerts when rate-based cardiac arrhythmias are detected andwhen physiological vital signs fall outside of selected parameters.
Summary ofTechnologyComparison	The Vios Monitoring System Model 2050 technology is based on the ViosMonitoring System Model 1000 and shares a common architecture andrun on a commercial IT platform. The VMS Model 2050 Chest Sensor usesa standard medical grade ECG electrode and an adapter plate to collectadditional ECG, impedance, accelerometer, and pulse oximetry data(finger or ear). The VMS Model 2050 BSM SW has been updated togenerate and display 7-lead ECG data, respiratory rate, SpO2, pulse rate,posture, activity, and non-latched physiological alarms. It can also displaynon-invasive blood pressure data from a medical grade, Bluetooth™-enabled NIBP cuff.
Summary of Non-Clinical, Clinical,and ConformanceTesting	The safety, effectiveness, and substantial equivalency of the VMS Model2050 have been confirmed through the following non-clinical, clinical, andconformance testing:Electrical safety, EMC, and vitals sign monitoring standards (IEC60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC60601-2-49, EC53)Biocompatibility standards (ISO 10993)Usability and human factors standards (EN 62366)Transportation Simulation testing (ASTM D4169-16)Software development life cycle (EN 62304)Risk Management (ISO 14971)Pulse oximetry clinical testing (IEC 80601-2-61)Respiratory Rate clinical testing
Conclusion:	Vios Medical's evaluation of the substantial equivalence of the VitalsMonitoring System Model 2050 to the predicate devices was based on acomparison of device classification, intended use, indications for use and

contraindications, warnings, technical characteristics, and performance
characteristics. Vios Medical also performed conformance testing and
clinical testing to demonstrate substantial equivalency. Based on this
comparison, Vios Medical concludes that Vios Monitoring System Model
2050 is substantially equivalent to the predicate devise and does not
introduce new safety or effectiveness issues.

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Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).