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 Description

The Vios Monitoring System includes the following components:
Bedside Monitor Software (BSM SW): Medical device software that analyzes and/or displays vitals data received via standard communication protocols from one or more compatible sensors or peripheral devices. The software runs on standard commercial IT equipment and can operate in stand-alone mode or networked mode using standard networking protocols. In networked mode, it can share its display with one or more

AI/ML Overview

The provided 510(k) summary for the Vios Monitoring System (K150992) indicates that safety and effectiveness were confirmed through non-clinical testing and conformance to standards. However, it does not contain specific acceptance criteria or detailed study results for device performance.

The document lists general standards compliance for various aspects like electrical safety (60601), electromagnetic compatibility (60601), usability (62366), risk management (14971), software development lifecycle (62304), and biocompatibility (10993). It also mentions "Reliability and Performance Testing."

Since the provided text does not contain the specific details required, I can only create a table that highlights the absence of this information in the document.

Summary of Device Acceptance Criteria and Performance (Based on Provided Document)

Feature/Metric	Acceptance Criteria	Reported Device Performance	Notes on Study and Data Provenance
ECG Monitoring	Not specified in document	Conforms to relevant standards (e.g., 60601-2-27)	General statement on "Reliability and Performance Testing" and standards compliance. No specific performance metrics (e.g., accuracy, sensitivity, specificity for arrhythmia detection) are provided.
Heart Rate Monitoring	Not specified in document	Conforms to relevant standards (e.g., 60601-2-27)
Pulse Rate Monitoring	Not specified in document	Conforms to relevant standards
Functional Oxygen Saturation (SpO2)	Not specified in document	Conforms to relevant standards (e.g., 60601-2-27 suggests pulse oximetry)
Axillary Temperature	Not specified in document	Conforms to relevant standards (e.g., 880.2910)
Non-Invasive Blood Pressure (NIBP)	Not specified in document	The device "allows for the input of non-invasive blood pressure," implying it displays external NIBP data rather than measures it directly. No performance for NIBP measurement is stated for the VMS itself.
Alert Generation (Arrhythmias)	Not specified in document	"VMS can generate alerts when rate-based cardiac arrhythmias are detected." Conforms to relevant standards (e.g., 60601-1-8).	No specific performance metrics (e.g., sensitivity, positive predictive value for arrhythmia detection, alarm limits) provided.
Alert Generation (Physiological Vital Signs)	Not specified in document	"VMS can generate alerts when physiological vital signs fall outside of selected parameters." Conforms to relevant standards (e.g., 60601-1-8).	No specific performance metrics (e.g., accuracy of threshold detection, alarm limits) provided.
Electrical Safety	Conformance to IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-27, and 60601-2-49	Confirmed through non-clinical testing	Bench testing
Electromagnetic Compatibility (EMC)	Conformance to IEC 60601-1-2	Confirmed through non-clinical testing	Bench testing
Usability	Conformance to IEC 62366	Confirmed through "Usability Testing (Formative and Summative)"	Bench testing
Risk Management	Conformance to ISO 14971	Confirmed through non-clinical testing	Bench testing
Software Development Lifecycle	Conformance to IEC 62304	Confirmed through non-clinical testing	Bench testing
Biocompatibility	Conformance to ISO 10993	Confirmed through non-clinical testing	Bench testing

Detailed Answers to Specific Questions:

1. A table of acceptance criteria and the reported device performance

See table above. The document primarily states conformance to standards rather than providing specific quantifiable acceptance criteria and performance results for the physiological monitoring functions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for performance testing related to ECG, heart rate, SpO2, or temperature.
Data provenance (country of origin, retrospective/prospective) is not mentioned. The "Non-Clinical Testing" section describes "bench testing," "Usability Testing (Formative and Summative)," "Reliability and Performance Testing," and "Transportation Simulation Testing." These are generally laboratory or in-house tests rather than clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The testing described appears to be technical validation against standards and internal benchmarks, not clinical studies requiring expert ground truth establishment for diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is typically relevant for clinical studies involving human interpretation or subjective measurements, which are not detailed here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The provided document does not mention or describe any MRMC comparative effectiveness study. The Vios Monitoring System is a vital signs monitor, and the context of AI assistance for human readers/interpretation, as seen in imaging devices, does not appear to be directly applicable based on this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document focuses on the Vios Monitoring System as a whole device, a "Vitals signs monitor." The mention of "alerts when rate-based cardiac arrhythmias are detected" indicates an algorithmic component. However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) of these algorithms are not detailed in the provided summary. The testing refers to the system as a unit conforming to standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document describes "non-clinical testing" and "standards compliance." For technical specifications (like electrical safety, EMC), the ground truth would be the defined parameters of the standards themselves (e.g., voltage limits, frequency ranges, signal characteristics). For physiological measurements, it would typically involve comparison to a recognized gold standard measurement device during bench or simulated testing. Specific details of these "ground truths" beyond "standards compliance" are not provided.

8. The sample size for the training set

The document describes non-clinical testing and standards compliance. It does not mention any "training set" as would be relevant for machine learning or AI algorithm development. The phrase "software development lifecycle (62304)" suggests robust software engineering practices, but not necessarily data-driven training in the AI sense.

9. How the ground truth for the training set was established

Since a "training set" is not mentioned in the context of AI/ML, the method for establishing its ground truth is also not applicable/not provided by this document.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.7300 Hudson Rd Blvd NSuite 140St. Paul, MN 55128
Contact Person:	Megan GrahamQuality and Regulatory Advisormegan@viosmedical.comOffice: 651-764-8467Fax: 651-237-7003
Date Prepared:	April 28, 2015
Trade Name:	Vios Monitoring System™
Common Name:	Vitals signs monitor
RegulationClassification:	21 CFR 870.2300 Cardiac Monitor including Cardiotachometer& Rate Alarm (Class II, Cardiovascular) 21 CFR 890.2910 Transmitters And Receivers, PhysiologicalSignal, Radiofrequency (Class II, Cardiovascular) 21 CFR 880.2910 Clinical Electronic Thermometer (Class IIexempt, General Hospital)
Review Panel:	Cardiovascular
Product Codes:	DRT, DRG, FLL
PredicateDevices:	ViSi Mobile Monitoring System (K143751) for vitals monitoringand temperature VitalConnect Platform (K141167) for physiological datatransmission and receipt
DeviceDescription:	The Vios Monitoring System includes the following components:Bedside Monitor Software (BSM SW): Medical device softwarethat analyzes and/or displays vitals data received via standardcommunication protocols from one or more compatible sensorsor peripheral devices. The software runs on standardcommercial IT equipment and can operate in stand-alone modeor networked mode using standard networking protocols. Innetworked mode, it can share its display with one or more
Indications forUse:	The Vios Monitoring System (VMS) is intended for use bymedically qualified personnel for physiological and vital signsmonitoring of adult (18+) patients in healthcare facilities. It isindicated for use in monitoring of ECG, heart rate, pulse rate,functional oxygen saturation of arterial hemoglobin, and axillarytemperature. VMS allows for the input of non-invasive bloodpressure and can display data from peripheral devices. VMS cangenerate alerts when rate-based cardiac arrhythmias are detectedand when physiological vital signs fall outside of selectedparameters.
Summary ofSubstantialEquivalence:	The Vios Monitoring System is substantially equivalent to thepredicate devices with respect to vitals signs monitoring in ahealthcare facility (product codes DRT, DRG, and FLL). Both theVMS and its predicates are wireless vitals monitoring systems thatcan operate in stand-alone or networked mode. Additionalfunctionality of the predicate devices is outside the scope of theVios Monitoring System.The safety and effectiveness of the Vios Monitoring System designhave been confirmed through non-clinical testing and conformanceto vital signs monitoring, electrical safety (60601), electromagneticcompatibility (60601), usability (62366), risk management (14971),software development lifecycle (62304), and biocompatibilitystandards (10993).
Non-ClinicalTesting:	The following bench testing was conducted to demonstrate safetyand efficacy of the Vios Monitoring System:Design Verification and Validation Standards Compliance Testing (60601-1, 60601-1-2,60601-1-8, 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,effective, and substantially equivalent to the legally marketedpredicate devices.

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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).