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, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when the physiological vital signs fall outside of selected parameters.

VMS can also generate alerts when cardias arrhythmias (Tachycardia, Asystole, Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected.

The ECG rhythm analysis is intended for use by medified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions.

The Vos 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 CSMCS SW receives, stores, and displays patient physiological and waveform data and alams generated by Vios proprietary patient vitals monitoring software.

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. The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station. 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,

AI/ML Overview

The Vios Monitoring System (VMS) Model 2050 was evaluated for its arrhythmia detection features, specifically assessing its performance against the ANSI/AAMI EC57:2012 standard and additional database records.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily references compliance with the ANSI/AAMI EC57:2012 standard for cardiac rhythm and ST-segment measurement algorithms. While specific numerical acceptance criteria (e.g., minimum sensitivity, positive predictivity) for each arrhythmia are not explicitly listed in the provided summary, the study's conclusion of meeting "performance requirements as outlined in the consensus standard ANSI/AAMI EC57:2012" implies that the device achieved the performance thresholds defined within that standard for the tested arrhythmias.

Arrhythmia Type	Standard	Reported Device Performance
Tachycardia	ANSI/AAMI EC57:2012	Met performance requirements
Bradycardia	ANSI/AAMI EC57:2012	Met performance requirements
Asystole	ANSI/AAMI EC57:2012	Met performance requirements
Ventricular Tachycardia/Ventricular Fibrillation	ANSI/AAMI EC57:2012	Met performance requirements
Atrial Fibrillation/Atrial Flutter	ANSI/AAMI EC57:2012	Met performance requirements

2. Sample Size for the Test Set and Data Provenance:

The document states that the device's performance was evaluated using:

Records from the ANSI/AAMI EC57 standard. This standard often utilizes a combination of standard ECG databases (e.g., MIT-BIH Arrhythmia Database).
Additional records from LTAF, AAEL, and VFDB databases.

The specific sample sizes (number of patients or ECG recordings) for each arrhythmia or for the combined test set are not provided in the summary. The provenance of LTAF, AAEL, and VFDB databases is not detailed; however, these are generally recognized public databases of ECG recordings used for algorithm testing, often comprising retrospective data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not state the number of experts used or their specific qualifications for establishing the ground truth of the test set. For publicly available and widely used databases like those mentioned (MIT-BIH, LTAF, AAEL, VFDB), the ground truth labels are typically established by multiple expert cardiologists or electrophysiologists using established criteria, often after multiple review rounds. However, this specific information is not in the provided text.

4. Adjudication Method for the Test Set:

The document does not specify the adjudication method used (e.g., 2+1, 3+1). For standard ECG databases, ground truth is usually established via expert consensus, which inherently involves an adjudication process, but the specific mechanics are not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The testing described is focused on the standalone performance of the device's arrhythmia detection algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Yes, a standalone performance evaluation was done. The summary explicitly states: "The non-clinical tests for evaluation of performance of Vios system with the addition of arrhythmia alarms is based on ANSI/AAMI EC57, showing substantial equivalence to the predicate (K180472). The subject device's performance was also evaluated using additional records from LTAF, AAEL, and VFDB database..." This describes the algorithm's performance without direct human intervention as part of the detection process.

7. Type of Ground Truth Used:

The ground truth for the test was established through expert consensus/annotations from well-known ECG databases (ANSI/AAMI EC57, LTAF, AAEL, and VFDB). These databases contain ECG recordings that have been meticulously reviewed and annotated by medical experts (typically cardiologists or electrophysiologists) to identify and label different cardiac events and arrhythmias,
Pathology and outcomes data are not mentioned as sources for ground truth in this context.

8. Sample Size for the Training Set:

The document does not specify the sample size used for the training set of the Vios Monitoring System's arrhythmia detection algorithm.

9. How the Ground Truth for the Training Set Was Established:

The document does not specify how the ground truth for the training set was established. However, it is common practice for such algorithms to be trained on large, expertly annotated ECG datasets, similar to those used for testing (expert consensus/annotations).

Summary

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March 22, 2024

Murata Vios, Inc. John Lansdown General Manager, Quality, Regulatory, & Compliance 700 Commerce Drive. #190 Woodbury, Minnesota 55125

Re: K232354

Trade/Device Name: Vios Monitoring System (Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050) Regulation Number: 21 CFR 870.2300 Regulation Name: Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: QYW, DQA, DPZ, DRG, DXJ, OUG Dated: February 22, 2024 Received: February 22, 2024

Dear John Lansdown:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K232354

Device Name

Vios Monitoring System(TM) Model 2050

Indications for Use (Describe)

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

VMS can also generate alerts when cardias arrhythmias (Tachycardia, Asystole, Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected.

The ECG rhythm analysis is intended for use by medified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions.

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

X 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:	Murata Vios, Inc.700 Commerce Drive, Suite 190Woodbury, MN 55125
Contact Person:	John LansdownGeneral Manager, Quality, Regulatory, & Compliancejohn.lansdown@murata.comOffice: 651-888-8125
Date Prepared:	8/4/2023
Trade Names:	Vios Monitoring System™ Model 2050Vios Central Station Monitor/Central Server Software 2050
Common Name:	Vital Signs monitor
Regulation:	21 CFR § 870.1025 Arrhythmia detector and alarm (including ST-segment measurementand alarm).21 CFR § 870.2300 Cardiac Monitor (including cardiotachometer and rate alarm)21 CFR § 870.2910 Radiofrequency physiological signal transmitter and receiver21 CFR § 870.2700 Oximeter21 CFR § 870.2710 Ear oximeter21 CFR § 870.2450 Medical cathode-ray tube display21 CFR § 880.6310 Medical device data system
Classification:	Class II
Review Panels:	Cardiovascular, Anesthesiology
Product Codes:	QYW, DQA, DPZ, DRG, DXJ, OUG
Predicate Devices:	Vios Monitoring System™ Model 2050 (K172586)Vios Central Station Monitor/Central Server Software 2050 (K173107)ViSi Mobile Monitoring System (K180472)
Device Description:	The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical deviceplatform that allows caregivers in healthcare settings to monitor patient vitals.The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter andCentral Server and Central Monitoring Station.The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, anddisplay physiological vitals data from one or more patient-worn sensors via standardcommunication protocols (Bluetooth™). It runs on a commercial IT platform and isintended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adaptersand can support peripheral, medical grade, Bluetooth™-enabled devices.The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use,
Indications for Use:	The Vios Monitoring System (VMS) is intended for use by medically qualified personnelfor physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It isindicated for use in monitoring of 7-lead ECG, heart rate, respiratory rate, pulse rate,functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, andpatient posture and activity. VMS allows for the input of body temperature, and candisplay data from peripheral devices. VMS can generate alerts when the physiologicalvital signs fall outside of selected parameters.VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia,Asystole, Ventricular Tachycardia/ Ventricular Fibrillation and Atrial Fibrillation/ AtrialFlutter) are detected.The ECG rhythm analysis is intended for use by medically qualified professionals in theidentification of arrhythmia events and to aid in clinical review of arrhythmias andmedical interventions.The Vios CSM/CS Software is indicated for use by healthcare professionals for thepurpose of centralized monitoring of patient data within a healthcare facility. The ViosCSM/CS SW receives, stores, manages, and displays patient physiological and waveformdata and alarms generated by Vios proprietary patient vitals monitoring software.
Summary ofSubstantialEquivalence	The Vios Monitoring System has the following similarities and differences with theindicated predicate devices:Intended use -The proposed device, Vios Monitoring System monitors the same vitalsigns as the predicate, previously cleared Vios Monitoring System (K172586) except forthe addition of arrhythmia detection feature, which is included in the predicate, VisiMonitoring System (K180472). Considered together, the intended use of the proposeddevice is the same as the Vios Monitoring System the addition of arrhythmia detectionlike the Visi System. The Vios Monitoring System, is similar to the predicate devices, isintended to be used by licensed practitioners in a healthcare environment.Device Performance – The modified Vios Monitoring System with the addition ofarrhythmia detection has been verified to meet the performance requirements as outlinedin the consensus standard ANSI/AAMI EC57:2012 - Testing and reporting performanceresults of cardiac rhythm and ST-segment measurement algorithms. The subject device'sperformance was also evaluated using additional records from LTAF, AAEL and VFDBdatabase. The predicate device (K180472) has also been tested for compliance to ANSI/AAMI EC57 for the arrhythmia features.Technology -The Vios Monitoring System is unchanged from its predicate submission(K172586) except for the addition of arrhythmia detection measurement. The VMSarrhythmia detection measurement feature are based on similar characteristic features to
Summary of Non-Clinical, Clinical, andConformance Testing	The non-clinical tests for evaluation of performance of Vios system with the addition ofarrhythmia alarms is based on ANSI/AAMI EC57, showing substantial equivalence to thepredicate (K180472). The subject device's performance was also evaluated usingadditional records from LTAF, AAEL, and VFDB database, other than referred in thestandard.
	Other system performance remains unchanged from the predicate (K172586) except thefollowing standard:
	• AAMI/ANSI EC57
	The safety and effectiveness of the VMS Model 2050 based on the following standardsremains unchanged:
	• Electrical safety, EMC, and vitals sign monitoring standards (IEC 60601-1, IEC60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-49, EC53)• Biocompatibility standards (ISO 10993)• Transportation Simulation testing (ASTM D4169-16)• Software development life cycle (EN 62304)• Usability and human factors standards (EN 62366)• Risk Management (ISO 14971)• Pulse oximetry clinical testing (ISO 80601-2-61)• Respiratory Rate clinical testing• Standard for evaluation of Wireless Coexistence (ANSI C63.27)
Conclusions:	Based on the results from the non-clinical tests performed, Murata Vios considers theVios Monitoring System to be as safe, as effective and substantially equivalent to thelegally marketed predicate 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).