(298 days)
Not Found
No
The summary describes standard physiological monitoring and alerting based on predefined parameters, with no mention of AI or ML algorithms for data analysis or prediction.
No
The device is described as a "Monitoring System" for physiological vital signs, not for providing therapy or treatment.
No
The device is a monitoring system that measures and displays physiological vital signs. While it generates alerts for out-of-range vital signs and detected arrhythmias, it does not explicitly state that it provides a diagnosis or aids in making a diagnosis.
No
The device description explicitly states that the Vios Monitoring System (VMS) includes a "Vios-proprietary vitals sensor with two Vios-proprietary adapters" and a "VMS Chest Sensor Model CS2050" which is a "small, patient-worn, non-sterile, multiple use, and rechargeable sensor". These are hardware components, not just software. While there is a "stand-alone software" component (BSM SW Model B2050), the overall system includes hardware.
Based on the provided text, the Vios Monitoring System (VMS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body ("in vitro").
- VMS Function: The VMS is described as a system for physiological vital signs monitoring of patients. It directly measures parameters like ECG, heart rate, respiratory rate, pulse rate, oxygen saturation, blood pressure, posture, and activity from the patient's body.
- Lack of Sample Analysis: The description does not mention the collection or analysis of any biological samples from the patient. The system acquires data directly from sensors attached to the patient.
Therefore, the VMS falls under the category of a patient monitoring system, which is distinct from an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DRT, DQA, DPZ, DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult (18+)
Intended User / Care Setting
Medically qualified personnel in healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety, effectiveness, and substantial equivalency of the VMS Model 2050 have been confirmed through the following non-clinical, clinical, and conformance testing:
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)
Pulse oximetry clinical testing (IEC 80601-2-61)
Respiratory Rate clinical testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
2
Indications for Use
510(k) Number (if known) K172586
Device Name Vios Monitoring System™ Model 2050
Indications for Use (Describe)
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.
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 190
Woodbury, MN 55125 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Megan Graham
Director, Quality and Compliance
megan@viosmedical.com
Office: 651-764-8467
Fax: 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,
Radiofrequency
21 CFR 870.2710 Ear oximeter
21 CFR 870.2700 Oximeter |
| Classification: | Class II |
| Review Panels: | Cardiovascular, Anesthesiology |
| Product Codes: | Primary: DRT
Other: 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 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. |
| Indications for Use: | 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 cardiac arrhythmias are detected and
when physiological vital signs fall outside of selected parameters. |
| Summary of
Technology
Comparison | The Vios Monitoring System Model 2050 technology is based on the Vios
Monitoring System Model 1000 and shares a common architecture and
run on a commercial IT platform. The VMS Model 2050 Chest Sensor uses
a standard medical grade ECG electrode and an adapter plate to collect
additional ECG, impedance, accelerometer, and pulse oximetry data
(finger or ear). The VMS Model 2050 BSM SW has been updated to
generate and display 7-lead ECG data, respiratory rate, SpO2, pulse rate,
posture, activity, and non-latched physiological alarms. It can also display
non-invasive blood pressure data from a medical grade, Bluetooth™-
enabled NIBP cuff. |
| Summary of Non-
Clinical, Clinical,
and Conformance
Testing | The safety, effectiveness, and substantial equivalency of the VMS Model
2050 have been confirmed through the following non-clinical, clinical, and
conformance testing:
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)Pulse oximetry clinical testing (IEC 80601-2-61)Respiratory Rate clinical testing |
| Conclusion: | Vios Medical's evaluation of the substantial equivalence of the Vitals
Monitoring System Model 2050 to the predicate devices was based on a
comparison 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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