(245 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its functions does not mention any AI/ML capabilities.
No
The device is described as a monitoring system that displays physiological and vital signs data and generates alerts. It does not provide any form of treatment or therapy.
Yes
The device clearly states its purpose is for "physiological and vital signs monitoring." While it can generate alerts for cardiac arrhythmias and abnormal vital signs, its primary function is to monitor, not to diagnose a specific disease or condition. Diagnostic devices typically aim to identify the presence or absence of a disease or condition, often through more in-depth analysis or imaging, which is not described here.
No
The device description explicitly states that the system includes "compatible sensors or peripheral devices" which are hardware components, and the software analyzes data received from these.
Based on the provided information, the Vios Monitoring System (VMS) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) outside of the body. The VMS monitors physiological and vital signs directly from the patient (ECG, heart rate, pulse rate, oxygen saturation, temperature, blood pressure).
- The intended use describes monitoring physiological parameters in vivo (within the living body). It does not mention any analysis of biological samples.
- The device description focuses on software that analyzes and displays data from sensors attached to the patient. It doesn't describe any components for handling or analyzing biological specimens.
Therefore, the Vios Monitoring System falls under the category of a patient monitoring system, which is a different type of medical device than an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DRT, DRG, FLL
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
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+) patients
Intended User / Care Setting
medically qualified personnel / 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 following bench testing was conducted to demonstrate safety and 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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7. 510(k) Summary
| Submitter: | Vios Medical, Inc.
7300 Hudson Rd Blvd N
Suite 140
St. Paul, MN 55128 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Megan Graham
Quality and Regulatory Advisor
megan@viosmedical.com
Office: 651-764-8467
Fax: 651-237-7003 |
| Date Prepared: | April 28, 2015 |
| Trade Name: | Vios Monitoring System™ |
| Common Name: | Vitals signs monitor |
| Regulation
Classification: | 21 CFR 870.2300 Cardiac Monitor including Cardiotachometer
& Rate Alarm (Class II, Cardiovascular) 21 CFR 890.2910 Transmitters And Receivers, Physiological
Signal, Radiofrequency (Class II, Cardiovascular) 21 CFR 880.2910 Clinical Electronic Thermometer (Class II
exempt, General Hospital) |
| Review Panel: | Cardiovascular |
| Product Codes: | DRT, DRG, FLL |
| Predicate
Devices: | ViSi Mobile Monitoring System (K143751) for vitals monitoring
and temperature VitalConnect Platform (K141167) for physiological data
transmission and receipt |
| 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 |
| Indications for
Use: | 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. |
| Summary of
Substantial
Equivalence: | The Vios Monitoring System is substantially equivalent to the
predicate devices with respect to vitals signs monitoring in a
healthcare facility (product codes DRT, DRG, and FLL). Both the
VMS and its predicates are wireless vitals monitoring systems that
can operate in stand-alone or networked mode. Additional
functionality of the predicate devices is outside the scope of the
Vios Monitoring System.
The safety and effectiveness of the Vios Monitoring System design
have been confirmed through non-clinical testing and conformance
to vital signs monitoring, electrical safety (60601), electromagnetic
compatibility (60601), usability (62366), risk management (14971),
software development lifecycle (62304), and biocompatibility
standards (10993). |
| Non-Clinical
Testing: | The following bench testing was conducted to demonstrate safety
and 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 marketed
predicate devices. |
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