(23 days)
Not Found
No
The document does not mention AI or ML, and the performance testing focuses on a "beat-picker" algorithm, which is a standard signal processing technique for ECG analysis, not necessarily indicative of AI/ML.
No.
The device is described as a monitoring system that measures vital signs; it does not mention any therapeutic functions or interventions.
Yes
The ViSi Mobile Monitoring System is intended for single or multi-parameter vital signs monitoring, including ECG, respiration rate, heart rate, non-invasive blood pressure, SpO2, pulse rate, and skin temperature. Monitoring these physiological parameters helps clinicians identify potential health issues or changes in a patient's condition, which is a diagnostic function.
No
The device description explicitly states it is a "lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display" and is designed to "continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature." This indicates the presence of hardware components for sensing and display, making it a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the ViSi Mobile Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ViSi Mobile Monitoring System directly monitors physiological parameters from the patient's body (ECG, blood pressure, SpO2, etc.) using sensors applied externally.
- The intended use and device description clearly state that it is a vital signs monitor for direct patient monitoring. It measures and displays physiological data from the patient in real-time.
- There is no mention of analyzing biological specimens.
Therefore, the ViSi Mobile Monitoring System falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.
Product codes
MWI, DRT, DXN, DQA, FLL
Device Description
The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients (18 years or older)
Intended User / Care Setting
clinicians and medically qualified personnel / hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Non-clinical performance testing of the new ECG beat-picker demonstrated equal to or better performance than the prior beat-picker on the MIT and AHA databases
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing of the new ECG beat-picker demonstrated equal to or better performance than the prior beat-picker on the MIT and AHA databases in terms of gross Q sensitivity and gross Q positive predictivity for the AHA database with a negligible reduction in gross Q positive predictivity for the MIT set. Given the overall result it was determined that there was an improvement of performance over the existing algorithm. Conformance to IEC 60601-2-27 was also demonstrated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
gross Q sensitivity and gross Q positive predictivity
Predicate Device(s)
ViSi Mobile Monitoring System; K133586, ViSi Mobile Monitoring System; K130709
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Sotera Wireless, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
Re: K143751 Trade/Device Name: Visi Mobile Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DRT, DXN, DQA, FLL Dated: December 30, 2014 Received: December 31, 2014
Dear Mark Job,
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 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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,
Melissa A. Torres -S
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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name ViSi Mobile Monitoring System
Indications for Use (Describe)
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including, general medical-surgical floors, intermediate care floors, and emergency departments.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5 510(K) SUMMARY
| Date prepared | November 13, 2014 |
|---|---|
| Name | Sotera Wireless, Inc. |
| 10020 Huennekens Street | |
| San Diego, CA 92121 | |
| T. 858.427.4620; F. 858.999.2487 | |
| Trade name | ViSi Mobile Monitoring System |
| Common name | Vital signs monitor |
| Regulation Name | Cardiac Monitor Including Cardiotachometer and Rate Alarm |
| Classification number | 21 CFR 870.2300 |
| Product code | MWI, DRT, DXN, DQA, FLL |
| Regulatory class | II |
| Predicate devices | ViSi Mobile Monitoring System; K133586 (Clearance: 12/18/2013) |
| ViSi Mobile Monitoring System; K130709 (Clearance: 10/7/2013) | |
| Description | The ViSi Mobile Monitoring System is a lightweight, body-worn vital |
| signs monitor featuring a high resolution, full color touch screen display, | |
| with visual and audible alarms and alerts. The ViSi Mobile Monitor is | |
| designed to continuously non-invasively measure ECG, heart rate, SpO2, | |
| blood pressure, pulse rate, respiration rate, and temperature. The ECG, | |
| SpO2, and Respiration waveforms are viewable on demand. The ViSi | |
| Mobile Monitoring System is capable of one-time and continuous NIBP | |
| measurements. | |
| Indications for use | The ViSi Mobile Monitoring System is intended for use by clinicians and |
| medically qualified personnel for single or multi-parameter vital signs | |
| monitoring of adult patients (18 years or older). It is indicated for ECG (3 | |
| or 5 lead wire), respiration rate (RESP), heart rate (HR), non-invasive | |
| blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), | |
| non-invasive monitoring of functional oxygen saturation of arterial | |
| hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in | |
| hospital-based facilities; including general medical-surgical floors, | |
| intermediate care floors, and emergency departments. | |
| The ViSi Mobile Monitoring System may be used as standalone devices or | |
| networked to ViSi Mobile Remote Viewers through wireless 802.11 | |
| communication. | |
| Summary of | The device design, technology, materials, processes, etc. have not been |
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substantial equivalence changed with this application. The modifications are: (1) to add the previously cleared cNIBP Indication for Use to the previously cleared networked ViSi Mobile Monitoring System and (2) to improve QRS detection across a wide range of ECG waveform morphologies to reduce the cases where noise on the ECG waveform is prohibiting the recognition of a QRS complex.
Non-clinical performance testing of the new ECG beat-picker demonstrated equal to or better performance than the prior beat-picker on the MIT and AHA databases in terms of gross Q sensitivity and gross Q positive predictivity for the AHA database with a negligible reduction in gross Q positive predictivity for the MIT set. Given the overall result it was determined that there was an improvement of performance over the existing algorithm. Conformance to IEC 60601-2-27 was also demonstrated.
Therefore the ViSi Mobile Monitoring System is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.