(77 days)
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No
The document does not mention AI, DNN, or ML, and the described algorithms appear to be rule-based or traditional signal processing for vital signs and posture/fall detection.
No
The device is intended for monitoring vital signs and does not describe any therapeutic function or intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring." Monitoring vital signs (ECG, respiration rate, heart rate, blood pressure, oxygen saturation, pulse rate, and skin temperature) is a diagnostic activity that helps in assessing a patient's health status and identifying potential medical issues.
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 device includes significant hardware components for sensing and display, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The ViSi Mobile Monitoring System measures vital signs directly from the patient's body (ECG, respiration rate, heart rate, blood pressure, SpO2, pulse rate, and skin temperature). This is done on the body (in vivo).
- Intended Use: The intended use clearly states it's for "single or multi-parameter vital signs monitoring of adult patients." This involves direct physiological measurements, not laboratory testing of specimens.
The device description and intended use clearly indicate that this is a patient monitoring system that takes measurements directly from the patient, which is not the function of 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), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive 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 (comma separated list FDA assigned to the subject device)
MWI, DRT, DXN, FLL, DQA
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
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult patients (18 years or older)
Intended User / Care Setting
Clinicians and medically qualified personnel in 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance (verification and validation) testing of the aforementioned features (posture alarm features: (1) undesirable posture technical alarm, (2) patient immobility technical alarm, and (3) patient fall alarm; and display of patient walking) was completed to confirm that the features, as implemented, met all requirements. Verification testing included code reviews, static testing and algorithm monitoring to ensure it performed as intended. Design validation testing consisted of the following tests:
- Code Reviews, Static Testing, Unit Testing
- SVT-000061 - Walking Algorithm Software Verification
- SVT-000062 Undesirable Posture, Immobility and Fall Detection . Software verification
- TP-670 – Undesirable Posture Alarms Validation
- TP-671 Immobility Alarms Validation
- TP-672 Patient Fall Alarm Validation
- . TP-673 - Posture Definitions and Walking Validation
The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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
April 30, 2015
Sotera Wireless, Inc. Carson Krupp Product Risk Assurance Engineer 10020 Huennekens Street San Diego, California 92121
Re: K150361
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, FLL, DQA Dated: April 1, 2015 Received: April 2, 2015
Dear Carson Krupp:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
heerely yours,
forBram 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) K150361
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), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Sotera Wireless. The word "Sotera" is written in a bold, black font. Above the word "Sotera" is a blue heart with a wireless signal coming from it. Below the word "Sotera" is a blue line, and below that is the word "WIRELESS" in a smaller, blue font.
510(K) SUMMARY 7
| Date prepared | March 25, 2015 |
|---|---|
| Name | Sotera Wireless, Inc. |
| 10020 Huennekens St | |
| 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; K143751 (Clearance: 01/23/2015) |
| 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), noninvasive blood pressure (NIBP), | |
| continuous noninvasive blood pressure (cNIBP), noninvasive 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. |
4
| Device | Modified ViSi System w/Posture
Feature Set [510(k) TBD] | ViSi System
Predicate (K143751) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Same as ViSi System (Predicate) | Sotera Wireless, Inc. |
| Intended Use | Same as ViSi System (Predicate) | 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), noninvasive blood
pressure (NIBP), continuous noninvasive
blood pressure (cNIBP), noninvasive
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. |
| Parameters monitored and
displayed | Same as ViSi System (Predicate) | Electrocardiogram (ECG), respiration rate,
blood oxygen saturation (SpO2), non-invasive
blood pressure (NIBP), continuous
noninvasive blood pressure (cNIBP), pulse
rate, heart rate, temperature |
| Posture Tracking | Posture (standing/sitting-up, reclined,
supine) is displayed on the RVD /
PWD and required to set-up cNIBP.
Patient Walking can be displayed.
Alarm features annunciate on
undesirable postures, immobility and
patient falls. | Posture (standing/sitting-up, reclined, supine)
is displayed on the RVD / PWD and required
to set-up cNIBP. |
| Patient population | Same as ViSi System (Predicate) | Adults ≥ 18 years |
| Environment of Use | Same as ViSi System (Predicate) | Hospital-based facility including emergency
departments, general medical-surgical and
intermediate care floors. |
| System Design | Same as ViSi System (Predicate) | Patient monitor displays vital signs and
waveforms. Communicates to server via
wireless access point.
Server is hardwired to display PC. |
| ECG Leads | Same as ViSi System (Predicate) | 3-wire: II
5-wire: I, II, III, AVL, AVR, AVF, V |
| Radio Frequency Telemetry | Same as ViSi System (Predicate) | 802.11 |
| Alarm Annunciation | Same as ViSi System (Predicate) | Monitor, Central Station (server-connected
PC) |
| Alarm levels/mgmt.
connected/linked | Same as ViSi System (Predicate) | Vital Signs |
Substantial Equivalence Table
5
Summary of substantial equivalence
The device design, technology, materials, processes, etc. have not been changed with this application. The modifications were to add the following posture alarm features: (1) undesirable posture technical alarm, (2) patient immobility technical alarm, and (3) patient fall alarm. (4) The last modification allows the system to display if the patient is walking along with the already existing ability to display if a patient is upright, reclined or lying-down. This modification is purely a visual icon and has no associated alarms. All four modifications were implemented to provide clinicians with information that will increase patient safety.
Non-clinical performance (verification and validation) testing of the aforementioned features was completed to confirm that the features, as implemented, met all requirements. Verification testing included code reviews, static testing and algorithm monitoring to ensure it performed as intended. Design validation testing consisted of the following tests:
- Code Reviews, Static Testing, Unit Testing
- SVT-000061 - Walking Algorithm Software Verification
- SVT-000062 Undesirable Posture, Immobility and Fall Detection . Software verification
- TP-670 – Undesirable Posture Alarms Validation
- TP-671 Immobility Alarms Validation ●
- TP-672 Patient Fall Alarm Validation ●
- . TP-673 - Posture Definitions and Walking Validation
The results demonstrated that all acceptance criteria were met, and therefore conforms to expected device performance and intended use.
Therefore the ViSi Mobile Monitoring System is as safe, as effective, and performs as well as or better than the legally marketed predicate device.