(293 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the performance studies rely on established databases and standards (AHA, MIT-BIH, CU, NST, ANSI/AAMI EC57) for arrhythmia analysis validation, which is typical for traditional signal processing algorithms rather than AI/ML training and testing.
No
The device is intended for vital signs monitoring and analysis, not for treatment or therapy.
Yes
The device is intended for "single or multi-parameter vital signs monitoring" and includes "basic arrhythmia analysis," which involves identifying medical conditions like "Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Flutter." This monitoring and analysis of physiological parameters to identify medical conditions falls under the definition of a diagnostic device. The text also states that "Automated arrhythmia analysis is an adjunct to clinician review of the analysis should precede any therapeutic intervention," indicating that it provides information for diagnosis.
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 mentions electrical safety and electromagnetic compatibility testing, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for monitoring vital signs of adult patients. This involves measuring physiological parameters directly from the patient's body (ECG, blood pressure, SpO2, respiration, etc.).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The device description reinforces that it's a body-worn monitor that measures vital signs non-invasively.
- Lack of Mention of Samples: There is no mention of the device analyzing samples taken from the patient.
Therefore, the ViSi Mobile Monitoring System falls under the category of patient monitoring devices, not in vitro diagnostics.
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, noninvasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Flutter) and alarm in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.
Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation.
The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older. It has not been evaluated on pediativ patients or neonates.
The arrhythmia analysis feature is intended for use by healthcation and treatification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinician review of the analysis should precede any therapeutic intervention.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to a ViSi Mobile Remote Viewer through wireless 802.11 communication.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSL, 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, basic arrhythmias [including ventricular tachycardia, ventricular fibrillation, asystole, and atrial fibrillation/atrial flutter], heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, Sp02, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.
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 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
The ViSi Monitoring System's basic arrhythmia analysis has been validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The basic arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282), which has been adapted for real time analysis in the ViSi System. The ViSi Monitoring System's basic arrhythmia analysis has been validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012. The QRS detection sensitivity of the ViSi System was comparable to the predicate device.
The safety and effectiveness of the design elements implemented into the ViSi System have been confirmed by compliance to Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28, 2003).
The ViSi System's basic arrhythmia analysis and alarms incorporates two additional rhythm classifications, artifact and unclassified, to minimize false alarms. Artifact detection prevents noisy signals from being detected as beats, thus excluding those signals from rhythm detection. In this way, false positive ventricular fibrillation and asystole events are minimized. If the artifact condition persists for >30 seconds, an equipment technical alarm is triggered. If the algorithm cannot classify the current rhythm, the rhythm is labeled as unclassified. If the condition persists for >30 seconds, an equipment technical alarm is triggered. These differences do not raise new questions of either safety or effectiveness.
Non-Clinical Testing:
The ViSi System has successfully undergone database and functional testing to demonstrate equivalence to the predicate devices. Verification and validation testing was identified to support the safety and effective of the ViSi System and were relied upon in the determination of substantial equivalence. These nonclinical tests included:
- . Performance against databases for arrhythmia analysis as specified in ANSI/AAMI EC57
- Electrical safety testing per AAMI/ANSI ES60601-1:2005 ●
- . Electromagnetic compatibility testing per IEC 60601-1-2 3rd Edition including Radiated Emissions, Electrostatic Discharge, Radio Frequency Electromagnetic Field Amplitude Modulated, Radio Frequency Common Mode, and Power Frequency Magnetic Field
- Alarm system testing per AAMI/ANSI/IEC 60601-1-8:2006
- . ECG performance according to AAMI/ANSI/IEC 60601-2-27:2011
The ViSi System has been tested and found to comply with the Special Controls Guidance, meet ANSI/AAMI EC57 performance requirements, and comply with recognized consensus standards for medical devices providing adequate support of substantial equivalence to the predicates devices. The results of all the testing demonstrate that the ViSi System is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The QRS detection sensitivity of the ViSi System was comparable to the predicate device.
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.
Automated ECG Analysis and Interpretation Analysis Software Library, K062282, Acuity Central Monitoring Station, K052160, ViSi Mobile Monitoring System; K122036, ViSi Mobile Monitoring System; K130709
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.
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or abstract human figures, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2015
Sotera Wireless, Inc. Eben Gordon Regulatory Consultant 10020 Huennekens Street San Diego, California 92121
Re: K142827
Trade/Device Name: ViSi Mobile Monitoring System, ViSi Mobile Chest Sensor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DSL, DRT, DXN, DQA, FLL Dated: June 10, 2015 Received: June 11, 2015
Dear Eben Gordon:
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. Iisting 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
1
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 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 vours.
Arthel Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142827
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, noninvasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Flutter) and alarm in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.
Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation.
The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older. It has not been evaluated on pediativ patients or neonates.
The arrhythmia analysis feature is intended for use by healthcation and treatification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinician review of the analysis should precede any therapeutic intervention.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to a ViSi Mobile Remote Viewer 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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
4
Image /page/4/Picture/1 description: The image is a logo for Sotera Wireless. The logo features the word "Sotera" in a bold, black font. Above the word "Sotera" is a blue heart with three curved lines emanating from it. Below the word "Sotera" is the word "WIRELESS" in a smaller, blue font.
510(K) SUMMARY
| Date prepared | July 7, 2015 |
|---|---|
| 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 | Arrhythmia detector and alarm (including ST-segment measurement and alarm) |
| Classification number | 21 CFR 870.1025 |
| Product code | MHX, DSI, DRT, DXN, DQA, FLL |
| Regulatory class | II |
| Predicate devices | Automated ECG Analysis and Interpretation Analysis Software Library, K062282 |
| (Clearance: 03/22/2007) | |
| Acuity Central Monitoring Station, K052160 (Clearance: 12/16/2005) | |
| ViSi Mobile Monitoring System; K122036 (Clearance: 8/15/2012) | |
| 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, basic arrhythmias [including | |
| ventricular tachycardia, ventricular fibrillation, asystole, and atrial | |
| fibrillation/atrial flutter], heart rate, SpO2, blood pressure, pulse rate, respiration | |
| rate, and temperature. The ECG, Sp02, and Respiration waveforms are viewable | |
| on demand. The ViSi Mobile Monitoring System is capable of one-time and | |
| continuous NIBP measurements. | |
| 510(k) Number | K142827 |
| 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, heart rate, noninvasive blood pressure (NIBP), continuous non- | |
| invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen | |
| saturation of arterial hemoglobin (SpO2), pulse rate, skin temperature, basic | |
| arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, | |
| Atrial Fibrillation/Atrial Flutter) and alarm in hospital-based facilities; including | |
| general medical surgical floors, intermediate care floors, and emergency |
departments.
5
Image /page/5/Picture/0 description: The image shows the logo for Sotera Wireless. The logo consists of the word "Sotera" in a bold, black font, with the word "WIRELESS" in a smaller, light blue font underneath. Above the word "Sotera" is a light blue graphic that resembles a heart with radio waves emanating from it.
Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation.
The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older. It has not been evaluated on pediatric patients or neonates.
The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to a ViSi Mobile Remote Viewer through wireless 802.11 communication.
Summary of The basic arrhythmia analysis is based on the same technology as the currently substantial equivalence cleared Monebo Technologies, Inc Arrhythmia library (K062282), which has been adapted for real time analysis in the ViSi System. The ViSi Monitoring System's basic arrhythmia analysis has been validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012. The QRS detection sensitivity of the ViSi System was comparable to the predicate device.
The safety and effectiveness of the design elements implemented into the ViSi System have been confirmed by compliance to Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28, 2003).
The ViSi System's basic arrhythmia analysis and alarms incorporates two additional rhythm classifications, artifact and unclassified, to minimize false alarms. Artifact detection prevents noisy signals from being detected as beats, thus excluding those signals from rhythm detection. In this way, false positive ventricular fibrillation and asystole events are minimized. If the artifact condition persists for >30 seconds, an equipment technical alarm is triggered. If the algorithm cannot classify the current rhythm, the rhythm is labeled as unclassified. If the condition persists for >30 seconds, an equipment technical alarm is triggered. These differences do not raise new questions of either safety or effectiveness.
Non-Clinical Testing
The ViSi System has successfully undergone database and functional testing to demonstrate equivalence to the predicate devices. Verification and validation testing was identified to support the safety and effective of the ViSi System and were relied upon in the determination of substantial equivalence. These nonclinical tests included:
- . Performance against databases for arrhythmia analysis as specified in ANSI/AAMI EC57
- Electrical safety testing per AAMI/ANSI ES60601-1:2005 ●
- . Electromagnetic compatibility testing per IEC 60601-1-2 3rd Edition including Radiated Emissions, Electrostatic Discharge, Radio Frequency
6
Image /page/6/Picture/1 description: The image contains the logo for Sotera Wireless. The logo features the word "Sotera" in a bold, sans-serif font, with a light blue line underneath. Above the word "Sotera" is a light blue heart-shaped icon with three curved lines emanating from it, resembling radio waves. Below the line and the word "Sotera" is the word "WIRELESS" in a smaller, sans-serif font.
Electromagnetic Field Amplitude Modulated, Radio Frequency Common Mode, and Power Frequency Magnetic Field
- Alarm system testing per AAMI/ANSI/IEC 60601-1-8:2006
- . ECG performance according to AAMI/ANSI/IEC 60601-2-27:2011
The ViSi System has been tested and found to comply with the Special Controls Guidance, meet ANSI/AAMI EC57 performance requirements, and comply with recognized consensus standards for medical devices providing adequate support of substantial equivalence to the predicates devices. The results of all the testing demonstrate that the ViSi System is as safe, as effective, and performs as well as or better than the predicate device.