(23 days)
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.
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.
This document is a 510(k) summary for the ViSi Mobile Monitoring System. It describes the device, its intended use, and provides a summary of non-clinical performance testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria in a quantitative manner (e.g., "sensitivity must be > X%"). Instead, it describes performance in terms of improvements or conformance to standards.
| Metric / Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| QRS Detection | Equal to or better performance than prior beat-picker | MIT Database: Equal to or better performance in gross Q sensitivity. Negligible reduction (no specific value given) in gross Q positive predictivity. |
| AHA Database: Equal to or better performance in gross Q sensitivity and gross Q positive predictivity. | ||
| Overall improvement in performance compared to existing algorithm | Determined to be an improvement in performance over the existing algorithm. | |
| IEC 60601-2-27 | Conformance to the standard | Conformance to IEC 60601-2-27 was demonstrated. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions the use of the "MIT and AHA databases." These are well-known, publicly available benchmark databases for ECG analysis. The specific number of records or patients from these databases used for testing is not explicitly stated in this summary.
- Data Provenance: The MIT and AHA databases are standard, established datasets. The country of origin and whether the data is retrospective or prospective is not specified in this document but is inherent to the nature of these established benchmark databases (typically retrospective and collected over time from various sources).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the MIT and AHA databases. For these widely recognized benchmark databases, the ground truth is typically meticulously annotated by multiple qualified experts over many years.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe the adjudication method used for establishing the ground truth of the MIT and AHA databases. This information is typically detailed in the documentation accompanying those specific databases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with or without AI assistance. The study described focuses on the standalone performance of the QRS detection algorithm against benchmark databases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The performance testing described, which involved the "new ECG beat-picker" against the MIT and AHA databases, is a standalone evaluation of the algorithm's performance without human-in-the-loop involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the MIT and AHA databases, which were used to evaluate QRS detection, is based on expert consensus annotations of the ECG waveforms.
8. The sample size for the training set
The document does not provide information regarding the sample size of the training set used for the development or training of the new ECG beat-picker algorithm.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set was established.
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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 StreetSan Diego, CA 92121T. 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 vitalsigns monitor featuring a high resolution, full color touch screen display,with visual and audible alarms and alerts. The ViSi Mobile Monitor isdesigned 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 ViSiMobile Monitoring System is capable of one-time and continuous NIBPmeasurements. |
| Indications for use | The ViSi Mobile Monitoring System is intended for use by clinicians andmedically qualified personnel for single or multi-parameter vital signsmonitoring of adult patients (18 years or older). It is indicated for ECG (3or 5 lead wire), respiration rate (RESP), heart rate (HR), non-invasiveblood pressure (NIBP), continuous non-invasive blood pressure (cNIBP),non-invasive monitoring of functional oxygen saturation of arterialhemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) inhospital-based facilities; including general medical-surgical floors,intermediate care floors, and emergency departments.The ViSi Mobile Monitoring System may be used as standalone devices ornetworked to ViSi Mobile Remote Viewers through wireless 802.11communication. |
| 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.
§ 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).