(27 days)
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard vital sign monitoring technologies.
No
The device is a monitoring system that measures vital signs, not a device intended to treat or cure a disease or condition.
No
The device is a vital signs monitor, which continuously measures physiological parameters, but it does not diagnose medical conditions.
No
The device description explicitly states it is a "lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display" and is "body-worn," indicating it is a physical hardware device that measures vital signs.
Based on the provided information, the ViSi Mobile Monitoring System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The ViSi Mobile Monitoring System is described as a patient vital signs monitor that continuously measures physiological parameters directly from the patient's body (ECG, heart rate, SpO2, pulse rate, respiration rate, temperature, NIBP).
The device's function is to monitor vital signs in vivo (within the living body), not to analyze samples in vitro (in a lab setting).
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. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), 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 central station through wireless 802.11 communication.
Product codes
MWI, DRT, DXN, DQA, FLL
Device Description
The ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals
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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ViSi Mobile Monitoring System; K122036
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).
0
K133586 Page 1 of 1
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8 510(K) SUMMARY
DEC 18 2013
| Date prepared | November 20, 2013 |
|---|---|
| Name | Sotera Wireless, Inc. |
| 9444 Waples Street, Suite 280 | |
| San Diego, CA 92121 | |
| T. 858.373.4841; F. 858.427.4639 | |
| Contact person | Eben Gordon |
| Senior Director, Regulatory | |
| 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; K122036 (Clearance: 8/18/2012) |
| Description | The ViSi Mobile Monitoring System is a lightweight, portable patient vital signs |
| monitor featuring a high resolution, full color touch screen display, with visual | |
| and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and | |
| designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration | |
| rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable | |
| on demand. NIBP can be measured as a onetime measurement, or it can be | |
| measured automatically at predefined intervals | |
| 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. It is indicated for ECG (3 or 5 leadwire), respiration rate | |
| (RESP), heart rate (HR), non-invasive blood pressure (NIBP), 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 central station through wireless 802.11 communication. | |
| Summary of | |
| substantial equivalence | The device design, technology, materials, processes, etc. have not been changed |
| with this application. The modification is only to increase the time to alarm for | |
| critically low, low, and high heart rates; therefore the ViSi Mobile Monitoring | |
| System as described in this submission is substantially equivalent to the predicate | |
| device. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2013
Sotera Wireless, Inc. Eben Gordon Senior Director, Regulatory 9444 Waples Street Suite 280 San Diego, CA 92121 US
Re: K133586
Trade/Device Name: Visi Mobile Monitioring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II (two) Product Code: MWI, DRT, DXN, DQA, FLL Dated: November 20, 2013 Received: November 21, 2013
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, 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
2
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Owen-DEaris-S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Sotera Wireless, Inc. ViSi Mobile Monitoring System Special 510(k)
A and a compression in
7 INDICATIONS FOR USE
510(k) Number (if known): __
ViSi Mobile Monitoring System _ Device Name: __________
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. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), 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 central station through wireless 802.11 communication.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by
Faris -S
Date: 2013.12.18
11:00:10 -05'00'
Page __ of __
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