(35 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on standard vital signs monitoring technology.
No
The device is described as a "monitoring system" intended for "vital signs monitoring" and does not mention any therapeutic function.
No
The device is a vital signs monitor that measures and displays physiological parameters. It does not analyze these measurements to provide a diagnosis of a disease or condition. The text also mentions its use for "monitoring," which is distinct from "diagnosing."
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 and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature." This indicates the device includes hardware components for sensing and display, not just software.
Based on the provided information, the ViSi Mobile Monitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- ViSi Mobile Function: The ViSi Mobile Monitoring System directly measures physiological parameters from the patient's body (ECG, respiration rate, heart rate, NIBP, SpO2, pulse rate, and skin temperature) using external sensors and electrodes. It does not analyze samples taken from the body.
The device is a patient vital signs monitor, which falls under a different category of medical devices.
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, heart rate, non-invasive blood pressure, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin, pulse rate, and skin temperature 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 a central station through wireless 802.11 communication.
Product codes
MWI, DRT, DXN, DQA and 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)
The ViSi System has been tested and complies with recognized performance, safety, and electromagnetic compatibility standards for medical devices. The verification and validation activities performed based the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection. These results demonstrate that the ViSi System is safe, as effective, and based on the similarities with the predicate devices, substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ViSi Mobile Monitoring System (K112478), Propaq LT VSM, Model 802 Series (K033378), Micropaq VSM, Models 402, 404 (K002725), Acuity Central Monitoring Station Predicate (K022453)
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
Sotera
WIRELES
510(k) Summary
AUG 1 5 2012
| Date prepared | May 30, 2012 |
|---|---|
| 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 |
| Classification name | Cardiac monitor (including cardiotachometer and rate alarm) |
| Classification regulation | 21 CFR 870.2300 |
| Product code | MWI, DRT, DXN, DQA and FLL |
| Predicate device | ViSi Mobile Monitoring System (K112478) |
| Propaq LT VSM, Model 802 Series (K033378) | |
| Micropaq VSM, Models 402, 404 (K002725) | |
| Acuity Central Monitoring Station Predicate (K022453) | |
| 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, heart rate, non-invasive blood pressure, non-invasive | |
| monitoring of functional oxygen saturation of arterial hemoglobin, pulse | |
| rate, and skin temperature 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 a central station through wireless 802.11 communication. | |
| Summary of substantial | |
| equivalence | The ViSi System has been tested and complies with recognized |
| performance, safety, and electromagnetic compatibility standards for | |
| medical devices. The verification and validation activities performed based |
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122036 page 2/
the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection. These results demonstrate that the ViSi System is safe, as effective, and based on the similarities with the predicate devices, substantially equivalent.
ਟ
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 15 2012
Sotera Wireless, Inc c/o Mr. Mark Job Third Party Reviewer: Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K122036
Trade Name: ViSi Mobile Monitoring System Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Including Cardiotachometer and Rate Alarm Regulatory Class: II (two) Product Code: MWI, DRT, DXN, DQA, FLL Dated: July 30, 2012 Received: July 31, 2012
Dear Mr. 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
3
Page 2 - Mr. Job
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K122036
Sotera Wireless, Inc. ViSi Mobile Monitoring System Traditional 510(k)
INDICATIONS FOR USE 4
510(k) Number (if known): _KI2Zo36
Device Name: ________________________________ ViSi Mobile Monitoring System _
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 . X
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) Page __ of ___________________________________________________________________________________________________________________________________________________________________ (Division Sigh-Off) Division of Cardiovascular Devices 510||k) Number
5/31/2012
Page 12