(27 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. 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.
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
This K133586 submission is a special 510(k) for a modification to the ViSi Mobile Monitoring System. The modification is only to increase the time to alarm for critically low, low, and high heart rates. The device design, technology, materials, and processes remain unchanged. Therefore, a comprehensive study proving the device meets acceptance criteria related to its vital sign measurements is not included or required in this specific submission. The submission focuses on the safety and effectiveness of the alarm modification.
However, based on the information provided, we can infer some details that would typically be part of a full device submission, and we can specifically address the modification's impact based on the available text.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a modification to alarm timing, the acceptance criteria would primarily relate to the accuracy and timing of the alarms themselves. The document states "The modification is only to increase the time to alarm for critically low, low, and high heart rates". This implies the original device already had established performance for heart rate measurement.
Acceptance Criteria for Alarm Timing Modification:
| Parameter | Acceptance Criteria (Implied for this modification) | Reported Device Performance (Implied from the submission being cleared) |
|---|---|---|
| Alarm Timing | Increased time to alarm for critically low, low, and high heart rates, meeting applicable safety standards (e.g., IEC 60601-1-8 for alarm systems). | The modified alarm timing was deemed substantially equivalent and safe. |
| Heart Rate Accuracy | (No change from predicate) Accuracy of heart rate measurement within a specified range (e.g., ±X bpm or X%). | (Presumed to meet predicate device's performance). |
| False Alarms | (No change from predicate) Acceptable rate of false alarms, potentially improved by increased alarm delay. | (Presumed to meet predicate device's performance). |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not detail a separate clinical or non-clinical test set for this specific modification. Since the change is only to alarm timing, a full-scale test set involving patient data for vital sign accuracy is not described. It is more likely that:
- Bench testing: The modified alarm logic would have been tested extensively in a lab setting using simulated heart rate data to verify the new alarm delays.
- Safety assessment: A risk analysis would have been performed to ensure the increased alarm delay does not pose an undue risk to patients.
Therefore, specific sample sizes for a "test set" in the context of vital sign accuracy or a large clinical study are not mentioned for this specific submission. The data provenance for such bench testing would originate from the manufacturer's internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this modification as it pertains to alarm timing logic, not the accuracy of a diagnostic output where expert consensus would be needed. The "ground truth" for alarm timing would be the specified delay parameter implemented in the software.
4. Adjudication Method for the Test Set
Not applicable for this modification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This device is a vital signs monitor, not an interpretive AI system that human readers would interact with in a diagnostic context. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that the alarm logic itself functions "standalone" as part of the device's software. The performance of the alarm delay would be tested independently of human intervention during the verification and validation process to ensure it triggers at the correct (newly modified) time. However, this is not an "AI algorithm" in the common sense of the term.
7. The Type of Ground Truth Used
For the specific modification of alarm timing, the ground truth would be:
- Defined Technical Specifications: The new, increased alarm delay times specified by the manufacturer.
- Validated System Behavior: Demonstrating that the device's software accurately implements these new delay times.
For the original vital sign measurements (HR, SpO2, NIBP, etc.) (from the predicate device's submission), the ground truth would typically be established using:
- Reference Devices: Comparing measurements from the ViSi Mobile Monitoring System to simultaneously acquired measurements from highly accurate,
calibrated reference devices (e.g., an invasive arterial line for NIBP, a co-oximeter for SpO2, a reference ECG for HR). - Physiological Stimulators: Using simulators to generate known vital signs for testing.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional sense. The alarm logic is rule-based and modified through program changes, not through machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device and modification.
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K133586 Page 1 of 1
・
8 510(K) SUMMARY
DEC 18 2013
| Date prepared | November 20, 2013 |
|---|---|
| Name | Sotera Wireless, Inc.9444 Waples Street, Suite 280San Diego, CA 92121T. 858.373.4841; F. 858.427.4639 |
| Contact person | Eben GordonSenior 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 signsmonitor featuring a high resolution, full color touch screen display, with visualand audible alarms and alerts. The ViSi Mobile Monitor is body-worn anddesigned to continuously measure ECG, heart rate, SpO2, pulse rate, respirationrate, and temperature. The ECG, SpO2, and Respiration waveforms are viewableon demand. NIBP can be measured as a onetime measurement, or it can bemeasured automatically at predefined intervals |
| Indications for use | The ViSi Mobile Monitoring System is intended for use by clinicians andmedically qualified personnel for single or multi-parameter vital signs monitoringof adult patients. It is indicated for ECG (3 or 5 leadwire), respiration rate(RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasivemonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulserate (PR), and skin temperature (TEMP) in hospital-based facilities; includinggeneral medical-surgical floors, intermediate care floors, and emergencydepartments.The ViSi Mobile Monitoring System may be used as standalone devices ornetworked to central station through wireless 802.11 communication. |
| Summary ofsubstantial equivalence | The device design, technology, materials, processes, etc. have not been changedwith this application. The modification is only to increase the time to alarm forcritically low, low, and high heart rates; therefore the ViSi Mobile MonitoringSystem as described in this submission is substantially equivalent to the predicatedevice. |
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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
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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
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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 __
K133586 Page 1 of 1
Page 23
§ 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).