(254 days)
Not Found
No
The document describes a system for centralized monitoring and display of vital signs from bedside monitors. It focuses on data collection, transmission, display, and alarm notification. There is no mention of AI or ML algorithms being used for analysis, interpretation, or prediction of patient data. The system appears to be a data aggregation and visualization tool.
No
The device is a medical information system designed for centralized monitoring and display of patient vital signs collected from other medical devices (bedside monitors); it does not directly provide therapy.
No
A diagnostic device typically identifies diseases or conditions. This device collects, displays, and stores vital sign information from other monitors, acting as a centralized monitoring system aiding in patient management rather than making a diagnosis itself.
No
The device description explicitly states that the system "includes a high-performance PC hardware system" and requires a "specific hardware environment such as a PC platform." While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "conduct centralized monitoring of adult, pediatric and neonatal vital sign information from multiple monitors". This involves collecting, displaying, and managing physiological data obtained directly from patients via bedside monitors.
- Device Description: The description clearly states it's a "medical information system" that works with "bedside monitors" to collect and display "physiological information".
- Nature of Data: The data it handles are vital signs (ECG, NIBP, SpO2, etc.) which are measured directly from the patient's body, not from in vitro samples (like blood, urine, tissue).
IVD devices are specifically designed to examine specimens taken from the human body (in vitro) to provide information for diagnosis, monitoring, or screening. This Central Monitoring System does not perform any analysis on such specimens. It is a system for managing and displaying real-time physiological data acquired from the patient.
N/A
Intended Use / Indications for Use
The Central Monitoring System is intended to conduct centralized monitoring of adult, pediatric and neonatal vital sign information from multiple monitors in hospitals or medical institutions, the monitoring parameters include ECG, NIBP, SpO2. PR, RESP, IBP, TEMP, CO2 and AG. It is not intended for home use.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
Central Monitoring System is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC platform, the PC and Operation System is dedicated. Depending on the specific hardware platform, the Central Monitor System constitutes a monitoring network system together with software, the Operation System and work together with bedside monitors. It can collect, and export the monitoring information of the patient transferred via network from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.
The HYPERVISOR VI Central Monitoring System is a medical information system. This System includes a high-performance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Mindray specified protocol, the Central Monitoring System obtains physiological information from cleared bedside monitors manufactured by Mindray, includes: PM-8000 Express, PM-9000 Express and VS-800.
The Central Monitoring System can maximally support the simultaneous networking of 32 bedside monitors. Also, TCP/IP protocol is applied to ensure reliable transmission of network data.
The Central Monitoring System offers centralized display of physiological information of many patients who are currently monitored simultaneously. The software can support two displays simultaneously, and can display information from up to 16 bedside monitors on a display and 32 bedside monitors on two displays simultaneously. And if any of the bedside monitors gives off alarm, prompt information will be immediately displayed by means of audible /words for medical personnel's attention.
The physiological waveforms displayed on the central monitoring system include to: ECG waveforms, RESP waveforms, CO2 waveforms, PLETH waveforms, IBP waveforms, and AG waveforms. The physiological parameters displayed on the central monitoring system include: HR, RR, SpO2, PR, SYS, DIA, MEAN, TEMP, CO2, AwRR.
Central Monitoring System makes an announcement for the physiological parameters based on the bedside monitor. The software also performs notification directly for alarms from the bedside monitor and triggers technical alarms for the error and failure of itself. Moreover database technology is applied to store these alarm events for the convenience of doctor's review and analysis.
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, pediatric and neonatal
Intended User / Care Setting
medical personnel's attention (doctors) / hospitals or medical institutions
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The conclusions drawn from testing and validation of the HYPERVISOR VI Central Monitoring System demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate device, the M3150 Information Center (K#011093, by Agilent Co., Ltd).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: K062194
APR 1 1 2007
Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China Tel: +86 755 2658 2888 Fax: +86 755 2658 2680
- Contact Person: .
- Li Dongling
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
- Date Prepared: .
July 14, 2006
Name of the device:
- Trade/Proprietary Name: HYPERVISOR VI Central Monitoring System
- Common Name: Central Monitoring System
. Classification
| 21 CFR 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm) | Class II |
|---|---|---|
| 21 CFR 870.1130 | Non-Invasive blood pressure measurement System | Class II |
| 21 CFR 870.1110 | Blood pressure computer | Class II |
| 21 CFR 880.2910 | Clinical Electronic Thermometers - | |
| Temperature Monitor with Probe | Class II | |
| 21 CFR 870.2700 | Oximeter, Pulse | Class II |
| 21 CFR 868.1400 | Carbon Dioxide Gas Analyzer | Class II |
| 21 CFR 868.1720 | Oxygen Gas Analyzer | Class II |
1
062194
Legally Marketed Predicate Device:
Agilent Technologies Information Center (AIC) Software K011093
Description:
Central Monitoring System is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC platform, the PC and Operation System is dedicated. Depending on the specific hardware platform, the Central Monitor System constitutes a monitoring network system together with software, the Operation System and work together with bedside monitors. It can collect, and export the monitoring information of the patient transferred via network from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.
The HYPERVISOR VI Central Monitoring System is a medical information system. This System includes a high-performance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Mindray specified protocol, the Central Monitoring System obtains physiological information from cleared bedside monitors manufactured by Mindray, includes: PM-8000 Express, PM-9000 Express and VS-800.
The Central Monitoring System can maximally support the simultaneous networking of 32 bedside monitors. Also, TCP/IP protocol is applied to ensure reliable transmission of network data.
The Central Monitoring System offers centralized display of physiological information of many patients who are currently monitored simultaneously. The software can support two displays simultaneously, and can display information from up to 16 bedside monitors on a display and 32 bedside monitors on two displays simultaneously. And if any of the bedside monitors gives off alarm, prompt information will be immediately displayed by means of audible /words for medical personnel's attention.
The physiological waveforms displayed on the central monitoring system include to: ECG waveforms, RESP waveforms, CO2 waveforms, PLETH waveforms, IBP waveforms, and AG waveforms. The physiological parameters displayed on the central monitoring system include: HR, RR, SpO2, PR, SYS, DIA, MEAN, TEMP, CO2, AwRR.
2
Central Monitoring System makes an announcement for the physiological parameters based on the bedside monitor. The software also performs notification directly for alarms from the bedside monitor and triggers technical alarms for the error and failure of itself. Moreover database technology is applied to store these alarm events for the convenience of doctor's review and analysis.
Statement of intended Use:
The Central Monitoring System is intended to conduct centralized monitoring of adult, pediatric and neonatal vital sign information from multiple monitors in hospitals or medical institutions, the monitoring parameters include ECG, NIBP, SpO2. PR, RESP, IBP, TEMP, CO2 and AG. It is not intended for home use.
Comparison of Technological Characteristics:
The HYPERVISOR VI Central Monitoring System is substantially equivalent to currently marketed predicate device. Both HYPERVISOR VI Central Monitoring System and the M3150 predicate device free-up doctors from clinical monitoring work and create centralized monitoring management.
The notable difference between the technical specifications of the HYPERVISOR VI and M3150 is shown as following:
-
- M3150 predicate can be used for ST segment and arrhythmia analysis, while the Central Monitoring System can not.
-
- M3150 can be used for Telemetry and wireless monitoring, while Central Monitoring System can not;
-
- The PC basic requirement is different, such as the operation system for Central Monitoring System is Windows XP professional, while M3150 is Windows NT4.0; the host CPU of Central Monitoring System is PIV 2.0 G, while the M3150 is PII 400+MHz;
-
- For Central Monitoring System, the maximum number of connecting bedside monitors is 32, while for M3150, the number is 16.
Conclusion:
The conclusions drawn from testing and validation of the HYPERVISOR VI Central Monitoring System demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate device, the M3150 Information Center (K#011093, by Agilent Co., Ltd).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2007
Shenzhen Mindray Bio-Medical Electronics Co. Ltd. c/o Ms. Susan D. Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K062194
Trade/Device Name: Hypervisor VI Central Monitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: March 9, 2007 Received: March 12, 2007
Dear Ms. Goldstein-Falk:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
4
Page 2 - Ms. Susan D. Goldstein-Falk
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment #
Exhibit #E
510(k) Number (if known): K062194 Page 1 of 1
Device Name: HYPERVISOR VI Central Monitoring System Indications For Use:
The Central Monitoring System is intended to conduct centralized monitoring of adult, pediatric and neonatal vital sign information from multiple monitors in hospitals or medical institutions, the monitoring parameters include ECG, NIBP, SpO2, PR, RESP, IBP, TEMP, CO2 and AG. It is not intended for home use.
Prescription Use X (Per 21 CFR 801 Subpart D) Over-The Counter Use OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummenauer
ular Devices