(69 days)
Not Found
No
The document describes a medical information system for monitoring physiological data and does not mention any AI or ML capabilities. The functions described are standard data transfer, storage, display, and basic processing.
No
The device, Central Monitoring System (CMS), is described as a medical information system that primarily handles communication, storage, processing, and display of information from networked devices, including a Telemetry Monitoring System (TMS). While the TMS obtains physiological information (ECG, SpO2), the CMS's role is to manage and process this data, not to directly treat or diagnose a condition. It facilitates monitoring, but does not itself provide therapy.
No
The CMS network primarily facilitates the transfer, storage, and processing of physiological information, while the Telemetry Monitoring System (TMS) obtains the physiological data (ECG, SpO2, etc.). Neither component is described as performing a diagnostic function; rather, they provide data that could be used by medical personnel for diagnosis.
No
The device description explicitly mentions hardware components like networked devices, sensors, transmitters, receivers, and a PC platform. While software is a key part of the system (CMS network, Hypervisor VI), it is integrated with and relies on these physical components to function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that the CMS and Telemetry Monitoring System are used to:
- Transfer information between networked medical devices.
- Monitor physiological information directly from patients (ECG, SpO2, Heart Rate, etc.) using sensors and wireless transmission.
- Store, print, review, and process this physiological data.
- Provide remote monitor management.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing specimens from the human body. The data is obtained directly from the patient's physiological signals.
Therefore, the device falls under the category of patient monitoring systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CMS network transfers information between HYPERVISOR VI Central Monitoring System and other networked devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and/or WLAN connections. CMS can be used for remote monitor management, storing, printing, reviewing or processing of information from networked devices, and it is operated by medical personnel in hospitals or medical institutions.
Telemetry Monitoring System is a sub-system of CMS, intended to obtain ECG and SpO2 physiological information from adult and pediatric patients, and send it to CMS via WMTS frequency within a defined coverage area.
Product codes (comma separated list FDA assigned to the subject device)
MSX, MHX, DQA, DPZ, DRG
Device Description
Central Monitoring System network is a kind of medical information system, which consists of different networked devices (which have separate 510(k) clearance). Hypervisor VI Central Monitoring System (CMS) is the primary maintainer of communication between other networked devices. It can store, print, review or process information from networked devices. It can also realize remote monitor management function to free doctors from clinical monitoring work and conduct centralized monitoring management.
In this submission, CMS adds the function of supporting communication with Telemetry Monitoring System. Besides this, CMS is improved to include some new functions, such as, add the function of ViewOtherBed and add the function of real-time print.
By using radiofrequency signal, TMS is intended to monitor Electrocardiogram (ECG), Heart Rate (HR), Arrhythmia Detection, ST Segment Analysis, Saturation of Pulse Oxygen (SpO2) and Pulse Rate (PR) for adult and pediatric patients. Physical signals are collected by sensors and wirelessly transmitted by transmitters in WMTS band, receivers get the signals and forward to CMS for processing, displaying, storing, printing, etc. It can be used within a defined coverage area in hospitals or medical institutions.
CMS is based on the PC platform, and the PC can be configured by users according to the requirements on the operator's manual.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
medical personnel in 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing has been conducted to validate and verify that the CMS (including TMS) meet all design specifications. Results of these tests demonstrate compliance to the requirements of all applied standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 870.2300 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
APR - 3 2008
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
08019-The assigned 510(k) number is:
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: .
January 4, 2008
Name of the Device:
- Trade/Proprietary Name: HYPERVISOR VI Central Monitoring System . (including TMS)
- Common Name: Central Monitoring System (CMS) ●
- Classification: ●
MSX, 21 CFR Part 870.2300 MHX, 21 CFR Part 870.1025
DQA, 21 CFR Part 870.2700
DPZ, 21 CFR Part 870.2710
DRG, 21 CFR Part 870.2910
System, Network and Communication, Physiological Monitors Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms) Oximeter Oximeter, Ear Transmitters and Receivers, Physiological Signal, Radiofrequency
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Legally Marketed Predicate Device:
HYPERVISOR VI Central Monitoring System, Shenzhen Mindray Bio-Medical K062194 Electronics Co., LTD.
Spacelabs Medical Ultraview Digital Telemetry System, Spacelabs Medical, Inc. K983996
Description:
Central Monitoring System network is a kind of medical information system, which consists of different networked devices (which have separate 510(k) clearance). Hypervisor VI Central Monitoring System (CMS) is the primary maintainer of communication between other networked devices. It can store, print, review or process information from networked devices. It can also realize remote monitor management function to free doctors from clinical monitoring work and conduct centralized monitoring management.
In this submission, CMS adds the function of supporting communication with Telemetry Monitoring System. Besides this, CMS is improved to include some new functions, such as, add the function of ViewOtherBed and add the function of real-time print.
By using radiofrequency signal, TMS is intended to monitor Electrocardiogram (ECG), Heart Rate (HR), Arrhythmia Detection, ST Segment Analysis, Saturation of Pulse Oxygen (SpO2) and Pulse Rate (PR) for adult and pediatric patients. Physical signals are collected by sensors and wirelessly transmitted by transmitters in WMTS band, receivers get the signals and forward to CMS for processing, displaying, storing, printing, etc. It can be used within a defined coverage area in hospitals or medical institutions.
CMS is based on the PC platform, and the PC can be configured by users according to the requirements on the operator's manual.
Statement of Intended Use:
The CMS network transfers information between HYPERVISOR VI Central Monitoring System and other networked devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and/or WLAN connections. CMS can be used for remote monitor management, storing, printing, reviewing or processing of information from networked devices, and it is operated by medical personnel in hospitals or medical institutions.
Telemetry Monitoring System is a sub-system of CMS, intended to obtain ECG and SpO2 physiological information from adult and pediatric patients, and send it to CMS via WMTS frequency within a defined coverage area.
Comparison of Technological Characteristics:
The CMS is substantially equivalent to the previously cleared CMS (K062194) in technological characteristics. Both of them apply the same design principles, and the
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modifications are concentrated on software consummating and network testing. The TMS is substantially equivalent to Ultraview Digital Telemetry System (K983996). Both of them monitor similar parameters of patients, and apply similar design principles.
Testing:
Laboratory testing has been conducted to validate and verify that the CMS (including TMS) meet all design specifications. Results of these tests demonstrate compliance to the requirements of all applied standards.
: 上
Conclusion:
The Central Monitoring System is substantially equivalent to the predicate devices.
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Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health. The caduceus has three snakes winding around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 2008
Shezhen Mindray Bio-Medical Electronics Co., Ltd c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Blvd, Suite 200 Great Neck, NY 11021
Re: K080192
HYPERVISOR VI Central Monitoring System (including Telemetry Monitoring System, Model TMS-6016) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: MSX Dated: January 4, 2008 Received: January 25, 2008
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.
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Page 2 - Ms. Susan D. Goldstein-Falk
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); 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/cdrl/industry/support/index.html.
Sincerely yours,
B.J. Zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
KO80x92
Device Name: HYPERVISOR VI Central Monitoring System (including TMS)
Indications for Use:
The CMS network transfers information between HYPERVISOR VI Central Monitoring System and other networked devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and/or WLAN connections. CMS can be used for remote monitor management, storing, printing, reviewing or processing of information from networked devices, and it is operated by medical personnel in hospitals or medical institutions.
Telemetry Monitoring System is a sub-system of CMS, intended to obtain ECG and SpO2 physiological information from adult and pediatric patients, and send it to CMS via WMTS frequency within a defined coverage area.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Vettumtor
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stan Sign-Of scular Devices