(365 days)
No
The description focuses on data transfer, storage, and basic processing within a network, with no mention of AI/ML terms or functionalities like learning, prediction, or complex data analysis beyond simple review and storage.
No
The device is described as a medical information system for managing and processing patient data, including ECG and SpO2 information, but it does not directly apply a therapeutic effect to the patient. Its function is data transfer and management, not treatment.
No
The device description indicates that the CMS network is a "medical information system" that "transfers information," "stores, prints, reviews or processes information from networked devices," and "realizes remote monitor management function." While it obtains physiological information from patients, it does not perform analysis or interpretation of that data to diagnose a disease, condition, or state of health. It acts as a central hub for data management and monitoring, which is a supportive function rather than a diagnostic one.
No
The device description explicitly states it consists of "different networked devices" and mentions hardware and software testing and validation, indicating it is not solely software.
Based on the provided information, this device 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. They are used to diagnose, monitor, or screen for medical conditions.
- Device Function: The description clearly states that the CMS network and Telemetry Monitoring System are designed to:
- Transfer information between networked medical devices.
- Store, print, review, and process physiological information (ECG and SpO2) obtained from patients.
- Provide remote monitor management and centralized monitoring.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on samples taken from the body. Its function is focused on collecting, transmitting, and managing physiological data obtained directly from the patient via sensors (ECG and SpO2).
Therefore, the device falls under the category of a patient monitoring system or medical information system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CMS network transfers information between Hypervisor 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
MSX, MHX, DQA, DPZ, DRQ
Device Description
The CMS network is a kind of medical information system, which consists of different networked devices (which have separate 510(k) clearance). 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.
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 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
The Hypervisor Central Monitoring System (including Telemetry Monitoring System, TMS-6016) comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors:
Requirements specification review Hardware and Software testing Code design and code reviews Environmental EMC testing Safety testing Performance testing Hardware and Software validation
Key Metrics
Not Found
Predicate Device(s)
HYPERVISOR VI Central Monitoring System (including Telemetry Monitoring System, K080192, TMS-6016)
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
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.
The assigned 510(k) number is: K132036
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 8188 8998 Fax: +86 755 2658 2680
- Contact Person: .
Russell Olsen VP Quality & Regulatory Affairs
Mindray North America 800 MacArthur Blvd. Mahwah, NJ 07430
Tel: 800.288.2121 Mobile: 201.962.0946 r.olsen@mindray.com
Date Prepared: .
Jun 24, 2013
Name of the devices:
. Trade/Proprietary Name:
Hypervisor Central Monitoring System (including Telemetry Monitoring System, TMS-6016)
● Common Name: Central Monitoring System
1
Classification
| 21 CFR 870.2300 | System, Network and Communication, Physiological Monitors | Class II |
|---|---|---|
| 21 CFR 870.1025 | Monitor, Physiological, Patient (With Arrhythmia Detection or | |
| Alarms) | Class II | |
| 21 CFR 870.1025 | Detector and Alarm, Arrhythmia | Class II |
| 21 CFR 870.1025 | Monitor, ST Segment with Alarm | Class II |
| 21 CFR 870.2300 | Cardiac monitor (including cardio tachometer and rate alarm) | Class II |
| 21 CFR 870.2700 | Oximeter, Pulse | Class II |
| 21 CFR 870.2710 | Oximeter, Ear | Class II |
| 21 CFR Part 870.2910 | Transmitters and Receivers, Physiological Signal, Radiofrequency | Class II |
Legally Marketed Predicate Devices:
HYPERVISOR VI Central Monitoring System (including Telemetry Monitoring System, K080192, TMS-6016), Shenzhen Mindray Bio-medical Electronics Co., LTD
Device Description:
The CMS network is a kind of medical information system, which consists of different networked devices (which have separate 510(k) clearance). 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.
Statement of intended Use:
The CMS network transfers information between Hypervisor 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.
Technology:
The Hypervisor Central Monitoring System (including Telemetry Monitoring System, TMS-6016) is substantially equivalent to the predicate devices HYPERVISOR VI Central Monitoring System (including Telemetry Monitoring System, TMS-6016) (K080192).
Page 2 of 3
2
Test Summary:
The Hypervisor Central Monitoring System (including Telemetry Monitoring System, TMS-6016) comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors:
Requirements specification review Hardware and Software testing Code design and code reviews Environmental EMC testing Safety testing Performance testing Hardware and Software validation
Conclusion:
The results of all testing demonstrate that the Hypervisor Central Monitoring System (including Telemetry Monitoring System, TMS-6016) is as safe, as effective, and perform as well as the predicate device.
3
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
DEPARTMENT OF HEALTH & HUMAN SERVICES USA
July 1, 2014
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Russell Olsen VP Quality & Regulatory Affairs 800 Macarthur Blvd. Mahwah, New Jersey 07430
Re: K132036
Trade/Device Name: Hypervisor central monitoring system (including telemetry monitoring system, tms-6016)
Regulation Number: 21 CFR 870.2300
Regulation Name: Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm)
Regulatory Class: Class II Product Code: MSX, MHX, DQA, DPZ, DRQ Dated: May 23, 2014 Received: May 29, 2014
Dear Russell Olsen,
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. Ilisting 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 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
4
Page 2 - Russell Olsen
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Athel Stei
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): _ K132036
Device Name: Hypervisor Central Monitoring System (including Telemetry Monitoring System, TMS-6016)
Indications for Use:
The CMS network transfers information between Hypervisor 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)
Date: 2014.07.01 Page 1 1 12:03:41 -04'00'