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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(k) summary.

Important Note: The provided document describes a Central Monitoring System and a Telemetry Monitoring System, which are hardware and software systems for patient monitoring. This 510(k) summary does NOT involve Artificial Intelligence (AI) or machine learning. Therefore, many of the questions related to AI models, such as training sets, ground truth establishment for training, or MRMC studies for AI assistance, are not applicable to this submission.

The "study" described is a series of tests to demonstrate the safety and effectiveness of the traditional medical device, particularly its substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device, the "acceptance criteria" are not framed as specific performance metrics like sensitivity/specificity for a diagnostic algorithm. Instead, they are compliance with recognized standards and successful completion of various engineering and validation tests. The "reported device performance" is the statement that the device passed these tests.

Acceptance Criterion	Reported Device Performance (as stated in the document)
Compliance with Recognized Safety Standards	Successfully complies.
Compliance with Recognized Performance Standards	Successfully complies.
Compliance with Recognized Electromagnetic Compatibility (EMC) Standards	Successfully complies.
Risk Analysis Development and Hazard Mitigation	Risk analysis developed; mitigation documented.
Requirements Specification Review	Completed successfully.
Hardware Testing	Completed successfully.
Software Testing	Completed successfully.
Code Design & Code Reviews	Completed successfully.
Environmental Testing	Completed successfully.
Safety Testing	Completed successfully.
Performance Testing	Completed successfully.
Hardware Validation	Completed successfully.
Software Validation	Completed successfully.
Substantial Equivalence to Predicate Device (K080192)	Determined to be substantially equivalent in safety, effectiveness, and performance.

Study Details (Applicable to Traditional Medical Devices, Not AI)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of patient data or case numbers typically associated with AI model testing. The "test set" here refers to the actual physical device and its software being subjected to various engineering and validation tests. These tests would involve specific test environments, simulated data inputs, and potentially real patient data in a controlled setting for certain functions (e.g., ECG or SpO2 signal acquisition). The document does not quantify this "sample size."
- Data Provenance: Not explicitly stated. Given that it's a hardware/software system, testing would likely be performed in a controlled lab environment by the manufacturer (Shenzhen Mindray Bio-medical Electronics Co., LTD, China). There is no mention of external data collection (country of origin, retrospective/prospective) because it's not a diagnostic AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a traditional monitoring system, "ground truth" (e.g., in terms of a gold standard diagnosis) is not established by human experts in the same way it would be for an AI diagnostic algorithm. The system's performance is verified against engineering specifications, known signal properties, and the performance of the predicate device. If human review was involved for specific signals (e.g., ECG waveform review), it's not detailed in this summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth for image interpretation or diagnostic tasks involving multiple human readers to resolve discrepancies. This is not relevant for the type of safety and performance testing described for this monitoring system.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is not an AI system. Therefore, no MRMC study involving AI assistance would have been performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Applicable / Misaligned Question. The device itself is a "standalone" system in terms of its functions (monitoring, data transfer, storage). Its performance for functions like ECG and SpO2 acquisition is "algorithm only" in the sense that the internal processing is automatic. However, the question typically refers to the standalone performance of an AI diagnostic algorithm. Since this is a monitoring system, its "standalone" performance would be assessed through the various engineering and validation tests (accuracy of readings, reliability of data transfer, alarm functionality, etc.). The document indicates these tests were performed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Predicate Device Performance. The "ground truth" for this monitoring system is its adherence to predefined engineering specifications, industry standards (e.g., for physiological measurement accuracy, network communication protocols), and its equivalency to the performance of its legally marketed predicate device (HYPERVISOR VI Central Monitoring System, K080192). For physiological parameters, "truth" would be established by calibrated measurement devices or validated simulators producing known signals.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
How the ground truth for the training set was established:
- Not Applicable. As this is not an AI/ML device, there is no training set or ground truth establishment for it in the context of machine learning.

Summary

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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

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Classification

21 CFR 870.2300	System, Network and Communication, Physiological Monitors	Class II
21 CFR 870.1025	Monitor, Physiological, Patient (With Arrhythmia Detection orAlarms)	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:

Statement of intended Use:

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

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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.

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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

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

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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

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Indications for Use

510(k) Number (if known): _ K132036

Device Name: Hypervisor Central Monitoring System (including Telemetry Monitoring System, TMS-6016)

Indications for Use:

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'

Regulation Number and Section

§ 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).