· Real time viewing of patient clinical data and alarms
· Storage and Historical review of patient clinical data and alarms
· Printing of real time and historical patient data
· Configuration of local settings as well as synchronizing settings across the network to a remote device
· Transfer of patient clinical data and settings between several CentralStations

The Hypervisor IX Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in a hospital or clinical environment to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WiFi (WLAN), and Wireless WMTS. The Hypervisor IX Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Hypervisor IX Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors.

The Hypervisor IX Monitoring System includes several Telemetry monitoring subsystems all of which operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.

· The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The CentralStation will support ECG, Heart Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS-6016.

• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data. The Centralstation will support ECG, Heart Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the Panorama Telepack-608.

· The TMS60 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The physiological data can be reviewed locally on the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

The Hypervisor IX Monitoring System is intended for use in a hospital or other clinical environment under the direct supervision of a licensed healthcare practitioner.

Device Description

The Hypervisor IX Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Hypervisor IX Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors.

The Hypervisor IX Monitoring System includes three telemetry monitoring systems all of which operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.

The Hypervisor IX Monitoring System consists the following components:

1. Central Station
1. View Station
1. Work Station
1. Telemetry Systems (TMS 6016, Telepak-608, TMS60)

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hypervisor IX Monitoring System, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantifiable manner (e.g., target accuracy, sensitivity, specificity). Instead, it describes general claims of meeting specifications and equivalence to a predicate device. The performance data section focuses on types of testing performed rather than specific quantitative results against pre-defined criteria.

Feature/Test	Acceptance Criteria (Not explicitly stated with quantifiable thresholds in the document)	Reported Device Performance
Functional and System Level Testing	Implied: Device meets all functional and system-level specifications.	"The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."
Compliance with Relevant Consensus Standards	Implied: Device meets all relevant consensus standards.	"Mindray has conducted testing to ensure the subject device meets relevant consensus standards." (References "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Guidance for Industry and FDA (10/28/2003)", "Cardiac Monitor Guidance (Including Cardiotachometer and Rate Alarm)", and "Class II Special Controls Guidance Document: Electrocardiograph Electrodes")
Wireless Functionality Testing	Implied: Device meets wireless specifications.	"Mindray conducted Wireless functionality testing to ensure the performance of the Hypervisor IX Monitoring System meets wireless specifications and is equivalent to the predicate device."
Substantial Equivalence (Overall System Performance)	Implied: Differences do not raise new questions of safety and effectiveness.	"Based on the detailed comparison of specifications for each of the modifications to the previously cleared Hypervisor Central Monitoring System, the functional and performance testing and conformance with applicable standards as well as the comparison of indications, the differences do not raise new questions of safety and effectiveness and the Hypervisor IX Monitoring System can be found substantially equivalent to the predicate device."
QT Monitoring	Implied: Performance comparable to cleared predicate with QT monitoring.	"Although QT monitoring was not included in the predicate Hypervisor device, it is present in the cleared Philips ST/AR ST and Arrhythmia Software (K101521), and thus does not constitute a new intended use for a patient monitoring system."

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not provide information regarding:

The specific sample size (number of patients, records, or tests) used for performance testing (test set).
The country of origin of the data.
Whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on:

The number of experts, if any, used to establish ground truth for the test set.
The qualifications of such experts.

The testing described (functional, system-level, wireless) appears to be primarily engineering verification against specifications rather than clinical validation requiring expert ground truth on patient data. The statement regarding QT monitoring references a predicate device (Philips ST/AR ST and Arrhythmia Software K101521) for establishing the safety/effectiveness of that function, implying reliance on that previous clearance rather than new clinical ground truthing on this specific device.

4. Adjudication Method for the Test Set

The document does not provide information on any adjudication method used for the test set. Given the nature of the described testing, formal adjudication by experts is unlikely to have been part of these specific tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not indicate that an MRMC comparative effectiveness study was done. This type of study is more relevant for diagnostic AI devices where human reader performance is a key metric. The Hypervisor IX Monitoring System is described as a networked patient monitoring system that displays, stores, prints, and transfers data; it explicitly states "No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors." This implies the system's role is data management and display, not AI-driven interpretation or diagnosis that would typically warrant an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document does not describe the device as incorporating an AI algorithm that would typically require standalone performance evaluation. The statement "No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors" suggests its function is passive.

7. The Type of Ground Truth Used

Based on the description of testing (functional, system-level, wireless compliance, and comparison to predicate specifications), the "ground truth" for the tests performed would likely be:

Engineering Specifications: For functional and system-level tests.
Regulatory Standards: For compliance with consensus standards.
Predicate Device Performance/Clearance: For demonstrating equivalence and justification for new features like QT monitoring.

There is no mention of ground truth derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set. This is consistent with the description of the device as not performing data processing or incorporating AI that would require machine learning training.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned or implied, there is no information on how ground truth for a training set would have been established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2015

Shenzhen Mindray Bio-medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Kenji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, 518057 CN

Re: K150632

Trade/Device Name: Hypervisor IX Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX, MHX, DRQ Dated: March 9, 2015 Received: March 11, 2015

Dear Yanhong Bai:

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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 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 vours

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) K150632

Device Name Hypervisor IX Monitoring System

Indications for Use (Describe)

The indications for use of the Hypervisor IX Monitoring System include:
· Real time viewing of patient clinical data and alarms
· Storage and Historical review of patient clinical data and alarms
· Printing of real time and historical patient data
· Configuration of local settings as well as synchronizing settings across the network to a remote device
· Transfer of patient clinical data and settings between several CentralStations

The Hypervisor IX Monitoring System is intended for use in a hospital or other clinical environment under the direct supervision of a licensed healthcare practitioner.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Hypervisor IX Monitoring System is provided below.

Device Common Name:	Physiological Monitors, Network and CommunicationSystem
Device Trade Name:	Hypervisor IX Monitoring System
Applicant:	SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680
Contact:	Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan 518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Prepared by:	Donna-Bea Tillman, Ph.D.Biologics Consulting Group, Inc.400 N. Washington St, Suite 100Alexandria, VA 22314Phone: 410-531-6542Email: dtillman@bcg-usa.com
Date Prepared:	March 20, 2015
Classification Regulation:	870.2300 - Cardiac Monitor (including cardiotachometer andrate alarm)Class II
Panel:	Cardiovascular
Product Code:	MSX - Physiological Monitors Network andCommunication System
Subsequent Product Codes:	DRQ- Transducer signal amplifier and conditioner
	MHX - Arrhythmia detector and alarm (including ST-segment measurement and alarm)

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K132036 – Hypervisor Central Monitoring System Predicate Device:

Indication for Use:

The indications for use of the Hypervisor IX Monitoring System include:

Real time viewing of patient clinical data and alarms ●
Storage and Historical review of patient clinical data and alarms ●
Printing of real time and historical patient data ●
Configuration of local settings as well as synchronizing settings across the network to a remote device
Transfer of patient clinical data and settings between several CentralStations ●

. The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS-6016.
. The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the Panorama Telepack-608.
The TMS60 transmitter is intended for use on Adult and Pediatric patients to monitor ● ECG and SpO2 physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate,

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SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

The Hypervisor IX Monitoring System is intended for use in a hospital or other clinical environment under the direct supervision of a licensed healthcare practitioner.

Device Description:

The Hypervisor IX Monitoring System consists the following components:

1. Central Station
1. View Station
1. Work Station
1. Telemetry Systems (TMS 6016, Telepak-608, TMS60)

Performance Data:

. To establish the substantial equivalence of the Hypervisor IX Monitoring System, Mindray conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
Mindray has conducted testing to ensure the subject device meets relevant consensus standards.
. Mindray conducted Wireless functionality testing to ensure the performance of the Hypervisor IX Monitoring System meets wireless specifications and is equivalent to the predicate device.
Mindray has followed the following FDA Guidance Documents relevant to this device:

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। Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Guidance for Industry and FDA (10/28/2003)
Cardiac Monitor Guidance (Including Cardiotachometer and Rate Alarm) ।
Class II Special Controls Guidance Document: Electrocardiograph Electrodes ।

Comparison of Technological Characteristics:

The technological characteristics of the subject device are compared to the predicate device in the table below.

	Predicate Device	Subject Device
Device Name	HYPERVISOR CENTRALMONITORING SYSTEM (INCLUDINGTELEMETRY MONITORING SYSTEM,TMS-6016)	Hypervisor IX Monitoring System
Manufacturer	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD	SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD
510(k)	K132036	TBD
Regulation	870.2300 - Cardiac Monitor (includingcardiotachometer and rate alarm)Class II	870.2300 - Cardiac Monitor (includingcardiotachometer and rate alarm)Class II
Product Code	MSX - Physiological Monitors Networkand Communication System	MSX - Physiological Monitors Networkand Communication System
OperatingSystem	Windows XP Professional Embedded SP3	Microsoft Windows 7 ProfessionalEmbedded SP1
NetworkConfiguration	100 Mbps, Ethernet 802.3	Same
HostComputers	HP Compaq 8380 Elite MT	HP Compaq 8380 Elite MTHP EliteDesk 800 G1 SFFKontron KISS 2U V2 KTQ87FLEX
PatientMonitorNumbers	Up to 16 monitors in the single-screenmode and 32 monitors in the dual- ormulti-screen mode simultaneouslySupport up to four local displays	Same
	Predicate Device	Subject Device
PatientMonitorConnectivity	Supports the following patient monitors:DPM3 (K072235)DPM4/5 (K070791)DPM6/7 (K092449)Passport 12M/17M (K143195)Passport8/12 (K132662)Accutorr 7 (K132038)T1 (K143195)	Supports the following patient monitors:DPM3 (K072235)DPM4/5 (K070791)DPM6/7 (K092449)Passport 12M/17M (K143195)Passport8/12 (K132662)Accutorr 7 (K132038)T1 (K143195)Spectrum (K062098)Spectrum OR (K062098)Passport II (K020550)Passport V (K091834)V12/21 (K132026)
	TelemetrySystem	TMS-6016 (K132036)	TMS-6016 (K132036)Telepack-608 (K142601)TMS60
		Calculations	Supports five calculation modes:Drug CalculationHemodynamics CalculationOxygenation CalculationVentilation CalculationRenal Calculation	No change
			RemoteMonitoring	Provided on supported monitors
	Data ReviewFeatures		Dynamic short trendTrend reviewWave reviewNIBP reviewEvent Review12-lead reviewST reviewCardiac output reviewPrint and DisplayRecords	Dynamic short trendTrend reviewWave reviewNIBP reviewEvent Review12-lead reviewST reviewCardiac output reviewPrint and Display (now includes QT View)Records
			Predicate Device	Subject Device
	ECG Features		Mindray or Mortara ECG Algorithms -selectable	Mindray or Mortara ECG Algorithms -selectable
			3-lead or 5-lead selectable	3-lead or 5-lead selectable
	arrhythmia detection	arrhythmia detection with adjustable leads
	ST segment analysis	ST segment analysis
	heart rate	heart rate
	Pace Mark	Pace Mark
	Pace Pulse Rejection	Pace Pulse Rejection
		QT Analysis
		J Point Auto detection
		QRS Detection Threshold

Device Comparison Table

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Comparison of Indications:

The indication for use statement of the Hypervisor IX Monitoring System includes the indication for the system as whole as well as cleared indications for each of the components of the system. Both the predicate device and the subject device are patient monitoring systems intended to be used in healthcare facilities under the direction of clinical professionals. Additional language has been added to the indications for use of the current device to more clearly describe existing functions, as well as to include the new feature of OT monitoring. Although QT monitoring was not included in the predicate Hypervisor device, it is present in the cleared Philips ST/AR ST and Arrhythmia Software (K101521), and thus does not constitute a new intended use for a patient monitoring system.

Substantial Equivalence Conclusion:

Based on the detailed comparison of specifications for each of the modifications to the previously cleared Hypervisor Central Monitoring System, the functional and performance testing and conformance with applicable standards as well as the comparison of indications, the differences do not raise new questions of safety and effectiveness and the Hypervisor IX Monitoring System can be found substantially equivalent to the predicate device.

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).