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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the HYPERVISOR VI Central Monitoring System (including TMS) but does not contain detailed information about acceptance criteria or specific study results that prove the device meets such criteria.

Here's an analysis based on the available information regarding your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states:
"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."
However, it does not specify what those design specifications or their acceptance criteria were, nor does it present the actual performance results in a table or any other format.

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

Not available in the provided text. There is no mention of a test set, its sample size, or the provenance of any data used for testing.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not available in the provided text. There is no information about expert involvement in establishing ground truth.

4. Adjudication Method for the Test Set

Not available in the provided text. No test set details, let alone an adjudication method, are mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable/Not available. The document describes a Central Monitoring System and a Telemetry Monitoring System, which are devices primarily focused on data communication, storage, and display of physiological parameters (ECG, HR, SpO2, PR). These are not AI-assisted interpretative or diagnostic tools for which an MRMC comparative effectiveness study would typically be performed to assess human reader improvement with AI assistance. The text does not mention any AI components or human-in-the-loop assistance features.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not available/Not applicable in the context of an "algorithm only" study as it is understood for diagnostic AI. The device is a monitoring system. The closest equivalent would be performance testing of its internal algorithms for parameter measurement (e.g., arrhythmia detection, ST segment analysis) and communication, but specific details of such studies are not provided beyond the general statement of "Laboratory testing."

7. Type of Ground Truth Used

Not available in the provided text. Given that the device is a monitoring system, ground truth would likely refer to validated reference measurements for ECG, SpO2, heart rate, and arrhythmia detection, but the document does not specify how this was established or what type of ground truth was used.

8. Sample Size for the Training Set

Not applicable/Not available. This device is a monitoring and communication system, not a device that typically "learns" from a training set in the way AI/ML algorithms do. Therefore, a training set in that sense is not relevant and not mentioned.

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

Not applicable/Not available, as there is no mention of a training set.

Summary of what is available regarding testing:

The 510(k) summary broadly states:

"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."

However, it does not provide:

Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
Detailed study protocols or methodologies.
Actual performance values (e.g., "The device achieved X sensitivity and Y specificity").
Information on data sets used (sample size, provenance).
Details about expert review or ground truth establishment.

The focus of this 510(k) appears to be primarily on establishing substantial equivalence to predicate devices based on technological characteristics and software modifications, rather than presenting detailed clinical performance data from a specific study against predefined acceptance criteria for a diagnostic/interpretive algorithm.

Summary

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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

ge 1 OF 3

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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:

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:

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

Page 2 of 3

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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.

Page 3 of 3

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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

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

KO80x92

Device Name: HYPERVISOR VI Central Monitoring System (including TMS)

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)

B. Vettumtor

Page

stan Sign-Of scular Devices

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).