Panorama Patient Monitoring Network

K150082 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · Sep 2, 2015 · Cardiovascular

Device Facts

• Record ID: K150082
• Device Name: Panorama Patient Monitoring Network
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The indications for use for the Panorama Patient Monitoring Network include: · Viewing real time patient clinical and demographic data · Graphical and numeric trending of clinical data · Storing and printing of clinical and demographic data · Setting independent alarm limits for data sent by the bedside monitor The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure(NIBP), Blood Oxygenation (SpO2), Pulse Rate (PR), Respiration Rate (RESP), Respiration Gases(O2, CO2), Temperature(TEMP), Anesthetic Gases (AG), Cardiac Output(C.O.), Bispectral Index (BIS), and Hemodynamics. The Panorama Patient Monitoring Network is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. The Panorama Patient Monitoring Network is not intended to the patient at any time or installed in a patient's vicinity. The Panorama Network includes the Panorama Telemetry System which acquires and monitors physiological data for ambulating patients within a defined coverage area. The system processes the physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The Panorama Telemetry System is intended for installation in a hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility. The physiological parameters monitored through telemetry include ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, OT Analysis and heart rate(HR)), blood oxygenation (SpO2), Pulse Rate (PR), Received data is calculated at the Panorama Central Station, and can be displayed, trended, stored and printed at the Panorama Central Station. The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

Device Story

Panorama Patient Monitoring Network acts as a central viewing station for physiological data; collects inputs from bedside monitors or ambulatory Telepack devices via telemetry; processes data to detect ECG arrhythmias and parameter limit violations; displays, trends, stores, and prints clinical/demographic data. Used in hospital/clinical settings by clinicians; not for direct patient connection. Includes ViewStation (remote display), WorkStation (remote management/alarm adjustment), Web Viewer (intranet access), and Gateway (HL7 translation). Enables remote patient oversight, facilitating clinical decision-making through real-time monitoring and alarm notification.

Clinical Evidence

Bench testing only. No clinical data performed. Safety and effectiveness established through compliance with recognized consensus standards (ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-1-6, IEC60601-1-8, IEC60601-2-27, EC57, ISO80601-2-61), risk analysis, and post-market analysis of end-user experience.

Technological Characteristics

Central station/telemetry system; Windows XP embedded OS; touch screen interface. Connectivity via WMTS (telemetry) and intranet (Web Viewer). Software-based arrhythmia, ST-segment, and QT analysis. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-2-27, EC57, and ISO 80601-2-61.

Indications for Use

Indicated for hospital/clinical patients requiring physiological monitoring, including ambulatory patients via telemetry. Monitors ECG (arrhythmia, ST, QT, HR), IBP, NIBP, SpO2, PR, RESP, gases, Temp, C.O., BIS, and hemodynamics. Intended for use under licensed practitioner supervision.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Panorama Patient Monitoring Network (K142601)
• Hypervisor central monitoring system (including telemetry monitoring system tms-6016) (K132036)
• Philips ST/AR ST and Arrhythmia software (K101521)

Reference Devices

• Passport 12M/17M Monitor (K143195)
• Passport 8/12 Monitor (K132662)
• T1 (K143195)
• Passport V Monitor (K091834)
• V Series Monitor (K132026)
• DPM 6/7 Monitor (K092449)
• Spectrum/ Spectrum OR Bedside Monitor (K062098)
• Passport 2 Bedside Monitor (K020550)

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human figures connected by flowing lines, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

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

September 2, 2015

Shenzhen Mindray Bio-medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Rd South, Hi-tech Industrial Park Nanshan, Shenzhen 518057, P.R. China

Re: K150082 Trade/Device Name: Panorama Patient Monitoring Network Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DQA, DRG, MSX Dated: July 31, 2015 Received: August 5, 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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mitchell Stein

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

K150082 510(k) Number (if known)

Page 1 of 2

Device Name

Panorama Patient Monitoring Network

Indications for Use (Describe)

The indications for use for the Panorama Patient Monitoring Network include:

· Viewing real time patient clinical and demographic data

- · Graphical and numeric trending of clinical data
- · Storing and printing of clinical and demographic data
- · Setting independent alarm limits for data sent by the bedside monitor

The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure(NIBP), Blood Oxygenation (SpO2), Pulse Rate (PR), Respiration Rate (RESP), Respiration Gases(O2, CO2), Temperature(TEMP), Anesthetic Gases (AG), Cardiac Output(C.O.), Bispectral Index (BIS), and Hemodynamics.

The Panorama Patient Monitoring Network is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. The Panorama Patient Monitoring Network is not intended to the patient at any time or installed in a patient's vicinity.

The Panorama Network includes the Panorama Telemetry System which acquires and monitors physiological data for ambulating patients within a defined coverage area. The system processes the physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The Panorama Telemetry System is intended for installation in a hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.

The physiological parameters monitored through telemetry include ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, OT Analysis and heart rate(HR)), blood oxygenation (SpO2), Pulse Rate (PR), Received data is calculated at the Panorama Central Station, and can be displayed, trended, stored and printed at the Panorama Central Station.

The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

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

اح Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

K150082 Page 2 of 2

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#### 5. 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Panorama Patient Monitoring Networks provided below.

| Device Common Name: | Central Station Monitor and Telemetry System |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | Panorama Patient Monitoring Network |
| Submitter: | SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>Shenzhen 518057, P.R. China<br>Tel: [phone]<br>Fax: [phone] |
| Contact: | Yanhong Bai<br>Manager Regulatory Affairs<br>SHENZHEN MINDRAY BIO-MEDICAL<br>ELECTRONICS CO., LTD.<br>Mindray Building, Keji 12th Road South<br>High-tech Industrial Park, Nanshan<br>518057, P.R. China<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | January 8, 2014 |
| Classification Regulation: | 21 CFR 870.1025, Class II, Arrhythmia detector<br>and alarm (including ST-segment measurement and<br>alarm) |
| Panel: | Cardiovascular |

| Product<br>Code | Regulation<br>Number | Panel | Regulation Description | Device Common Name |
|-----------------|----------------------|----------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Primary | | | | |
| MHX | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and<br>alarm (including ST-<br>segment measurement<br>and alarm) | monitor, physiological,<br>patient (with arrhythmia<br>detection or alarms) |
| Secondary | | | | |

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510(k) Premarket Notification

| Product<br>Code | Regulation<br>Number | Panel | Regulation Description | Device Common Name |
|-----------------|----------------------|----------------|--------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| DSI | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and<br>alarm (including ST-<br>segment measurement<br>and alarm) | detector and alarm,<br>arrhythmia |
| MLD | 21 CFR<br>870.1025 | Cardiovascular | Arrhythmia detector and<br>alarm (including ST-<br>segment measurement<br>and alarm) | monitor, st segment with<br>alarm |
| DRT | 21 CFR<br>870.2300 | Cardiovascular | Cardiac Monitor<br>(including<br>cardiotachometer and<br>rate alarm) | monitor, cardiac (incl.<br>cardiotachometer & rate<br>alarm) |
| DQA | 21 CFR<br>870.2700 | Cardiovascular | Oximeter | Oximeter |
| DRG | 21 CFR<br>870.2910 | Cardiovascular | Radiofrequency<br>physiological signal<br>transmitter and receiver. | transmitters and receivers,<br>physiological signal,<br>radiofrequency |
| MSX | 21 CFR<br>870.2300 | Cardiovascular | Cardiac monitor<br>(including<br>cardiotachometer and<br>rate alarm). | system,network and<br>communication,physiological<br>monitors |

Predicate Device: Panorama Patient Monitoring Network (K142601)

Hypervisor central monitoring system(including telemetry monitoring system.tms-6016) (K132036)

Philips ST/AR ST and Arrhythmia software (K101521)

#### Indications for Use:

The indications for use for the Panorama Patient Monitoring Network include:

- Viewing real time patient clinical and demographic data ●
- Graphical and numeric trending of clinical data o
- . Storing and printing of clinical and demographic data
- o Setting independent alarm limits for data sent by the bedside monitor

The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), Invasive Blood Pressure (IBP), Non-Invasive Blood Pressure(NIBP), Blood Oxygenation (SpO2), Pulse Rate (PR), Respiration Rate (RESP), Respiration Gases(02,CO2), Temperature(TEMP), Anesthetic Gases(AG), Cardiac Output(C.O.), Bispectral Index (BIS), and Hemodynamics.

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The Panorama Patient Monitoring Network is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. The Panorama Patient Monitoring Network is not intended to be directly connected to the patient at any time or installed in a patient's vicinity.

The Panorama Network includes the Panorama Telemetry System which acquires and monitors physiological data for ambulating patients within a defined coverage area. The system processes the physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The Panorama Telemetry System is intended for installation in a hospital or clinical environment to provide clinicians with patient physiological data, while allowing for patient mobility.

The physiological parameters monitored through telemetry include ECG (Lethal and Non-Lethal Arrhythmia Detection, ST Segment Analysis, QT Analysis and heart rate(HR)), blood oxygenation (SpO2), Pulse Rate (PR). Received data is calculated at the Panorama Central Station, and can be displayed, trended, stored and printed at the Panorama Central Station.

The Panorama Patient Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

## Device Description:

The subject Panorama Patient Monitoring Network includes eight Components:

- o Panorama Central Station
- Panorama Telemetry System
- Panorama Telepack ●
- Compatible Physiological Monitor(s) ●
- o ViewStation
- WorkStation ●
- Web Viewer ●
- Gateway ●
- 1、The Panorama Central Station is a device that monitors patients, collects and stores data.and performs alarm notification .The clinical data displayed at the Central Station is derived from compatible physiological monitor(s) or the Panorama Telepack.
- 2、The Panorama Telemetry System is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.
- 3、The Panorama Telepack is a battery powered ambulatory monitoring device intended for use in a hospital/clinical environment to provide clinicians with patient

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physiological data, while allowing for patient mobility. Data received from the Telepack is transmitted to the Panorama Telemetry System .

- 4、Mindray's cleared Compatible Physiological Monitors that transmit patient data to the Central Station include:
- · Passport 12M/17M Monitor(K143195)
- · Passport 8/12 Monitor(K132662)
- · T1(K143195)
- · Passport V Monitor(K091834)
- · V Series Monitor(K132026)
- · DPM 6/7 Monitor(K092449)
- · Spectrum/ Spectrum OR Bedside Monitor(K062098)
- · Passport 2 Bedside Monitor (K020550)
- 5、The Panorama ViewStation is a software application that allows the user to remotely display and print patient information from the Central Station.
- 6、The Panorama WorkStation is a software application that allows the user to remotely display and print patient information, enter or change patient demographic information, change alarm limits and responses, place patients in standby or discharge patients.
- 7、The Panorama Web Viewer is a software application that provides the user to remotely view patient information from the Central Station through a facilities intranet using a Microsoft Internet Explorer web browser.
- 8、The Panorama Gateway is an embedded Windows XP software application that allows translation of the Mindray proprietary network format into standard formats such as HL7.

## Summary of performance testing

- The Panorama Network has been tested and found to be in compliance with ● recognized safety, performance and electromagnetic compatibility standards.
- A risk analysis has been developed to identify potential hazards and document the o mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements.
- The Panorama Network has been tested and complies with the following recognized ● consensus standards:
- V ANSI/AAMI ES60601-1
- > IEC60601-1-2
- > IEC60601-1-6
- > IEC60601-1-8
- A IEC60601-2-27
- > EC57

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A ISO80601-2-61

- o The Panorama Network was tested and complies with established parameter performance specifications.
- o No clinical tests were performed on the Panorama Network. The clinical safety and effectiveness of the central monitoring networks has been long established through analysis of end-user experience and feedback gained through post-market analysis.

### Substantial Equivalence:

### Comparison of Indications -

The Panorama Patient Monitoring Network/K142601 shall serve as the primary predicate device respecting Indications for Use, performance specifications and technology.

The Hypervisor Central Monitoring System /K132036 is provided as a predicate device supporting bispectral index (BIS) that has been added to the subject Panorama. Section 12.4.4 includes additional details related to this new parameter.

The Philips ST/AR ST and Arrhythmia software/K101521 is provided as a predicate device supporting QT analysis that has been added to the subject Panorama. Section 12.4.1 includes additional details related to this new parameter.

The subject Panorama considered substantially equivalent to the predicate devices respecting the indications for use.

## Comparison of Technological Characteristics –

The table below compares the key technological feature of the subject devices to the primary predicate device 。

| Technology | Subject /<br>Panorama Patient<br>Monitoring Network | Predicate /<br>Panorama Patient<br>Monitoring Network<br>(K142601) |
|--------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Central Station<br>Telemetry Server<br>Keyboard<br>Mouse | 2U (Horizontal) or Vertical<br>2U (Horizontal) Tower<br>Yes<br>Yes | 2U (Horizontal) or Vertical<br>2U (Horizontal) Tower<br>Yes<br>Yes |
| Display<br>Operating System<br>Longview-VGA extender | Touch screen<br>Windows XP (embedded)<br>Yes | Touch screen<br>Windows XP (embedded)<br>Yes |
| Telemetry System<br>TIM Transceiver<br>Frequency<br>Repeater | 2U (horizontal rack mount)<br>4U (horizontal rack mount)<br>WMTS<br>Yes | 2U (horizontal rack mount)<br>4U (horizontal rack mount)<br>WMTS<br>Yes |

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| Antenna | Radio Frequency | Radio Frequency |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telepack | Telepack-608(WMTS) | Telepack-608(WMTS) |
| Compatible Physiological<br>Monitors | Passport 12M/17M<br>Monitor(K143195)<br>Passport 8/12<br>Monitor(K132662)<br>T1(K143195)<br>Passport V<br>Monitor(K091834)<br>V Series Monitor(K132026)<br>DPM 6/7<br>Monitor(K092449)<br>Spectrum/ Spectrum OR<br>Bedside Monitor(K062098)<br>Passport 2 Bedside Monitor<br>(K020550) | Passport 12M/17M<br>Monitor(K143195)<br>Passport 8/12<br>Monitor(K132662)<br>T1(K143195)<br>Passport V<br>Monitor(K091834)<br>V Series Monitor(K132026)<br>DPM 6/7<br>Monitor(K092449)<br>Spectrum/ Spectrum OR<br>Bedside Monitor(K062098)<br>Passport 2 Bedside<br>Monitor (K020550) |
| ViewStation | Yes | Yes |
| WorkStation | Yes | Yes |
| Web Viewer | Yes | Yes |
| Gateway | Yes | Yes |
| Monitoring Parameters | ECG (Lethal and Non-<br>Lethal Arrhythmia<br>Detection, ST Segment<br>Analysis, QT Analysis and<br>heart rate(HR)), Invasive<br>Blood Pressure (IBP), Non-<br>Invasive Blood<br>Pressure(NIBP), Blood<br>Oxygenation (SpO2), Pulse<br>Rate (PR), Respiration Rate<br>(RESP), Respiration<br>Gases(02,CO2),<br>Temperature(TEMP),<br>Anesthetic Gases(AG),<br>Cardiac Output(C.O.),<br>Bispectral Index (BIS), and<br>Hemodynamics. | ECG (Lethal and Non-<br>Lethal Arrhythmia<br>Detection, ST Segment<br>Analysis, and heart<br>rate(HR)), Invasive Blood<br>Pressure (IBP), Non-<br>Invasive Blood<br>Pressure(NIBP), Blood<br>Oxygenation (SpO2), Pulse<br>Rate (PR), Respiration<br>Rate (RESP), Respiration<br>Gases(02,CO2),<br>Temperature(TEMP),<br>Anesthetic Gases(AG),<br>Cardiac Output(C.O.), and<br>Hemodynamics. |