Panorama Patient Monitoring Network

K142601 · Shenzhen Mindray Bio-Medical Electronics Co. · MHX · Nov 14, 2014 · Cardiovascular

Device Facts

• Record ID: K142601
• Device Name: Panorama Patient Monitoring Network
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co.
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 14, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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 waveforms Invasive and Non-Invasive Blood Pressure, Blood Oxygenation (SpO2), Heart Rate, Respiration Rate, Respiration Gasses, Temperature, Carbon Dioxide, , inspired and end tidal, Ventricular Arrhythmia analysis,ST Segment analysis, Arrhythmia Detection derived from 3/5 lead measurements, Cardiac Output, and Anesthetic Gas, and Pulse Rate. 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 include ECG, blood oxygenation (SpO2), Heart Rate, Lethal and Non-Lethal Arrhythmia Detection and ST Segment Analysis. Received data is sent to the Panorama Server for ECG processing via Ethernet. This information can be displayed, trended, stored and printed at the Panorama Central Station. The Panorama Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.

Device Story

Central monitoring network; aggregates physiological data (ECG, BP, SpO2, CO2, etc.) from bedside monitors and telemetry transmitters. Inputs: physiological signals via Ethernet or WMTS telemetry. Processing: Panorama Server performs ECG arrhythmia detection, ST segment analysis, and parameter limit violation monitoring. Outputs: real-time waveforms, numeric trends, and alarms displayed at a central station. Used in hospitals/clinics; operated by clinicians. Benefits: enables remote patient surveillance, centralized data management, and patient mobility via telemetry. Healthcare providers use output for clinical decision-making regarding patient status and alarm response.

Clinical Evidence

No clinical tests were performed. Evidence consists of bench testing for safety, performance, and electromagnetic compatibility, including compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-8, EC13, EC53, EC57, ISO 80601-2-61, ISO 14970, and ISO 15223. Performance specifications for ECG, arrhythmia analysis, ST segment analysis, and SpO2 were verified.

Technological Characteristics

Central monitoring network; includes Panorama Server, Telemetry System (WMTS), and Central Station. Hardware: 2U/4U rack-mount servers, touch screen displays. Connectivity: Ethernet, WMTS. Software: Windows XPe (embedded). Parameters: ECG, SpO2, NIBP/IBP, CO2, anesthetic gas, temperature. Standards: IEC 60601 series, EC13, EC53, EC57, ISO 80601-2-61.

Indications for Use

Indicated for adult and pediatric patients in hospital or clinical settings requiring physiological monitoring, including ECG, blood pressure, SpO2, heart rate, respiration, temperature, CO2, cardiac output, and anesthetic gas. Supports ambulatory patients via telemetry and fixed-location central station monitoring.

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

• ViewPoint Central Monitoring System (K031760)
• Hypervisor VI Central Monitoring System (K080192)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

November 14, 2014

Mindray DS USA, Inc. Diane Arpino Directory, Regulatory Affairs 800 MacArthur Blvd. Mahwah, New Jersey 07430

Re: K142601 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, MLD, DSI, DRG, DOA, DOK, DPZ, DSK, DXN, CCK, NHO, CBQ, NHQ, NHP, CBS, CBR, CCL, DRT, DQA, MUD, FLL, GWM, DSB, DXG Dated: September 10, 2014 Received: September 16, 2014

Dear Diane Arpino,

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 [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,

Melissa A. Torres -S

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):

Device Name: Panorama Patient Monitoring Network

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
- Storing and printing of clinical and demographic data ●
- Setting independent alarm limits for data sent by the bedside monitor o

The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes: ECG waveforms Invasive and Non-Invasive Blood Pressure, Blood Oxygenation (SpO2), Heart Rate, Respiration Rate, Respiration Gasses, Temperature, Carbon Dioxide, , inspired and end tidal, Ventricular Arrhythmia analysis,ST Segment analysis, Arrhythmia Detection derived from 3/5 lead measurements, Cardiac Output, and Anesthetic Gas, and Pulse Rate.

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 include ECG, blood oxygenation (SpO2), Heart Rate, Lethal and Non-Lethal Arrhythmia Detection and ST Segment Analysis. Received data is sent to the Panorama Server for ECG processing via Ethernet. This information can be displayed, trended, stored and printed at the Panorama Central Station.

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

| Prescription Use | X | AND |
|-----------------------------|---|-----|
| (Part 21 CFR 801 Subpart D) | | |

D/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary Panorama Patient Monitoring Network

This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.

| Date: | August 15, 2014 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Diane Arpino<br>Director, Regulatory and Clinical Affairs<br>Mindray DS USA, Inc.<br>800 MacArthur Blvd<br>Mahwah, New Jersey 07430<br>Telephone: [phone]<br>Facsimile: 201-995-8605 |
| Device Trade Name: | Panorama Patient Monitoring Network |
| Common Name: | Central Station Monitor and Telemetry System |
| Device Classification: | Primary:<br>§870.1025- MHX -Physiological Monitor (with Arrhythmia detector and<br>alarm)<br><br>Secondary:<br>§870.1025- MLD - ST Segment with Alarm Monitor<br>§870.1025- DSI - Arrhythmia Detector and Alarm<br>§21 CFR 870.2910- DRG - Radiofrequency physiological signal<br>transmitter and receiver<br>§21 CFR 870.2700- DQA - Oximeter<br>§870.1425- DQK - Programmable Diagnostic Computer<br>§870.2700- DPZ - Ear Oximeter, Pulse<br>§870.1110- DSK- Blood Pressure Computer<br>§870.1130- DXN - Non-invasive Blood Pressure Measurement<br>System<br>§868.1400- CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase<br>§868.1500- NHO/CBQ/NHQ/NHP - Enflurane Gas Analyzer<br>§868.1620- CBS - Halothane Gas Analyzer<br>§868.1700- CBR - Nitrous Oxide Gas Analyzer<br>§868.1720- CCL - Oxygen Gas Analyzer<br>§870.2300- DRT - Cardiac Monitor (Incl. Cardiotachometer and<br>Rate Alarm)<br>§870.2700- DQA- Oximeter Sensor<br>§870.2700- MUD- Oximeter, Tissue Saturation<br>§880.2910- FLL - Clinical Electronic Thermometer<br>§822.1620- GWM – Intracranial Pressure Monitoring Device<br>§870.2700- DSB- Impedance plethysmograph<br>Mindray DS USA, Inc.<br>Page 1 of 5 |
| | §870.1435- DXG- Single-function, preprogrammed diagnostic computer |
| Predicate Devices: | ViewPoint Central Monitoring System (marketed as the Panorama Patient Monitoring Network) – K031760 |
| | Hypervisor VI Central Monitoring System (including telemetry pulse oximetry) – K080192 |
| Device description/<br>Indications for Use: | The indications for use for the Panorama Patient Monitoring Network include:<br>A. Viewing real time patient clinical and demographic data<br>B. Graphical and numeric trending of clinical data<br>C. Storing and printing of clinical and demographic data<br>D. Setting independent alarm limits for data sent by the bedside monitor.<br><br>The clinical data displayed by the Panorama Patient Monitoring Network is obtained from one or more compatible physiological monitors and includes:<br>ECG waveforms, Invasive Blood Pressure Non-Invasive Blood Pressure, Pulse Oximetry(SpO2), Heart Rate Respiration Rate, Respiration Gasses, Temperature, Carbon Dioxide (CO2), Ventricular Arrhythmia analysis, ST Segment analysis from 3/5 lead measurements, Arrhythmia Detection derived from 3/5 lead measurements, Cardiac Output (CO), and Anesthetic Gas (AG) Pulse Rate (PR) The Panorama Patient Monitoring Network is intended for use in a fixed |

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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 Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes the physiological data to

> Mindray DS USA, Inc. Page 2 of 5

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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 include ECG, blood oxygenation (SpO2), Heart Rate, Lethal and Non-Lethal Arrhythmia Detection and ST Segment Analysis. Received data is sent to the Panorama Server for ECG processing via Ethernet. This information can be displayed, trended, stored and printed at the Panorama Central Station.

## Technological Comparison to Predicate Device: The Panorama Network is equivalent to the predicate device the ViewPoint Central Monitoring System respecting the indications for use, basic operation, performance specifications, technology and materials (patient contacting). There are no changes to the device's intended use and fundamental scientific technology relative to the predicate device.

The Hypervisor Central Monitoring System serves at the predicate relative to Telemetry monitoring for SpO2.

| Technology | Subject /<br>Panorama Patient<br>Monitoring Network | Predicate /<br>ViewPoint Central<br>Monitoring System<br>K031760 | Predicate /<br>Hypervisor Central<br>Monitoring System (including<br>telemetry pulse oximetry)<br>K080192 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Viewing real time patient clinical<br>and demographic data<br>Graphical and numeric trending<br>of clinical data<br>Storing and printing of clinical<br>and demographic data<br>Setting independent alarm limits<br>for data sent by the bedside<br>monitor. | Viewing real time patient<br>clinical and demographic<br>data<br>Graphical and numeric<br>trending of clinical data<br>Storing and printing of<br>clinical and demographic data<br>Setting independent alarm<br>limits for data sent by the<br>bedside monitor. | The Central Monitoring System<br>(CMS) network transfers<br>information between the<br>Hypervisor VI Central System<br>and other network devices. It<br>also allows information transfer<br>between several CMS. Network<br>connections consist of<br>hardwired network cables<br>and/or WLAN connections.<br>CMS can be used for remote<br>monitor management, storing,<br>printing, reviewing or<br>processing information from<br>networked devices, and it is<br>operated by medical<br>institutions.<br><br>Telemetry System is a sub-<br>system of CMS, intended to<br>obtain ECG and SpO2<br>physiological information from |

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| | | | adult and pediatric patients, and<br>send it to CMS via WMTS<br>frequency with a defined<br>coverage area. |
|-------------------------------------|-------------------------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------|
| Central Station | 2U (Horizontal) or Vertical<br>Tower | Vertical Tower only | N/A |
| Telemetry Server | | Vertical Tower only | N/A |
| TIM Transceiver | 2U (Horizontal) Tower | Yes | N/A |
| Keyboard | Yes | Yes | N/A |
| Mouse | Yes | Yes | N/A |
| Display | Yes | Touch screen | N/A |
| Operating System | Touch screen | Windows NT | N/A |
| Longview-VGA<br>extender | Windows XPe (embedded) | No | N/A |
| | Yes | | N/A |
| Telemetry System | 2U (horizontal rack mount) | Vertical Tower | N/A |
| TIM Transceiver | 4U (horizontal rack mount) | 4U (horizontal rack mount) | N/A |
| Frequency | WMTS | 2.4 GHz | N/A |
| Repeater | Yes | No | N/A |
| Antenna | Radio Frequency | Radio Frequency | N/A |
| Telepack | Telepack-608(WMTS) | Telepack (2.4 GHz) | TMS-6016 (WMTS) |
| SpO2 Module | Yes | No | Yes |
| Accessories (used with<br>Telepack) | ECG Electrodes<br>ECG Lead Wires<br>SpO2 Sensor | ECG Electrodes<br>ECG Lead Wires | ECG Electrodes<br>ECG Lead Wires<br>SpO2 Sensor |

## 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 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:

- IEC60601-1 O IEC60601-1-2 o IEC60601-1-4 O IEC60601-1-8 O EC13 O EC53 O O EC57 ISO 80601-2-61 O ISO14970 O o ISO15223
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The Panorama Network was tested and complies with established parameter performance specifications respecting ECG, Arrhythmia analysis, ST Segment analysis and SpO2.

No clinical tests were performed on the Panorama Network. The substantial equivalence of the central monitoring networks has been long established through analysis of end-user experience and feedback gained through post-market analysis.