(64 days)
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.
The Panorama Patient Monitoring Network is a Central Station Monitor and Telemetry System. It is intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. It receives clinical data from compatible physiological monitors and displays, trends, stores, and prints this data. It also allows for setting independent alarm limits. The system includes a Telemetry System for monitoring ambulating patients within a defined coverage area, processing physiological data to detect ECG arrhythmia events and parameter limit violations. The system consists of a Central Station, Telemetry Server, TIM Transceiver, Keyboard, Mouse, Display, and operates on Windows XPe (embedded). The Telemetry System includes a TIM Transceiver, operates on WMTS frequency, and uses a Radio Frequency Antenna and Telepack-608(WMTS) with an SpO2 Module.
The provided text describes the Mindray Panorama Patient Monitoring Network, a central monitoring system and telemetry system. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized safety and performance standards rather than presenting a performance study with detailed acceptance criteria and results for the device's diagnostic capabilities (e.g., arrhythmia detection accuracy).
Based on the provided information, I cannot provide a table of acceptance criteria and reported device performance for specific clinical diagnostic tasks, nor details about sample sizes, expert qualifications, or ground truth establishment for such tasks. The document explicitly states: "No clinical tests were performed on the Panorama Network."
Here's what can be extracted regarding performance testing and regulatory compliance:
1. A table of acceptance criteria and the reported device performance:
The document does not provide specific quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy) for clinical diagnostic features like arrhythmia detection accuracy or ST segment analysis accuracy. Instead, it states compliance with general design and electrical safety standards and established parameter performance specifications.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with recognized safety standards | IEC60601-1, IEC60601-1-2, IEC60601-1-4, IEC60601-1-8 |
| Compliance with recognized performance standards | EC13, EC53, EC57, ISO 80601-2-61, ISO14970, ISO15223 |
| Compliance with established parameter performance specifications | Complies with established parameter performance specifications respecting ECG, Arrhythmia analysis, ST Segment analysis and SpO2. |
| Risk analysis and mitigation | Developed risk analysis to identify potential hazards and document mitigation. |
| Software verification and validation | Software has been verified and validated in accordance with appropriate test requirements. |
| Substantial equivalence | The Panorama Network is equivalent to the predicate device the ViewPoint Central Monitoring System respecting indications for use, basic operation, performance specifications, technology and materials. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states, "No clinical tests were performed on the Panorama Network." Therefore, there is no information about a test set size or data provenance for clinical performance evaluation. The "tests" mentioned are related to engineering, safety, and performance standard compliance, not clinical data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. As no clinical tests were performed, no experts were used to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical tests were performed.
5. 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. The Panorama Network is a monitoring system and does not describe AI assistance for human readers in a diagnostic setting. Furthermore, no clinical tests were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device performs "Ventricular Arrhythmia analysis," "ST Segment analysis," and "Arrhythmia Detection derived from 3/5 lead measurements." The document states it "complies with established parameter performance specifications respecting ECG, Arrhythmia analysis, ST Segment analysis and SpO2." However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are provided for these algorithmic analyses. The compliance is broadly stated without quantitative results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the statement "No clinical tests were performed," there is no mention of ground truth derived from expert consensus, pathology, or outcomes data for the device's diagnostic performance. The "established parameter performance specifications" likely refer to internal engineering criteria and adherence to recognized standards for signal processing and parameter measurement.
8. The sample size for the training set:
Not applicable. This is a medical device submission based on substantial equivalence, and the document does not describe the development of an AI/ML algorithm that would typically involve a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned in the context of this submission.
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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 (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,
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)
Page 1 of 1
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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 ArpinoDirector, Regulatory and Clinical AffairsMindray DS USA, Inc.800 MacArthur BlvdMahwah, New Jersey 07430Telephone: 201-995-8391Facsimile: 201-995-8605 |
| Device Trade Name: | Panorama Patient Monitoring Network |
| Common Name: | Central Station Monitor and Telemetry System |
| Device Classification: | Primary:§870.1025- MHX -Physiological Monitor (with Arrhythmia detector andalarm)Secondary:§870.1025- MLD - ST Segment with Alarm Monitor§870.1025- DSI - Arrhythmia Detector and Alarm§21 CFR 870.2910- DRG - Radiofrequency physiological signaltransmitter and receiver§21 CFR 870.2700- DQA - Oximeter§870.1425- DQK - Programmable Diagnostic Computer§870.2700- DPZ - Ear Oximeter, Pulse§870.1110- DSK- Blood Pressure Computer§870.1130- DXN - Non-invasive Blood Pressure MeasurementSystem§868.1400- CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase§868.1500- NHO/CBQ/NHQ/NHP - Enflurane Gas Analyzer§868.1620- CBS - Halothane Gas Analyzer§868.1700- CBR - Nitrous Oxide Gas Analyzer§868.1720- CCL - Oxygen Gas Analyzer§870.2300- DRT - Cardiac Monitor (Incl. Cardiotachometer andRate Alarm)§870.2700- DQA- Oximeter Sensor§870.2700- MUD- Oximeter, Tissue Saturation§880.2910- FLL - Clinical Electronic Thermometer§822.1620- GWM – Intracranial Pressure Monitoring Device§870.2700- DSB- Impedance plethysmographMindray DS USA, Inc.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/Indications for Use: | The indications for use for the Panorama Patient Monitoring Network include:A. Viewing real time patient clinical and demographic dataB. Graphical and numeric trending of clinical dataC. Storing and printing of clinical and demographic dataD. 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 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 /Panorama PatientMonitoring Network | Predicate /ViewPoint CentralMonitoring SystemK031760 | Predicate /Hypervisor CentralMonitoring System (includingtelemetry pulse oximetry)K080192 |
|---|---|---|---|
| Indications for Use | Viewing real time patient clinicaland demographic dataGraphical and numeric trendingof clinical dataStoring and printing of clinicaland demographic dataSetting independent alarm limitsfor data sent by the bedsidemonitor. | Viewing real time patientclinical and demographicdataGraphical and numerictrending of clinical dataStoring and printing ofclinical and demographic dataSetting independent alarmlimits for data sent by thebedside monitor. | The Central Monitoring System(CMS) network transfersinformation between theHypervisor VI Central Systemand other network devices. Italso allows information transferbetween several CMS. Networkconnections consist ofhardwired network cablesand/or WLAN connections.CMS can be used for remotemonitor management, storing,printing, reviewing orprocessing information fromnetworked devices, and it isoperated by medicalinstitutions.Telemetry System is a sub-system of CMS, intended toobtain ECG and SpO2physiological information from |
Mindray DS USA, Inc. Page 3 of 5
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| adult and pediatric patients, andsend it to CMS via WMTSfrequency with a definedcoverage area. | |||
|---|---|---|---|
| Central Station | 2U (Horizontal) or VerticalTower | 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-VGAextender | 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 withTelepack) | ECG ElectrodesECG Lead WiresSpO2 Sensor | ECG ElectrodesECG Lead Wires | ECG ElectrodesECG Lead WiresSpO2 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
Mindray DS USA, Inc. Page 4 of 5
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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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.