(64 days)
Not Found
No
The document describes a patient monitoring network that displays, trends, stores, and prints data from physiological monitors. It also performs arrhythmia detection and parameter limit violation detection, but the description of these functions does not mention the use of AI or ML. The performance studies focus on compliance with standards and parameter performance specifications, not on AI/ML-specific metrics.
No
The device is a monitoring system that displays, trends, stores, and prints clinical data from physiological monitors; it does not directly treat or diagnose a disease or condition.
No
The device is a patient monitoring network and telemetry system used to display, trend, store, and print clinical data obtained from compatible physiological monitors. It is not directly connected to the patient and does not perform active diagnostic analysis; rather, it presents data for a healthcare practitioner to interpret.
No
The device description explicitly lists hardware components such as a Central Station, Telemetry Server, TIM Transceiver, Keyboard, Mouse, Display, Radio Frequency Antenna, and Telepack-608 with an SpO2 Module.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Panorama Patient Monitoring Network receives and displays physiological data directly from compatible physiological monitors connected to the patient. It does not analyze samples taken from the patient's body.
- Data Source: The data it processes (ECG, blood pressure, SpO2, etc.) is obtained in vivo (from within the living body) via sensors and monitors attached to the patient, not from in vitro (in glass/lab) samples.
- Intended Use: The intended use is for viewing, trending, storing, and printing real-time patient clinical data and setting alarms, all based on data acquired directly from the patient.
Therefore, the Panorama Patient Monitoring Network falls under the category of patient monitoring systems, which are distinct from in vitro diagnostic devices.
N/A
Intended Use / 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 (Part 21 CFR 801 Subpart D)
Product codes (comma separated list FDA assigned to the subject device)
MHX, MLD, DSI, DRG, DOA, DOK, DPZ, DSK, DXN, CCK, NHO, CBQ, NHQ, NHP, CBS, CBR, CCL, DRT, DQA, MUD, FLL, GWM, DSB, DXG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 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 Panorama Monitoring Network is intended for use under the direct supervision of a licensed healthcare practitioner.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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
3
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 |
| Director, Regulatory and Clinical Affairs | |
| Mindray DS USA, Inc. | |
| 800 MacArthur Blvd | |
| Mahwah, New Jersey 07430 | |
| Telephone: 201-995-8391 | |
| Facsimile: 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 and | |
| alarm) |
Secondary:
§870.1025- MLD - ST Segment with Alarm Monitor
§870.1025- DSI - Arrhythmia Detector and Alarm
§21 CFR 870.2910- DRG - Radiofrequency physiological signal
transmitter 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 Measurement
System
§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 and
Rate 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 plethysmograph
Mindray 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 data
B. Graphical and numeric trending of clinical data
C. Storing and printing of clinical and demographic data
D. 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 |
4
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
5
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 Patient
Monitoring Network | Predicate /
ViewPoint Central
Monitoring System
K031760 | Predicate /
Hypervisor Central
Monitoring System (including
telemetry pulse oximetry)
K080192 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | 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 Central Monitoring System
(CMS) network transfers
information between the
Hypervisor VI Central System
and other network 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 information from
networked devices, and it is
operated by medical
institutions.
Telemetry System is a sub-
system of CMS, intended to
obtain ECG and SpO2
physiological information from |
Mindray DS USA, Inc. Page 3 of 5
6
| | | | adult and pediatric patients, and
send it to CMS via WMTS
frequency with a defined
coverage area. |
|-------------------------------------|-------------------------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------|
| Central Station | 2U (Horizontal) or Vertical
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
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
Telepack) | ECG Electrodes
ECG Lead Wires
SpO2 Sensor | ECG Electrodes
ECG Lead Wires | ECG Electrodes
ECG Lead Wires
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
Mindray DS USA, Inc. Page 4 of 5
7
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.