Vista CMS

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 24, 2026 Shanghai Draeger Medical Instrument Co., Ltd. Xuguang Miao Senior Regulatory Affairs Specialist No.229 HuPo Road, Shanghai International Medical Zone Pudong New Area Shanghai, 201321 China Re: K250349 Trade/Device Name: Vista CMS 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 Dated: March 25, 2026 Received: March 25, 2026 Dear Xuguang Miao: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250349 - Xuguang Miao Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K250349 - Xuguang Miao Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # KIMBERLY N. CROWLEY -S For: Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K250349 Device Name Vista CMS Indications for Use (Describe) Vista central monitoring software (hereinafter referred to as Vista CMS) supports centralized management of patients' clinical data provided by Vista Series patient monitors. Clinicians can obtain patient clinical data from networked devices via Vista CMS. The functionalities of Vista CMS include: - Viewing patient real-time clinical data and alarms. - Storing and reviewing patient clinical data and alarms. - Printing real-time and history patient data. - Configuring local settings as well as synchronizing settings to a remote device through network. - Accessing patient clinical data between several departments. Vista CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals. Vista CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 {4} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary # 510(k) Premarket Notification Summary ## Submitter: Shanghai Draeger Medical Instrument Co., Ltd. 3#, No.229, Hupo Road Shanghai International Medical Zone 201321, Shanghai, China Establishment's registration number: 3019545235 ## Contact Person: Name: Xuguang Miao Title: Associate Regulatory Manager E-Mail: xuguang.miao@draeger.com Telephone: +86 021 3108 6000 ## US agent: Name: Melissa Gray Title: Sr Mgr Regulatory Affairs Address: Draeger Medical Systems, Inc. 6 Tech Dr Andover, Massachusetts, 01810, USA E-mail: melissa.gray@draeger.com Telephone: +1 978-447-3613 ## Date prepared: April 23, 2026 ## Device Name: Trade name: Vista CMS Common name: Vista CMS Classification name: Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) Regulation number: 21 CFR § 870.1025 Product code: MHX Class: II ## Predicate device: Central Monitoring System (MFM-CMS), K232694 ## Device Description Vista CMS is a software-only networked patient monitoring system intended to provide clinicians central monitoring in professional healthcare facilities. The system that integrates and displays patient information from networked monitoring devices can be configured to restrict controls and access based on user role, supporting the user in securely delivering quality patient care. Page 1 of 12 {5} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary Vista CMS Central Monitoring System supports to display, store, print, and transfer information received from the compatible monitoring devices as well as bi-directional configuration of the compatible monitors. ## Intended Use/Indications for Use Vista central monitoring software (hereinafter referred to as Vista CMS) supports centralized management of patients' clinical data provided by Vista Series patient monitors. Clinicians can obtain patient clinical data from networked devices via Vista CMS. The functionalities of Vista CMS include: - Viewing patient real-time clinical data and alarms. - Storing and reviewing patient clinical data and alarms. - Printing real-time and history patient data. - Configuring local settings as well as synchronizing settings to a remote device through network. - Accessing patient clinical data between several departments. Vista CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals. Vista CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data. Page 2 of 12 {6} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary Comparison to Predicate | - | Proposed device Vista CMS | Predicate device Central Monitoring System (MFM-CMS) | Comments | | --- | --- | --- | --- | | Manufacturer | Shanghai Draeger Medical Instrument Co., Ltd. | Edan Instruments, Inc. | - | | 510(k) number | K250349 | K232694 | - | | Regulation number | 21 CFR 870.1025 | 21 CFR 870.1025 | Same | | Classification description | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | Same | | Regulatory class | Class II | Class II | Same | | Product code | MHX | MHX | Same | | 1. Intended Use | | | | {7} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary | - | Proposed device Vista CMS | Predicate device Central Monitoring System (MFM-CMS) | Comments | | --- | --- | --- | --- | | Intended Use/ Indications for Use | Vista central monitoring software (hereinafter referred to as Vista CMS) supports centralized management of patients' clinical data provided by Vista Series patient monitors. Clinicians can obtain patient clinical data from networked devices via Vista CMS. The functionalities of Vista CMS include: - Viewing patient real-time clinical data and alarms. - Storing and reviewing patient clinical data and alarms. - Printing real-time and history patient data. - Configuring local settings as well as synchronizing settings to a remote device through network. - Accessing patient clinical data between several departments. Vista CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals. Vista CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data. | MFM-CMS Central Monitoring System (hereinafter referred to as MFM-CMS) supports centralized management of patients' clinical data provided by EDAN medical devices. Clinicians can obtain patient clinical data via MFM-CMS. The indications for use of the MFM-CMS central monitoring system include: - Viewing patient real-time clinical data and alarms. - Storing and reviewing patient clinical data and alarms. - Printing real-time and history patient data. - Configuring local settings as well as synchronizing settings to a remote device through network. - Accessing patient clinical data between several departments. MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals. MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data. | Same | | Contraindications | None | None | Same | Page 4 of 12 {8} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary | - | | Proposed device Vista CMS | | Predicate device Central Monitoring System (MFM-CMS) | | Comments | | --- | --- | --- | --- | --- | --- | --- | | Patient population | | • Adult • Pediatric • Neonate | | • Adult • Pediatric • Neonate | | Same | | Intended user | | Well-trained healthcare professionals | | Well-trained healthcare professionals. | | Same | | Environments of use | | Hospital or clinical environment | | Hospital or clinical environment. | | Same | | Conclusion | | As determined in the above, the proposed device’s Intended Use is substantially equivalent to the predicate device. | | | | | | 2. Technological Characteristics – Hardware as recommended [not part of the medical device to be cleared] | | | | | | | | System Components | | Vista CMS requires the following hardware to run and function optimally: - Clients (Monitoring Station, Viewer Station) - Computer platform (to be provided by user) - Network devices (to be provided by user) - Printer (to be provided by user) - UPS (to be provided by user) | | MFM-CMS Central Monitoring System consists of the following components: - Central Station - Viewer Station (optional) - Computer platform (to be provided by user) - Network devices (to be provided by user) - Printer (to be provided by user) - UPS (to be provided by user) | | Same | | PC workstation (Recommended configuration) | Monitoring Station Server Terminal | CPU | Intel Core i5, 3rd generation, Quad 3.1 GHz or above | CPU | Intel Core i5, 3rd generation, Quad 3.1 GHz or above | Different | | | | Memory | At least 8 G | Memory | At least 8 G | | | | | Hard disk | At least 1 T | Hard disk | At least 1 T | | | | | Display interface | 2 or above (at least one VGA interface and one HDMI interface) | Display interface | 2 or above (at least one VGA interface and one HDMI interface) | | | | | LAN port | 2 or above | LAN port | 2 or above | | Page 5 of 12 {9} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary | - | | Proposed device Vista CMS | | Predicate device Central Monitoring System (MFM-CMS) | | Comments | | --- | --- | --- | --- | --- | --- | --- | | | | USB port | 2 or above | USB port | 2 or above | | | | | Operating system | Windows 11 Pro 64-bit, Server 2016 OS, Server 2019, Server 2022, virtual machine | Operating system | Windows 10 Pro 32/64 bit, Windows 11 Pro 64-bit, Server 2012, Server 2016 OS, virtual machine | | | | Viewer Station | CPU | Intel Core i5, Duo 3.1 GHz or above | CPU | Intel Core i5, 3rd generation, Quad 3.1 GHz or above | Same | | | | Memory | At least 4 G | Memory | At least 4 G | | | | | Hard disk | At least 120 GB | Hard disk | At least 120 GB | | | | | Display interface | 2 or above (at least one VGA interface and one HDMI interface) | Display interface | 2 or above (at least one VGA interface and one HDMI interface) | | | | | LAN port | 2 or above | LAN port | 2 or above | | | | | USB port | 4 or above | USB port | 4 or above | | | | | Operating system | Windows 11 Pro 64-bit | Operating system | Windows 10 Pro 32/64 bit, Windows 11 Pro 64-bit | | | Display | Dimensions (inch) | Dimensions (inch) | Dimensions (inch) | Dimensions (inch) | Same | | | | | 19 (widescreen) | 1440X900 | 19 (widescreen) | | 1440X900 | | | | 19 (regular-screen) | 1280X1024 | *19 (regular-screen) | | 1280X1024 | | | | 22 (widescreen) | 1920X1080 | 22 (widescreen) | | 1920X1080 | | | | 24 (widescreen) | 1920X1080 | *Recommended | | | Page 6 of 12 {10} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary | - | Proposed device Vista CMS | | Predicate device Central Monitoring System (MFM-CMS) | | Comments | | --- | --- | --- | --- | --- | --- | | User interface / Input controls | PS/2 or USB keyboard, PS/2 or USB mouse | | PS/2 or USB keyboard, PS/2 or USB mouse | | Same | | Printer | HP LaserJet series | | HP LaserJet series | | Same | | Audio outputs | Built-in speaker is recommended | | Built-in speaker is recommended | | Same | | Uninterruptible Power Supply (UPS) | 1000 W | | 1000 W | | Same | | 3. Technological Characteristics – Network/ Communication | | | | | | | Network connect | Support wired and wireless network | | Support wired and wireless network | | Same | | Network device | Structure | Ethernet 802.3 | Structure | Ethernet 802.3 | Same | | | Device | Network switch | Device | Network switch | | | | Band Width | 100 Mbps (802.3u), 1000 Mbps (802.3ab/802.3z) | Band Width | 100 Mbps (802.3u), 1000 Mbps (802.3ab/802.3z) | | | | Transmitted information | Waveforms, parameters, and alarms of all networked bedside monitors | Transmitted information | Waveforms, parameters, and alarms of all networked bedside monitors | | | | Compatible monitors | Patient monitors complying with Dräger network protocol | Compatible monitors | Patient monitors complying with EDAN network protocol | | | WIFI protocol | IEEE: 802.11a/b/g/n | | IEEE: 802.11a/b/g/n | | Same | | Bi-directional configuration | Support | | Support | | Same | | Wired data security | TLS (Transport Layer Security) | | TLS (Transport Layer Security) | | Same | Page 7 of 12 {11} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary | - | Proposed device Vista CMS | Predicate device Central Monitoring System (MFM-CMS) | Comments | | --- | --- | --- | --- | | Wireless data security | TLS (Transport Layer Security) | TLS (Transport Layer Security) | Same | | **4. Technological Characteristics – Software (physiological parameter)** | | | | | Parameters supported | Support the monitoring of the parameters of ECG, RESP, NIBP, SpO2, PR, TEMP, IBP, CO2, C.O., AG, and BIS parameters derived from the monitoring equipment. | Support the monitoring of the parameters of ECG, RESP, NIBP, SpO2, PR, TEMP, IBP, CO2, C.O., AG, RM, ICG, and BIS parameters derived from the monitoring equipment. | Different | | **5. Technological Characteristics – Software (function)** | | | | | Alarm system function | - Alarm Indicators: audible and visual alarms. - Alarm Categories: Physiological Alarm, Technical Alarm, Prompts. - Alarm Priorities: High, Medium, Low. - Alarm Source and Alarm Communication Methods: Alarms, triggered by a physiological sign that appears abnormal or by technical problems of the monitoring devices, are sent to the Vista CMS by the monitoring devices and then indicated to the users by the Vista CMS. Alarms on the monitoring devices are displayed in the patient sectors and in the single bed view window. The alarm and prompts triggered by the Vista CMS are displayed in the system information area on the upper screen. | - Alarm Indicators: Audible and visual alarms. - Alarm Categories: Physiological Alarm, Technical Alarm. - Alarm Priorities: High, Medium, Low, Prompts. - Alarm Source and Alarm Communication Methods: Alarms, triggered by a physiological sign that appears abnormal or by technical problems of the monitoring devices, are sent to the MFM-CMS. MFM-CMS provides visual and audible alarm indications. Most of the alarms come from bedside devices. Alarms detected by the MFM-CMS are displayed in the system information area at the top of the screen. | Same | Page 8 of 12 {12} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary | - | Proposed device Vista CMS | Predicate device Central Monitoring System (MFM-CMS) | Comments | | --- | --- | --- | --- | | Data Review | - Short trend: Latest 12 hours of short trends for all parameters. - Trend graph and trend table: Latest 720 hours of trend graph and trend table for all parameters. - Full disclosure waveforms: Latest 720 hours of ECG full size waveforms and ECG compressed waveforms. - Physiological alarm events: Latest 720 hours of the events. - NIBP review: Latest 720 hours of NIBP measurement data. - C.O. review: Latest 720 hours of C.O. measurement results. - Score trend review: Latest 720 hours of score trend results. | - Most recent 12 hours of short trends for all parameters: - Most recent 720 hours of trend graph and trend table for all parameters; - Most recent 720 hours of full disclosure waveforms and ECG compressed waveforms; - Most recent 720 hours of the physiological alarm events, nurse call events, and patient call events; - Most recent 720 hours of 12-lead analysis results; - Most recent 720 hours of NIBP measurement data; - Most recent 720 hours of C.O. measurement results. - Most recent 720 hours of score trend review. | Different | | Calculations | Vista CMS provides functions including drug calculation and titration table, hemodynamic calculation, oxygenation calculation, renal function calculation and ventilation calculation. | MFM-CMS provides functions including drug calculation and titration table, hemodynamic calculation, oxygenation calculation, renal function calculation and ventilation calculation. | Same | Page 9 of 12 {13} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary | - | Proposed device Vista CMS | Predicate device Central Monitoring System (MFM-CMS) | Comments | | --- | --- | --- | --- | | Print | - Patient information - Real-time monitoring data - Alarm list or waveform - Waveform review - Trend table/graph - NIBP review - C.O. review - Score trend - Calculation result | - Patient information - Real-time monitoring data - Alarm list or waveform - Waveform review - Trend table-graph - NIBP review - 12-lead analysis result - C.O. review - Score trend - ECG, NIBP - Nursing report - Calculation result | Different | | License Authorization | Support | Support | Same | | Distributed function | - Support several CMS network. - Up to 10 Monitoring Station or 10 Viewer Station connections are supported for one Central Station. | - Support several CMS network. - Up to 10 Monitoring Station or 10 Viewer Station connections are supported for one Central Station. | Same | | Maximum number of patient monitor supported | - The Monitoring Station can admit up to 128 Dräger physiological monitoring devices via wired or wireless connection. | - The Monitoring Station can admit up to 128 EDAN physiological monitoring devices via wired or wireless connection. | Different | | **6. Technological Characteristics – Environmental** | | | | | Temperature | Working | +5 °C to +40 °C(+41 °F ~+104 °F) | +5 °C to +40 °C(+41 °F ~+104 °F) | | | Transport and Storage | -20 °C to +55 °C(-4 °F ~+131 °F) | -20 °C to +55 °C(-4 °F ~+131 °F) | | Humidity | Working | 15%RH ~ 95%RH (non-condensing) | 15%RH ~ 95%RH (non-condensing) | Page 10 of 12 {14} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary | - | | Proposed device Vista CMS | Predicate device Central Monitoring System (MFM-CMS) | Comments | | --- | --- | --- | --- | --- | | | Transport and Storage | 15%RH ~ 95%RH (non-condensing) | 15%RH ~ 95%RH (non-condensing) | Same | | Altitude | Working | 70 kPa ~ 106 kPa | 70 kPa ~ 106 kPa | Same | | | Transport and Storage | 70 kPa ~ 106 kPa | 70 kPa ~ 106 kPa | Same | | Conclusion | | Based on the above, the product’s technical data have been determined to be substantially equivalent to the predicate device. | | | Page 11 of 12 {15} Vista CMS Traditional 510(k) - K250349 Dräger 510(k) Summary ## Discussion of Non-clinical Testing - Biocompatibility Testing: Not applicable. - Electrical safety and electromagnetic compatibility (EMC): Not applicable. - Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." - Bench Testing: Draeger has conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets relevant consensus standards. - IEC 60601-1-8:2006 + Am1:2012 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. - Clinical testing: Not applicable. ## Conclusion Based on the indications for use/intended use, technological characteristics, performance/non-clinical testing, and comparison to the predicate device, the new device is substantially equivalent to the predicate device K232694. - END -