Digistat Care

{0}  September 12, 2026 Ascom Ums Srl Unipersonale % Thomas Kroenke Principal Consultant Speed To Market, Inc. P.O. Box 3018 Nederland, Colorado 80466 Re: K261287 Trade/Device Name: Digistat Care Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MSX, PHC Dated: April 17, 2026 Received: April 20, 2026 Dear Thomas Kroenke: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261287 - Thomas Kroenke Page 2 (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 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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-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). {2} K261287 - Thomas Kroenke Page 3 Sincerely, JENNIFER W. SHIH -S 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: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K261287 Device Name Ascom Digistat Care Indications for Use (Describe) Digistat Care is stand-alone software intended to: - Receive, aggregate, process, display and distribute physiologic waves, parameters, alarms and events for multiple patients. - Generates alarm signals for user notification, based on the alarm signal determined and sent by compatible medical devices. - Provides ability to view alarms remotely. - Provides review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgment of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required. - Provides connection and information exchange to other systems not associated with active patient monitoring, such as information systems. Digistat Care is intended for use by trained healthcare professionals in professional healthcare facilities and is not intended for home use. The mobile application may be used remotely to view patient data and alarms that are occurring on compatible medical devices. 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 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} # 510(k) Summary (in accordance with 21 CFR 807.92) Submission Date: 07 August 2026 Submitter: ASCOM UMS srl Unipersonale Via Amilcare Ponchielli 29 50018, Scandicci (FI), Italy Submitter Contact: Mr. Tomaso Muzzu, PhD Digistat Regulatory Affairs Manager Phone: +011 39 055 0621 542 Email: Tomaso.Muzzu@ascom.com Official Contact: Mr. Thomas Kroenke Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 +1 (303) 956-4232 tkroenke@speedtomarket.net Manufacturing Site: ASCOM UMS srl Unipersonale Via Amilcare Ponchielli 29 50018, Scandicci (FI), Italy Trade Name: Ascom Digistat Care Classification Name: System, Network And Communication, Physiological Monitors Primary Classification Regulation / Product Code, and Name 21 CFR §870.2300 / MSX System, Network And Communication, Physiological Monitors Secondary Classification Regulations / Product Code, and Name 21 CFR §880.5725 / PHC Infusion Safety Management Software Substantially Equivalent Devices: Predicate 510(k) Number Predicate Manufacturer / Model K211900 Philips Medizin Systeme Böblingen GmbH / Patient Information Center iX (primary) K180430 ASCOM UMS srl Unipersonale / Digistat Smart Central (secondary) K261287 Page 1 of 10 {5} # **Device Description:** The Ascom UMS srl Unipersonale (Ascom) Digistat Suite is a modular patient data management system (PDMS) and alarm notification system intended to create solutions to address healthcare organization needs related to patient data management. The different solutions are created enabling the necessary modules that are part of the two (2) products of the suite: - Ascom Digistat Care (a Class II medical device). Ascom Digistat Care (Digistat Care) is a software that transfers, stores, elaborates, organizes and displays patient information and patient related data, including alarms, events, vital signs and technical information acquired from FDA cleared bedside medical devices, wearable devices and clinical systems using validated device drivers. It provides information to support the treatment, diagnoses, prevention, monitoring, prediction, prognosis and mitigation of disease. Therefore, Digistat Care is a medical device, and is the subject device of this 510(k) submission. - Ascom Digistat Docs (not a medical device); Ascom Digistat Docs is a software that records, transfers, stores, organizes and displays patient information and patient related data in order to support caregivers to establish an electronic patient record, and therefore is not classified as a medical device and is not part of the subject device of this 510(k) submission. It is only described here for completeness. Both products are modular. The healthcare organization may choose whether to enable all the available modules or only a sub-set, according to their needs and goals. Modules can be added at different times. The resultant software suite can change over time according to the possible changes in the healthcare organization's needs. In these cases, additional training is delivered specific to the added modules, and the configuration is validated again involving the responsible organization. Ascom Digistat Care implements the following set of functionalities: - Displays dashboards for the near real time monitoring of the patients, to add collected parameters inside the system, to provide a way to calculate well-established derived parameters (ex. NEWS). - Integrates with selected source medical devices, e.g. infusion pumps, patient monitor, ventilator, dialysis machine, etc., to display, on workstation PCs and selected smartphones, and provides an overview of the device's status, highlighting alarms and/or warnings occurring on selected connected device, so that the user is informed at a glance about the situation in the ward. These are secondary notifications of events and alert to the clinical users. - Displays data from source medical devices and clinical systems that implement: - IEC 60601-1-8 distributed information system (DIS) (unreliable) compliant communication protocols, and - IEC 60601-1-8 distributed alarm system (DAS) or distributed alarm system with operator confirmation (CDAS) compliant communication protocols, using validated drivers to connect to these medical devices and clinical systems, informed at a glance about the situation in the ward. Page 2 of 10 K261287 510(k) Summary {6} **Device Description** **(continued):** - Provides wearables support. - Provides additional information to the clinicians such as scoring systems (even in combination with wearables) and clinical decision support, e.g. automatic fluid balance calculation, drugs interaction or patient's allergy notification. Ascom Digistat Care is used in healthcare facilities in critical care units, sub-intensive units, general wards and other departments. It is used by trained healthcare professionals. The patient population and patient conditions are not defined by Ascom Digistat Care but established by the source medical devices and clinical systems, and by the particular configuration of the product requested by the healthcare organization. Ascom Digistat Care is deployed on general purpose hardware and operates in a Windows server, Windows client, Android and iOS mobile devices and supported browsers environment. Data from Ascom Digistat Care are displayed on: - Windows clients running the Ascom Digistat Care desktop client application. - Android and iOS devices running the Ascom Digistat Care mobile client application. - Windows Server (server-side) and supported web browsers running the Ascom Digistat Care web application. **Indications for Use:** Digistat Care is stand-alone software intended to: - Receive, aggregate, process, display and distribute physiologic waves, parameters, alarms and events for multiple patients. - Generates alarm signals for user notification, based on the alarm signal determined and sent by compatible medical devices. - Provides ability to review alarms remotely. - Provides review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgment of a medical professional and are not intended to be the sole source of information for decision making. Thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required. - Provides connection and information exchange to other systems not associated with active patient monitoring, such as information systems. Digistat Care is intended for use by trained healthcare professionals in professional healthcare facilities and is not intended for home use. The mobile application may be used remotely to view patient data and alarms that are occurring on compatible medical devices. K261287 510(k) Summary Page 3 of 10 {7} # **Technology Comparison:** | Characteristic | ASCOM UMS srl Unipersonale / Ascom Digistat Care (Subject Device) | Philips Medizin Systeme Böblingen / Patient Information Center iX (K211900) Primary Predicate | ASCOM UMS srl Unipersonale / Ascom Digistat Smart Central (K180430) Secondary Predicate | Substantial Equivalence Discussion | | --- | --- | --- | --- | --- | | Indications for Use (IFU) | Digistat Care is stand-alone software intended to: • Receive, aggregate, process, display and distribute physiologic waves, parameters, alarms and events for multiple patients. • Generates alarm signals for user notification, based on the alarm signal determined and sent by compatible medical devices. • Provides ability to review alarms remotely. • Provides review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgment of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required. • Provides connection and information exchange to other systems not associated with active patient monitoring, such as information systems. Digistat Care is intended for use by trained healthcare professionals in professional healthcare facilities and is not intended for home use. The mobile applications may be used remotely to view patient data and alarms that are occurring on compatible medical devices, | The intended use of the Patient Information Center iX device is to: • Receive, aggregate, process, display and distribute physiologic waves, parameters, alarms and events for multiple patients. • Determines alarm conditions and generates alarm signals for Philips-approved medical devices that send physiological data and do not have the ability to determine the alarm condition. Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2. • Generates alarm signals for user notification, based on the alarm signal determined and sent by Philips-approved medical devices. • Provides ability to manage alarms and initiate measurements remotely. Performs diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips-approved medical devices. Results may be displayed, printed and/or distributed to Philips-approved medical devices. | The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert. The Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices. | Digistat Care and the primary predicate have equivalent IFUs related to alarm management. Digistat Care software does not have certain features present in the primary predicate. For example, Digistat Care does not determine alarm conditions for devices that cannot determine the alarm condition. It also does not initiate measurements remotely on any device and does not perform analysis and interpretation of ECG data. Digistat Care and the secondary predicate have equivalent IFUs with the main difference of Digistat Care being capable of primary alarming for compatible source devices and not limited to parallel and redundant forwarding mechanism of medical related events. | K261287 510(k) Summary Page 4 of 10 {8} Technology Comparison (continued): | Characteristic | ASCOM UMS srl Unipersonale / Ascom Digistat Care (Subject Device) | Philips Medizin Systeme Böblingen / Patient Information Center iX (K211900) Primary Predicate | ASCOM UMS srl Unipersonale / Ascom Digistat Smart Central (K180430) Secondary Predicate | Substantial Equivalence Discussion | | --- | --- | --- | --- | --- | | Indications for Use (IFU) (continued) | - | • Provides review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgment of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required. • Provides connection and information exchange to other systems not associated with active patient monitoring, such as information systems. • Monitors adult and/or specified pediatric subgroup patients (Newborn [neonate], Infant, Child, and Adolescent) as indicated by labeling of the medical device providing the data. • The Patient Information Center iX is intended for use by trained healthcare professionals in professional healthcare facilities and is not intended for home use. The web and mobile applications may be used remotely, and any action on the mobile application affecting active patient monitoring is intended for use in professional healthcare facilities. Rx Use Only. | - | - | | Primary Product Code, Regulation | MSX, 21 CFR §870.2300 | MHX, 21 CFR §870.1025 | MSX, 21 CFR §870.2300 | Same as one of primary predicate's secondary product code. Same as secondary predicate. | K261287 510(k) Summary Page 5 of 10 {9} **Technology Comparison (continued):** | Characteristic | ASCOM UMS srl Unipersonale / Ascom Digistat Care *(Subject Device)* | Philips Medizin Systeme Böblingen / Patient Information Center iX (K211900) *Primary Predicate* | ASCOM UMS srl Unipersonale / Ascom Digistat Smart Central (K180430) *Secondary Predicate* | Substantial Equivalence Discussion | | --- | --- | --- | --- | --- | | Secondary Product Code, Regulation | PHC, 21 CFR §880.5725 | DSH, 21 CFR §870.2800 DSI, 21 CFR §870.1025 MLD, 21 CFR §870.1025 MSX, 21 CFR §870.2300 OUG, 21 CFR §880.6310 | PHC, 21 CFR §880.5725 | Same as secondary predicate. | | Serves as secondary means of annunciating patient events | Yes | Yes | Yes | Same. | | Serves as primary means of annunciating patient events | Yes | Yes | No | Same as primary predicate. The subject device and primary predicate can serve as primary alarm notifications in distributed alarm system (DAS) and distributed alarm system with operator confirmation (CDAS). | | Provides confirmed delivery of alarms from connected medical devices | Yes, with compatible medical devices | Yes, with compatible medical devices | No | Same as primary predicate. The subject device and secondary predicate can serve as primary alarm notifications in CDAS. | | Bi-directional control of alarms and compatible device parameters | No | Yes | No | Same as secondary predicate. The primary predicate can control alarm settings on certain source devices while the subject device only reliably forwards alarms generated by source medical devices and clinical systems. | K261287 510(k) Summary Page 6 of 10 {10} **Technology Comparison (continued):** | Characteristic | ASCOM UMS srl Unipersonale / Ascom Digistat Care (Subject Device) | Philips Medizin Systeme Böblingen / Patient Information Center iX (K211900) Primary Predicate | ASCOM UMS srl Unipersonale / Ascom Digistat Smart Central (K180430) Secondary Predicate | Substantial Equivalence Discussion | | --- | --- | --- | --- | --- | | Prioritization of alarms | No | Yes | No | Same as secondary predicate. The primary predicate can control alarm settings (including alarm limits) on certain source devices while the subject device only reliably forwards alarms with the same priority generated by source medical devices and clinical systems. | | Modification of incoming device data (e.g., filtering) | No | Yes | No | Same as secondary predicate. The primary predicate processes ECG data while the subject device only reliably forwards parameters and alarms generated by source medical devices and clinical systems without any modification. | | Summary patient view? | Yes, with waveform, alarms, and vital signs for each bed | Yes, with waveform, alarms, and vital signs for each bed | Yes, with alarms and vital signs for each bed | Same as primary predicate. The summary view of the secondary predicate does not provide waveform data. | | Determine clinical alarm conditions? | No | Yes | No | Same as secondary predicate. The primary predicate can determine clinical alarm conditions based on data received from source devices while the subject device only reliably forwards alarms generated by source medical devices and clinical systems. | K261287 510(k) Summary Page 7 of 10 {11} # **Technology Comparison (continued):** | *Characteristic* | *ASCOM UMS srl Unipersonale / Ascom Digistat Care (Subject Device)* | *Philips Medizin Systeme Böblingen / Patient Information Center iX (K211900) Primary Predicate* | *ASCOM UMS srl Unipersonale / Ascom Digistat Smart Central (K180430) Secondary Predicate* | *Substantial Equivalence Discussion* | | --- | --- | --- | --- | --- | | *Supported medical alarm device inputs* | Compatible medical devices | Philips approved medical devices | Patient monitors, ventilators, infusion pumps, hemodialysis machines, and infant incubators | Same. All have a method of qualification and compatibility testing to ensure safety and effectiveness of alarm forwarding and identify compatible devices as compared to the predicate. Patient monitoring using the source medical devices and clinical systems is limited to the indications of the same. | | *Interfaces/Hospital Information System – Inputs* | AD and ADT integrations | AD and ADT integrations | AD and ADT integrations | Same. | | *Interfaces/Hospital Information Systems - Output* | IHE HL7 PCD-01 outbound | IHE HL7 PCD-01 outbound | IHE HL7 PCD-01 outbound | Same. | K261287 510(k) Summary Page 8 of 10 {12} # **Performance Testing:** Software, Cybersecurity, and Interoperability Ascom Digistat Care is ENHANCED software documentation level. Software was designed and developed according to a robust software development process and was rigorously verified and validated. Software and cybersecurity information is provided in accordance with the following standards and guidance documents: - AAMI TIR57: 2016, Principles for medical device security – Risk management. - AAMI TIR97: 2019, Principles for medical device security – Postmarket risk management for device manufacturers. - ANSI/AAMI SW96: 2023, Standard for medical device security – Security risk management for device manufacturers. - IEC 62304: 2015, Medical device software – Software life cycle processes. - IEC 80001-1: 2010, Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities. - IEC 82304-1: 2016, Health software – General requirements for product safety. - IEC TR 80001-2-1: 2012, Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples. - IEC TR 80001-2-2: 2012, Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls. - IEC TR 80001-2-3: 2012, Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks. - IEC TR 80001-2-4: 2012, Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization. - IEC TR 80001-2-5: 2012, Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems. - ISO 14971: 2019, Medical devices – Application of risk management to medical devices. - FDA guidance: The content of premarket submissions for software contained in medical devices, 14 Jun 23. - FDA guidance: Off-the-shelf software use in medical devices, 11 Aug 23. - FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. - FDA guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, 03 Feb 26. - FDA guidance: Postmarket Management of Cybersecurity in Medical Devices, 28 Dec 16. K261287 510(k) Summary Page 9 of 10 {13} Software, Cybersecurity, and Interoperability (continued) - FDA guidance: Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. - FDA guidance: Infusion Pumps Total Product Life Cycle, 02 Dec 14. Test results indicate that the Ascom Digistat Care complies with its predetermined specifications and the applicable standards and guidance documents. Performance Testing – Bench Ascom Digistat Care was tested for performance in accordance with internal requirements, applicable portions of the following standards, and the following guidance document: - IEC 60601-1-8: 2020, 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. - IEC 62366-1: 2020, Medical devices – Part 1: Application of usability engineering to medical devices. Test results indicate that the Ascom Digistat Care complies with its predetermined specifications, and applicable portions of the aforementioned standards. Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the Ascom Digistat Care. The results of these activities demonstrate that the Ascom Digistat Care is as safe and as effective in comparison to the predicate devices when used in accordance with its intended use and labeling. Therefore, the Ascom Digistat Care is considered substantially equivalent to the predicate device. K261287 510(k) Summary Page 10 of 10