ARC Intensive Care Information System (ARC System)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. June 6, 2023 Ordinatrum Solutions % H. Semih Oktay, Ph.D. President CardioMed Device Consultants, LLC. 3168 Braverton Street Suite 200 Edgewater, MD 21037 Re: K220117 Trade/Device Name: ARC Intensive Care Information System (ARC System) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, OUG Dated: May 5, 2023 Received: May 5, 2023 Dear Semih Oktay: 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. 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 located 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. # Robert T. Kazmierski -S for LCDR Stephen Browning 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220177 Device Name ARC System #### Indications for Use (Describe) The ARC System is an intensive care information system indicated for aggregating, displaying, and managing physiology and other patient information. The system collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring. The ARC System software is intended to be used by healthcare professionals for the following purposes: - · To remotely consult, regarding a patient's status - · To remotely review other standard or critical near real-time patient data, waveforms, and alarms in order to utilize this information to aid in clinical decisions and deliver patient care - · To create and manage Patient Prioritization Rules - · To access Patient Prioritization information WARNING: - Rx Only. - · Do not use the ARC System as an active patient monitoring. - · Do not use the ARC System to replace any part of the hospital's device monitoring. - · Do not rely on the ARC System software as the sole source of patient status information. Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | <span></span> | 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." {3}------------------------------------------------ # K220117 ## 1. 510(k) Summary In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. ## Applicant: | Submitter name: | Ordinatrum Solutions | |---------------------|---------------------------------| | Responsible person: | Ali Yasin Ozturk | | Phone: | (858) 537-7065 | | E-mail: | aozturk@ordinatrumsolutions.com | #### Official Correspondent: | Contact person: | Semih Oktay, Ph.D. | |-----------------|-------------------------| | Phone: | (410)271-2088 | | E-Mail: | soktay@cardiomedllc.com | | Date prepared: | June 6th, 2023 | #### Device Name: | Proprietary name: | ARC Intensive Care Information System (ARC System) | |----------------------|----------------------------------------------------------------------------------------| | 510(k) number: | K220117 | | Common name: | Physiological Patient Monitor (without arrhythmia detection or alarms) | | Classification name: | Class II, 21 CFR§870.2300, Cardiac monitor (including cardiotachometer and rate alarm) | | Product code: | MWI | ## Indications for Use: The ARC System is an intensive care information system indicated for aggregating, displaying, and managing physiologic and other patient information. The system collects and displays data from FDA-cleared patient bedside medical devices and patient information systems. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring. The ARC System software is intended to be used by healthcare professionals for the following purposes: - To remotely consult, regarding a patient's status . - . To remotely review other standard or critical near real-time patient data, waveforms, and alarms in order to utilize this information to aid in clinical decisions and deliver patient care - To create and manage Patient Prioritization Rules ● - To access Patient Prioritization information ● WARNING: - Rx Only. ● - Do not use the ARC System as an active patient monitoring. ● - Do not use the ARC System to replace any part of the hospital's device monitoring. ● - Do not rely on the ARC System software as the sole source of patient status information. ● {4}------------------------------------------------ ## K220117 #### Device Description: The ARC ICU Information System is intended to provide the Intensive Care Unit (ICU) with clinical decision support, workflow management, interoperability and device connectivity. The system receives near real-time data from medical devices in the ICU and presents them on a single dashboard to provide secondary clinical decision support. Patient vitals from ventilators, monitors, pumps, smart beds, IoT sensors etc. are connected to the ARC Box. From the ARC Box, data is propagated through the ARC software, and displayed on a central monitoring system, the ARC DS. The data is available on remote monitoring devices, such as a mobile device or physician tablet. The ARC System is composed of a physical hardware component (ARC Box), which interfaces with the ICU medical devices, and the ARC System Software components. Decision support algorithms, treatment protocols and applications used within ARC System do not come with a predefined procedure or standard. A skilled health care professional can use ARC System to create and define a healthcare workflow dynamically on the basis of an individual hospital, clinic or physician. ARC ICIS is a Web-based and Cloud Ready system that is built on IoMT and BigData technologies. It is intended to provide reliable and secure access to patient information. ARC Box is a vendor-neutral connectivity solution that retrieves patient data from different device makers and transfers this data, via serial ports and/or ethernet ports, to a central dashboard. It is built on IoT for secure and quick communication between medical devices while gathering rich data. It temporarily stores data in the event of unexpected circumstances such as power outage or server failure and transfers saved data to ARC ICIS to be visualized for Clinical Decision Support. This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review. #### Predicate Device: Substantial Equivalence is claimed with the device, K141206 - Decision Health Patient Dashboard manufactured by Decision Health, Inc. on the basis of equivalent intended use / indications for use, technological characteristics and principle of operation. ## Comparison of Technological Characteristics: The table below provides a comparison of the predominant technical characteristics of the new device and the legally marketed predicate device. {5}------------------------------------------------ | System Information | ARC ICU Information System | Predicate Device | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K220177 | K142106 | | Device Trade Name | ARC System | Decisio Health Patient<br>Dashboard | | Classification<br>Regulation | Class II, 870.2300 | Same | | Product Code(s) | MWI, Monitor, Physiological, Patient (Without<br>Arrhythmia Detection or Alarms) | Same | | Indications for Use | The ARC System is an intensive care information<br>system indicated for aggregating, displaying, and<br>managing physiologic and other patient<br>information. The system collects and displays<br>data from FDA-cleared patient bedside medical<br>devices and patient information systems. The Arc<br>System allows healthcare professionals to define<br>rule-based algorithms to receive notifications for<br>patient prioritization and continuous patient<br>monitoring.<br><br>The ARC System software is intended to be used<br>by healthcare professionals for the following<br>purposes:<br>To remotely consult, regarding a<br>patient's status To remotely review other standard or<br>critical near real-time patient data,<br>waveforms, and alarms in order to utilize<br>this information to aid in clinical<br>decisions and deliver patient care To create and manage Patient<br>Prioritization Rules To access Patient Prioritization<br>information WARNING:<br>Rx Only. Do not use the ARC System as an active<br>patient monitoring. Do not use the ARC System to replace<br>any part of the hospital's device<br>monitoring. Do not rely on the ARC System software<br>as the sole source of patient status<br>information. | The Decisio Health Patient<br>Dashboard is a decision support<br>device indicated for aggregating,<br>displaying, and managing<br>physiologic and other patient<br>information. This information is<br>generated by third party medical<br>devices and patient information<br>systems. The device performs<br>automated calculations on patient<br>data collected by third party<br>devices based on approved<br>clinical protocols at patient care<br>facilities.<br><br>The Decisio Health Patient<br>Dashboard is intended for use by<br>clinicians in healthcare facilities. | | Intended Use | The ARC System is intended to provide<br>Intensive Care Unit (ICU) clinical staff decision<br>support, workflow management, interoperability<br>and device connectivity. | Same | | Target patient<br>population | Adults | Same | {6}------------------------------------------------ | System Information | ARC ICU Information System | Predicate Device | |------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | Intended User | Clinicians in healthcare facilities;<br>Administrators; Physicians: Nurses | Same | | Display Features | Computer or Mobile device (app) | Patient monitor, computer, or a<br>mobile device | | Connectivity | Web-based | Same | | Inputs | FDA Cleared Devices:<br>EMR<br>Vital signs monitors<br>Ventilators<br>IV Pumps<br>Foley Catheters | Same | | Hardware<br>Specifications | Ports: Serial (rs-232) port, Ethernet (tcp) port,<br>HTTPS ports<br>Protocols: Tcp, Https (443,8080) | Similar | | Use Environments | Intensive Care Unit | Same | | Alarms | Yes | N/A | | Supportive Testing | Software Validation; Cybersecurity; human<br>factors; Unit, integration and system level<br>testing, IEC 60601-1-8 | Similar | | Software Level of<br>Concern | Moderate | Similar | | Sterilization | Non-sterile | Same | | Shelf Life | Not likely to be susceptible to degradation | Same | | Biocompatibility | No direct nor indirect tissue-contacting<br>components | Same | The ARC ICU Information System has the same intended use and similar technological characteristics as the predicate device. Although there are some differences in indications for use specificity, this level of clarity aligns with other ICIS-type software under product code MWI. The ARC system is different from the predicate device with regards to the difference in what platform patient data is displayed on. The ARC system does not include display features on the patient monitor. The Arc System allows healthcare professionals to define rule-based algorithms to receive notifications for patient prioritization and continuous patient monitoring, including receiving pass-through alarms. Testing has demonstrated that differences in the technological characteristics will have no impact on safety or effectiveness. ## Summary of Testing: Performance testing to demonstrate substantial equivalence and ensure that the ARC System performs as intended has been conducted. Unit, integration, security, vulnerability and system level testing demonstrated that the ARC System meets its specifications. A human factors usability study has been completed evaluating 30 typical users (15 intensivists and 15 critical care nurses). #### Conclusion: The information included in this submission demonstrates that the ARC System is substantially equivalent to the predicate device (K142106). Although there are minor differences noted between the proposed system and the predicate device, these differences do not raise significant new questions of safety or effectiveness.