(508 days)
Not Found
No
The description mentions "rule-based algorithms" and the ability for healthcare professionals to "create and define a healthcare workflow dynamically," which are characteristic of traditional programming and decision support systems, not necessarily AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an information system for aggregating and displaying patient data and is intended for clinical decision support, not for direct therapeutic intervention.
No
Explanation: The ARC System is described as an intensive care information system that aggregates, displays, and manages patient information from other FDA-cleared devices. Its intended use is to aid healthcare professionals in making clinical decisions by providing organized data and allowing rule-based notifications. The warnings explicitly state "Do not use the ARC System as an active patient monitoring" and "Do not rely on the ARC System software as the sole source of patient status information," indicating it is for information management and secondary decision support, not for directly diagnosing medical conditions.
No
The device description explicitly states that the ARC System is composed of a physical hardware component (ARC Box) in addition to the software components.
Based on the provided information, the ARC System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- ARC System's Function: The ARC System aggregates, displays, and manages physiology and other patient information collected from FDA-cleared patient bedside medical devices and patient information systems. It does not analyze biological specimens.
- Intended Use: The intended use focuses on remote consultation, reviewing near real-time patient data and alarms, creating patient prioritization rules, and accessing prioritization information. These activities are based on data already collected by other medical devices, not on the analysis of biological samples.
- Device Description: The description emphasizes data connectivity from medical devices (ventilators, monitors, pumps, etc.) and presenting this data on a dashboard for clinical decision support. It does not mention any components or processes related to handling or analyzing biological specimens.
In summary, the ARC System is a medical information system that facilitates the management and display of patient data from other medical devices. It does not perform diagnostic tests on biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, OUG
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.
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
Adults
Intended User / Care Setting
Clinicians in healthcare facilities; Administrators; Physicians: Nurses
Use Environments: Intensive Care Unit
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)
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).
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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)
| 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."
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 |
| Dashboard | ||
| Classification | ||
| Regulation | Class II, 870.2300 | Same |
| Product Code(s) | MWI, Monitor, Physiological, Patient (Without | |
| Arrhythmia Detection or Alarms) | Same | |
| 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. | The Decisio Health Patient
Dashboard is a decision support
device indicated for aggregating,
displaying, and managing
physiologic and other patient
information. This information is
generated by third party medical
devices and patient information
systems. The device performs
automated calculations on patient
data collected by third party
devices based on approved
clinical protocols at patient care
facilities.
The Decisio Health Patient
Dashboard is intended for use by
clinicians in healthcare facilities. |
| Intended Use | The ARC System is intended to provide
Intensive Care Unit (ICU) clinical staff decision
support, workflow management, interoperability
and device connectivity. | Same |
| Target patient
population | Adults | Same |
6
| System Information | ARC ICU Information System | Predicate Device |
|---|---|---|
| Intended User | Clinicians in healthcare facilities; | |
| Administrators; Physicians: Nurses | Same | |
| Display Features | Computer or Mobile device (app) | Patient monitor, computer, or a |
| mobile device | ||
| Connectivity | Web-based | Same |
| Inputs | FDA Cleared Devices: | |
| EMR | ||
| Vital signs monitors | ||
| Ventilators | ||
| IV Pumps | ||
| Foley Catheters | Same | |
| Hardware | ||
| Specifications | Ports: Serial (rs-232) port, Ethernet (tcp) port, | |
| HTTPS ports | ||
| Protocols: Tcp, Https (443,8080) | Similar | |
| Use Environments | Intensive Care Unit | Same |
| Alarms | Yes | N/A |
| Supportive Testing | Software Validation; Cybersecurity; human | |
| factors; Unit, integration and system level | ||
| testing, IEC 60601-1-8 | Similar | |
| Software Level of | ||
| Concern | Moderate | Similar |
| Sterilization | Non-sterile | Same |
| Shelf Life | Not likely to be susceptible to degradation | Same |
| Biocompatibility | No direct nor indirect tissue-contacting | |
| 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.