(193 days)
The intended use of Critical Alert CommonPath Enterprise is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s).
For medical, near real time alarms, Critical Alert CommonPath Enterprise is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Critical Alert CommonPath Enterprise does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audible and/or vibrating mechanism upon receipt of the alert.
Critical Alert CommonPath Enterprise is intended for use as a secondary alert. It does not replace the alarm function on the primary device.
Critical Alert CommonPath Enterprise (CommonPath) is a software application installed on a Windows server environment capable of acquiring alarms, events, and parameters from clinical systems and intelligently forwarding this information as notifications to designated display devices provided by third-party mobile device companies.
Critical Alert CommonPath Enterprise is intended for use as a secondary alarm; it does not replace the alarm function on the primary device.
Users receive interactive, time-critical information from clinical systems directly via their display devices as text (visual) or alarms (audible) or data. Received attributes related to the presentation of alerts include text and tones (beeps) in addition to and in coordination with event priorities. CommonPath allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system.
CommonPath connects to the information sources through wired ethernet connections which are part of the customer's infrastructure and acquires patient data from clinical systems. The user configures CommonPath to determine which information, including alarm notifications, is delivered to which users. CommonPath then formats the data for wireless delivery to the display devices through a messaging server.
The provided text describes a 510(k) premarket notification for a medical device called "Critical Alert CommonPath Enterprise." This documentation is primarily a regulatory submission aiming to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and the results of a clinical trial or large-scale validation study in the way one might for an AI/ML diagnostic device.
The "acceptance criteria" and "device performance" in this context refer to the device meeting its specified functional requirements and regulatory standards rather than statistical performance metrics of an AI algorithm (e.g., sensitivity, specificity, AUC).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the device's intended use and the regulatory standards it aims to comply with. The "performance" is stated as compliance with these standards and internal requirements.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: | Meets or exceeds the functional characteristics of the predicate device (Ascom Sweden AB Unite Connect for Clinical Systems K180566). |
| - Interface with clinical systems for forwarding event information | Confirmed: Provides interface with clinical systems to forward information to designated display devices. |
| - Parallel, redundant, forwarding mechanism for near real-time medical alarms | Confirmed: Intended to serve as a parallel, redundant, forwarding mechanism for medical, near real time alarms. |
| - Does not alter behavior of primary medical devices/alarm annunciations | Confirmed: Does not alter the behavior of primary medical devices and associated alarm annunciations. |
| - Secondary alarm, does not replace primary device alarm | Confirmed: Intended for use as a secondary alarm; it does not replace the alarm function on the primary device. |
| System Capabilities: | |
| - Display device provides visual, audible, and/or vibrating mechanism | Confirmed: Display device provides a visual, and/or audible and/or vibrating mechanism upon receipt of the alert. |
| - Collects alarms, events, parameters from clinical systems | Confirmed: Capable of acquiring alarms, events, and parameters from clinical systems. |
| - Intelligently forwards information as notifications | Confirmed: Intelligently forwarding this information as notifications to designated display devices. |
| - Support for duty assignments/user configuration | Confirmed: User configures CommonPath to determine which information is delivered to which users; supports duty assignments, shift planning, assignment of devices to staff. |
| - Scalability (e.g., number of locations, assignees) | Tested for 141 number of locations (units) supported; Max redirection levels: 3; Max combined assignees: 6,000; Max combined locations/events: 1,200. (These exceed predicate's stated 128 locations / 30 concurrent assignment clients) |
| - Connectivity (Ethernet, wireless delivery) | Confirmed: Connects via wired ethernet; formats data for wireless delivery. |
| - Time synchronization | Supports NTP server (NTPv4 compatible). |
| Software Quality & Compliance: | |
| - Designed and developed according to robust software development process | Confirmed: Software was designed and developed according to a robust software development process. |
| - Rigorously verified and validated | Confirmed: Software was rigorously verified and validated. |
| - Compliance with FDA guidance documents (e.g., software, cybersecurity, interoperability) | Confirmed: Complies with listed FDA guidance documents. |
| - Compliance with relevant standards (IEC 60601-1-8, IEC 62366-1) | Confirmed: Tested for performance in accordance with internal requirements and IEC 60601-1-8 (Clause 6.11 only), IEC 62366-1. |
| Safety and Effectiveness: | |
| - Demonstrates safety and effectiveness compared to predicate | Confirmed: Results demonstrate Critical Alert CommonPath Enterprise is as safe and as effective in comparison to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML model where a specific number of cases are evaluated for accuracy. Instead, the testing appears to be functional and performance testing of a software system. The "sample size" would refer to the various configurations, alarm types, and system loads tested to ensure functionality and performance. Specific numbers of test scenarios or user types are not provided.
- Data Provenance: Not applicable in the context of clinical data for AI/ML validation. The "data" here are system events, alarms, and configurations generated or simulated during software testing. There is no mention of country of origin or retrospective/prospective clinical data for evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not an AI diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for this device is its defined functional specifications and compliance with regulatory standards.
4. Adjudication Method for the Test Set
Not applicable. There's no subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a communication and alarm forwarding system, not an image-based diagnostic AI. It does not involve human readers interpreting cases with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is inherently a "standalone" software system in that it processes and forwards information automatically. Its performance is evaluated on its ability to correctly interface, process, and forward alarms based on predefined rules, not on diagnostic accuracy of an AI algorithm. So, while it's "algorithm only" in its core function, it's not "standalone" in the typical AI diagnostic sense where it would produce a diagnostic output without human review. Its function is to inform humans.
7. The Type of Ground Truth Used
The "ground truth" for this device's validation is its functional specification, software requirements, and compliance with relevant medical device standards (e.g., IEC 60601-1-8 for alarm systems, IEC 62366-1 for usability). The testing verifies that the device adheres to these defined specifications and performance benchmarks (e.g., processing speed, number of supported connections, correct routing of alarms), and that these meet or exceed the predicate device's capabilities.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set" of data to learn patterns or make predictions. It is a communication system with programmed logic and rules.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model. The "ground truth" for its development would be its functional design specifications and clinical needs defined by engineers and medical professionals involved in its design.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 11, 2020
Critical Alert % Thomas Kroenke Principal Consultant Speed to Market, Inc. PO Box 3018 Nederland, Colorado 80466
Re: K193043
Trade/Device Name: Critical Alert CommonPath Enterprise Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, PHC Dated: March 30, 2020 Received: March 31, 2020
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 (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.
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
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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 (OS) 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,
Jennifer Shih Assistant Director (Acting) 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
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Indications for Use
510(k) Number (if known): K193043
Device Name: Critical Alert CommonPath Enterprise
Indications For Use: The intended use of Critical Alert CommonPath Enterprise is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s).
For medical, near real time alarms, Critical Alert CommonPath Enterprise is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Critical Alert CommonPath Enterprise does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audible and/or vibrating mechanism upon receipt of the alert.
Critical Alert CommonPath Enterprise is intended for use as a secondary alert. It does not replace the alarm function on the primary device.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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| Submission Date: | 11 May 2020 | ||
|---|---|---|---|
| Submitter: | Critical Alert4901 Belfort Road, Suite 130Jacksonville, FL 32256 | ||
| SubmitterCorrespondent | Mr. John ElmsPhone: +1 (904) 260-6334Email: JElms@criticalalert.com | ||
| ApplicationCorrespondent: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net+1 (303) 956 4232 | ||
| Manufacturing Site: | Critical Alert4901 Belfort Road, Suite 130Jacksonville, FL 32256 | ||
| Trade Name: | Critical Alert CommonPath Enterprise | ||
| Common Name: | Physiological Monitors Network And Communication System | ||
| ClassificationName: | Physiological Monitors Network And Communication System | ||
| ClassificationRegulation: | 21 CFR §870.2300, 21 CFR §880.5725 | ||
| Product Code: | MSX, PHC | ||
| SubstantiallyEquivalent Devices: | New Critical AlertModel | Predicate510(k) Number | PredicateManufacturer / Model |
| Critical AlertCommonPathEnterprise | K180566 | Ascom Sweden AB / UniteConnect for Clinical Systems(Primary) | |
| K130208 | Cardiopulmonary Corporation/ Bernoulli Enterprise Software(Secondary) |
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| Device Description: | Critical Alert CommonPath Enterprise (CommonPath) is a software application installed on a Windows server environment capable of acquiring alarms, events, and parameters from clinical systems and intelligently forwarding this information as notifications to designated display devices provided by third-party mobile device companies.Critical Alert CommonPath Enterprise is intended for use as a secondary alarm; it does not replace the alarm function on the primary device.Users receive interactive, time-critical information from clinical systems directly via their display devices as text (visual) or alarms (audible) or data. Received attributes related to the presentation of alerts include text and tones (beeps) in addition to and in coordination with event priorities. CommonPath allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system.CommonPath connects to the information sources through wired ethernet connections which are part of the customer's infrastructure and acquires patient data from clinical systems. The user configures CommonPath to determine which information, including alarm notifications, is delivered to which users. CommonPath then formats the data for wireless delivery to the display devices through a messaging server. |
|---|---|
| Indications for Use: | The intended use of Critical Alert CommonPath Enterprise is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s).For medical, near real time alarms, Critical Alert CommonPath Enterprise is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Critical Alert CommonPath Enterprise does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audible and/or vibrating mechanism upon receipt of the alert.Critical Alert CommonPath Enterprise is intended for use as a secondary alarm. It does not replace the alarm function on the primary device. |
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Technology Comparison:
Critical Alert CommonPath Enterprise employs the same technological characteristics as the predicate device.
| Characteristic | Ascom Sweden ABUnite Connect for Clinical Systems(K180566) | Critical AlertCommonPath Enterprise(Proposed Device) | |
|---|---|---|---|
| Indications forUse | The intended use of the AscomUnite Connect for Clinical Systemsis to provide an interface withclinical systems to forwardinformation associated to theparticular event to the designateddisplay device(s). | The intended use of Critical AlertCommonPath Enterprise is toprovide an interface with clinicalsystems to forward informationassociated to the particular event tothe designated display device(s). | |
| For medical, near real time alarms,the Connect for Clinical Systems isintended to serve as a parallel,redundant, forwarding mechanism toinform healthcare professionals ofparticular medical related events. | For medical, near real time alarms,Critical Alert CommonPathEnterprise is intended to serve as aparallel, redundant, forwardingmechanism to inform healthcareprofessionals of particular medicalrelated events. | ||
| Connect for Clinical Systems doesnot alter the behavior of the primarymedical devices and associatedalarm annunciations. The displaydevice provides a visual, and/oraudio and/or vibrating mechanismupon receipt of the alert. | Critical Alert CommonPathEnterprise does not alter thebehavior of the primary medicaldevices and associated alarmannunciations. The display deviceprovides a visual, and/or audibleand/or vibrating mechanism uponreceipt of the alert. | ||
| Connect for Clinical Systems isintended for use as a secondaryalarm. It does not replace theprimary alarm function on themonitor. | Critical Alert CommonPathEnterprise is intended for use as asecondary alarm. It does not replacethe alarm function on the primarydevice. | ||
| Serves assecondary meansof annunciatingpatient events | Yes | Same | |
| Uses computerhardware togather andformat alarmevent information | Windows-based personal computer(PC)• Memory: 4 GB RAM• Processor: 2 GHz• Connection: TCP/IP base LANDisk Space: 50 GB minimum(recommended free disk space forinstallation) | Typical rack mount server from avendor such as Dell or HP.• Memory - 16 GB RAM• Hard Disk – 4 x 500 GB 15KRPM - Raid 10• Processor - 2 x 3.0 GHz QuadCore (4 core minimum)• NIC - Support for 10-100Mbit(minimum) | |
| TechnologyComparison(continued): | Characteristic(continued) | Ascom Sweden ABUnite Connect for Clinical Systems(K180566) | Critical AlertCommonPath Enterprise(Proposed Device) |
| Duty assignments | Scale is based on maximum numberof locations supported perintegration. Current maximumnumber of locations: 128Maximum number of concurrentassignment clients: 30 | Tested for 141 number of locations(units) supported. | |
| Maximum redirection levels: 3 | |||
| Supports a fully configurablelocation layout. | |||
| Supports assignment clients withshift planning and assignment ofdisplay and/or alerting devices tostaff members. | |||
| Supports assignment of staff topatients with escalation chains. | |||
| Unassigned location warning when alocation or a group of events are notassigned. | |||
| Maximum number combinedassignees: 6,000 | |||
| Maximum number of combinedlocations and events per location:1,200 (e.g. 128 locations with ~9assignable events per location) | |||
| Time sources | NTP server (NTPv4 compatible withNTPv2 and NTPv3). Time can beset manually from a Web browser. | ||
| Messagingcomponentcompatibility list | Unite Connectivity Manager(v5.10.0 and higher)Unite Communication Server (1.3.1and higher)TAP (v1.01) | ||
| ECG-SNPP (v1.03)ECG-OAI (2.05)ECG-Cisco (1.21) | |||
| SMTP (2.24) | |||
| Software | Critical Alert CommonPath Enterprise software was designed anddeveloped according to a robust software development process and wasrigorously verified and validated.Software information is provided in accordance with internalrequirements and the following guidance documents and standards: | ||
| FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99. FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 02 Oct 14. Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) software, 14 Jan 05. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. Infusion Pumps Total Product Life Cycle, 02 Dec 14. | |||
| Test results indicate that Critical Alert CommonPath Enterprise complies with its predetermined specifications and the guidance documents. | |||
| Performance Testing– Bench | Critical Alert CommonPath Enterprise was tested for performance in accordance with internal requirements and the following standard. | ||
| IEC 60601-1-8: 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 (Clause 6.11 only). IEC 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. |
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Summary of Performance Testing:
Test results indicated that Critical Alert CommonPath Enterprise complies with internal requirements and the applicable Standard.
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Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to Critical Alert CommonPath Enterprise. The results of these activities demonstrate that Critical Alert CommonPath Enterprise is as safe and as effective in comparison to the predicate device when used in accordance with its intended use and labeling.
Therefore, Critical Alert CommonPath Enterprise is considered substantially equivalent to the predicate device.
§ 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).