(193 days)
No
The description focuses on intelligent forwarding based on user configuration, not on learning or adaptive algorithms. The terms "AI," "DNN," or "ML" are explicitly listed as "Not Found."
No
The device's intended use is to forward information as a secondary, redundant alarm system, not to directly treat or diagnose a medical condition.
No
The device's function is to forward information and alarms from clinical systems to display devices, acting as a secondary alert system. It does not analyze patient data to make a diagnosis or assist in the diagnostic process.
Yes
The device is explicitly described as a "software application installed on a Windows server environment" and its function is to acquire, format, and forward information to third-party display devices. There is no mention of any proprietary hardware component included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to forward information and alarms from clinical systems to display devices for healthcare professionals. It explicitly states it does not alter the behavior of primary medical devices and serves as a secondary alert. This focuses on communication and notification, not on analyzing biological samples or providing diagnostic information.
- Device Description: The description reinforces the function of acquiring and forwarding data from clinical systems to display devices. It describes the data as "alarms, events, and parameters" and "patient data," but the purpose is for awareness and notification, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function falls outside of that definition.
N/A
Intended Use / 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.
Product codes
MSX, PHC
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.
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
Not Found
Intended User / Care Setting
Not Found
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 – 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.
Summary of Performance Testing: Test results indicated that Critical Alert CommonPath Enterprise complies with internal requirements and the applicable Standard.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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: 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
1
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)
Page 1 of _1 _________________________________________________________________________________________________________________________________________________________________
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| Submission Date: | 11 May 2020 | ||
|---|---|---|---|
| Submitter: | Critical Alert | ||
| 4901 Belfort Road, Suite 130 | |||
| Jacksonville, FL 32256 | |||
| Submitter | |||
| Correspondent | Mr. John Elms | ||
| Phone: +1 (904) 260-6334 | |||
| Email: JElms@criticalalert.com | |||
| Application | |||
| Correspondent: | Thomas Kroenke | ||
| Principal Consultant | |||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| tkroenke@speedtomarket.net | |||
| +1 (303) 956 4232 | |||
| Manufacturing Site: | Critical Alert | ||
| 4901 Belfort Road, Suite 130 | |||
| Jacksonville, FL 32256 | |||
| Trade Name: | Critical Alert CommonPath Enterprise | ||
| Common Name: | Physiological Monitors Network And Communication System | ||
| Classification | |||
| Name: | Physiological Monitors Network And Communication System | ||
| Classification | |||
| Regulation: | 21 CFR §870.2300, 21 CFR §880.5725 | ||
| Product Code: | MSX, PHC | ||
| Substantially | |||
| Equivalent Devices: | New Critical Alert | ||
| Model | Predicate | ||
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Critical Alert | |||
| CommonPath | |||
| Enterprise | K180566 | Ascom Sweden AB / Unite | |
| Connect 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 AB
Unite Connect for Clinical Systems
(K180566) | Critical Alert
CommonPath Enterprise
(Proposed Device) | |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The intended use of the Ascom
Unite Connect for Clinical Systems
is to provide an interface with
clinical systems to forward
information associated to the
particular event to the designated
display device(s). | 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,
the Connect for Clinical Systems is
intended to serve as a parallel,
redundant, forwarding mechanism to
inform healthcare professionals of
particular medical related events. | 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. | |
| | Connect for Clinical Systems 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. | 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. | |
| | Connect for Clinical Systems is
intended for use as a secondary
alarm. It does not replace the
primary alarm function on the
monitor. | Critical Alert CommonPath
Enterprise is intended for use as a
secondary alarm. It does not replace
the alarm function on the primary
device. | |
| Serves as
secondary means
of annunciating
patient events | Yes | Same | |
| Uses computer
hardware to
gather and
format alarm
event information | Windows-based personal computer
(PC)
• Memory: 4 GB RAM
• Processor: 2 GHz
• Connection: TCP/IP base LAN
Disk Space: 50 GB minimum
(recommended free disk space for
installation) | Typical rack mount server from a
vendor such as Dell or HP.
• Memory - 16 GB RAM
• Hard Disk – 4 x 500 GB 15K
RPM - Raid 10
• Processor - 2 x 3.0 GHz Quad
Core (4 core minimum)
• NIC - Support for 10-100Mbit
(minimum) | |
| Technology
Comparison
(continued): | Characteristic
(continued) | Ascom Sweden AB
Unite Connect for Clinical Systems
(K180566) | Critical Alert
CommonPath Enterprise
(Proposed Device) |
| | Duty assignments | Scale is based on maximum number
of locations supported per
integration. Current maximum
number of locations: 128
Maximum number of concurrent
assignment clients: 30 | Tested for 141 number of locations
(units) supported. |
| | | | Maximum redirection levels: 3 |
| | | | Supports a fully configurable
location layout. |
| | | | Supports assignment clients with
shift planning and assignment of
display and/or alerting devices to
staff members. |
| | | | Supports assignment of staff to
patients with escalation chains. |
| | | | Unassigned location warning when a
location or a group of events are not
assigned. |
| | | | Maximum number combined
assignees: 6,000 |
| | | | Maximum number of combined
locations and events per location:
1,200 (e.g. 128 locations with ~9
assignable events per location) |
| | | Time sources | NTP server (NTPv4 compatible with
NTPv2 and NTPv3). Time can be
set manually from a Web browser. |
| | | Messaging
component
compatibility list | Unite Connectivity Manager
(v5.10.0 and higher)
Unite Communication Server (1.3.1
and 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 and
developed according to a robust software development process and was
rigorously verified and validated.
Software information is provided in accordance with internal
requirements 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. | | |
6
7
Summary of Performance Testing:
Test results indicated that Critical Alert CommonPath Enterprise complies with internal requirements and the applicable Standard.
8
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.