Cordiana Dx16 is a web-based software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary records, consisting of measurements, text and digitized waveforms, with associated reports and documents. Users do not need to download or install any additional software or plug-ins to use the zero-footprint browser client.

Cordiana Dx16 provides authenticated users the ability to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools. Cordiana Dx16 is intended for use by healthcare professionals, including (but not limited to) physicians, nurses and medical technicians, trained on the use of the software.

Cordiana Dx16 is intended to be used in hospitals or facilities providing patient care, where cardiopulmonary studies are stored in a remote storage system, such as a Picture Archive and Communication System (PACS), with which records, reports and documents can be queried, retrieved and stored using DICOM or similar interface standards.

Cordiana Dx16 does not provide storage of records or associated reports and documents, does not modify the original record and waveform information, and is not intended for real-time monitoring.

Indications for use of Cordiana Dx16 are quantification and reporting of cardiopulmonary function of patients (adults and children of any age from birth upwards) with suspected disease to support the physicians in the diagnosis.

Cordiana Dx16 does not provide automated determination of fiducial points, interpretative statements, or patient diagnosis.

Device Description

Cordiana Dx16 is a web-based software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary studies from various cardio-pulmonary device manufacturers.

The studies are stored in open standardized formats in a remote storage system, such as a Picture and Communication System (PACS) or a Vendor Neutral Archive (VNA). Cordiana Dx16 does not provide own storage of records or associated reports and does not modify records or the original waveform information stored on the remote storage system.

Authenticated users can use Cordiana Dx16 to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools.

The system consists of two logical parts which are installed, configured and maintained as one:

A web server, which is installed centrally in a hospital's IT infrastructure. The Gateway serves as a stateless server to the browser clients. It also serves as a client to the remote storage system, such as the PACS/VNA, with which records, reports and documents are queried, retrieved and stored using the DICOM standard.
Zero-footprint browser clients, which are loaded and updated on demand as single-page applications into an HTML5 enabled web-browser. Users do not need to download or install any additional software or plugins to use the clients.

Cordiana Dx16, when used as intended with a remote storage system, acts as a traditional cardiopulmonary data management system, such as an ECG Management System.

The clients can optionally be integrated ("embedded") as-is with an external application which provides authentication and workflow support. When authentication is done in the external application, the externally authenticated user's credentials are passed to Cordiana Dx16 using Single Sign-On Authentication. When the external application provides workflow support, the search screens are bypassed, and the user is brought directly to a requested study.

Cordiana Dx16 does not store studies or patient related information in the browser clients, does not directly communicate with cardiographs or other acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to quantify measurements (e.g. intervals and amplitudes) or provide diagnostic statements.

Cordiana Dx16 functions as a non-real-time system and is not intended for real-time monitoring.

AI/ML Overview

The provided text describes the Cordiana Dx16, a web-based software system for viewing, editing, and printing cardiopulmonary records. However, the document does not contain information about specific acceptance criteria, tabulated device performance data, sample sizes for test or training sets, details on expert ground truth establishment, or any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.

The document focuses on demonstrating substantial equivalence to a predicate device (MUSE Cardiology Information System K152993) by comparing functional and technical characteristics, and by stating that non-clinical testing was performed.

Here's an analysis based on the available information, with missing sections noted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that "Non-clinical testing performed included software verification... to ensure that Cordiana Dx16 meets design specifications and requirements. Unit and system level testing included assurance of interoperability with representative remote systems and accuracy of displayed waveforms and related information in a simulated user test environment." It also mentions "Bench testing performed verified the Cordiana Dx16 display and measurement capabilities using sample cases based on technical characteristics and relevancy to the intended function of the Cordiana Dx16 application." However, the specific acceptance criteria and the quantitative results (e.g., accuracy percentages, error rates, or specific values for measurement consistency) are not detailed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text mentions "sample cases" for bench testing but does not specify the number of cases or their origin (e.g., retrospective/prospective, country of origin).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The device is a "Programmable Diagnostic Computer" for reviewing and editing cardiopulmonary records. While human experts would typically be involved in establishing ground truth for such data, the document does not mention the use of experts for the test set.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the absence of details on expert involvement, no adjudication method is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the document, and it seems unlikely given the nature of the device. The Cordiana Dx16 is described as a system for viewing, editing, and managing cardiopulmonary records, not as a device that provides automated diagnostic interpretations or AI assistance for human readers in the sense of improving their diagnostic performance (e.g., by detecting abnormalities). It explicitly states: "Cordiana Dx16 does not provide automated determination of fiducial points, interpretative statements, or patient diagnosis." and "Cordiana Dx16 does not use any automatic electronic data processing and pattern recognition methods to quantify measurements (e.g. intervals and amplitudes) or provide diagnostic statements." Therefore, an MRMC study related to AI assistance for human readers would not be applicable to this device's stated functionality.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

A standalone performance study for an algorithm is not applicable in the context of this device. As mentioned above, the device does not employ "automatic electronic data processing and pattern recognition methods to quantify measurements... or provide diagnostic statements." It is a web-based system for manual review and editing by healthcare professionals.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance testing, beyond verifying "accuracy of displayed waveforms and related information" and "display and measurement capabilities using sample cases." Given its function as a viewing and editing system, the ground truth would likely refer to the fidelity of the displayed data compared to the original source, and the accuracy of manual measurement tools. This would typically be based on established standards for waveform display and measurement.

8. The Sample Size for the Training Set

This information is not provided in the document. The device is not described as using machine learning or AI that would typically require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. As the device does not appear to be an AI/ML product requiring a training set, the concept of establishing ground truth for a training set is not relevant here.

Summary of what the document does provide regarding "proof" of meeting criteria:

The "proof" provided for the Cordiana Dx16 predominantly relies on:

Substantial Equivalence to a Predicate Device: The majority of the "Performance Testing" and "Substantial Equivalence Discussion" sections are dedicated to comparing Cordiana Dx16 to the MUSE Cardiology Information System (K152993) and arguing that any differences (like data storage method) do not raise new questions of safety or effectiveness.
Compliance with Standards: The manufacturer states that the device's development conformed to various recognized consensus standards (e.g., IEC 62304 for software lifecycle processes, IEC 62366-1 for usability engineering, ISO 14971 for risk management, NEMA PS 3.1 – 3.20 for DICOM, and IEC 60601-2-25 for electrocardiographs).
Non-Clinical Testing: The document briefly mentions "software verification" to meet design specifications, "unit and system level testing" for interoperability and accuracy of displayed information, and "bench testing" to verify display and measurement capabilities. It concludes that "In all instances, the Cordiana Dx16 functioned as intended by the design requirements and the observed results demonstrated substantial equivalence with the predicate device." However, no specific data or metrics from these tests are quantifiable in the document.

Summary

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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" in blue and "ADMINISTRATION" in a smaller font size below.

November 16, 2020

Cordiana Medical Informatics AG Johan Sandberg CEO Platz 4 Root, LU 6039 Switzerland

Re: K201060

Trade/Device Name: Cordiana Dx16 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 8, 2020 Received: October 16, 2020

Dear Johan Sandberg:

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,

for Lt. Stephen Browning, USPS Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, & Monitoring Devices OHT2: 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) K201060

Device Name

Cordiana Dx16

Indications for Use (Describe)

Cordiana Dx16 does not provide storage of records or associated reports and documents, does not modify the original record and waveform information, and is not intended for real-time monitoring.

Cordiana Dx16 does not provide automated determination of fiducial points, interpretative statements, or patient diagnosis.

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)

Prescription OSC (Part 21 CFR 601 Subpart D)

☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for "cordiana medical informatics". The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of three intertwined rings in blue and green. The company name is written in gray, with "cordiana" on the top line and "medical informatics" on the bottom line.

510(k) Summary for Cordiana Dx16

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Sponsor

Sponsor:	Cordiana Medical Informatics AGPlatz 4CH-6039 Root D4Switzerland
Contact Person:	Johan Sandberg, CEOPhone: +41 41 534 56 38E-Mail: johan.sandberg@cordiana.com
Date Prepared:	October 08, 2020

Device Name and Classification

Proprietary Name:	Cordiana Dx16
Common/Usual Name:	ECG Analysis Computer
Classification Name:	Computer, Diagnostic, Programmable(21 CFR 870.1425, Product Code DQK)

Predicate Device

Predicate Device: MUSE Cardiology Information System K152993

Intended Use

Cordiana Dx16 does not provide storage of records or associated reports and documents, does not modify the original record and waveform information, and is not intended for real-time monitoring.

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K201060

Image /page/4/Picture/1 description: The image shows the logo for Cordiana medical informatics. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of three intertwined bands of blue and green. The company name is written in gray, with "cordiana" on the top line and "medical informatics" on the bottom line.

Cordiana Dx16 does not provide automated determination of fiducial points, interpretative statements, or patient diagnosis.

Device Description and Function

Cordiana Dx16 is a web-based software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary studies from various cardio-pulmonary device manufacturers.

Authenticated users can use Cordiana Dx16 to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools.

The system consists of two logical parts which are installed, configured and maintained as one:

A web server, which is installed centrally in a hospital's IT infrastructure. The Gateway serves as a stateless server to the browser clients. It also serves as a client to the remote storage system, such as the PACS/VNA, with which records, reports and documents are queried, retrieved and stored using the DICOM standard.
Zero-footprint browser clients, which are loaded and updated on demand as single-page applications into an HTML5 enabled web-browser. Users do not need to download or install any additional software or plugins to use the clients.

Cordiana Dx16, when used as intended with a remote storage system, acts as a traditional cardiopulmonary data management system, such as an ECG Management System.

Cordiana Dx16 functions as a non-real-time system and is not intended for real-time monitoring.

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Image /page/5/Picture/1 description: The image shows the logo for Cordiana medical informatics. The logo consists of a blue and green circular design on the left, followed by the company name "cordiana" in gray, and the words "medical informatics" in a smaller font size below it. The circular design is made up of two intertwined loops, one blue and one green.

Predicate Device Comparison

Characteristic	New Device	Predicate Device	Similar / Different
510(k) Number	K201060	K152993	N/A
Device Trade Name	Cordiana Dx16	MUSE CardiologyInformation System	N/A
Manufacturer	Cordiana MedicalInformatics AG	GE Medical SystemsInformation Technologies,Inc.	N/A
Intended Use
Patient Population	Adults and children of anyage from birth upwards	Adult and pediatricpatients	Same
Accessed and managedinformation	Measurements, text anddigitized waveforms	Measurements, text, anddigitized waveforms	Same
Functionality	Search for, list, display,edit and confirmcardiopulmonary studiesthrough the use ofreviewing, onscreenmeasuring and editingtools	Review and editelectrocardiographicprocedures on screen,through the use ofreviewing, measuring,and editing tools	Similar
User Population	Healthcare professionalstrained on the use of thesoftware	Under the directsupervision of a licensedhealthcare practitioner,by trained operators	Similar
Use Location	In hospitals or facilitiesproviding patient care	In a hospital or facilityproviding patient care	Same
Intended for real-timemonitoring.	No	No	Same
Functional Equivalence
Own storage of records orassociated reports anddocuments	No	Yes	Different (See SubstantialEquivalence Discussionbelow)
Search for, list and openECG studies	Yes	Yes	Same
List and open other ECGsfor the same patient	Yes	Yes	Same
View and print digitizedECG waveforms, discretemeasurements, anddiagnostic statements	Yes	Yes	Same
Characteristic	New Device	Predicate Device	Similar / Different
View and print digitizedwaveforms usingcommon display layouts	Yes	Yes	Same
Adjust displayedwaveform gain and speed	Yes	Yes	Same
Measure intervals andamplitudes in digitizedwaveforms usingonscreen calipers	Yes	Yes	Same
Filter displayedwaveforms	Yes	Yes	Same
Serial presentation ofECGs for the same patient	Yes	Yes	Same
Algorithmic serialcomparison with the firstprevious ECG for thesame patient	No	Workstation: YesWeb Client: No	Same as predicatedevice's web client
Manual editing of discreteECG measurements	Yes	Yes	Same
Algorithmic reanalysis ofwaveforms to quantifymeasurements andprovide diagnosticstatements	No	Workstation: YesWeb Client: No	Same as predicatedevice's web client
View, edit, print, andconfirm diagnosticstatements	Yes	Yes	Same
Embedded integration inan external application	Yes	Workstation: NoWeb Client: Yes	Same as predicatedevice's web client
Single sign-on access todevice from withinexternal application	Yes	Yes	Same
Manage user groups andauthorizations centrally	Yes	Yes	Same
Comprehensive audit logs	Yes	Yes	Same
Technical Equivalence
Software only	Yes	Yes	Same
HTML5 web client	Yes	Workstation: NoWeb Client: Yes	Same as predicatedevice's web client
Characteristic	New Device	Predicate Device	Similar / Different
Access centrally storedrecords via TCP/IPnetwork communication	Yes, using open standardDICOM protocols anddata formats	Yes, using non-disclosedproprietary protocols anddata formats	Different (See SubstantialEquivalence Discussionbelow)
Secure networkcommunication	Yes	Yes	Same
Externally facing DICOMinterface	Yes	Yes	Same
Externally facing LDAPinterface	Yes	Yes	Same
Externally facing HL7interface	N/A	Yes	Subject device does notprovide own storage

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Image /page/6/Picture/1 description: The image shows the logo for "cordiana medical informatics". The logo consists of a circular graphic on the left and the company name on the right. The circular graphic is made up of three intertwined arcs in blue and green. The company name is written in gray, with "cordiana" on the top line and "medical informatics" on the bottom line.

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Image /page/7/Picture/1 description: The image shows the logo for Cordiana Medical Informatics. The logo consists of a blue and green circular design on the left, followed by the text "cordiana" in gray. Below "cordiana" is the text "medical informatics" in a smaller font, also in gray. The circular design appears to be three interlocking rings of blue and green.

With the exception of own storage of records or associated reports and documents, further discussed below, the Predicate Device Comparison demonstrates that Cordiana Dx16's indications and intended use, functionality, and technological characteristics are the same or significantly similar to the predicate device, and especially its web client (marketed as "MUSE™ NX").

Substantial Equivalence Discussion

The predicate device provides its own storage of records in a central server, with which its Workstations and Web Clients communicate over a network using a non-disclosed proprietary protocol. Cordiana Dx16 relies on storage of records in a remote storage system, with which it communicates over a network using the open and standardized DICOM protocol.

Reliance on the DICOM standard for network communication with and storage of records in remote storage systems, such as Picture Archive and Communication Systems (PACS), is well defined, mature, and in wide use for a great number of different medical devices for acquisition and post processing in medical imaging. The DICOM standard furthermore includes comprehensive provisions for network communication and storage of records (including discrete measurements, text and digitized waveforms), reports and documents for cardiopulmonary diagnostics.

The demonstrated difference between Cordiana Dx16 and the predicate device is therefore neither critical to its intended use, nor does it raise different questions of safety and effectiveness, compared with the predicate device's proprietary network communication and own storage of records, when used as labeled.

Performance Testing

Non-clinical testing performed included software verification, in compliance with IEC 62304 and IEC 62366-1, to ensure that Cordiana Dx16 meets design specifications and requirements. Unit and system level testing included assurance of interoperability with representative remote systems and accuracy of displayed waveforms and related information in a simulated user test environment.

Bench testing performed verified the Cordiana Dx16 display and measurement capabilities using sample cases based on technical characteristics and relevancy to the intended function of the Cordiana Dx16 application. In particular, the testing was performed to ensure user readability and quality on different supported browsers.

In all instances, the Cordiana Dx16 functioned as intended by the design requirements and the observed results demonstrated substantial equivalence with the predicate device.

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Image /page/8/Picture/1 description: The image contains the logo for "cordiana medical informatics". The logo consists of a circular graphic on the left, made up of three intertwined bands of color: blue, dark blue, and green. To the right of the graphic is the word "cordiana" in gray, with the words "medical informatics" in a smaller font size below it.

Performance Standards

There are no applicable FDA mandated performance standards for this device. However, Cordiana Medical Informatics AG's in-house standard operating procedures were used for the development of the software; these procedures conform to the following FDA recognized consensus standards:

ISO 14971:2007 Medical devices — Application of risk management to medical devices
IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices
IEC 62304:2006 Medical device software — Software life cycle processes, as amended by IEC 62304:2006/AMD 1:2015 Medical device software ife cycle processes — Amendment 1

Querying, retrieving and storing records, reports and documents in a remote storage system comply with applicable provisions of the FDA recognized consensus standard:

NEMA PS 3.1 – 3.20 (2016): Digital Imaging and Communications in Medicine (DICOM)
Furthermore, Cordiana Dx16's requirements and design specifications were defined to comply with the applicable ECG Report and Filter requirements of the FDA recognized consensus standard:
IEC 60601-2-25:2011 Medical electrical equipment — Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

Conclusion

As a result of the product's technical characteristics, performance testing activities, and standards compliance, Cordiana Medical Informatics AG considers Cordiana Dx16 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).