CARDIOSERVER by DATRIX | FDA 510(k) Summary

The CardioServer ECG Management System software is intended to be marketed to medical professionals and for point-of-care use. The software is designed to provide a database used through out the medical community to store, display, edit and print high resolution ECG data received from devices such as electrocardiographs.

The CardioServer ECG Management System software allows medical professionals responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease to: review and edit specific patient ECG data including intervals such as QT measurements and algorithm generated preliminary interpretative statements. ECG records are all associated by patient ID and other demographic data. Secure access to the database is provided.

Device Description

CardioServer ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG data transferred from a Datrix Cardio WiFi electrocardiograph device. All ECG records are associated by patient ID, and a final record including physician interpretation can be created.

The software system analyzes data using an ECG analysis algorithm developed under direction of Dr. Peter MacFarlane, University of Glasgow (note: the same algorithm is contained in the predicate device to which equivalency is being claimed). The ECG display is able to show 1, 3, or 12 leads at once, full disclosure, user-selected strips, and interpretations editable bv physician. Hardware requirements: are Windows 2000 or 2003 Server operating system; Pentium IV, 2GHz (minimum); 512 MB RAM (minimum); 10/100 Ethernet (minimum); RAID 5 storage; 1024x768 monitor; and standard back-up technology.

AI/ML Overview

The provided text describes a 510(k) summary for the Datrix CardioServer ECG Management System. However, it does not contain specific acceptance criteria, a detailed study proving the device meets criteria, or the types of quantitative performance metrics typically associated with AI/ML device evaluations.

Instead, the submission focuses on:

Establishing substantial equivalence to a predicate device (Quinton Pyramis ECG Management System K032038).
Describing the software's functionality, intended use, and hardware requirements.
Stating compliance with the FDA Guidance Document: "General Principles of Software Validation."
Highlighting that the device utilizes the same ECG analysis algorithm (University of Glasgow ECG Algorithm) as the predicate device.

Given this, I cannot provide the requested information in the format specified because the document does not contain it. The provided text primarily addresses regulatory compliance through substantial equivalence, general software validation, and technological comparison to a predicate device. It lacks the details of a performance study with specific acceptance criteria and outcome metrics for algorithmic performance.

Here's what I can extract based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document primarily focuses on software validation and equivalence to a predicate device, rather than explicit performance-based acceptance criteria for the algorithm's diagnostic accuracy.	The device meets the "FDA Guidance Document: General Principles of Software Validation; Final Guidance for Industry and FDA Staff with acceptable results..."
	"...demonstrating substantial equivalence [to the predicate device]."
	The device utilizes the University of Glasgow ECG Algorithm, which is also present in the predicate device.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified.
Data Provenance: Not specified. The document mentions the University of Glasgow ECG Algorithm, implying its origin, but does not detail a specific dataset used for this device's testing or validation of the algorithm's performance.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not specified. The document does not describe a performance study involving expert-established ground truth. Interpreted statements are "editable by physician," but this pertains to clinical use, not the validation process.

4. Adjudication method for the test set:

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, an MRMC study was not described. The document does not mention any studies involving human readers or comparative effectiveness with AI assistance.

6. If a standalone (algorithm only without human-in-the-loop performance) was done:

A standalone performance study of the algorithm's diagnostic accuracy, as typically reported today, is not detailed. The document states: "The software system analyzes data using an ECG analysis algorithm developed under direction of Dr. Peter MacFarlane, University of Glasgow (note: the same algorithm is contained in the predicate device to which equivalency is being claimed)." This indicates the algorithm itself has a history, but a specific standalone validation study for this device is not provided in terms of performance metrics. The testing focused on software validation and functionality.

7. The type of ground truth used:

Not specified. For the algorithm (University of Glasgow ECG Algorithm), it is generally understood that such algorithms are developed and validated against expert consensus or clinically confirmed diagnoses, but the details for this submission are absent.

8. The sample size for the training set:

Not specified. This refers to the training of the University of Glasgow ECG Algorithm, which is an external component, and its training details are not provided in this 510(k) summary.

9. How the ground truth for the training set was established:

Not specified. (Refer to point 8).

Summary of Missing Information:

The provided 510(k) summary is primarily concerned with establishing substantial equivalence to a predicate device and demonstrating software validation according to FDA guidance. It leverages the fact that it uses the same ECG analysis algorithm as the predicate device. It does not contain the detailed performance study data (acceptance criteria, test set characteristics, ground truth establishment, expert involvement, specific performance metrics for diagnostic accuracy) that would be expected for a more modern AI/ML device submission demonstrating algorithmic performance.

Summary

{0}------------------------------------------------

Appendix G

510(k) Summary of Safety and Effectiveness for Datrix, Inc CardioServer ECG Management System

1. Date Summary Prepared:

9-26-2005

2. SUBMITTER'S NAME AND ADDRESS:

Linda Gluckman Datrix, Inc 340 State Place Escondido, CA 92029

3. Contact Person:

Linda Gluckman Datrix QA Manager

4. Device Name:

Proprietary (trade) Name:	Datrix CardioServer ECG Management System
Common Name:	ECG Management System
Classification Name:	Programmable Diagnostic Computer/ 870.1425
Product Code:	DQK
Class:	II

5. PREDICATE DEVICE: The legally marketed device/s to which equivalence is being claimed is: Quinton Pyramis ECG Management System 3303 Monte Villa Parkway Bothell, WA 98021 K032038

{1}------------------------------------------------

Appendix G

6. Device Description:

7. Intended Use:

The CardioServer ECG Management System software is intended to be marketed to medical professionals and for point-of-care use. The software is designed to work with ECG Management databases located through out the medical community that commonly store, retrieve, display, edit, and print high-resolution records of ECG data received from devices such as the Datrix Cardio WiFi electrocardiograph.

The CardioServer ECG Management System software allows medical professionals responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease to do the following:

1. Review specific patient ECG data which is available through on-screen display, printer, email, fax, or Hospital Information System (HIS) results which report by interface or other customized data bases.
1. Analyze ECG data using calipers for measurement of various intervals.

The CardioServer system does not modify the original ECG waveform information, but it does provide an automated ECG interpretive analysis of the data.

The ECG data display can show 1, 3, or 12 leads at once, full disclosure, user-selected strips, interpretations (editable by physician), and lists studies using various filters (study type, patient, etc.), Resulting ECG records are

{2}------------------------------------------------

Appendix G

all associated by patient ID and include the physician interpretation.

8. Non-clinical Tests Used in Determination of Safety:

The substantial equivalence of the Datrix ECG Management System is Demonstrated by the following non-clinical testing:

Testing to the FDA Guidance Document: General Principles of Software . Validation; Final Guidance for Industry and FDA Staff.
Testing for the performance, functionality, and reliability characteristics of . the software device followed established test procedures in a quality system.

9. Conclusions from Non-clinical Testing:

Datrix's CardioServer ECG Management system meets the FDA Guidance Document: General Principles of Software Validation; Final Guidance for Industry and FDA Staff with acceptable results, demonstrating substantial equivalence.

10. Technological Comparison with Predicate:

Both systems:

Receive ECGs via wireless LAN, LAN, USB2, and other standard . transmission modes;
Store, archive, and display ECGs; .
Export ECGs in industry standard formats to electronic health . records;
Print ECGs; ●
Utilize Windows standards; .
Are delivered as software only system; ●
Provide secure access to patient health information; .
Log all interaction with patient health information; .
Provide clinical access to ECG data across the users network; ●
Utilize the University of Glasgow ECG Algorithm for data . interpretation;
Utilize the University of Glasgow ECG Algorithm for serial . comparison of ECGs;
Allow user editing of ECG interpretation; .
Provide ECG measurements: .
Contain calipers for user edit of ECG measurements; .
Generate management reports such as departmental ECG volume. .

{3}------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------4

Datrix CServer 510(k) Summary Appendix G

{4}------------------------------------------------

Image /page/4/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2005

Datrix, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K052883

Trade Name: Datrix CardioServer ECG Management System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 10, 2005 Received: October 13, 2005

Dear Mr. Job:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, F12A may publish further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Mr. Mark Job

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Blummatfor

Brand D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Appendix E

Indications for Use Statement

510(k) Number (if known): Kos2883

Device Name: Datrix ECG Management System

Datrix CardioServer Model:

Indications for Use: The CardioServer ECG Management System software is intended to be marketed to medical professionals and for point-of-care use. The software is designed to provide a database used through out the medical community to store, display, edit and print high resolution ECG data received from devices such as electrocardiographs.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Bummuma

sion of Cardlovascular Devices k) Number 252000

1/1

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).