The Cardio WiFi Electrocardiograph is a small portable digital cardiograph intended for use by medical professionals to acquire 12-lead ECG's from single or multiple patients in a clinical or point of care setting. ECG data is first recorded to a secure digital flashcard and then transferred to an ECG management system for review by a physician or other qualified professional.

Device Description

The Cardio WiFi electrocardiograph continuously records data to a flashcard and displays it at high resolution. It features a large, liquid crystal display ("LCD") that allows a medical professional to periodically check the test subject's full, 12-lead ECG, either at intervals or in the event of a patient symptom. The device is portable and is battery-powered. Data is stored for later review at an ECG review station. Data transfer is accomplished via WLAN 802.11 b or g.

AI/ML Overview

This device, the Datrix Cardio WiFi Electrocardiograph, is a portable electrocardiograph without analysis capabilities. As such, the submission primarily focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from applicable standards)	Reported Device Performance
AAMI EC11 (Performance Requirements for Diagnostic Electrocardiographs)	Successfully tested and met acceptable results.
IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety)	Successfully tested and met acceptable results.
IEC 60601-1-2 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests)	Successfully tested and met acceptable results.
IEC 60601-2-25 (Medical Electrical Equipment - Part 2-25: Particular Requirements for the Safety of Electrocardiographs)	Successfully tested and met acceptable results.
Performance, Functionality, and Reliability Characteristics	Followed established test procedures in a quality system, with acceptable results.

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

This submission did not involve a clinical study with a "test set" in the traditional sense of evaluating diagnostic accuracy or a human-in-the-loop performance. Instead, the evaluation was based on non-clinical testing to established international and national standards for electrocardiographs. Therefore, there is no sample size of patient data or provenance information to report.

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

Not applicable. The ground truth for this type of device (a data acquisition device without analysis) is adherence to established engineering and performance standards, not diagnostic accuracy. Therefore, no experts were used to establish ground truth from patient data.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring adjudication of patient data.

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

Not applicable. This device is a basic electrocardiograph without analysis, meaning it does not incorporate Artificial Intelligence (AI) for interpretation or diagnostic assistance. Therefore, no MRMC study was conducted to evaluate human reader improvement with or without AI.

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

Not applicable. This device does not have an "algorithm" for diagnostic interpretation in the sense of AI. It acquires and stores ECG data. The performance evaluation was based on the device's ability to accurately and safely perform its intended function of acquiring ECG data, not on the performance of a standalone algorithm for diagnosis.

7. The Type of Ground Truth Used:

The ground truth used for this submission was based on established engineering and performance standards for electrocardiographs, specifically:

AAMI EC11
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-25
Internal quality system test procedures for performance, functionality, and reliability.

8. The Sample Size for the Training Set:

Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set" of data.

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

Not applicable as there is no training set.

Summary

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K053083; page 1 of 2

Datrix, Inc

NOV 3 0 2005

Appendix G

510(k) Summary of Safety and Effectiveness for Datrix Cardio WiFi Electrocardiograph

1. DATE SUMMARY PREPARED:	SEPTEMBER 26, 2005
2. SUBMITTER'S NAME AND ADDRESS:	Datrix340 State PlaceEscondido, CA 92016-1120
	Phone: (760) 480-8874
	Fax: (760) 480-9474
3. CONTACT PERSON:	Linda Gluckman, QA Manager
4. DEVICE NAME:
Proprietary (trade) Name:	Cardio WiFi Electrocardiograph
Common Name:	Portable Electrocardiograph without analysis
Classification Name:	Electrocardiograph (CFR 870:2340)
Product Code:	DPS
Class:	2

PREDICATE DEVICE: 5.

The legally marketed device/s to which equivalence is being claimed is the CardioCollect Portable Electrocardiograph manufactured by Reynolds Medical, Ltd. (K013367).

6. DEVICE DESCRIPTION

Data is stored for later review at an ECG review station. Data transfer is accomplished via WLAN 802.11 b or g.

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Datrix, Inc

Appendix G

7. INTENDED USE

. .

The Cardio WiFi electrocardiograph is a small portable digital electrocardiograph intended for use by medical professionals to acquire 12-lead ECG's from single or multiple patients in a clinical or point of care setting. ECG data is first recorded to a secure digital flashcard and then transferred to an ECG Management System for review by a physician or other qualified professional.

8. NON-CLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The substantial equivalence of the Datrix electrocardiograph (Cardio WiFi) is demonstrated by the following non-clinical testing:

Testing to applicable standards: AAMI EC11, IEC 60601-1; IEC 60601-1-2, . IEC 60601-2-25
Testing for the performance, functionality, and reliability characteristics of the . device followed established test procedures in a quality system.

9. CONCLUSIONS FROM NON-CLINICAL TESTING

Prior to marketing in the US, the Datrix Cardio WiFi electrocardiograph will have completed the testing listed above with acceptable results, demonstrating substantial equivalence.

10. SUBSTANTIAL EQUIVALENCE CONCLUSION

In summary: Comparison to the predicate device listed in item #5 shows nearly identical technical data, same indications for use, same safety standards tested to, and raises no new questions of safety or efficacy. Therefore, the Datrix Cardio WiFi electrocardiograph supports a claim of substantial equivalence.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2005

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

Re: K053083

Trade Name: Datrix Cardio WiFi Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: November 14, 2005 Received: November 16, 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 general volurely would 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, FDA may publish further announcements concerning your device in the Federal Register.

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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,

B. Hummerhofer

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

Enclosure

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Datrix, Inc

Indications for Use Statement

510(k) Number (if known):

Prescription Use

Device Name: Datrix Cardio WiFi Electrocardiograph

Datrix Cardio WiFi Model:

Indications for Use: The Cardio WiFi Electrocardiograph is a small portable digital cardiograph intended for use by medical professionals to acquire 12-lead ECG's from single or multiple patients in a clinical or point of care setting. ECG data is first recorded to a secure digital flashcard and then transferred to an ECG management system for review by a physician or other qualified professional.

(21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Over-The-Counter Use

Виттиsence of CDRH, Office of Device Evaluation (ODF)

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vision of Cardiovascular Devices

10(k) Number K053083

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Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).