(28 days)
Not Found
No
The summary describes a standard digital electrocardiograph for acquiring and transferring ECG data, with no mention of AI or ML for analysis or interpretation.
No
The device is an electrocardiograph used for acquiring ECGs, which is a diagnostic tool, not a therapeutic one. It records and displays data for review, but does not provide treatment.
Yes
The device is described as an "Electrocardiograph" intended to "acquire 12-lead ECG's" for "review by a physician or other qualified professional," which is a diagnostic purpose.
No
The device description explicitly mentions hardware components such as a portable digital cardiograph, a secure digital flashcard, a large LCD, and battery power. It also describes data transfer via WLAN, indicating a physical device with wireless capabilities.
Based on the provided information, the Cardio WiFi Electrocardiograph is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the Cardio WiFi Electrocardiograph is used to acquire 12-lead ECGs directly from patients. This is a measurement of physiological signals from the body, not an analysis of a biological specimen.
- The device measures electrical activity of the heart. This is a direct physiological measurement, not a test performed on a sample outside the body.
Therefore, the Cardio WiFi Electrocardiograph falls under the category of a medical device that performs a physiological measurement, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
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.
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
medical professionals / clinical or point of care setting
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)
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.
Prior to marketing in the US, the Datrix Cardio WiFi electrocardiograph will have completed the testing listed above with acceptable results, demonstrating substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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: | Datrix |
| 340 State Place | |
| Escondido, 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
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.
1
K053083; page 2 of 2
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.
2
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.
3
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
4
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)
vision Sign-Oft)
vision of Cardiovascular Devices
10(k) Number K053083
X
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