(177 days)
No
The device description explicitly states that the software "does not perform any diagnosis of data by itself" and only displays calculated values and graphical representations for the physician to review and interpret. There is no mention of AI, ML, or any related concepts in the provided text.
No.
The device is a software for analyzing ECG recordings and does not provide any therapy or treatment.
No
The device explicitly states it "does not perform any diagnosis of data by itself" and only "displays ECG morphologies and associated, calculated graphs." The diagnosis is performed by a trained physician or healthcare professional.
Yes
The device description explicitly states that CardioDay® is a "software package" that allows for the download, analysis, review, and reporting of ECG data collected by a separate digital flash memory Holter recorder. It does not include the hardware recorder itself.
Based on the provided information, CardioDay® is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CardioDay® Function: CardioDay® analyzes electrocardiographic (ECG) data, which is a recording of the electrical activity of the heart. This data is collected externally from the patient's body using a Holter recorder, not from a specimen taken from the body.
- Intended Use: The intended use describes the analysis of ECG recordings for cardiac assessment, not the analysis of biological specimens.
- Device Description: The description clearly states that it processes data from a Holter recorder and displays ECG morphologies and calculated graphs. It does not mention any interaction with biological samples.
Therefore, CardioDay® falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CardioDay® is a software package that allows you, a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports.
This device is available only upon the order of a physician or other licensed medical professional and not intended for any ambulatory or home applications.
United States federal law restricts CardioDay® to sale by or on the order of a physician.
CardioDay® is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to judge their current cardiac functionality such as patients who have recently received pacemakers.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
CardioDay® is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.
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
trained physician or health care professional
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)
Non-clinical testing that has been conducted includes:
a. ECG performance testing according to AAMI / ANSI / EC 38:
b. Software development life cycle according to AAMI / ANSI / IEC 62304
None of the testing demonstrated that CardioDay® 2.4 brought up any issues of safety or effectiveness.
No clinical testing was performed in order to support safety or effectiveness.
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.
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
§ 870.1425 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).
0
| Technical Documentation | getemed |
|---|---|
| CardioDay® | 0505-TD-0096-00 |
| 510(K) SUMMARY | 2013-02-22 |
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:K130516.
- Submitter's Identification: 1.
ﻟﺘﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
GETEMED Medizin- und Informationstechnik AG Oderstrasse 77, 14513 Teltow, Germany Tel: + 49 - 3328 3942 0
AUG 2 3 2013
Contact: Dr. Bert Schadow Requlatory Affairs Manager GETEMED Medizin- und Informationstechnik AG Oderstrasse 77, 14513 Teltow, GERMANY Tel: + 49 - 3328 3942 70 Fax: + 49 - 3328 3942 99
Date Summary Prepared: February 22, 2013
- Name of the Device: CardioDay® 2.
- Device Class: Class II 3.
- Common or Usual Name: Holter evaluation software 4.
5. Predicate Device Information:
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| CardioDay® 2.0 | GETEMED Medizin- und | |
| Informationstechnik AG | K070280 |
ર્દ . Device Description:
CardioDay® is a software package that allows a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, calculated graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.
1
| Technical Documentation | getemed |
|---|---|
| CardioDay® | 0505-TD-0096-00 |
| 510(K) SUMMARY | 2013-02-22 |
7. Intended Use:
ﭘﺎﮐﺴﺘﺎﻥ ﮐﮯ ﺷﮩﺮ ﺑﮭﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﮐﮯ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾ
CardioDay® is a software package that allows you, a trained physician or health care professional knowledgeable in Holter interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording on digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports.
This device is available only upon the order of a physician or other licensed medical professional and not intended for any ambulatory or home applications.
United States federal law restricts CardioDay® to sale by or on the order of a physician.
Comparison to Predicate Devices: 8.
The Holter evalution software CardioDay® 2.4 is substantially equivalent to CardioDay® 2.0 (K070280) from GETEMED Medizin- und Informationstechnik AG. There have been no changes implemented in the modifications to CardioDay® 2.4 that impact either the fundamental technology or the indications for use. Some incremental changes were made in the workflow and in the naming of menu entries to improve the usability, to support more Holter ECG recorders and to bring the technical details up-to date. A TWA (T-Wave Altemance) algorithm was implemented that is identical to an already FDA approved TWA algorithm (510(k)# K032513).
Discussion of Non-Clinical Tests Performed for Determination of Substantial 9. Equivalence are as follows:
Non-clinical testing that has been conducted includes:
a. ECG performance testing according to AAMI / ANSI / EC 38:
- b. Software development life cycle according to AAMI / ANSI / IEC 62304
None of the testing demonstrated that CardioDay® 2.4 brought up any issues of safety or effectiveness.
Discussion of Clinical Tests Performed: 10.
No clinical testing was performed in order to support safety or effectiveness.
11. Conclusion:
CardioDay® version 2.4 is identical to its predicate device in intended use, indications for use and operating principle. Some incremental changes were made in the workflow to identify artefacts in the ECG recording. To improve the usability some menus are relabeled. Some more Holter ECG recorders are supported. A TWA (T-Wave Alternance) algorithm was implemented that is identical to an already FDA approved TWA algorithm (510(k) # K032513).
Verification and validation of CardioDay 2.4 demonstrated that these small differences do not raise any new questions of safety and effectiveness to the subject device and the subject device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wavy lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 23, 2013
Getemed Medizin - Und Informationstechnik Ag C/O Dr. Bert Schadow Oderstr. 77 Teltow, Brandenburg Germany 14513
Re: K130216
Trade/Device Name: CardioDay version 2.4 Regulation Number: 21 CFR 870.1425 Regulation Name: Holter ECG Evaluation Software Regulatory Class: Class II Product Code: DQK Dated: July 9, 2013 Received: July 10, 2013
Dear Dr. Schadow:
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. 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.
3
Page 2 - Dr. Bert Schadow
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen=P.Earis-S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ogetemed
Indications for Use
510(k) Number (if known): K130516
Device Name: CardioDay® 2.4
Indications For Use:
CardioDay® is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to judge their current cardiac functionality such as patients who have recently received pacemakers.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Digitally signed by 2013.08.23
Page 1 of