CARDIODAY

K130516 · Getemed Medizin- Und Informationstechnik AG · DQK · Aug 23, 2013 · Cardiovascular

Device Facts

• Record ID: K130516
• Device Name: CARDIODAY
• Applicant: Getemed Medizin- Und Informationstechnik AG
• Product Code: DQK · Cardiovascular
• Decision Date: Aug 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

CardioDay® is Holter evaluation software used by trained physicians/healthcare professionals in clinical settings to process data from digital flash memory Holter recorders. Input consists of long-term continuous ECG recordings. The software downloads, analyzes, and displays ECG morphologies, heart rate trends, RR variability, and statistical values. It does not perform automated diagnosis; it provides tools for the physician to review, edit, and generate printed reports. Workflow includes artifact identification. The device incorporates a T-Wave Alternance (TWA) algorithm for analysis. Output assists clinicians in evaluating cardiac functionality and diagnosing symptoms like syncope or palpitations. The device is not for home or ambulatory use.

Clinical Evidence

No clinical testing was performed. Safety and effectiveness were supported by non-clinical bench testing, including ECG performance testing per AAMI/ANSI/EC 38 and software development life cycle validation per AAMI/ANSI/IEC 62304.

Technological Characteristics

Software-based Holter ECG evaluation system. Operates on digital ECG data. Implements T-Wave Alternance (TWA) algorithm. Complies with AAMI/ANSI/EC 38 for ECG performance and AAMI/ANSI/IEC 62304 for software development life cycle.

Indications for Use

Indicated for patients requiring long-term continuous ECG recording, including those with palpitations, syncope, chest pain, shortness of breath, or those requiring assessment of cardiac functionality, such as post-pacemaker implantation patients.

Regulatory Classification

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.

Predicate Devices

• CardioDay® 2.0 (K070280)

Reference Devices

• TWA algorithm (K032513)

Submission Summary (Full Text)

{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<br>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 [phone] or [phone] 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 [phone] or [phone] 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