CARDIODAY, VERSION 2.0

• K Number: K070280
• Device Name: CARDIODAY, VERSION 2.0
• Manufacturer: GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
• Date Cleared: 2007-02-23 ( 25 days)
• Product Code: DQK
• Regulation Number: 870.1425

Intended 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 be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.

Device Description

CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited 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.

Predicate Devices

K051471

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states that it "does not perform any diagnosis of data by itself" and only displays data for physician review. There are no mentions of AI, ML, or related concepts in the provided text.

Therapeutic

No.
The device is described as software that displays ECG data for review by a physician; it does not perform any therapeutic function itself, nor does it directly treat any conditions.

Diagnostic

No.
The device description explicitly states, "CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited graphs such as heart rate trends, RR variability, and other statistical values in graphical form." This indicates it provides data for a physician to interpret, rather than making a diagnosis itself.

SaMD (Software as a Medical Device)

Yes

The device is described as "Holter software" and its function is to display and process ECG data collected elsewhere. The description focuses solely on the software's capabilities for data review, editing, and printing, without mentioning any associated hardware components included with the submission. The performance studies section also only mentions "Verification and validation test plans" for the software, not hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, it is unlikely that CardioDay® is considered an IVD (In Vitro Diagnostic) device. Here's why:

• IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• CardioDay®'s Function: CardioDay® processes and displays electrocardiographic (ECG) recordings, which are electrical signals from the heart, not specimens derived from the body.
• Intended Use: The intended use describes the software as a tool for analyzing and displaying ECG data for physician review and interpretation. It explicitly states that the software "does not perform any diagnosis of data by itself."
• Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.

While the software is used in a clinical setting to aid in the diagnosis and management of cardiac conditions, its function is based on analyzing electrical signals, not biological samples. This places it outside the typical scope of an IVD device.

Therefore, based on the provided text, CardioDay® is best classified as a medical device for ECG data analysis and display, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 be monitored 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® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited 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

CardioDay® is a software package that allows a trained physician or health care professional knowledgeable in Holter ECG interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording using a 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.

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:
Verification and validation test plans were completed in accordance with getemed AG procedures and GMP guidelines. A Hazard Analysis was completed and hazards were resolved as appropriate.

The CardioDay® software complies to the following standards:

• IEC 60601-1-4,
• IEC 60601-2-47,
• IEC 60601-2-51 (Part 50.101.2),
• ANSI/AAMI EC 38,
• ISO 14971.
• EN 980,
• ISO 15223,
• EN 1041

Also the following FDA-Guidelines were met:

• "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices",
• "General Principles of Software Validation".

All system specifications were met and testing performed to demonstrate substantial equivalence.

Clinical Testing:
Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K051471

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Special 510(k) Notification	getemec
CardioDay®	Project ID: 0505S1
Executive - Summary	Section 16-0001-Rev B

• 510(k) Summary

| Name and address of the
manufacturer and sponsor
of the 510(k) submission: | getemed Medizin- und Informationstechnik AG
Oderstr. 77
14513 Teltow
Germany
Tel.: +49 3328 - 3942-0
Fax: +49 3328 – 3942-99 |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Official contact person
for all correspondence: | Dr. Bert Schadow
Regulatory Affairs Manager
E-mail: [e-mail] |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AG
Oderstr. 77
14513 Teltow
Germany |
| Date of Preparation: | 2006-12-19 |
| Device Name / Trade Name: | CardioDay® |
| Generic name of the device: | Holter ECG |
| Classification of new device: | Class II |
| Classification Panel: | Computer, Diagnostic, Programmable |
| Product Code and: | DQK |
| CFR Regulation Number: | 21 CFR 870.1425 |
| Legally Marketed Devices: | CardioDay® (K051471, getemed AG) |

Description of Device:

CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited 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.

Specifications	Legally marketed device CardioDay Version 1.9.5 (K051471)	New / Modified Device CardioDay Version 2.0
Type	IBM PC AT compatible	IBM PC AT compatible
CPU	Pentium III, 500MHz or greater	Pentium III, 500MHz or greater
RAM	128 Mbytes minimum,
256 Mbytes minimum for XP	256 Mbytes minimum
Free hard disk space	5 GB minimum
20 GB for 12-lead recordings	5 GB minimum
20 GB for 12-lead recordings
Display	17" CRT or 15" TFT, 1024 x 768
pixel (XGA), 256 colors	17" CRT or 15" TFT, 1024 x 768
pixel (XGA), 256 colors
Disc drive / floppy drive	Not required	Not required

Comparison of Device Technological Characteristics to Predicate Device:

0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc CONFIDENTIAL AND PROPRIETARY

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	Special 510(k) Notification		getemed
	CardioDay®		Project ID: 0505S1
	Executive - Summary		Section 16-0001-Rev B
Specifications	Legally marketed device
CardioDay Version 1.9.5 (K051471)		New / Modified Device
CardioDay® Version 2.0
CD-ROM drive	For installation only.
Needs to be replaced by a CD-
ROM writer or DVD writer if archive
option implemented		For installation only.
Needs to be replaced by a CD-
ROM writer or DVD writer if archive
option implemented
Operating system	Windows 98 SE, NT (SP6a),
2000 or XP		Windows 2000 or XP (SP2)
Ports	1 parallel port sufficient; if USB
devices used for printing, software
key or card reader, then
corresponding USB ports required		1 parallel port sufficient; if USB
devices used for printing, software
key, card reader, Bluetooth-Dongle,
or connection for Holter recorder
CardioMem® then corresponding
USB ports required
Printer	Printer as any Windows™
compatible, 300 dpi		Printer as any Windows™
compatible, 300 dpi
Keyboard	Standard device		Standard device
Mouse	Standard, 2 or 3-button device		Standard, 2 or 3-button device
Installation media	(1) CD		(1) CD
Further periphery	CompactFlash (Type I) memory
card reader		CompactFlash (Type I) memory
card reader

Comparison of Software Characteristics:

Patient Screen	Legally marketed device CardioDay Version 1.9.5 (K051471)	New / Modified Device CardioDay Version 2.0
Patient Identification Number	Yes	Yes
Patient Name, Address, Telephone	Yes	Yes
Patient Personal Data (Age, Gender, Date of Birth,
etc.)	Yes	Yes
Medication	Yes	Yes
Indication	Yes	Yes
Physician's Name	Yes	Yes
Date of Recording	Yes	Yes

| Analysis Options | Legally marketed device
CardioDay® Version 1.9.5
(K051471) | New / Modified Device
CardioDay® Version 2.0 |
|------------------------------|------------------------------------------------------------------|-------------------------------------------------|
| Analysis Duration | Yes | Yes |
| Primary Channel Selection | Yes | Yes |
| Sensitivity / Signal Quality | Yes | Yes |
| Tachycardia Threshold [bpm] | Yes | Yes |
| Bradycardia Threshold [bpm] | Yes | Yes |
| Pause Duration [ms] | Yes | Yes |
| SV Prematurity [%] | Yes | Yes |
| V Prematurity [%] | Yes | Yes |
| R on T [ms] | Yes | Yes |
| Pacemaker Type | Yes | Yes |
| Minimum Pulse Rate [bpm] | Yes | Yes |
| Maximum Pulse Rate [bpm] | Yes | Yes |

0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc
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| Special 510(k) Notification
CardioDay® | | getemed
Project ID: 0505S1 | |
|-------------------------------------------|------------------------------------------------------------------|-------------------------------------------------|--|
| Executive - Summary | | Section 16-0001-Rev B | |
| Analysis Options | Legally marketed device
CardioDay® Version 1.9.5
(K051471) | New / Modified Device
CardioDay® Version 2.0 | |
| Superimposition / QuickScan | Yes | Yes | |
| 12-Lead ECG Module | Yes | Yes | |
| Holter Data Transfer | Yes | Yes | |

| Events Detected | Legally marketed device
CardioDay Version 1.9.5
(K051471) | New / Modified Device
CardioDay Version 2.0 |
|-------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| VES / PVC | Yes | Yes |
| SVES / SVE | Yes | Yes |
| Couplet | Yes | Yes |
| Triplet | Yes | Yes |
| VTACH / VE Tachycardia | Yes | Yes |
| Bigeminy | Yes | Yes |
| R on T | Yes | Yes |
| ST-Analysis | Yes | Yes |
| SVTACH / SVE Tachycardia | Yes | Yes |
| Arrhythmia / N-N Delay | Yes | Yes |
| Bradycardia | Yes | Yes |
| Burst / VE Run (4 beats) | Yes | Yes |
| V. STIM / V. Paced | Yes | Yes |
| A. STIM / A. Paced | Yes | Yes |
| AV. STIM / AV Paced | Yes | Yes |
| Undersense / Sense Failure | Yes | Yes |
| Exitblock / Capture Failure | Yes | Yes |
| Oversense / Inhibition | Yes | Yes |
| Pause / R-R Pause / N-N Pause | Yes | Yes |
| Event Marker | Yes | Yes |
| HR Stripes | Yes | Yes |
| Artifact | Yes | Yes |
| Normal | Yes | Yes |

| Functionality Available | Legally marketed device
CardioDay® Version 1.9.5
(K051471) | New / Modified Device
CardioDay® Version 2.0 |
|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------|
| The comparison between the legally marketed device and the NEW DEVICE is based on their functions only and not on their names. | | |
| Start | Yes | Yes |
| Read Tape | Yes | Yes |
| Read Digital Recorder | Yes | Yes |
| Import | Yes | Yes |
| Analyze New | Yes | Yes |
| Open | Yes | Yes |
| Edit Patient Data | Yes | Yes |
| Print Preview | Yes | Yes |
| Print | Yes | Yes |
| Close Recording | Yes | Yes |
| Close | Yes | Yes |

0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc
CONF!DENTIAL AND PROPRIETARY

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Special 510(k) Notification			getemed
CardioDay®		Project ID: 0505S1
Executive - Summary			Section 16-0001-Rev B
Functionality Available	Legally marketed device
CardioDay Version 1.9.5
(K051471)	New / Modified Device
CardioDay Version 2.0
Delete Recording	Yes	Yes
Archive	Yes	Yes
Diagnosis	Yes	Yes
View ECG	Yes	Yes
View ECG Online via OptoLink Cable	Yes	Yes
View ECG Online via USB Cable	No	Yes
View ECG Online via Bluetooth Data Transfer	No	Yes
Print Preview	Yes	Yes
Screen Scale Calibration	Yes	Yes
Screen: Color Setup	Yes	Yes
FFT Setup	Yes	Yes
Report Setup	Yes	Yes
Classes Display	Yes	Yes
PM Events Display	Yes	Yes
Events Display	Yes	Yes
HR Min./Max. Display	Yes	Yes
Statistics Display	Yes	Yes
Diagnosis Display	Yes	Yes
Overview Display	Yes	Yes
Context sensitive Help	Yes	Yes
Keyboard Shortcuts Help	Yes	Yes
Menu Entries Help	Yes	Yes
Help: About	Yes	Yes
Help: Version	Yes	Yes

| Icons/Buttons Available | Legally marketed device
CardioDay® Version 1.9.5
(K051471) | New / Modified Device
CardioDay® Version 2.0 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------|
| The following comparison between the legally
marketed device and the NEW DEVICE is based on
their functions only. The label and form of the icons
/ buttons, however, are different. It might even take
more than one click to initiate a given action. | | |
| Start: Read Digital Recorder | Yes | Yes |
| Start: Read Tape Recorder | Yes | Yes |
| Start: Open Existing Record | Yes | Yes |
| Digital Recorder | Yes | Yes |
| Tape Recorder | Yes | Yes |
| Open: List of Patients | Yes | Yes |
| Print | Yes | Yes |
| Rhythm Analysis | Yes | Yes |
| Print Preview on Screen | Yes | Yes |

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Special 510(k) Notification	getemed
CardioDay®	Project ID: 0505S1
Executive - Summary	Section 16-0001-Rev B

| Options Available | Legally marketed device
CardioDay® Version 1.9.5
(K051471) | New / Modified Device
CardioDay® Version 2.0 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------|
| The following comparison between the legally mar-
keted device and the NEW DEVICE is based on their
functions only. The name of those options may vary. | | |
| Classes | Yes | Yes |
| Events | Yes | Yes |
| Heart Rate Min/Max | Yes | Yes |
| Average Heart Rate | Yes | Yes |
| Statistics: FFT Analysis | Yes | Yes |
| Statistics: ST Diagrams | Yes | Yes |
| Report | Yes | Yes |
| Overview | Yes | Yes |
| Heart Variability: RR Delay | Yes | Yes |
| Heart Rate Variability: RR FFT | Yes | Yes |
| Heart Rate Variability: 24h RR FFT | Yes | Yes |
| Heart Rate Variability: RR Histograms | Yes | Yes |

| Graphics & Displays Available | Legally marketed device
CardioDay Version 1.9.5
(K051471) | New / Modified Device
CardioDay Version 2.0 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| The following comparison between the legally mar-
keted device and the NEW DEVICE is based on their
functions only. The label and appearance of those
displays may vary. | | |
| Basis Sampling Rate for Graphical Displays | 8 ms | 4 ms |
| Classified Beats Grouped into Morphology Bins | Yes | Yes |
| Zoomed Version of Selected Beat | Yes | Yes |
| Context of Selected Beat | Yes | Yes |
| Events | Yes | Yes |
| Heart Rate Trend in Recording Period | Yes | Yes |
| Average RR Interval | Yes | Yes |
| Y-T Distribution | Yes | Yes |
| RR > 50ms Distribution | Yes | Yes |
| FFT Analysis | Yes | Yes |
| ST Diagrams | Yes | Yes |
| Overview 2 channels at Different Scaling Factors | Yes | Yes |
| Indicator for Atrial Fibrillation | No | Yes |

| Printout Options | Legally marketed device
CardioDay Version 1.9.5
(K051471) | New/ Modified Device
CardioDay Version 2.0 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------|
| The following comparison between the legally mar-
keted device and the NEW DEVICE is based on their
functionality only. The commands to generate a
given printout as well as its appearance do vary. | | |
| Full Disclosure 2 Channels, 1 h/Page | Yes | Yes |
| Full Disclosure 2 Channels, 15 min./Page | Yes | Yes |
| Full Disclosure 2 Channels, 30 min./Page | Yes | Yes |
| Marked Events: 8 Events/Page | Yes | Yes |

0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc
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Special 510(k) Notification			getemed
CardioDay®			Project ID: 0505S1
Executive - Summary			Section 16-0001-Rev B
Printout Options	Legally marketed device
CardioDay® Version 1.9.5
(K051471)	New / Modified Device
CardioDay® Version 2.0
Marked Events: 32 Events/Page	Yes	Yes
Marked Events: Analysis Channel 25 mm/s	Yes	Yes
Marked Events: Analysis Channel 2.5 min + 25mm/s	Yes	Yes
Selected Channels 25 mm/s	Yes	Yes
Selected Channels 1 min. + 25 mm/s	Yes	Yes
Selected Channels 2.5 min. + 25 mm/s	Yes	Yes
Selected Channels 10 min. + 25 mm/s	Yes	Yes
Event Table	Yes	Yes
Event Histogram	Yes	Yes
Heart Rate and ST Diagrams	Yes	Yes
HR diagram + Min/Max per Minute	Yes	Yes
RR Intervals	Yes	Yes
RR Delay	Yes	Yes
RR Histograms	Yes	Yes
RR Interval Spectra	Yes	Yes
Pacemaker Event Histogram	Yes	Yes
Pacemaker Function Analysis	Yes	Yes
Report	Yes	Yes
Print to File (PDF)	Yes	Yes
Save as Default Option	Yes	Yes

| Editing & Reviewing Options | Legally marketed device
CardioDay Version 1.9.5
(K051471) | New / Modified Device
CardioDay Version 2.0 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| The following comparison between the legally mar-
keted device and the NEW DEVICE is based on their
functions only. The label and appearance of those
options may vary. | | |
| Scroll through all Beats in a Morphology Bin | Yes | Yes |
| Edit all Beat Labels in a Morphology Bin | Yes | Yes |
| Scroll through ECG and Edit Single Beat Labels | Yes | Yes |
| Scroll through Events of the Same Type | Yes | Yes |
| Edit Event Marker | Yes | Yes |
| View Patient Event Markers | Yes | Yes |
| Jump from any Statistics Diagram to the
corresponding ECG | Yes | Yes |
| Jump from ECG Overview to the corresponding ECG | Yes | Yes |
| Select Time Interval for Time Domain RR Parameters | Yes | Yes |
| Edit Report | Yes | Yes |

。

『 、 : 人

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Special 510(k) Notification

CardioDay®	Project ID: 0505S1
Executive - Summary	Section 16-0001-Rev B

| Miscellaneous | Legally marketed device
CardioDay Version 1.9.5
(K051471) | New / Modified Device
CardioDay Version 2.0 |
|---------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------|
| RZ153+ Digital Recorder Supported (K022540) | Yes | Yes |
| CardioMem® CM 3000 (SMA) Supported | Yes | Yes |
| CardioMem® CM 3000-12 Supported (K051686) | Yes | Yes |
| CardioMem® CM 3000-12BT Supported | No | Yes
Bluetooth functionality
only with Microsoft
Windows XP (SP2) |
| CD Installation Medium | Yes | Yes |

Standards Comparison

| Standard | Legally marketed device
CardioDay Version 1.9.5
(K051471) | New / Modified Device
CardioDay Version 2.0 |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| 21 CFR 820 (FDA cGMP Good Manufacturing
Practice) | Yes | Yes |
| ISO 9001:2000 / ISO 13485:2003 Quality
Management Systems | Yes | Yes |
| IEC 60601-1-4 + A1 Programmable Electrical
Medical Systems | Yes | Yes |
| ANSI/AAMI EC38 Ambulatory Electrocardiographs | Yes | Yes |
| IEC 60601-2-47 Particular Requirements for the
Safety, including Essential Performance, of
Ambulatory Electrocardiographic Systems | Yes | Yes |
| ISO 14971 +A1 Application of the Risk
Management to Medical Devices | Yes | Yes |
| EN 980 Graphic Symbols for the Marking of
Medical Devices | Yes | Yes |
| EN 1041 Supply of Information by the Manufacturer
of a Medical Device | Yes | Yes |
| ISO 15223 + AMD1 + AMD2 Symbols to be Used
with Medical Devices | Yes | Yes |

Intended use:

CardioDay® is a software package that allows a trained physician or health care professional knowledgeable in Holter ECG interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording using a 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.

0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc CONFIDENTIAL AND PROPRIETARY

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Special 510(k) Notification	getemed
CardioDay®	Project ID: 0505S1
Executive - Summary	Section 16-0001-Rev B

Non-Clinical Testing:

Verification and validation test plans were completed in accordance with getemed AG procedures and GMP guidelines. A Hazard Analysis was completed and hazards were resolved as appropriate.

The CardioDay® software complies to the following standards:

• IEC 60601-1-4,
• IEC 60601-2-47,
• IEC 60601-2-51 (Part 50.101.2),
• ANSI/AAMI EC 38,
• ISO 14971.
• EN 980,
• ISO 15223,
• EN 1041

Also the following FDA-Guidelines were met:

• "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices",
• "General Principles of Software Validation".

All system specifications were met and testing performed to demonstrate substantial equivalence.

Clinical Testing:

Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness.

Conclusion:

The CardioDay® evaluation software is substantially equivalent to the predicate device listed in this Summary and the device, as changed, does not raise any new issues of safety and effectiveness.

• • 16

8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2007

Getemed Medizin c/o Mr. Bert Schadow Regulatory Affairs Manager 14514 Teltow Germany

Re: K070280

Trade Name: CardioDay Regulation Number: 21 CFR 870.1425 Regulation Name: Computer, Diagnostic, Programmable Regulatory Class: Class II Product Code: DQK Dated: January 3, 2007 Received: January 29, 2007

Dear Mr. 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.

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.

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

9

Page 2 - Mr. Schadow

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Brimmerfor

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

Enclosure

10

K070280
Exhibit 1

Image /page/10/Picture/1 description: The image shows the logo for Getemed. The logo consists of a heart shape inside a circle, followed by the word "getemed" in bold, sans-serif font. The heart and the text are both black, and the background is white.

Medizin- und Informationstechnik AG

Indications for Use

510(k) Number (if known):

CardioDay® Device Name:

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 be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.

న 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)

K.Bermmmo

Page 1 of

Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K070280