CARDIODAY, VERSION 2.0

K070280 · Getemed Medizin- Und Informationstechnik AG · DQK · Feb 23, 2007 · Cardiovascular

Device Facts

• Record ID: K070280
• Device Name: CARDIODAY, VERSION 2.0
• Applicant: Getemed Medizin- Und Informationstechnik AG
• Product Code: DQK · Cardiovascular
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for 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.

Device Story

CardioDay® is a software-based Holter ECG analysis system used in clinical settings by physicians or trained healthcare professionals. It ingests ECG data from digital flash memory Holter recorders via USB, OptoLink, or Bluetooth. The software displays ECG morphologies, heart rate trends, RR variability, and statistical graphs. It does not perform automated diagnosis; instead, it provides tools for the clinician to review, edit, and annotate ECG data, classify beats into morphology bins, and generate reports. The clinician uses these outputs to evaluate cardiac rhythm and function, supporting clinical decision-making for patients with symptoms like syncope or palpitations. The system facilitates data management, including printing and archiving, and supports various analysis parameters like tachycardia/bradycardia thresholds and ST-segment analysis.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, verification, and validation of software specifications in accordance with FDA guidance and recognized standards (IEC 60601-1-4, IEC 60601-2-47, ANSI/AAMI EC 38).

Technological Characteristics

Software-based Holter ECG analysis system. Operates on IBM PC AT compatible hardware (Pentium III, 256MB RAM). Connectivity via USB, parallel port, and Bluetooth. Supports digital flash memory Holter recorders. Complies with IEC 60601-1-4, IEC 60601-2-47, and ANSI/AAMI EC 38. Software validation follows FDA guidance for premarket submissions.

Indications for Use

Indicated for patients requiring long-term continuous ECG monitoring, including those with palpitations, syncope, chest pain, shortness of breath, or those requiring cardiac functionality assessment, 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® (K051471)

Reference Devices

• RZ153+ Digital Recorder (K022540)
• CardioMem® CM 3000 (SMA)
• CardioMem® CM 3000-12 (K051686)

Submission Summary (Full Text)

{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<br>manufacturer and sponsor<br>of the 510(k) submission: | getemed Medizin- und Informationstechnik AG<br>Oderstr. 77<br>14513 Teltow<br>Germany<br>Tel.: +49 3328 - 3942-0<br>Fax: +49 3328 – 3942-99 |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Official contact person<br>for all correspondence: | Dr. Bert Schadow<br>Regulatory Affairs Manager<br>E-mail: [e-mail] |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AG<br>Oderstr. 77<br>14513 Teltow<br>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,<br>256 Mbytes minimum for XP | 256 Mbytes minimum |
| Free hard disk space | 5 GB minimum<br>20 GB for 12-lead recordings | 5 GB minimum<br>20 GB for 12-lead recordings |
| Display | 17" CRT or 15" TFT, 1024 x 768<br>pixel (XGA), 256 colors | 17" CRT or 15" TFT, 1024 x 768<br>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<br>CardioDay Version 1.9.5 (K051471) | | New / Modified Device<br>CardioDay® Version 2.0 |
| CD-ROM drive | For installation only.<br>Needs to be replaced by a CD-<br>ROM writer or DVD writer if archive<br>option implemented | | For installation only.<br>Needs to be replaced by a CD-<br>ROM writer or DVD writer if archive<br>option implemented |
| Operating system | Windows 98 SE, NT (SP6a),<br>2000 or XP | | Windows 2000 or XP (SP2) |
| Ports | 1 parallel port sufficient; if USB<br>devices used for printing, software<br>key or card reader, then<br>corresponding USB ports required | | 1 parallel port sufficient; if USB<br>devices used for printing, software<br>key, card reader, Bluetooth-Dongle,<br>or connection for Holter recorder<br>CardioMem® then corresponding<br>USB ports required |
| Printer | Printer as any Windows™<br>compatible, 300 dpi | | Printer as any Windows™<br>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<br>card reader | | CompactFlash (Type I) memory<br>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,<br>etc.) | Yes | Yes |
| Medication | Yes | Yes |
| Indication | Yes | Yes |
| Physician's Name | Yes | Yes |
| Date of Recording | Yes | Yes |

| Analysis Options | Legally marketed device<br>CardioDay® Version 1.9.5<br>(K051471) | New / Modified Device<br>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 |

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

| Events Detected | Legally marketed device<br>CardioDay Version 1.9.5<br>(K051471) | New / Modified Device<br>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<br>CardioDay® Version 1.9.5<br>(K051471) | New / Modified Device<br>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<br>CardioDay Version 1.9.5<br>(K051471) | New / Modified Device<br>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<br>CardioDay® Version 1.9.5<br>(K051471) | New / Modified Device<br>CardioDay® Version 2.0 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------|
| The following comparison between the legally<br>marketed device and the NEW DEVICE is based on<br>their functions only. The label and form of the icons<br>/ buttons, however, are different. It might even take<br>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<br>CardioDay® Version 1.9.5<br>(K051471) | New / Modified Device<br>CardioDay® Version 2.0 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------|
| The following comparison between the legally mar-<br>keted device and the NEW DEVICE is based on their<br>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<br>CardioDay Version 1.9.5<br>(K051471) | New / Modified Device<br>CardioDay Version 2.0 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| The following comparison between the legally mar-<br>keted device and the NEW DEVICE is based on their<br>functions only. The label and appearance of those<br>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<br>CardioDay Version 1.9.5<br>(K051471) | New/ Modified Device<br>CardioDay Version 2.0 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------|
| The following comparison between the legally mar-<br>keted device and the NEW DEVICE is based on their<br>functionality only. The commands to generate a<br>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<br>CardioDay® Version 1.9.5<br>(K051471) | New / Modified Device<br>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<br>CardioDay Version 1.9.5<br>(K051471) | New / Modified Device<br>CardioDay Version 2.0 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| The following comparison between the legally mar-<br>keted device and the NEW DEVICE is based on their<br>functions only. The label and appearance of those<br>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<br>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 |

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### Special 510(k) Notification

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

| Miscellaneous | Legally marketed device<br>CardioDay Version 1.9.5<br>(K051471) | New / Modified Device<br>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<br>Bluetooth functionality<br>only with Microsoft<br>Windows XP (SP2) |
| CD Installation Medium | Yes | Yes |

#### Standards Comparison

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

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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

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#### 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

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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