Who is the manufacturer of CARDIODAY?

Getemed Medizin- Und Informationstechnik AG filed the 510(k) submission for CARDIODAY (K051471).

What is the FDA product code for CARDIODAY?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CARDIODAY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CARDIODAY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CARDIODAY

Q: What are the predicate devices for CARDIODAY?

Holter for Windows® (K930564).

K051471 · Getemed Medizin- Und Informationstechnik AG · DQK · Jun 29, 2005 · Cardiovascular

Device Facts

Record ID	K051471
Device Name	CARDIODAY
Applicant	Getemed Medizin- Und Informationstechnik AG
Product Code	DQK · Cardiovascular
Decision Date	Jun 29, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

Intended Use

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. 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. Federal law restricts CardioDay® to use on order of a physician.

Device Story

CardioDay is a software package for clinical use by trained physicians/healthcare professionals to analyze long-term continuous ECG data recorded on digital flash memory Holter recorders. The device imports data from the recorder, performs high-speed analysis, and displays ECG morphologies, heart rate trends, RR variability, and statistical values. It does not perform automated diagnosis; the physician reviews, edits, and prints reports to support clinical decision-making. The device is used in clinical settings (not home/ambulatory) to assist in evaluating cardiac functionality and arrhythmias. Benefits include providing organized, reviewable data for diagnostic assessment of cardiac symptoms.

Clinical Evidence

No clinical data. Performance evaluation conducted using standard American Heart Association (AHA) and Massachusetts Institute of Technology (MIT) databases to validate analysis modes and parameters.

Technological Characteristics

Software package delivered on CD; runs on IBM PC AT compatible hardware (Pentium III 500MHz+, 128MB RAM, Windows 98 SE/NT/2000/XP). Complies with IEC 60601-1-4, IEC 60601-2-47, and ANSI/AAMI EC38. Performs high-speed ECG analysis and graphical display of statistical values.

Indications for Use

Indicated for patients requiring long-term continuous ECG monitoring, including those with palpitations, syncope, chest pain, shortness of breath, or those needing cardiac functionality assessment (e.g., post-pacemaker implantation).

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

Holter for Windows® (K930564)

Related Devices

K162023 — CardioDay V2.5 · Getemed Medizin- Und Informationstechnik AG · Mar 24, 2017
K070280 — CARDIODAY, VERSION 2.0 · Getemed Medizin- Und Informationstechnik AG · Feb 23, 2007
K130516 — CARDIODAY · Getemed Medizin- Und Informationstechnik AG · Aug 23, 2013
K031466 — IQMARK DIGITAL HOLTER · Brentwood Medical Technology Corp. · Jun 11, 2003
K053369 — MEDILOG DARWIN HOLTER ANALYSIS · Huntleigh Healthcare · Dec 22, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ JUN 29 2005 | 510(k) Notification | getemed | |---------------------|----------------------| | CardioDay® | Project ID: 0429S1 | | 510(k) - Summary | Section 1-0001-Rev D | #### 1 510(k) - Summary | Submitted By: | getemed Medizin- und Informationstechnik AG Oderstr. 59 14513 Teltow Germany Tel.: +49 3328 - 3942-70 Fax: +49 3328 - 3942-99 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Dr. Bert Schadow Regulatory Affairs Manager | | Manufacturing Facility: | getemed Medizin- und Informationstechnik AG Oderstr. 59 14513 Teltow Germany | | Date of Preparation: | 2005-06-13 | | Trade Name: | CardioDay® | | Common Name: | Holter ECG | | Classification Name: | Computer, Diagnostic, Programmable | | Product Classification: | 21 CFR 870.1425, Class II | | Product Code: | DQK | | Legally Marketed Devices: | Holter for Windows® (K930564, Northeast Monitoring Inc.) | #### Reason for Submission Premarket notification for CardioDay® (Version 1.9.5), a New Device, seeking authority to market the device under Section 510(k) as a device that is substantially equivalent to the Holter for Windows® evaluation software (K930564, Northeast Monitoring Inc.). #### Intended Use 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. 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. Federal law restricts CardioDay® to use on order of a physician. 0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY {1}------------------------------------------------ | 510(k) Notification | getemed | |---------------------|----------------------| | CardioDay® | Project ID: 0429S1 | | 510(k) - Summary | Section 1-0001-Rev D | #### Indications for Use CardioDay is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, 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. #### WARNING: 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. #### Device Description 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. | Description | | | |--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Holter for Windows® is Holter monitoring software, designed to perform high-speed data analysis of continuous, long-term electrocardiograms saved in the form of direct recordings on a cassette tape or flash memory card. Holter for Windows® is intended for use as an analysis tool and produces printed reports to be reviewed by a person knowledgeable in Holter interpretation. Federal law restricts Holter for Windows® to use on order of a physician. | 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. 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. Federal law restricts CardioDay® to use on order of a physician. | ## Comparison to Legally Marketed Device 0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY Page 2 of 11 {2}------------------------------------------------ | 510(k) Notification | | getemed | | |---------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | CardioDay® | | Project ID: 0429S1 | | | 510(k) - Summary | | Section 1-0001-Rev D | | | Description | Facility's CardioDay® Predicate Index | | | | Indications for use | Same as CardioDay® | 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. WARNING: 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. | | | Device description | Same as CardioDay® | 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. | | | Target population | Same as CardioDay® | 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. | | | Design / materials | Same as CardioDay® | CardioDay® is a software package which is delivered on CD. | | | Sterility | This section does not apply. | This section does not apply. | | | Biocompatibility | This section does not apply. | This section does not apply. | | | Mechanical safety | This section does not apply. | This section does not apply. | | | Chemical safety | This section does not apply. | This section does not apply. | | | Anatomical sites | This section does not apply. | This section does not apply. | | 0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY · Page 3 of 11 ાં ડા {3}------------------------------------------------ | 510(k) Notification | | getemed | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CardioDay® | | Project ID: 0429S1 | | 510(k) - Summary | | Section 1-0001-Rev D | | Description | Holter for Windows® | | | Human factors | Same as CardioDay® | Human factors engineering: - device technology (see comparison of technology characteristics), - the users (see target population), - environment in which the technology will be used (see intended use), - how dangerous is the use of the device (see level of concern in section 2), - how critical is the device for patient care (see product classification and level of concern in section 2). | | Energy used and/or delivered | This section does not apply. | This section does not apply. | | Compatibility with environment and other devices | See comparison of technology characteristics and miscellaneous | See comparison of technology characteristics and miscellaneous | | Where used: hospital, home, ambulance, etc. | Holter for Windows® is available for sale only upon the order of a physician or other related licensed medical professional. | CardioDay® is available for sale only upon the order of a physician or other related licensed medical professional and not intended for any home use applications. | | Electrical safety | This section does not apply. | This section does not apply. | | Thermal safety | This section does not apply. | This section does not apply. | | Radiation safety | This section does not apply. | This section does not apply. | Comparison of Technology Characteristics Compared to Legally Marketed Device: | Specifications | | | |------------------------------|-------------------------------------------|-----------------------------------------------------------| | Type | IBM PC AT compatible | IBM PC AT compatible | | CPU | Pentium II Processor | Pentium III, 500MHz or greater | | RAM | 32 Mbytes minimum | 128 Mbytes minimum, 256 Mbytes minimum for XP | | Free hard disk space | 200 MB minimum | 5 GB minimum 20 GB for 12-lead recordings | | Display | VGA, 14", 1024 x 768 pixel, 256 colors | 17" CRT or 15" TFT, 1024 x 768 pixel (XGA), 256 colors | | Disc drive / floppy drive | 1.4 Mbytes | Not required | 0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY . {4}------------------------------------------------ | 510(k) Notification CardioDay® | | o getemed | |-----------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Project ID: 0429S1 | | | | | 510(k) - Summary | Section 1-0001-Rev D | | Specifications | Hotter for Win | | | CD-ROM drive | For installation only | For installation only. Needs to be replaced by a CD-ROM writer or DVD writer if archive option implemented | | Operating system | Windows 98 | Windows 98 SE, NT (SP6a), 2000 or XP | | Ports | One free parallel port | 1 parallel port sufficient; if USB devices used for printing, software key or card reader, then corresponding USB ports required | | Printer | Printer as any Windows ™ compatible | Printer as any Windows ™ compatible, 300 dpi | | Keyboard | Standard device | Standard device | | Mouse | Standard, 2-button device | Standard, 2 or 3-button device | | Installation media | (1) CD | (1) CD | | Further periphery | Compact Flash card reader | CompactFlash (Type I) memory card reader | # Comparison of Software Characteristics: | Patient Screen | FORM DESIGNATION Section Windows | | |-------------------------------------------------------------|-------------------------------------|-----| | 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 | | | |------------------------------|-----|-----| | 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 | | Superimposition / QuickScan | Yes | Yes | 0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY · Page 5 of 11 长0.51471/51 75/11 {5}------------------------------------------------ | 510(k) Notification | | getemed | | |---------------------------------------------|--------------------|-------------------------|--| | CardioDay® | | Project ID: 0429S1 | | | 510(k) - Summary | | Section 1-0001-Rev D | | | Analysis Options | Holter for Windows | New Device CardioDay | | | 12-Lead ECG Module | Yes | Yes | | | Holter Data Transfer | Yes | Yes | | | Events Detected | Holter for Windows | New Device CardioDay | | | Burst | Yes | Yes | | | VES / VPB (Extrasystole) | Yes | Yes | | | SVES / SVPB (Supraventricular Extrasystole) | Yes | Yes | | | Couplet / VPB Pair | Yes | Yes | | | Triplet | Yes | Yes | | | VTACH / VTAC (Ventricular Tachycardia) | Yes | Yes | | | Bigeminy | Yes | Yes | | | R on T | Yes | Yes | | | ST-Analysis | Yes | Yes | | | SVTACH / SVT (Supraventricular Tachycardia) | Yes | Yes | | | Arrhythmia / Irregular R-R | Yes | Yes | | | Bradycardia | Yes | Yes | | | VTACH (with 4 Beats) / Burst | 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 / Arrest | Yes | Yes | | | Event Marker | Yes | Yes | | | HR Stripes | Yes | Yes | | | Artifact | Yes | Yes | | | Normal | Yes | Yes | | | Functionality Available | | | |------------------------------------------------------------------------------------------------------------------------------------------|-----|-----| | The comparison between the legally marketed de- vice and the NEW DEVICE is based on their func- tions 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 | 0429S1-Sec01-0001-RevD-CardioDay-Execulive_Summary.doc CONFIDENTIAL AND PROPRIETARY Page 6 of 11 {6}------------------------------------------------ | 510(k) Notification | | o getemed | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------|--| | CardioDay® | | Project ID: 0429S1 | | | 510(k) - Summary | Section 1-0001-Rev D | | | | Functionality Available | Legally Marketed Device Holter for Windows | Predicate Device CardioDay | | | Delete Recording | Yes | Yes | | | Archive | Yes | Yes | | | Diagnosis | Yes | Yes | | | View ECG | Yes | Yes | | | Print Preview | Yes | Yes | | | Screen Scale Calibration | Yes | Yes | | | Screen: Colour 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 (Hotar or Window) | NEW DEVICE (Display) | | | 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 | | | Options Available | Legally Marketed Device (Note on Wind) | New Device (Note on Wind) | | | 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 | | 0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY Page 7 of 11 051471/51 {7}------------------------------------------------ | 510(k) Notification | getemed | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------------------| | CardioDay® | Project ID: 0429S1 | | | 510(k) - Summary | Section 1-0001-Rev D | | | Options Available | Legally Marketed Device Holter for Windows | New Device CardioDay | | 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: Holter for Windows | New Device: CardioDay | | 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. | | | | 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 | | Printout Options | Legally Marketed Device Hoferator Window | New Device CardioDay | | 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 | No | Yes | | Full Disclosure 2 Channels, 30 min./Page | Yes | Yes | | Marked Events: 8 Events/Page | Yes | Yes | | 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 | No | 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 | No | Yes | | Selected Channels 10 min. + 25 mm/s | No | Yes | | Event Table | Yes | Yes | 0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY Page 8 of 11 051471/51 가이디 {8}------------------------------------------------ | 510(k) Notification | getemed | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------| | CardioDay® | Project ID: 0429S1 | | | 510(k) - Summary | Section 1-0001-Rev D | | | Printout Options | Legally Marketed Device Holter for Window | New Device CardioDay | | Event Histogram | Yes | Yes | | Heart Rate and ST Diagrams | Yes | Yes | | HR diagram + Min/Max per Minute | No | Yes | | RR Intervals | Yes | Yes | | RR Delay | No | Yes | | RR Histograms | No | Yes | | RR Interval Spectra | No | 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 to Windows | New Device CardioDay | | 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 | No | Yes | | Scroll through ECG and Edit Single Beat Labels | No | 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 | No | Yes | | Jump from ECG Overview to the corresponding ECG | Yes | Yes | | Select Tme Interval for Time Domain RR Parameters | Yes | Yes | | Edit Report | Yes | Yes | | Miscellaneous | Legally Marketed Device Holter for Windows | New Device Cardiology | | RZ153+ Digital Recorder Supported (K022540) | Yes | Yes | | CardioMem® CM 3000 (SMA) Supported | Yes | Yes | | CardioMem® CM 3000-12 Supported | No | Yes | | CD Installation Medium | Yes | Yes | | RZ151 Analog Recorder Supported | No | No | | CD Installation Medium | Yes | Yes | # Standards Comparison | Standard | Device Master Record Device History Record | CardioDay | |------------------------------------------------------|-----------------------------------------------|-----------| | 21 CFR 820 (FDA cGMP Good Manufacturing Practice) | Yes | Yes | 042951-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY 1/5/ 4/ {9}------------------------------------------------ | 510(k) Notification | o getemed | | | |------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------------------------|--| | CardioDay® | | Project ID: 0429S1 | | | 510(k) - Summary | Section 1-0001-Rev D | | | | Standard | Comply Marked Device Holter for Windows | Non-Device (C-Code Only) | | | ISO 9001:2000 / EN 46001 / 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 | | # Differences between the Legally Marketed Device (Holter for Windows®) and the New Device (CardioDay®): # Where Used: Hospital, Home, Ambulance, etc.: CardioDay® clearly excludes home use applications. This has no influence on safety and effectiveness. ## Performance CardioDay and Holter for Windows® have the following different technology specifications: | Specifications | Legally Marketed Device Hot for Windows | New Device OrtotoBay | |---------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | CPU | Pentium II Processor | Pentium III, 500MHz or greater | | RAM | 32 Mbytes minimum | 128 Mbytes minimum, 256 Mbytes minimum for XP | | Free hard disk space | 200 MB minimum | 5 GB minimum 20 GB for 12-lead recordings | | Display | VGA, 14", 1024 x 768 pixel, 256 colors | 17" CRT or 15" TFT, 1024 x 768 pixel (XGA), 256 colors | | Disc drive / floppy drive | 1.4 Mbytes | Not required | | CD-ROM drive | For installation only | For installation only. Needs to be replaced by a CD-ROM writer or DVD writer if archive option implemented | | Operating system | Windows 98 | Windows 98 SE, NT (SP6a), 2000 or XP | 0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY Page 10 of 11 {10}------------------------------------------------ K051471/SI \$\frac{11}{11}\$ | | 510(k) Notification | getemed | |-------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | | CardioDay® | Project ID: 0429S1 | | | 510(k) - Summary | Section 1-0001-Rev D | | Ports | One free parallel port | 1 parallel port sufficient; if USB devices used for printing, software key or card reader, then corresponding USB ports required | The minimum hardware requirements, such as CPU, RAM, free Hard disk space, display, CD-ROM drive and ports and supported operating system of CardioDay® correspond to the current state of the art. No influence on safety and effectiveness is expected. # Software characteristics The new device CardioDay offers a number of editing and printing options not available in the legally marketed device. No influence on safety and effectiveness is expected. # Miscellaneous Holter for Windows® does not support the Holter recorder CardioMem® CM 3000-12. No influence on safety and effectiveness is expected. CardioDay® does not support the RZ 151 analog tape recorder. This technology is no longer state of the art and therefore it is not supported. No influence on safety and effectiveness is expected. # Conclusion CardioDay and Holter for Windows® software packages are both used in clinical applications to allow trained physicians or other health care providers to download, review and print electrocardiographic (ECG) data recorded on digital Holter recorders. Both are computerized programs which run under a computer operating system. Both perform a high-speed analysis of the recorded ECG data and use the computer operating system to access the displayed data. CardioDay® has the same analysis modes as Holter for Windows®. The impact of all parameters, especially those specified above, is evaluated with the help of the data bases from American Heart Association (AHA) and Massachusetts Institute of Technology (MIT) and performance evaluations. # WARNING:…