(26 days)
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.
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.
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.
CardioDay® is a software package which is delivered on CD.
The provided document is a 510(k) summary for CardioDay®, a Holter ECG software. The submission aims to establish substantial equivalence to a predicate device, Holter for Windows®. The document focuses on comparing the new device against the predicate in terms of various characteristics and functionality, rather than presenting a performance study with specific acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not explicitly available in the provided text. The document primarily makes a claim of substantial equivalence based on comparison rather than a standalone performance study with defined criteria.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a formal table of device performance metrics against such criteria. Instead, equivalence is established through qualitative comparisons of features and functionalities with the predicate device. The performance is implied to be equivalent to the predicate.
Below is a summary of the comparative analysis, which serves as the basis for claiming "performance":
| Feature Category | Predicate Device (Holter for Windows®) Performance/Characteristic | New Device (CardioDay®) Performance/Characteristic | Equivalence Claim |
|---|---|---|---|
| Intended Use | Holter monitoring software for high-speed data analysis of continuous, long-term ECG, producing printed reports for physician review. Federal law restricts use to physician order. | Software allows trained physician/healthcare professional to download, analyze, review, and produce printed reports from long-term continuous ECG recordings. Available only upon physician order and not for ambulatory/home use. | Substantially Equivalent. The wording is slightly different but the core function and user restrictions are the same. |
| Indications for Use | For patients who benefit from long-term continuous ECG recording, including those with palpitations, syncope, chest pain, shortness of breath, or needing cardiac functionality monitoring (e.g., post-pacemaker). | Same as predicate. | Substantially Equivalent. |
| Device Description | Displays ECG morphologies and associated calculated graphs; physician reviews, edits, and prints data. | Displays ECG morphologies and associated calculated graphs (heart rate trends, RR variability, statistical values); physician reviews, edits, and prints data. Does not perform diagnosis itself. | Substantially Equivalent. Both devices are analysis tools, not diagnostic. |
| Hardware Specs | Pentium II, 32MB RAM, 200MB HDD, VGA 14" display, 1.4MB floppy, Windows 98, parallel port. | Pentium III 500MHz+, 128MB RAM (256MB for XP), 5GB HDD (20GB for 12-lead), 17" CRT/15" TFT XGA display, no floppy required, Windows 98 SE/NT/2000/XP, parallel/USB ports. | Not identical, but determined to have "No influence on safety and effectiveness" as CardioDay®'s requirements "correspond to the current state of the art." |
| Software Features | Broad range including patient data, analysis options (tachycardia, bradycardia thresholds, ST-analysis, pacemaker events), various event detections (VES, VTACH, Pause, etc.), and standard functionalities (start, read, analyze, print). | Broad range including patient data, analysis options, event detections, and standard functionalities. Includes additional editing and printing options not available in the predicate (e.g., "Edit all Beat Labels in a Morphology Bin", more specific printout options). | Substantially Equivalent. Specific differences in editing/printing options are noted but considered to have "No influence on safety and effectiveness." The core analysis modes are the same. |
| Supported Recorders | RZ153+ Digital Recorder, CardioMem® CM 3000 (SMA). | RZ153+ Digital Recorder, CardioMem® CM 3000 (SMA), CardioMem® CM 3000-12. Does not support RZ151 Analog Recorder. | Not identical, but determined to have "No influence on safety and effectiveness." The additional recorder support is seen as an enhancement, and the lack of analog tape recorder support is due to outdated technology. |
| Regulatory Standards | Complies with 21 CFR 820, ISO 9001, IEC 60601-1-4, ANSI/AAMI EC38, IEC 60601-2-47, ISO 14971, EN 980, EN 1041, ISO 15223. | Complies with 21 CFR 820, ISO 9001 / EN 46001 / ISO 13485:2003, IEC 60601-1-4 + A1, ANSI/AAMI EC38, IEC 60601-2-47, ISO 14971 +A1, EN 980, EN 1041, ISO 15223 + AMD1 + AMD2. | Substantially Equivalent. Both devices comply with relevant standards for medical device quality management and safety. |
2. Sample size used for the test set and the data provenance
The document mentions that "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." This indicates that public domain databases (AHA and MIT-BIH Arrhythmia Database are commonly used for Holter analysis algorithm validation) were used for performance evaluations. However, the specific sample size used from these databases for the test set, or details on data provenance (e.g., country of origin, retrospective/prospective) are not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for any test set derived from the AHA or MIT databases. These databases typically come with expert-verified annotations, but this fact is not explicitly stated in relation to this device's validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method used for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention any MRMC study or any study evaluating the improvement of human readers with or without AI assistance. The device is described as a software for trained professionals to review, edit, and print data, explicitly stating that it "does not perform any diagnosis of data by itself." This implies it's an analysis and presentation tool, not an AI-powered diagnostic aid designed to directly assist human readers in improving their diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document notes that performance evaluations used "data bases from American Heart Association (AHA) and Massachusetts Institute of Technology (MIT)." This implies that the algorithms within CardioDay® were tested against these reference databases, which constitutes a form of standalone performance evaluation. However, specific metrics, methodology, and results are not provided in this summary. The output of the device (ECG morphologies, graphs, statistical values) is then reviewed and edited by human users.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the mention of AHA and MIT databases, the ground truth for the algorithm evaluation would typically be expert annotations/consensus provided with these publicly available arrhythmia databases.
8. The sample size for the training set
The document does not provide any information about the sample size used for a training set. As a rule-based or conventional signal processing software (not explicitly stated as AI/machine learning), it might not have a "training set" in the modern sense. If it did employ machine learning, this detail is omitted.
9. How the ground truth for the training set was established
Not applicable, as no training set information is provided. If the algorithms were trained, the ground truth would likely be derived from expert annotations, similar to the test set ground truth.
{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 AGOderstr. 5914513 TeltowGermanyTel.: +49 3328 - 3942-70Fax: +49 3328 - 3942-99 |
|---|---|
| Contact: | Dr. Bert SchadowRegulatory Affairs Manager |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AGOderstr. 5914513 TeltowGermany |
| 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, NortheastMonitoring 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 Holtermonitoring software, designed toperform high-speed data analysisof continuous, long-termelectrocardiograms saved in theform of direct recordings on acassette tape or flash memorycard. Holter for Windows® isintended for use as an analysistool and produces printed reportsto be reviewed by a personknowledgeable in Holterinterpretation.Federal law restricts Holter forWindows® to use on order of aphysician. | CardioDay® is a software packagethat allows a trained physician orhealth care professionalknowledgeable in Holterinterpretation, after havingperformed a long-term continuouselectrocardiographic (ECG)recording on digital flash memoryHolter recorder, to download andanalyze the data from the recorder,review it and produce printedreports.This device is available only uponthe order of a physician or otherlicensed medical professional andnot intended for any ambulatory orhome applications.Federal law restricts CardioDay® touse on order of a physician. |
Comparison to Legally Marketed Device
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY
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| 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 softwarewhich is indicated for patients whomay benefit from a long-termcontinuous electrocardiographic(ECG) recording, including, but notlimited to, those with complaints ofpalpitations, syncope, chest pain,shortness of breath, or those thatneed to be monitored to judge theircurrent cardiac functionality such aspatients who have recently receivedpacemakers.WARNING:CardioDay® does not perform anydiagnosis of data by itself but onlydisplays ECG morphologies andassociated, calculated graphs suchas heart rate trends, RR variability,and other statistical values. | |
| Device description | Same as CardioDay® | CardioDay® does not perform anydiagnosis of data by itself but onlydisplays ECG morphologies andassociated, calculated graphs suchas heart rate trends, RR variability,and other statistical values ingraphical form. The physician will beable to review, edit, and print thedata collected. | |
| Target population | Same as CardioDay® | Patients who may benefit from along-term continuouselectrocardiographic (ECG)recording, including, but not limitedto, those with complaints ofpalpitations, syncope, chest pain,shortness of breath, or those thatneed to be monitored to judge theircurrent cardiac functionality such aspatients who have recently receivedpacemakers. | |
| Design / materials | Same as CardioDay® | CardioDay® is a software packagewhich 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. |
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| 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 (seecomparison of technologycharacteristics),- the users (see targetpopulation),- environment in which thetechnology will be used (seeintended use),- how dangerous is the use of thedevice (see level of concern insection 2),- how critical is the device forpatient care (see productclassification and level ofconcern in section 2). |
| Energy used and/ordelivered | This section does not apply. | This section does not apply. |
| Compatibility withenvironment andother devices | See comparison of technologycharacteristics and miscellaneous | See comparison of technologycharacteristics and miscellaneous |
| Where used:hospital, home,ambulance, etc. | Holter for Windows® is availablefor sale only upon the order of aphysician or other related licensedmedical professional. | CardioDay® is available for sale onlyupon the order of a physician orother related licensed medicalprofessional and not intended forany 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 diskspace | 200 MB minimum | 5 GB minimum20 GB for 12-lead recordings |
| Display | VGA, 14", 1024 x 768 pixel, 256colors | 17" CRT or 15" TFT, 1024 x 768pixel (XGA), 256 colors |
| Disc drive / floppydrive | 1.4 Mbytes | Not required |
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc
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{4}------------------------------------------------
| 510(k) NotificationCardioDay® | 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-ROMwriter or DVD writer if archive optionimplemented |
| Operating system | Windows 98 | Windows 98 SE, NT (SP6a), 2000or XP |
| Ports | One free parallel port | 1 parallel port sufficient; if USBdevices used for printing, softwarekey or card reader, thencorresponding 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) memorycard reader |
Comparison of Software Characteristics:
| Patient Screen | FORM DESIGNATIONSection 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 |
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| 510(k) Notification | getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0429S1 | ||
| 510(k) - Summary | Section 1-0001-Rev D | ||
| Analysis Options | Holter for Windows | New DeviceCardioDay | |
| 12-Lead ECG Module | Yes | Yes | |
| Holter Data Transfer | Yes | Yes | |
| Events Detected | Holter for Windows | New DeviceCardioDay | |
| 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 |
| Yes | Yes | |
| Close Recording | Yes | Yes |
| Close | Yes | Yes |
0429S1-Sec01-0001-RevD-CardioDay-Execulive_Summary.doc
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{6}------------------------------------------------
| 510(k) Notification | o getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0429S1 | ||
| 510(k) - Summary | Section 1-0001-Rev D | ||
| Functionality Available | Legally Marketed DeviceHolter for Windows | Predicate DeviceCardioDay | |
| 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 legallymarketed device and the NEW DEVICE is based ontheir functions only. The label and form of the icons/ buttons, however, are different. It might even takemore 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 | |
| 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 theirfunctions only. The name of those options may vary. | |||
| Classes | Yes | Yes | |
| Events | Yes | Yes | |
| Heart Rate Min/Max | Yes | Yes |
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| 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 theirfunctions only. The label and appearance of thosedisplays 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 DeviceHoferator Window | New DeviceCardioDay |
| The following comparison between the legally mar-keted device and the NEW DEVICE is based on their | ||
| functionality only. The commands to generate agiven 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 |
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| 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 RecordDevice History Record | CardioDay |
|---|---|---|
| 21 CFR 820 (FDA cGMP Good ManufacturingPractice) | Yes | Yes |
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{9}------------------------------------------------
| 510(k) Notification | o getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0429S1 | ||
| 510(k) - Summary | Section 1-0001-Rev D | ||
| Standard | Comply Marked DeviceHolter for Windows | Non-Device (C-Code Only) | |
| ISO 9001:2000 / EN 46001 / ISO 13485:2003Quality Management Systems | Yes | Yes | |
| IEC 60601-1-4 + A1 Programmable ElectricalMedical Systems | Yes | Yes | |
| ANSI/AAMI EC38 Ambulatory Electrocardiographs | Yes | Yes | |
| IEC 60601-2-47 Particular Requirements for theSafety, including Essential Performance, ofAmbulatory Electrocardiographic Systems | Yes | Yes | |
| ISO 14971 +A1 Application of the RiskManagement to Medical Devices | Yes | Yes | |
| EN 980 Graphic Symbols for the Marking ofMedical Devices | Yes | Yes | |
| EN 1041 Supply of Information by the Manufacturerof a Medical Device | Yes | Yes | |
| ISO 15223 + AMD1 + AMD2 Symbols to be Usedwith 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 DeviceHot for Windows | New DeviceOrtotoBay |
|---|---|---|
| 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 minimum20 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-ROMwriter or DVD writer if archive optionimplemented |
| 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
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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 devicesused for printing, software key or cardreader, then corresponding USB portsrequired |
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:
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.
CardioDay conforms to Good Manufacturing Procedures outlined by the FDA GMP. This software is safe and effective for the application for which it is intended and has been tested to confirm the safety and efficacy of the software. CardioDay® is found to be substantially equivalent to the Holter for Windows® software.
0429S1-Sec01-0001-RevD-CardioDay-Executive_Summary.doc CONFIDENTIAL AND PROPRIETARY
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Image /page/11/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A."
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
getemed Medizin-und Informationstechnik AG c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road Newtown, CT 06470
Re: K051471 Trade Name: CardioDay® Regulation Number: 21 CFR 870.1425 Regulation Name: Diagnostic Programmable Computer Regulatory Class: Class II (two) Product Code: DOK Dated: June 16, 2005 Received: June 17, 2005
Dear Mr. Borsai:
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.
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Page 2 - Mr. Tamas Borsai
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); 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 (240) 276-0295_ 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Blummer for
R. D. Zuber, M.D.
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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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.
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.
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)
Blommima
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
Page 1 of __ 1
§ 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).