new 2 9 2005 510(k) notification c getemed · 2005. 7. 11. · classification name: computer,...

JUN 2 9 2005

510(k) Notification C getemedCardinDayf Project ID: 0429S1

510(k) - Summary Section 1-0001-Rev D

I 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: getemned Medizin- und Informationstechnik AGOderstr. 5914513 TeltowGermany

Date of Preparation: 2005-06-13

Trade Name: CardioDayf

Common Name: Holter ECG

Classification Name: Computer, Diagnostic, Programmable

Product Classification: 21 CFR 870.1425, Class I1

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 marketthe device under Section 510(k) as a device that is substantially equivalent to the Holter forWindows evaluation software (K930564, Northeast Monitoring Inc.).

Intended UseCardioDayf is a software package that allows a trained physician or health care professionalknowledgeable in Holter interpretation, after having performed a long-term continuouselectrocardiographic (ECG) recording on digital flash memory Holter recorder, to download andanalyze 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 professionaland not intended for any ambulatory or home applications.

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

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510(k) Notification 0 getemedCardioDayO Project ID: 0429S1


Indications for Use

CardioDayf is a Hoater software which is indicated for patients who may benefit from a long-termcontinuous electrocardiographic (ECG) recording, including, but not limited to, those withcomplaints of palpitations, syncape, chest pain, shortness of breath, or those that need to bemonitored to judge their current cardiac functionality such as patients who have recentlyreceived pacemakers.WARNING:CardioDayf does not perform any diagnosis of data by itself but only displays ECGmorphologies and associated, calculated graphs such as heart rate trends, RR variability, andother statistical values.

Device Description

CardioDay® does not perform any diagnosis of data by itself but only displays ECGmorphologies and associated, calculated graphs such as heart rate trends, RR variability, andother statistical values in graphical form. The physician will be able to review, edit, and print thedata collected.

Comparison to Legally Marketed Device

Description

Intended use Holter for Windows' is Holter Cardiooay is a software packagemonitoring software, designed to that allows a trained physician orperform high-speed data analysis health care professionalof continuous, long-term knowledgeable in Hotterelectrocardiograms saved in the interpretation, after havingform of direct recordings on a performed a long-term continuouscassette tape or flash memory electrocardiographic (ECG)card. Holter for Windows' is recording on digital flash memoryintended for use as an analysis Holter recorder, to download andtool and produces printed reports analyze the data from the recorder,to be reviewed by a person review it and produce printedknowledgeable in Hotter reports.interpretation.

This device is available only uponFederal law restricts Holter for the order of a physician or otherWindowse to use on order of a licensed medical professional andphysician. not intended for any ambulatory or

home applications.

Federal law restricts CardioDay® touse on order of a physician.

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510(k) Notification 0 getemedCardioDayf Project ID: 0429S1


Description

Indications for use Same as CardioDaf CardicDay t is a Hotter 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 CardioDayf CardioDayo 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 Cardiouay/ 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 CardioDayt CardioDayf 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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Description

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 ofconcem in section 2).

Energy used and/or This section does not apply. This section does not apply.deliveredCompatibility with See comparison of technology See comparison of technologyenvironment and characteristics and miscellaneous characteristics and miscellaneousother devicesWhere used: Holter for Windows w is available CardioDay? is available for sale onlyhospital, home, for sale only upon the order of a upon the order of a physician orambulance, etc. physician or other related licensed other related licensed medical

medical professional. professional 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 compatibleCPU Pentium II Processor Pentium III, 500MHz or greaterRAM 32 Mbytes minimum 128 Mbytes minimum,

256 Mbytes minimum for XPFree hard disk 200 MB minimum 5 GB minimumspace 20 GB for 12-lead recordingsDisplay VGA, 14", 1024 x 768 pixel, 256 17" CRT or 15"TFT, 1024 x 768

colors pixel (XGA), 256 colorsDisc drive I floppy 1.4 Mbytes Not requireddrive

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510(k) -Summary Section 1-0001-Rev D

Specifications

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 I parallel prt sufficient; if USBdevices used for printing, softwarekey or card reader, thencorresponding USB ports required

Printer Printer as any Windows"4 Printer as any Windowsmcompatible compatible, 300 dpi

Keyboard Standard device Standard deviceMouse Standard, 2-button device Standard, 2 or 3-button deviceInstallation media (1) CD (1) CDFurther periphery Compact Flash card reader CompactFlash (Type I) memory

card reader

Comparison of Software Characteristics:

Patient ScreenPatient Identification Number Yes YesPatient Name, Address, Telephone Yes YesPatient Personal Data (Age, Gender, Date of Birth, Yes Yesetc.)Medication Yes YesIndication Yes YesPhysician's Name Yes YesDate of Recording Yes Yes

Analysis Options

Analysis Duration Yes YesPrimary Channel Selection Yes YesSensitivity I Signal Quality Yes YesTachycardia Threshold [bpm] Yes YesBradycardia Threshold [bpm] Yes YesPause Duration [ms] Yes YesSV Prematurity [%I Yes YesV Prematurity [%] Yes YesR on T [ms] Yes YesPacemaker Type Yes YesMinimum Pulse Rate [bpm] Yes YesMaximum Pulse Rate [bpm] Yes YesSuperimposition / QuickScan Yes Yes

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510(k) Notification O getemedCardioDay" Project ID: 0429S1


Analysis Options

12-Lead ECG Module Yes YesHolter Data Transfer Yes Yes

Events Detected

Burst Yes YesVES / VPB (Extrasystole) Yes YesSVES / SVPB (Supraventricular Extrasystole) Yes YesCoupleth/ VPB Pair Yes YesTdiplet Yes YesVTACH I VTAC (Ventricular Tachycardia) Yes YesBigeminy Yes YesR onST Yes Yes

ST-Analysis Yes YesSVTACH / SI'T (Supraventricular Tachycardia) Yes YesArrhythmia / I trregular RR Yes YesPBradycardia r Yes YesVTACH (with 4 Beats) / Burst Yes YesV. STIM / V. Paced Yes YesA. STIM / A. Paced Yes Yes

oAV STr M / AV Paced Yes YesUndersense / Sense Failure Yes YesvExithlock / Capture Failure bae o Yes YesOversense / Inhibition their Ynaes.Pause / ArrrYes YesEvent Marker Yes YesHR Stripes R Yes YesA ort Yes Yes

ANalyze New Ye Yes

OpeN Yes Yes

dFunctionality AvailableThe comparison between the legally marketed de-1vice and the NEW DEVICE Is based on their func-tions nl and not on their names.Start Yes YesRead Tape YesYeRead Digital Recorder YesYeImport Yes YesAnalyze New YesYeOpen Yes YesEdit Patient Data Yes YesPrint Preview Yes YesPrint Yes YesClose Recording Yes YesClose Yes Yes

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510(k) Notification a getemedCardioDaya Project ID: 0429S1


Functionality Available

Delete Recording Yes YesArchive Yes YesDiagnosis Yes YesView ECG Yes YesPrint Preview Yes YesScreen Scale Calibration Yes YesScreen: Colour Setup Yes YesFFT Setup Yes YesReport Setup Yes YesClasses Display Yes YesPM Events Display Yes YesEvents Display Yes YesHR Min/Max. Display Yes YesStatistics Display Yes YesDiagnosis Display Yes YesOverview Display Yes YesContext sensitive Help Yes YesKeyboard Shortcuts Help Yes YesMenu Entries Help Yes YesHelp: About .Ye Yes"Help: Version Yes Yes

icons/Buttons Available

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 iven action.Start: Read Digital Recorder Yes YesStart: Read Tape Recorder Yes YesStart: Open Existing Record Yes YesDigital Recorder Yes YesTape Recorder Yes YesOpen: List of Patients Yes YesPrint Yes YesRhythm Analysis Yes YesPrint Preview on Screen Yes Yes

Options Available

The following comparison between the lglymrketed device and the NEW DEVICE is ba s d o h ifunctions only. The name of those optiosmyvr...Classes Yes YesEvents YesYeHeart Rate Min/Max YesYe

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510(k) Notification O getem edCardioDay? Project ID: 0429S1


Options Available

Average Heart Rate Yes YesStatistics: FFT Analysis Yes YesStatistics: ST Diagrams Yes YesReport Yes YesOverview Yes YesHeart Variability: RR Delay _. Yes YesHeart Rate Variability: RR FFT YesHeart Rate Variability: 24h RR FFT Yes YesHeart Rate Variability: RR Histograms Yes Yes

Graphics & Displays Available

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 YesZoomed Version of Selected Beat Yes YesContext of Selected Beat Yes YesEvents Yes YesHeart Rate Trend in Recording Period Yes YesAverage RR Interval Yes YesY-T Distribution Yes YesRR > 50ms Distribution Yes YesFFT Analysis Yes YesST Diagrams Yes YesOverview 2 channels at Different Scaling Factors Yes Yes

Printout Options

The following comparison between the legally mar-keted device and the NEW DEVICE is based on theirfunctionality only. The commands to generate agiven printout as well as its appcearance do varyFull Disclosure 2 Channels, I h/Page Yes YesFull Disclosure 2 Channels, 15 min./Page No YesFull Disclosure 2 Channels, 30 min.Page Yes YesMarked Events: 8 Events/Page Yes YesMarked Events: 32 Events/Page Yes YesMarked Events: Analysis Channel 25 mm/s Yes WsMarked Events: Analysis Channel 2.5 min + No Yes25mm/sSelected Channels 25 mm/s Yes YesSelected Channels 1 min. + 25 mm/s Yes YesSelected Channels 2.5 min. + 25 mm/s No YesSelected Channels 10 min. + 25 mm/s No YesEvent Table Yes Yes

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510(k) Notification 0 getemedCardioDay® Project ID: 0429S1


Printout Options

Event Histogram Yes YesHeart Rate and ST Diagrams Yes YesHR diagram + Min/Max per Minute No YesRR Intervals Yes YesRR Delay No YesRR Histograms No YesRR Interval Spectra No YesPacemaker Event Histogram Yes YesPacemaker Function Analysis Yes YesReport Yes YesPrint to File (PDF) Yes YesSave as Default Option Yes Yes

Editing & Reviewing Options

The following comparison between the legally mar-keted device and the NEW DEVICE is based on theirfunctions only. The label and appearance of thoseoptions may vary.Scroll through all Beats in a Morphology Bin Yes YesEdit all Beat Labels in a Morphology Bin No YesScroll through ECG and Edit Single Beat Labels No YesScroll through Events of the Same Type Yes YesEdit Event Marker Yes YesView Patient Event Markers Yes YesJump from any Statistics Diagram to the No Yescorresponding ECGJump from ECG Overview to the corresponding ECG Yes YesSelect Tme Interval for Time Domain RR Parameters ye YesEdit Report Yes Yes

MiscellaneousRZ153+ Digital Recorder Supported (K022540) Yes YesCardioMem®CM 3000 (SMA) Supported -Yes YeCardioMem® CM 3000-12 Supported No YesCD Installation Medium Yes YesRZI51 Analog Recorder Supported Yes NoCD Installation Medium Yes Yes

Standards Comparison

Standard

21 CFR 820 (FDA cGMP Good Manufacturing Yes YesPractice) iIYe

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510(k) -Summary Section 1-0001 -Rev D

Standard

ISO 9001:2000 / EN 46001 / ISO 13485:2003 Yes YesQuality Management SystemsIEC 60601-1-4 + Al Programmable Electrical Yes YesMedical SystemsANSI/AAMI EC38 Ambulatory Electrocardiographs Yes YesIEC 60601-2-47 Particular Requirements for the Yes YesSafety, including Essential Performance, ofAmbulatory Electrocardiographic SystemsISO 14971 +AI Application of the Risk Yes YesManagement to Medical DevicesEN 980 Graphic Symbols for the Marking of Yes YesMedical DevicesEN 1041 Supply of Information by the Manufacturer Yes Yesof a Medical DeviceISO 15223 + AMD1 + AMD2 Symbols to be Used Yes Yeswith Medical Devices

Differences between the Legally Marketed Device (Hotter for Windows') and the NewDevice (CardioDaye):

Where Used: Hospital, Home, Ambulance, etc.:CardioDay® clearly excludes home use applications. This has no influence on safety andeffectiveness.

Performance

CardioDayf and Holter for Windowse have the following different technology specifications:

Specifications

CPU Pentium II Processor Pentium III, 500MHz or greaterRAM 32 Mbytes minimum 128 Mbytes minimum,

256 Mbytes minimum for XPFree hard disk 200 MB minimum 5 GB minimumspace 20 GB for 12-lead recordingsDisplay VGA, 14", 1024 x 768 pixel, 17" CRT or 15" TFT, 1024 x 768 pixel

256 colors (XGA), 256 colorsDisc drive I floppy 1.4 Mbytes Not requireddriveCD-ROM drive For installation only For installation only.

Needs to be replaced by a CD-ROMwriter or DVD writer if archive option

_________________ W indows______________98___ implementedOperating system Windows 98 __J Windows 98 SE, NT (SP6a), 2000 or XP

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Ports One free parallel port I 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 currentstate of the art. No influence on safety and effectiveness is expected.

Software characteristicsThe new device CardioDay® offers a number of editing and printing options not available in thelegally marketed device. No influence on safety and effectiveness is expected.

MiscellaneousHolter for Windows® does not support the Holter recorder CardioMem® CM 3000-12. Noinfluence on safety and effectiveness is expected.

CardioDay® does not support the RZ 151 analog tape recorder. This technology is no longerstate of the art and therefore it is not supported. No influence on safety and effectiveness isexpected.

Conclusion

CardioDay® and Holter for Windows® software packages are both used in clinical applications toallow trained physicians or other health care providers to download, review and printelectrocardiographic (ECG) data recorded on digital Holter recorders. Both are computerizedprograms which run under a computer operating system. Both perform a high-speed analysis ofthe 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 AmericanHeart Association (AHA) and Massachusetts Institute of Technology (MIT) and performanceevaluations.

WARNING:CardioDay® does not perform any diagnosis of data by itself but only displays ECGmorphologies and associated, calculated graphs such as heart rate trends, RR variability, andother statistical values.

CardioDay® conforms to Good Manufacturing Procedures outlined by the FDA GMP. Thissoftware is safe and effective for the application for which it is intended and has been tested toconfirm the safety and efficacy of the software. CardioDay® is found to be substantiallyequivalent to the Holter for Windows® software.

04295-SecOl-0O1-RCVO-CardiOay-Eweflive_Surmay doc f 11CONFIDENTIAL AND PROPRIETARY

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration9200 Corporate BoulevardRockville MD 20850

JUN 2,9 200[

getemed Medizin-und Informationstechnik AGc/o Mr. Tamas BorsaiDivision Manager, Medical DivisionTUV Rheinland of North America12 Commerce RoadNewtown, CT 06470

Re: K051471Trade Name: CardioDay®Regulation Number: 21 CFR 870.1425Regulation Name: Diagnostic Programmable ComputerRegulatory Class: Class II (two)Product Code: DQKDated: June 16, 2005Received: June 17, 2005

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmay be subject to such additional controls. Existing major regulations affecting your device canbe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Mr. Tamas Borsai

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct 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 legallymarketed predicate device results in a classification for your device and thus, permits your deviceto proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact 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 obtainother general information on your responsibilities under the Act from the Division of SmallManufacturers, 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,

Br6 '&Zu~ckerman,7~7~ MTM.D. ~

DirectorDivision of Cardiovascular DevicesOffice of Device EvaluationCenter for Devices andRadiological Health

Enclosure

Kosw -7)/5 I

Indications for Use

510(k) Number (if known):

Device Name: CardioDay®

Indications For Use:

CardioDay® is a Holter Software which is indicated for patients who may benefit from along-term continuous electrocardiographic (ECG) recording, including, but not limited to,those with complaints of palpitations, syncope, chest pain, shortness of breath, or thosethat need to be monitored to judge their current cardiac functionality such as patients whohave recently received pacemakers.

WARNING:CardioDay® does not perform any diagnosis of data by itself but only displaysECG morphologies and associated, calculated graphs such as heart rate trends, RRvariability, and other statistical values.

Prescription Use . - AND/OR Over-The-Counter Use(Part 21 CFR 801 Subpart D0 (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Div n Sign-Off) Page I ofDivision of Cardiovascular Devices510k) Number_/__._7/

new 2 9 2005 510(k) notification c getemed · 2005. 7. 11. · classification name: computer,...

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