(25 days)
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.
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.
The provided document describes a Special 510(k) notification for the CardioDay® software, which is a Holter ECG device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (CardioDay® Version 1.9.5, K051471) rather than presenting a performance study with specific acceptance criteria that would typically involve numerical metrics like sensitivity, specificity, or accuracy for an AI/algorithm-driven device.
The "acceptance criteria" in this context are primarily related to the functional equivalence of the new version (CardioDay® Version 2.0) to the predicate device and compliance with relevant medical device standards. The study proving this effectively involves comparing the technical and functional characteristics of the new device to the predicate.
Here's an analysis based on the provided text, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
Since this is a Special 510(k) for a software update rather than a new device with novel AI algorithms, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity) but rather as functional and technical equivalence to the predicate device and compliance with standards. The "reported device performance" is the demonstration that these equivalences and compliances are met.
Below is a summary table based on the document's comparison of the new device (CardioDay® Version 2.0) to the legally marketed predicate (CardioDay® Version 1.9.5). The acceptance criterion implicitly embedded in this type of submission is "maintains all predicate functionalities" and "introduces no new safety or effectiveness concerns."
| Acceptance Criteria (Functional Equivalence / Compliance) | Reported Device Performance (CardioDay® Version 2.0 vs. Predicate) |
|---|---|
| Hardware Specifications: CPU, RAM, Hard Disk Space, Display, Peripherals (CD-ROM, Operating System, Ports, Printer, Keyboard, Mouse, Installation Media, Further Periphery) | All specifications are either identical or improved (e.g., increased minimum RAM, updated OS compatibility), maintaining or exceeding predicate capabilities. New features like Bluetooth connectivity are noted. |
| Software Features (Patient Screen): Patient ID, Name, Address, Personal Data, Medication, Indication, Physician's Name, Date of Recording | All features are identical ("Yes" for both new and predicate). |
| Software Features (Analysis Options): Analysis Duration, Primary Channel Selection, Sensitivity/Signal Quality, Tachycardia/Bradycardia Threshold, Pause Duration, Prematurity, R on T, Pacemaker Type/Thresholds, Superimposition/QuickScan, 12-Lead ECG Module, Holter Data Transfer | All features are identical ("Yes" for both new and predicate). |
| Software Features (Events Detected): VES/PVC, SVES/SVE, Couplet, Triplet, VTACH, Bigeminy, R on T, ST-Analysis, SVTACH, Arrhythmia, Bradycardia, Burst, V. STIM, A. STIM, AV. STIM, Undersense, Exitblock, Oversense, Pause, Event Marker, HR Stripes, Artifact, Normal | All event detection capabilities are identical ("Yes" for both new and predicate). |
| Software Features (Functionality Available): Start, Read Tape/Digital Recorder, Import, Analyze New, Open, Edit Patient Data, Print Preview, Print, Close Recording/Close, Delete Recording, Archive, Diagnosis, View ECG (Online via OptoLink/USB/Bluetooth), Screen Calibration/Setup, FFT Setup, Report Setup, Various Displays (Classes, PM Events, Events, HR Min./Max., Statistics, Diagnosis, Overview), Help Functions | Most functionalities are identical. New features include "View ECG Online via USB Cable" and "View ECG Online via Bluetooth Data Transfer" (not present in predicate). |
| Software Features (Icons/Buttons Available): Start: Read Digital/Tape Recorder, Open Existing Record, Digital Recorder, Tape Recorder, Open: List of Patients, Print, Rhythm Analysis, Print Preview | All features are identical ("Yes" for both new and predicate). The document notes "The label and form of the icons/buttons, however, are different." |
| Software Features (Options Available): Classes, Events, Heart Rate Min/Max, Average Heart Rate, Statistics (FFT, ST Diagrams), Report, Overview, Heart Rate Variability (RR Delay, RR FFT, 24h RR FFT, RR Histograms) | All features are identical ("Yes" for both new and predicate). The document notes "The name of those options may vary." |
| Software Features (Graphics & Displays Available): Basis Sampling Rate for Graphical Displays, Classified Beats, Zoomed/Context of Selected Beat, Events, Heart Rate Trend, Average RR Interval, Y-T, RR > 50ms Distribution, FFT/ST Diagrams, Overview 2 channels. | The "Basis Sampling Rate for Graphical Displays" was improved from 8 ms to 4 ms. A new indicator for Atrial Fibrillation was added. All other features are identical. |
| Software Features (Printout Options): Full Disclosure (various channels/times), Marked Events (various per page/channels), Event Table/Histogram, HR/ST Diagrams, HR diagram + Min/Max, RR Intervals/Delay/Histograms/Spectra, Pacemaker Event Histogram/Function Analysis, Report, Print to File (PDF), Save as Default Option | All features are identical ("Yes" for both new and predicate). The document notes "The commands to generate a given printout as well as its appearance do vary." |
| Software Features (Editing & Reviewing Options): Scroll through Beats/Events, Edit Beat Labels/Event Marker, View Patient Event Markers, Jump from Statistics/Overview to ECG, Select Time Interval for RR Parameters, Edit Report | All features are identical ("Yes" for both new and predicate). The document notes "The label and appearance of those options may vary." |
| Supported Recorders: RZ153+ Digital Recorder, CardioMem® CM 3000, CardioMem® CM 3000-12, CardioMem® CM 3000-12BT | RZ153+, CM 3000, CM 3000-12 are supported in both. CM 3000-12BT is newly supported with Bluetooth functionality. |
| Compliance with Standards: 21 CFR 820, ISO 9001:2000 / ISO 13485:2003, IEC 60601-1-4, ANSI/AAMI EC38, IEC 60601-2-47, ISO 14971, EN 980, EN 1041, ISO 15223 | The new device continues to comply with all listed standards, as well as several FDA guidelines ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Principles of Software Validation"). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness." This implies there was no formal "test set" of patient data used in the sense of a clinical trial or performance evaluation for the software's diagnostic capabilities. The evaluation was primarily based on a comparison of technical and functional specifications and compliance with standards. Therefore, information on sample size, data provenance, retrospective/prospective nature is not applicable or not provided in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since clinical testing was not performed and no patient data test set was used for diagnostic performance evaluation, there were no experts used to establish ground truth for a test set. The submission focuses on software verification and validation, ensuring that the software functions as intended and is equivalent to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set was utilized for evaluating diagnostic performance, no adjudication method was applied to 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
No MRMC comparative effectiveness study was done. The CardioDay® software, as described, "does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected." It is a tool for physicians to review and analyze Holter ECG data, not an AI diagnostic algorithm that assists human readers in making a diagnosis from scratch.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The software is explicitly stated to be a tool for physicians and "does not perform any diagnosis of data by itself." Therefore, a standalone performance evaluation (algorithm only) designed to establish diagnostic accuracy was not performed nor would it be appropriate for a device with this stated functionality. Its performance is tied to its role as a display and analysis tool for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that no clinical performance study was conducted, there was no ground truth established for diagnostic accuracy. The "ground truth" for this submission revolves around the software's functional correctness and compliance with its own specifications and relevant standards.
8. The sample size for the training set
The document does not describe any machine learning or AI models requiring a "training set." Therefore, information on the sample size for a training set is not applicable or not provided.
9. How the ground truth for the training set was established
As there is no mention of a training set for machine learning/AI, this point is not applicable. The "ground truth" for the software's development likely refers to software requirements specifications, design documents, and medical device standards against which its functionality was verified.
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| Special 510(k) Notification | getemec |
|---|---|
| CardioDay® | Project ID: 0505S1 |
| Executive - Summary | Section 16-0001-Rev B |
- 510(k) Summary
| Name and address of themanufacturer and sponsorof the 510(k) submission: | getemed Medizin- und Informationstechnik AGOderstr. 7714513 TeltowGermanyTel.: +49 3328 - 3942-0Fax: +49 3328 – 3942-99 |
|---|---|
| Official contact personfor all correspondence: | Dr. Bert SchadowRegulatory Affairs ManagerE-mail: schadow@getemed.de |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AGOderstr. 7714513 TeltowGermany |
| Date of Preparation: | 2006-12-19 |
| Device Name / Trade Name: | CardioDay® |
| Generic name of the device: | Holter ECG |
| Classification of new device: | Class II |
| Classification Panel: | Computer, Diagnostic, Programmable |
| Product Code and: | DQK |
| CFR Regulation Number: | 21 CFR 870.1425 |
| Legally Marketed Devices: | CardioDay® (K051471, getemed AG) |
Description of Device:
CardioDay® does not perform any diagnosis of data by itself but only displays ECG morphologies and associated, claudited graphs such as heart rate trends, RR variability, and other statistical values in graphical form. The physician will be able to review, edit, and print the data collected.
| Specifications | Legally marketed device CardioDay Version 1.9.5 (K051471) | New / Modified Device CardioDay Version 2.0 |
|---|---|---|
| Type | IBM PC AT compatible | IBM PC AT compatible |
| CPU | Pentium III, 500MHz or greater | Pentium III, 500MHz or greater |
| RAM | 128 Mbytes minimum,256 Mbytes minimum for XP | 256 Mbytes minimum |
| Free hard disk space | 5 GB minimum20 GB for 12-lead recordings | 5 GB minimum20 GB for 12-lead recordings |
| Display | 17" CRT or 15" TFT, 1024 x 768pixel (XGA), 256 colors | 17" CRT or 15" TFT, 1024 x 768pixel (XGA), 256 colors |
| Disc drive / floppy drive | Not required | Not required |
Comparison of Device Technological Characteristics to Predicate Device:
0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc CONFIDENTIAL AND PROPRIETARY
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| Special 510(k) Notification | getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0505S1 | ||
| Executive - Summary | Section 16-0001-Rev B | ||
| Specifications | Legally marketed deviceCardioDay Version 1.9.5 (K051471) | New / Modified DeviceCardioDay® Version 2.0 | |
| CD-ROM drive | For installation only.Needs to be replaced by a CD-ROM writer or DVD writer if archiveoption implemented | For installation only.Needs to be replaced by a CD-ROM writer or DVD writer if archiveoption implemented | |
| Operating system | Windows 98 SE, NT (SP6a),2000 or XP | Windows 2000 or XP (SP2) | |
| Ports | 1 parallel port sufficient; if USBdevices used for printing, softwarekey or card reader, thencorresponding USB ports required | 1 parallel port sufficient; if USBdevices used for printing, softwarekey, card reader, Bluetooth-Dongle,or connection for Holter recorderCardioMem® then correspondingUSB ports required | |
| Printer | Printer as any Windows™compatible, 300 dpi | Printer as any Windows™compatible, 300 dpi | |
| Keyboard | Standard device | Standard device | |
| Mouse | Standard, 2 or 3-button device | Standard, 2 or 3-button device | |
| Installation media | (1) CD | (1) CD | |
| Further periphery | CompactFlash (Type I) memorycard reader | CompactFlash (Type I) memorycard reader |
Comparison of Software Characteristics:
| Patient Screen | Legally marketed device CardioDay Version 1.9.5 (K051471) | New / Modified Device CardioDay Version 2.0 |
|---|---|---|
| Patient Identification Number | Yes | Yes |
| Patient Name, Address, Telephone | Yes | Yes |
| Patient Personal Data (Age, Gender, Date of Birth,etc.) | Yes | Yes |
| Medication | Yes | Yes |
| Indication | Yes | Yes |
| Physician's Name | Yes | Yes |
| Date of Recording | Yes | Yes |
| Analysis Options | Legally marketed deviceCardioDay® Version 1.9.5(K051471) | New / Modified DeviceCardioDay® Version 2.0 |
|---|---|---|
| Analysis Duration | Yes | Yes |
| Primary Channel Selection | Yes | Yes |
| Sensitivity / Signal Quality | Yes | Yes |
| Tachycardia Threshold [bpm] | Yes | Yes |
| Bradycardia Threshold [bpm] | Yes | Yes |
| Pause Duration [ms] | Yes | Yes |
| SV Prematurity [%] | Yes | Yes |
| V Prematurity [%] | Yes | Yes |
| R on T [ms] | Yes | Yes |
| Pacemaker Type | Yes | Yes |
| Minimum Pulse Rate [bpm] | Yes | Yes |
| Maximum Pulse Rate [bpm] | Yes | Yes |
0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc
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| Special 510(k) NotificationCardioDay® | getemedProject ID: 0505S1 | ||
|---|---|---|---|
| Executive - Summary | Section 16-0001-Rev B | ||
| Analysis Options | Legally marketed deviceCardioDay® Version 1.9.5(K051471) | New / Modified DeviceCardioDay® Version 2.0 | |
| Superimposition / QuickScan | Yes | Yes | |
| 12-Lead ECG Module | Yes | Yes | |
| Holter Data Transfer | Yes | Yes |
| Events Detected | Legally marketed deviceCardioDay Version 1.9.5(K051471) | New / Modified DeviceCardioDay Version 2.0 |
|---|---|---|
| VES / PVC | Yes | Yes |
| SVES / SVE | Yes | Yes |
| Couplet | Yes | Yes |
| Triplet | Yes | Yes |
| VTACH / VE Tachycardia | Yes | Yes |
| Bigeminy | Yes | Yes |
| R on T | Yes | Yes |
| ST-Analysis | Yes | Yes |
| SVTACH / SVE Tachycardia | Yes | Yes |
| Arrhythmia / N-N Delay | Yes | Yes |
| Bradycardia | Yes | Yes |
| Burst / VE Run (4 beats) | Yes | Yes |
| V. STIM / V. Paced | Yes | Yes |
| A. STIM / A. Paced | Yes | Yes |
| AV. STIM / AV Paced | Yes | Yes |
| Undersense / Sense Failure | Yes | Yes |
| Exitblock / Capture Failure | Yes | Yes |
| Oversense / Inhibition | Yes | Yes |
| Pause / R-R Pause / N-N Pause | Yes | Yes |
| Event Marker | Yes | Yes |
| HR Stripes | Yes | Yes |
| Artifact | Yes | Yes |
| Normal | Yes | Yes |
| Functionality Available | Legally marketed deviceCardioDay® Version 1.9.5(K051471) | New / Modified DeviceCardioDay® Version 2.0 |
|---|---|---|
| The comparison between the legally marketed device and the NEW DEVICE is based on their functions only and not on their names. | ||
| Start | Yes | Yes |
| Read Tape | Yes | Yes |
| Read Digital Recorder | Yes | Yes |
| Import | Yes | Yes |
| Analyze New | Yes | Yes |
| Open | Yes | Yes |
| Edit Patient Data | Yes | Yes |
| Print Preview | Yes | Yes |
| Yes | Yes | |
| Close Recording | Yes | Yes |
| Close | Yes | Yes |
0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc
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| Special 510(k) Notification | getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0505S1 | ||
| Executive - Summary | Section 16-0001-Rev B | ||
| Functionality Available | Legally marketed deviceCardioDay Version 1.9.5(K051471) | New / Modified DeviceCardioDay Version 2.0 | |
| Delete Recording | Yes | Yes | |
| Archive | Yes | Yes | |
| Diagnosis | Yes | Yes | |
| View ECG | Yes | Yes | |
| View ECG Online via OptoLink Cable | Yes | Yes | |
| View ECG Online via USB Cable | No | Yes | |
| View ECG Online via Bluetooth Data Transfer | No | Yes | |
| Print Preview | Yes | Yes | |
| Screen Scale Calibration | Yes | Yes | |
| Screen: Color Setup | Yes | Yes | |
| FFT Setup | Yes | Yes | |
| Report Setup | Yes | Yes | |
| Classes Display | Yes | Yes | |
| PM Events Display | Yes | Yes | |
| Events Display | Yes | Yes | |
| HR Min./Max. Display | Yes | Yes | |
| Statistics Display | Yes | Yes | |
| Diagnosis Display | Yes | Yes | |
| Overview Display | Yes | Yes | |
| Context sensitive Help | Yes | Yes | |
| Keyboard Shortcuts Help | Yes | Yes | |
| Menu Entries Help | Yes | Yes | |
| Help: About | Yes | Yes | |
| Help: Version | Yes | Yes |
| Icons/Buttons Available | Legally marketed deviceCardioDay® Version 1.9.5(K051471) | New / Modified DeviceCardioDay® Version 2.0 |
|---|---|---|
| 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 |
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| Special 510(k) Notification | getemed |
|---|---|
| CardioDay® | Project ID: 0505S1 |
| Executive - Summary | Section 16-0001-Rev B |
| Options Available | Legally marketed deviceCardioDay® Version 1.9.5(K051471) | New / Modified DeviceCardioDay® Version 2.0 |
|---|---|---|
| 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 |
| 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 deviceCardioDay Version 1.9.5(K051471) | New / Modified DeviceCardioDay Version 2.0 |
|---|---|---|
| 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. | ||
| Basis Sampling Rate for Graphical Displays | 8 ms | 4 ms |
| Classified Beats Grouped into Morphology Bins | Yes | Yes |
| Zoomed Version of Selected Beat | Yes | Yes |
| Context of Selected Beat | Yes | Yes |
| Events | Yes | Yes |
| Heart Rate Trend in Recording Period | Yes | Yes |
| Average RR Interval | Yes | Yes |
| Y-T Distribution | Yes | Yes |
| RR > 50ms Distribution | Yes | Yes |
| FFT Analysis | Yes | Yes |
| ST Diagrams | Yes | Yes |
| Overview 2 channels at Different Scaling Factors | Yes | Yes |
| Indicator for Atrial Fibrillation | No | Yes |
| Printout Options | Legally marketed deviceCardioDay Version 1.9.5(K051471) | New/ Modified DeviceCardioDay Version 2.0 |
|---|---|---|
| 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 appearance do vary. | ||
| Full Disclosure 2 Channels, 1 h/Page | Yes | Yes |
| Full Disclosure 2 Channels, 15 min./Page | Yes | Yes |
| Full Disclosure 2 Channels, 30 min./Page | Yes | Yes |
| Marked Events: 8 Events/Page | Yes | Yes |
0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc
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| Special 510(k) Notification | getemed | ||
|---|---|---|---|
| CardioDay® | Project ID: 0505S1 | ||
| Executive - Summary | Section 16-0001-Rev B | ||
| Printout Options | Legally marketed deviceCardioDay® Version 1.9.5(K051471) | New / Modified DeviceCardioDay® Version 2.0 | |
| Marked Events: 32 Events/Page | Yes | Yes | |
| Marked Events: Analysis Channel 25 mm/s | Yes | Yes | |
| Marked Events: Analysis Channel 2.5 min + 25mm/s | Yes | Yes | |
| Selected Channels 25 mm/s | Yes | Yes | |
| Selected Channels 1 min. + 25 mm/s | Yes | Yes | |
| Selected Channels 2.5 min. + 25 mm/s | Yes | Yes | |
| Selected Channels 10 min. + 25 mm/s | Yes | Yes | |
| Event Table | Yes | Yes | |
| Event Histogram | Yes | Yes | |
| Heart Rate and ST Diagrams | Yes | Yes | |
| HR diagram + Min/Max per Minute | Yes | Yes | |
| RR Intervals | Yes | Yes | |
| RR Delay | Yes | Yes | |
| RR Histograms | Yes | Yes | |
| RR Interval Spectra | Yes | Yes | |
| Pacemaker Event Histogram | Yes | Yes | |
| Pacemaker Function Analysis | Yes | Yes | |
| Report | Yes | Yes | |
| Print to File (PDF) | Yes | Yes | |
| Save as Default Option | Yes | Yes |
| Editing & Reviewing Options | Legally marketed deviceCardioDay Version 1.9.5(K051471) | New / Modified DeviceCardioDay Version 2.0 |
|---|---|---|
| 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 | Yes |
| Edit all Beat Labels in a Morphology Bin | Yes | Yes |
| Scroll through ECG and Edit Single Beat Labels | Yes | Yes |
| Scroll through Events of the Same Type | Yes | Yes |
| Edit Event Marker | Yes | Yes |
| View Patient Event Markers | Yes | Yes |
| Jump from any Statistics Diagram to thecorresponding ECG | Yes | Yes |
| Jump from ECG Overview to the corresponding ECG | Yes | Yes |
| Select Time Interval for Time Domain RR Parameters | Yes | Yes |
| Edit Report | Yes | Yes |
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Special 510(k) Notification
| CardioDay® | Project ID: 0505S1 |
|---|---|
| Executive - Summary | Section 16-0001-Rev B |
| Miscellaneous | Legally marketed deviceCardioDay Version 1.9.5(K051471) | New / Modified DeviceCardioDay Version 2.0 |
|---|---|---|
| RZ153+ Digital Recorder Supported (K022540) | Yes | Yes |
| CardioMem® CM 3000 (SMA) Supported | Yes | Yes |
| CardioMem® CM 3000-12 Supported (K051686) | Yes | Yes |
| CardioMem® CM 3000-12BT Supported | No | YesBluetooth functionalityonly with MicrosoftWindows XP (SP2) |
| CD Installation Medium | Yes | Yes |
Standards Comparison
| Standard | Legally marketed deviceCardioDay Version 1.9.5(K051471) | New / Modified DeviceCardioDay Version 2.0 |
|---|---|---|
| 21 CFR 820 (FDA cGMP Good ManufacturingPractice) | Yes | Yes |
| ISO 9001:2000 / ISO 13485:2003 QualityManagement 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 |
Intended use:
CardioDay® is a software package that allows a trained physician or health care professional knowledgeable in Holter ECG interpretation, after having performed a long-term continuous electrocardiographic (ECG) recording using a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports.
This device is available only upon the order of a physician or other licensed medical professional and not intended for any ambulatory or home applications.
United States federal law restricts CardioDay® to sale by or on the order of a physician.
0505S1-Sec16-0001-RevB-CardioDay-510k_Summary.doc CONFIDENTIAL AND PROPRIETARY
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| Special 510(k) Notification | getemed |
|---|---|
| CardioDay® | Project ID: 0505S1 |
| Executive - Summary | Section 16-0001-Rev B |
Non-Clinical Testing:
Verification and validation test plans were completed in accordance with getemed AG procedures and GMP guidelines. A Hazard Analysis was completed and hazards were resolved as appropriate.
The CardioDay® software complies to the following standards:
- IEC 60601-1-4,
- IEC 60601-2-47,
- IEC 60601-2-51 (Part 50.101.2),
- ANSI/AAMI EC 38,
- ISO 14971.
- EN 980,
- ISO 15223,
- EN 1041
Also the following FDA-Guidelines were met:
- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices",
- "General Principles of Software Validation".
All system specifications were met and testing performed to demonstrate substantial equivalence.
Clinical Testing:
Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness.
Conclusion:
The CardioDay® evaluation software is substantially equivalent to the predicate device listed in this Summary and the device, as changed, does not raise any new issues of safety and effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2007
Getemed Medizin c/o Mr. Bert Schadow Regulatory Affairs Manager 14514 Teltow Germany
Re: K070280
Trade Name: CardioDay Regulation Number: 21 CFR 870.1425 Regulation Name: Computer, Diagnostic, Programmable Regulatory Class: Class II Product Code: DQK Dated: January 3, 2007 Received: January 29, 2007
Dear Mr. Schadow:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Brimmerfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
K070280
Exhibit 1
Image /page/10/Picture/1 description: The image shows the logo for Getemed. The logo consists of a heart shape inside a circle, followed by the word "getemed" in bold, sans-serif font. The heart and the text are both black, and the background is white.
Medizin- und Informationstechnik AG
Indications for Use
510(k) Number (if known):
CardioDay® Device Name:
Indications For Use:
CardioDay® is a Holter software which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers.
న Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K.Bermmmo
Page 1 of
Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K070280
§ 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).