(246 days)
The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis.
The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years):
- · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia.
- · Evaluation of patients for ST segment changes
- Evaluation of patients with pacemakers
- · Reporting of time domain heart rate variability
- · Evaluation of a patient's response after resuming occupational activities (e.g., after MI. or cardiac surgery.)
- · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
- Clinical and epidemiological research studies
The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used.
The Cardiospy ECG Holter System includes a recorder, an USB dongle (for blue tooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Exportavailable.
The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8 operating systems.
The connection between the Holter and computer is performed by using Bluetooth and USB dongle.
The Cardiospy analysis software provides ECG records of excellent quality.
The provided text describes the Cardiospy ECG Holter System, its intended use, and its equivalence to predicate devices, but it does NOT contain an explicit study section with detailed acceptance criteria, reported performance, or specifics about a study design (like sample size, ground truth establishment, expert qualifications, or MRMC studies).
However, it does reference compliance with specific standards which contain performance requirements. I will extract the relevant information from those standards and the document's general claims to construct a response as best as possible.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was tested and found to fulfill the standard requirements. The most relevant standard for performance claims for an ambulatory ECG system with an analysis algorithm is AAMI / ANSI EC57:2012, "Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms." While the document doesn't explicitly list specific performance metrics from this standard as acceptance criteria, its inclusion implies compliance with the performance objectives outlined in EC57.
Since specific numerical acceptance criteria and reported performance values are not provided in the document, I will infer general performance aspects based on the device description and the standards it claims to meet.
| Acceptance Criteria (Inferred from EC57:2012 and device description) | Reported Device Performance (Inferred from compliance claims) |
|---|---|
| Arrhythmia Detection & Classification Accuracy (e.g., QRS detection, Ventricular Ectopic Beat, Supraventricular Ectopic Beat, Atrial Fibrillation) | "precise automatic QRS and PM detection, template and rhythm analysis, QRS classification" (General claim of accuracy implicit in meeting standards) |
| ST Segment Measurement Accuracy | "efficient ST...analysis" (General claim of accuracy implicit in meeting standards) |
| Pacer Detection Accuracy | "precise automatic...PM detection" (General claim of accuracy implicit in meeting standards) |
| Heart Rate Variability (HRV) Analysis (Time and Frequency Domain) | "efficient...HRV time and frequency based analysis" (General claim of accuracy implicit in meeting standards) |
| QT Interval Measurement Accuracy | "efficient...QT...analysis" (General claim of accuracy implicit in meeting standards) |
| General ECG Recording Quality | "provides ECG records of excellent quality" |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2 Edition 3:2007-03) | "Was tested and certified by TÜV Rheinland Intercert Kft." |
| Basic Safety and Essential Performance (IEC 60601-1:2005 Third edition and IEC 60601-2-47:2012) | "test results prove that the device fulfills the standard requirements." |
| Usability (IEC 60601-1-6 Edition 3.0 2010-01) | Implicitly meets usability requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Non-clinical testing of the product and its accessory proves that the following standard requirements are met" and "The test results prove that the device fulfills the standard requirements." It does not provide details of any clinical or non-clinical performance study data directly.
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 information on the number of experts, their qualifications, or how ground truth was established for any test set. The standards like EC57:2012 typically involve a "reference truth" or "expert-annotated" datasets, but the submission itself doesn't detail their use.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not provide information on any 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 a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI/algorithm assistance. The device is described as an "ECG Holter System" with an "analysis algorithm" to "support the medical staff in analyzing and deciding the proper and adequate diagnosis," implying human-in-the-loop, but no comparative effectiveness study is presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies a standalone analytical capability for the algorithm with features like "precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis." However, it explicitly states that the data and analysis "will be reviewed, confirmed, and used by trained medical personnel in the diagnosis." It does not provide specific standalone performance metrics or a study demonstrating algorithm-only performance. The compliance with EC57:2012 would typically require demonstrating algorithm performance, but the details are not in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for performance evaluation. For devices complying with AAMI/ANSI EC57, ground truth is typically established through expert consensus or a "reference truth" dataset, but details are absent here.
8. The sample size for the training set
The document does not provide any information about a training set or its sample size.
9. How the ground truth for the training set was established
The document does not provide any information about a training set or how its ground truth was established.
Summary based on the provided document:
The submission largely relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards for safety and performance (IEC 60601 series, AAMI EC57, ISO 14971, etc.). It claims that the device was tested and fulfills these standard requirements, leading to the conclusion that differences do not raise new questions of safety and effectiveness. However, it does not provide the specific details of performance studies such as sample sizes, data provenance, expert ground-truthing, or comparative effectiveness. These details would typically be found in a separate study report or a more extensive section of the 510(k) submission, which is not included in this excerpt.
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Image /page/0/Picture/1 description: The image contains the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging to form a single, unified image. The profiles are facing to the right and are meant to represent the department's commitment to health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
LABTECH KFT. Zsolt Katonai Quality Manager Vagu 4 Debrecen, 4031 HU
Re: K140847
Trade/Device Name: CARDIOSPY ECG Holter Systems Regulation Number: 21 CFR 870.2800 Regulation Name: Electrocardiograph, Ambulatory, With Analysis Algorithm Regulatory Class: Class II Product Code: MLO Dated: October 20, 2014 Received: October 22, 2014
Dear Zsolt Katonai:
This letter corrects our substantially equivalent letter of December 5, 2014.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{1}------------------------------------------------
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Melissa A. Torres -S
For 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) K140847
Device Name Cardiospy ECG Holter System
Indications for Use (Describe)
The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis.
The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years):
- · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia.
- · Evaluation of patients for ST segment changes
- Evaluation of patients with pacemakers
- · Reporting of time domain heart rate variability
- · Evaluation of a patient's response after resuming occupational activities (e.g., after MI. or cardiac surgery.)
- · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
- Clinical and epidemiological research studies
Type of Use (Select one or both, as applicable)
|× Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
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{4}------------------------------------------------
LABTECH
Vág utca 4. H-4031, Debrecen, Hungary Phone : +36-(52)-310-128 Fax : +36-(52)-412-023 E-mail:service@labtech.hu
(Cardiospy ECG Holter System)
Date: 4t0 December 2014
510(k) Summary of Safety & Effectiveness 510(k) Number: K140847
Submitter
Labtech Kft. Vág utca 4. H-4031, Debrecen, Hungary Phone : +36-(52)-310-128 Fax : +36-(52)-412-023 E-mail : medical@labtech.hu
Responsible person and title : Mr. Dr. Béla Kincs - Managing Director
Contact person and title : Mr. Zsolt Katonai – Quality Manager
Device trade name: Cardiospy ECG Holter System
Common/Usual name: Ambulatory ECG Holter System
Classification name : Electrocardiograph, Ambulatory with analysis algorithm (per 21CFR section 870.2800)
Product code: MLO
Device class: II (according to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm)
Device models: EC-1H, EC-2H, EC-3H, EC-12H
Predicate devices
| 1. Vista Plus – Novacor France | - K042108 |
|---|---|
| 2. Spiderview ELA MEDICAL Inc. | - K032466 |
| 3. Cardio ID+(RZI153±) - ScottCare (ROZINN ELECTRONICS Inc.) | - K022540 |
| 4. Digitrak Plus - BRAEMAR CORP | - K993617 |
Device Description
The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used.
The Cardiospy ECG Holter System includes a recorder, an USB dongle (for blue tooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Exportavailable.
{5}------------------------------------------------
A LABTECH
The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8 operating systems.
The connection between the Holter and computer is performed by using Bluetooth and USB dongle.
The Cardiospy analysis software provides ECG records of excellent quality.
Indications for use:
The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis.
The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years):
- Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia.
- Evaluation of patients for ST segment changes
- Evaluation of patients with pacemakers
- Reporting of time domain heart rate variability
- Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after MI. or cardiac surgery.)
- . Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
- Clinical and epidemiological research studies
Intended Use:
The ECG Holter System is intended for acquiring ambulatory ECG signals from patients. Patients are people with coronary problems or suspected coronary problems.
This ambulatory electrocardiograph, and associated analysis system, can be used on patients without limitation on patient age or gender.
The Holter Recorder procedure is one of the many tools that clinicians use to capture infrequent or activity provoked ECG rhythm abnormalities outside of the physician's office. Indications for conducting Holter recording are:
- Arrhythmias
- Chest pain
- Unexplained syncope
- Shortness of breath
- Palpitations
- Evaluation of a pacemaker
- Regulation of anti-arrhythmic drugs
- Evaluation of a patient after myocardial infarction
- Family history of heart disease
Non-clinical testing of the product and its accessory proves that the following standard requirements are met:
{6}------------------------------------------------
K140847
A LABTECH
510(k) SUMMARY of SAFETY & EFFECTIVENESS (according to CFR 807.92)
Vág utca 4. H-4031, Debrecen, Hungary Phone : +36-(52)-310-128 Fax : +36-(52)-412-023 E-mail:service@labtech.hu
| RecognitionNumber | StandardDevelopingOrganization | StandardDesignationNumber andDate | Title of Standard | FRPublicationDate | Remarks |
|---|---|---|---|---|---|
| 5-53 | IEC | 60601-1-2 Edition3:2007-03 | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests | 08/05/2013 | Was tested and certified byTÜV Rheinland IntercertKft.- Product CertificationBody1132 Budapest Váci út 48A-B Hungary |
| 5-85 | IEC | 60601-1-6 Edition3.0 2010-01 | Medical electrical equipment --Part 1-6: General requirementsfor basic safety and essentialperformance -- CollateralStandard: Usability | 01/30/2014 | |
| 3-127 | AAMI / ANSI /ISO | 60601-2-47:2012, | medical electrical equipment --part 2-47: particularrequirements for the basicsafety and essentialperformance of ambulatoryelectrocardiographic systems.(Cardiovascular) | 07/09/2014 | |
| 3-118 | AAMI / ANSI | EC57:2012 | Testing and reportingperformance results of cardiacrhythm and st-segmentmeasurement algorithms.(Cardiovascular) | 01/30/2014 | |
| 3-72 | AAMI ANSI | EC53:1995/(R)2008 | ECG cables and leadwires | 01/30/2014 | |
| 5-40 | ISO | 14971 Secondedition 2007-03-01 | Medical devices - Application ofrisk management to medicaldevices | 08/20/2012 | |
| 13-32 | AAMI ANSIIEC | 62304:2006 | Medical device software -Software life cycle processes | 08/20/2012 | |
| 5-73 | ISO | 15223-1 SecondEdition 2012-07-01 | Medical devices - Symbols tobe used with medical devicelabels, labelling, andinformation to be supplied - Part1: General requirements | 01/15/2013 | |
| 2-181 | AAMI ANSIISO | 14155:2011 | Clinical investigation of medicaldevices for human subjects -Good clinical practice | 03/16/2012 | |
| Voluntary | IEC | 60601-1:2005(Third edition) | Medical electrical equipment.Part 1: General requirementsfor basic safety and essentialperformance | 12/01/2005 | |
| Voluntary | IEC(EN) | 61000-3-2:2005(EQV)(61000-3-2:2006 +A1+A2) | Electromagnetic compatibility(EMC) - Part 3-2: Limits -Limits for harmonic currentemissions (equipment inputcurrent ≤16 A per phase) | 11/01/2006 | Was tested and certified byTÜV Rheinland IntercertKft.- Product CertificationBody1132 Budapest Váci út 48A-B Hungary |
| Voluntary | IEC(EN) | 61000-3-3:2008(EQV)(61000-3-3:2008) | Electromagnetic compatibility(EMC) - Part 3-3: Limits -Limitation of voltage changes,voltage fluctuations and flickerin public low-voltage supplysystems, for equipment withrated current <= 16 A per phaseand not subject to conditionalconnection | 06/01/2009 | Was tested and certified byTÜV Rheinland IntercertKft. - Product CertificationBody1132 Budapest Váci út 48A-B Hungary |
| Voluntary | ISO | 13485:2003(E) | Medical devices -- Qualitymanagement systems --Requirements for regulatorypurposes | 07/15/2003 | Extended according to 21CFR Part 820 andCMDCAS requirements.QMS certificate issued bySGS United Kingdom Ltd. |
| RecognitionNumber | StandardDevelopingOrganization | StandardDesignationNumber andDate | Title of Standard | FRPublicationDate | Remarks |
| Voluntary | CouncilDirective | 93/42/EEC | Council Directive 93/42/EEC of14 June 1993 concerningmedical devices | 10/11/2007 | Certificate issued by SGSUnited Kingdom Ltd |
{7}------------------------------------------------
A LABTEC
510(k) SUMMARY of SAFETY & EFFECTIVENESS (according to CFR 807.92)
Vág utca 4. H-4031, Debrecen, Hungary Phone : +36-(52)-310-128 Fax : +36-(52)-412-023 E-mail : service@labtech.hu
The test results prove that the device fulfills the standard requirements.
Comparison of technology characteristics to predicate devices
| Table 2 - Comparison with predicate devices | |||||
|---|---|---|---|---|---|
| Device | Vista Plus | Spiderview | Cardio Id+(RZ153+) | Digitrak Plus | Cardiospy ECGHolter System |
| Manufacturer | Novacor | ELA Medical | Rozinn(ScottCare) | Braemar(delivered byZYMED/PHILIPS) | Labtech Kft |
| 510(k) FDA registration | K042108 | K032466 | K022540 | K993617 | K140847 |
| Type | Digital | Digital | Digital | Digital | Digital |
| Number of channels | 1, 2, 3 | 2, 3, 5, 9 | 2, 3, 12 (option) | 2, 3 | 1, 2, 3, 12 |
| Recording duration | Up to: 264 h | Up to: 96 h | Up to: 48 h | Up to: 120 h | 24, 48, 72, 168 h |
| Recording rate | 200 Hz | 200 Hz | 1024 Hz | 175 Hz | 128 Hz ... 1024 Hz |
| Resolution | 10 bit | 15 bit | 12 bit | 10 bit | 16 bit |
| Dynamic range | +/- 6 mV | +/- 16 mV | +/- 6 mV or+/- 3 mV or+/- 1,5 mV | +/- 20 mV | |
| Pacemaker spike detectionand reporting | Yes | Yes | Yes | Yes | Yes |
| Open lead detection | Yes | Yes | Yes | Yes | Yes |
| Impedance test | Yes | Yes | Yes | Yes | Yes |
| Storage capacity | Up to 512 MB | Up to 64 MB | Up to 512 MB | 2GB | |
| Memory type | CF card | MMC or SD flashcard | CF card | Internal Flashmemory (nonremovable) | microSD |
| LCD | Yes | Yes | Yes | Yes | Yes |
| Size | 86x54x19 mm | 97x54x23 mm | 108x79x22 mm | 85x65x20 mm | 53x67.5x18.5 mm |
| Weight | 100 g | 110 g | 145 g | 100 g | 50 g |
| Accessories | Belt, shoulderstrap, pouch, neckpouch | Belt + pouch | Belt + pouch | Belt + pouch | Belt + pouchattachable topatient's belt +pouch attachableto patient's neck |
| Batteries | 2 AAA 1,5 V | 1 AA 1,5 V | 2 AAA 1,5 V | 1 AA 1,5 V | 1x1.2 V AAA NiMHbattery(or 1x1.5 V AAAalkaline battery) |
| Rechargeable batteries | Accepted | Accepted | Accepted | Accepted | Accepted |
| Device | Vista Plus | Spiderview | Cardio Id+(RZ153+) | Digitrak Plus | Cardiospy ECGHolter System |
| ECG display | At any time(programmable) | Preview only | Preview only | Preview only | Preview only |
| Real-type built in analysis | HR calculation | No | No | No | No |
| Event marker | Yes | Yes | Yes | Yes | Yes |
| Display during recording | |||||
| Time | Yes | Yes | Yes | Yes | Yes |
| HR | Programmable | No | No | No | No |
| HR curve | Programmable | No | No | No | No |
| Replay and analysis system | HolterSoft Ultima | Syneview/Synescope | Holter forWindows | Philips 1810 seriesor 2010 software | Cardiospy software |
| Software | HolterSoft Ultima | Synetec | 2010 Plus Holter | Mars Unity | Cardiospy software |
| Software developer | Novacor | ELA Medical | AietMaq | Marquette | Labtech Kft |
| PC based | Yes | Yes | Yes | Yes | Yes |
| OS compatibility | Windows98,NT,2000, XP | Windows98,NT,2000, XP | Windows98,NT,2000, XP | NA | Windows XP (Service Pack 2 )Windows XP SP3,Vista, 7, 8(32 and 64 bit) |
| Input data | Digital (CF cardfrom Vista seriesrecorders) | Digital (PCMCIAflashcards fromSyneflad/MMCor SM cardsfromSpiderview) andtape | Digital (USBtransfer fromZymed DigitrakPlus recorder) | Digital (USBtransfer from the"Seer Light"interface) and tape | Digital (Bluetoothor USB transfer) |
| Graphic User Interface | Yes | Yes | Yes | Yes | Yes |
| Templates (shapes) edition | Yes | Yes | Yes | Yes | Yes |
| Events list display | Yes | Yes | Yes | Yes | Yes |
| Arrhythmia detection | Yes | Yes | Yes | Yes | Yes |
| Conduction abnormalitiesdetection | Yes | Yes | Yes | Yes | Yes |
| ST segment | Multi channel | Multi channel | Multi channel | Multi channel | Multi channel |
| Superimposition | Yes | Yes | Yes | Yes | Yes |
| PM patient analysis | Yes | Yes | Yes | Yes | Yes |
| Report customization | Yes | Yes | Yes | Yes | Yes |
| Report edition | Yes | Yes | Yes | Yes | Yes |
| ECG strip edition andprinting | Yes | Yes | Yes | Yes | Yes |
| Archiving | Yes | Yes | Yes | Yes | Yes |
| Report Export | Yes | No | No | No | Yes |
| Device | Vista Plus | Spiderview | Cardio Id+(RZ153+) | Digitrak Plus | Cardiospy ECGHolter System |
| Afib | Yes | No | No | No | Yes |
| Events Histograms/trends | Yes | Yes | Yes | Yes | Yes |
| RR histogram | Yes | Yes | Yes | Yes | Yes |
| Editing/Printing fulldisclosure | Yes | Yes | Yes | Yes | Yes |
| Editing tools for QRSinsertion/suppression | Yes | Yes | Yes | Yes | Yes |
| Time domain HRV | Yes | Yes | Yes | Yes | Yes |
| Frequency Domain | Yes | Yes | Yes | Yes | Yes |
| HRV | Yes | Yes | Yes | Yes | Yes |
| QT | Yes | Yes | Yes | Yes | Yes |
| Networking | Yes | Yes | Yes | Yes | Yes |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for Labtech. The logo consists of a blue triangle on the left, followed by the word "LABTECH" in blue, with a thin blue line underneath. The logo is simple and modern.
Vág utca 4. H-4031, Debrecen, Hungary Phone : +36-(52)-310-128 Fax : +36-(52)-412-023 E-mail:service@labtech.hu
{9}------------------------------------------------
LABTECH
Vág utca 4. H-4031, Debrecen, Hungary Phone : +36-(52)-310-128 Fax : +36-(52)-412-023 E-mail : service@labtech.hu
Statement indicating the device is similar to the products of comparable type in commercial distribution
In conclusion the Holter ECG System can be declared identical in intended use, indications for use to the predicate devices listed and very similar in functionality, design, material and performance to applicable standards. The main modification is the implementation of the Bluetooth wireless technology.
The test results in this submission demonstrated that these small differences do not raise any new questions of safety and effectiveness to the subject device and the subject device is substantially equivalent to the predicate devices.
This information provides reasonable assurance that the Cardiospy ECG Holter System in a safe and effective manner.
Dr. Béla Kincs managing director
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).