CARDIOSPY ECG HOLTER SYSTEMS

K140847 · Labtech Kft. · MLO · Dec 5, 2014 · Cardiovascular

Device Facts

• Record ID: K140847
• Device Name: CARDIOSPY ECG HOLTER SYSTEMS
• Applicant: Labtech Kft.
• Product Code: MLO · Cardiovascular
• Decision Date: Dec 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Battery-powered ambulatory ECG Holter system; records 1, 2, 3, or 12-channel ECG data for 24-168 hours. Input: patient ECG signals via recorder and patient cable. Data transfer: Bluetooth or USB to PC. Software: Cardiospy; performs automatic QRS and pacemaker detection, template/rhythm analysis, QRS classification, ST/QT/AF/HRV analysis. Output: full disclosure ECG recordings, color-coded displays, and reports. Used in clinical settings by qualified professionals to support diagnosis of rhythm patterns and cardiac abnormalities. Benefits: enables capture of infrequent or activity-provoked ECG events outside the office; supports therapeutic monitoring and research.

Clinical Evidence

Bench testing only. Compliance with AAMI/ANSI/ISO 60601-2-47 (ambulatory ECG systems) and AAMI/ANSI EC57 (cardiac rhythm and ST-segment measurement algorithms) was demonstrated. No clinical trial data presented.

Technological Characteristics

Digital ambulatory ECG recorder; 1, 2, 3, or 12-channel; 16-bit resolution; 128-1024 Hz sampling rate; 2GB microSD storage. Connectivity: Bluetooth/USB. Power: 1.2V NiMH or 1.5V alkaline AAA battery. Software: PC-based (Windows XP/Vista/7/8). Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-47, AAMI EC57, EC53, ISO 14971, 13485, 15223-1.

Indications for Use

Indicated for patients of all ages (including children) requiring ambulatory (Holter) monitoring for 24, 48, 72, or 168 hours. Used for evaluation of rhythm disturbances, arrhythmia, ST segment changes, pacemaker function, heart rate variability, response to therapeutic interventions (e.g., post-MI or cardiac surgery), and clinical/epidemiological research.

Regulatory Classification

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.

Predicate Devices

• Vista Plus – Novacor France (K042108)
• Spiderview ELA MEDICAL Inc. (K032466)
• Cardio ID+(RZI153±) - ScottCare (ROZINN ELECTRONICS Inc.) (K022540)
• Digitrak Plus - BRAEMAR CORP (K993617)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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LABTECH

Vág utca 4. H-4031, Debrecen, Hungary Phone : [phone] Fax : [phone] E-mail:[e-mail]

# (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 : [phone] Fax : [phone] E-mail : [e-mail]

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.

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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:

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#### K140847

A LABTECH

### 510(k) SUMMARY of SAFETY & EFFECTIVENESS (according to CFR 807.92)

Vág utca 4. H-4031, Debrecen, Hungary Phone : [phone] Fax : [phone] E-mail:[e-mail]

| Recognition<br>Number | Standard<br>Developing<br>Organization | Standard<br>Designation<br>Number and<br>Date | Title of Standard | FR<br>Publication<br>Date | Remarks |
|-----------------------|----------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 5-53 | IEC | 60601-1-2 Edition<br>3:2007-03 | Medical electrical equipment -<br>Part 1-2: General requirements<br>for basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic<br>compatibility - Requirements<br>and tests | 08/05/2013 | Was tested and certified by<br>TÜV Rheinland Intercert<br>Kft.- Product Certification<br>Body<br>1132 Budapest Váci út 48<br>A-B Hungary |
| 5-85 | IEC | 60601-1-6 Edition<br>3.0 2010-01 | Medical electrical equipment --<br>Part 1-6: General requirements<br>for basic safety and essential<br>performance -- Collateral<br>Standard: Usability | 01/30/2014 | |
| 3-127 | AAMI / ANSI /<br>ISO | 60601-2-47:2012, | medical electrical equipment --<br>part 2-47: particular<br>requirements for the basic<br>safety and essential<br>performance of ambulatory<br>electrocardiographic systems.<br>(Cardiovascular) | 07/09/2014 | |
| 3-118 | AAMI / ANSI | EC57:2012 | Testing and reporting<br>performance results of cardiac<br>rhythm and st-segment<br>measurement algorithms.<br>(Cardiovascular) | 01/30/2014 | |
| 3-72 | AAMI ANSI | EC53:1995/(R)<br>2008 | ECG cables and leadwires | 01/30/2014 | |
| 5-40 | ISO | 14971 Second<br>edition 2007-03-<br>01 | Medical devices - Application of<br>risk management to medical<br>devices | 08/20/2012 | |
| 13-32 | AAMI ANSI<br>IEC | 62304:2006 | Medical device software -<br>Software life cycle processes | 08/20/2012 | |
| 5-73 | ISO | 15223-1 Second<br>Edition 2012-07-<br>01 | Medical devices - Symbols to<br>be used with medical device<br>labels, labelling, and<br>information to be supplied - Part<br>1: General requirements | 01/15/2013 | |
| 2-181 | AAMI ANSI<br>ISO | 14155:2011 | Clinical investigation of medical<br>devices for human subjects -<br>Good clinical practice | 03/16/2012 | |
| Voluntary | IEC | 60601-1:2005<br>(Third edition) | Medical electrical equipment.<br>Part 1: General requirements<br>for basic safety and essential<br>performance | 12/01/2005 | |
| Voluntary | IEC<br>(EN) | 61000-3-2:2005<br>(EQV)<br>(61000-3-<br>2:2006 +A1+A2) | Electromagnetic compatibility<br>(EMC) - Part 3-2: Limits -<br>Limits for harmonic current<br>emissions (equipment input<br>current ≤16 A per phase) | 11/01/2006 | Was tested and certified by<br>TÜV Rheinland Intercert<br>Kft.- Product Certification<br>Body<br>1132 Budapest Váci út 48<br>A-B Hungary |
| Voluntary | IEC<br>(EN) | 61000-3-3:2008<br>(EQV)<br>(61000-3-3:2008) | Electromagnetic compatibility<br>(EMC) - Part 3-3: Limits -<br>Limitation of voltage changes,<br>voltage fluctuations and flicker<br>in public low-voltage supply<br>systems, for equipment with<br>rated current <= 16 A per phase<br>and not subject to conditional<br>connection | 06/01/2009 | Was tested and certified by<br>TÜV Rheinland Intercert<br>Kft. - Product Certification<br>Body<br>1132 Budapest Váci út 48<br>A-B Hungary |
| Voluntary | ISO | 13485:2003(E) | Medical devices -- Quality<br>management systems --<br>Requirements for regulatory<br>purposes | 07/15/2003 | Extended according to 21<br>CFR Part 820 and<br>CMDCAS requirements.<br>QMS certificate issued by<br>SGS United Kingdom Ltd. |
| Recognition<br>Number | Standard<br>Developing<br>Organization | Standard<br>Designation<br>Number and<br>Date | Title of Standard | FR<br>Publication<br>Date | Remarks |
| Voluntary | Council<br>Directive | 93/42/EEC | Council Directive 93/42/EEC of<br>14 June 1993 concerning<br>medical devices | 10/11/2007 | Certificate issued by SGS<br>United Kingdom Ltd |

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A LABTEC

#### 510(k) SUMMARY of SAFETY & EFFECTIVENESS (according to CFR 807.92)

Vág utca 4. H-4031, Debrecen, Hungary Phone : [phone] Fax : [phone] E-mail : [e-mail]

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+<br>(RZ153+) | Digitrak Plus | Cardiospy ECG<br>Holter System |
| Manufacturer | Novacor | ELA Medical | Rozinn<br>(ScottCare) | Braemar<br>(delivered by<br>ZYMED/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<br>+/- 3 mV or<br>+/- 1,5 mV | | +/- 20 mV |
| Pacemaker spike detection<br>and 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 flash<br>card | CF card | Internal Flash<br>memory (non<br>removable) | 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, shoulder<br>strap, pouch, neck<br>pouch | Belt + pouch | Belt + pouch | Belt + pouch | Belt + pouch<br>attachable to<br>patient's belt +<br>pouch attachable<br>to 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 NiMH<br>battery<br>(or 1x1.5 V AAA<br>alkaline battery) |
| Rechargeable batteries | Accepted | Accepted | Accepted | Accepted | Accepted |
| Device | Vista Plus | Spiderview | Cardio Id+<br>(RZ153+) | Digitrak Plus | Cardiospy ECG<br>Holter System |
| ECG display | At any time<br>(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/Synes<br>cope | Holter for<br>Windows | Philips 1810 series<br>or 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 | Windows<br>98,NT,2000, XP | Windows<br>98,NT,2000, XP | Windows<br>98,NT,2000, XP | NA | Windows XP (<br>Service Pack 2 )<br>Windows XP SP3,<br>Vista, 7, 8<br>(32 and 64 bit) |
| Input data | Digital (CF card<br>from Vista series<br>recorders) | Digital (PCMCIA<br>flashcards from<br>Syneflad/MMC<br>or SM cards<br>from<br>Spiderview) and<br>tape | Digital (USB<br>transfer from<br>Zymed Digitrak<br>Plus recorder) | Digital (USB<br>transfer from the<br>"Seer Light"<br>interface) and tape | Digital (Bluetooth<br>or 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 abnormalities<br>detection | 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 and<br>printing | Yes | Yes | Yes | Yes | Yes |
| Archiving | Yes | Yes | Yes | Yes | Yes |
| Report Export | Yes | No | No | No | Yes |
| Device | Vista Plus | Spiderview | Cardio Id+<br>(RZ153+) | Digitrak Plus | Cardiospy ECG<br>Holter System |
| Afib | Yes | No | No | No | Yes |
| Events Histograms/trends | Yes | Yes | Yes | Yes | Yes |
| RR histogram | Yes | Yes | Yes | Yes | Yes |
| Editing/Printing full<br>disclosure | Yes | Yes | Yes | Yes | Yes |
| Editing tools for QRS<br>insertion/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 |

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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 : [phone] Fax : [phone] E-mail:[e-mail]

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LABTECH

Vág utca 4. H-4031, Debrecen, Hungary Phone : [phone] Fax : [phone] E-mail : [e-mail]

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