Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ECG analysis techniques (QRS detection, template analysis, ST/QT analysis, HRV) and does not mention AI or ML. The analysis is described as "automatic" but with "interactive modification possibilities," suggesting rule-based algorithms rather than adaptive learning.

Therapeutic

No
Explanation: The device is used for monitoring and analysis of cardiac data and arrhythmia, aiding in diagnosis. It does not provide treatment or modify body function, which are characteristics of therapeutic devices.

Diagnostic

Yes

The device clearly states its purpose is to "support the medical staff in analyzing and deciding the proper and adequate diagnosis" and that 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". Furthermore, its indications for use include "evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia" and "evaluation of patients for ST segment changes", all of which are diagnostic activities.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes a recorder and a USB dongle, in addition to the software. This indicates the presence of hardware components, making it a hardware and software system, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Cardiospy ECG Holter System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a patient's health.
Cardiospy Function: The Cardiospy ECG Holter System directly measures and records electrical activity of the heart from the patient's body using electrodes placed on the skin. It analyzes this data to assess cardiac rhythm and other related parameters. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's for "ambulatory (Holter) monitoring" and "prospective and retrospective cardiac data and arrhythmia analysis" based on ECG recordings from the patient.

Therefore, the Cardiospy ECG Holter System falls under the category of a medical device that directly interacts with the patient's body to acquire physiological data, rather than an IVD device that analyzes samples from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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

Product codes

MLO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

children and adults of all ages (up to 2 years)

Intended User / Care Setting

clinical, by qualified professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing of the product and its accessory proves that the following standard requirements are met:

IEC 60601-1-2 Edition 3:2007-03 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6 Edition 3.0 2010-01 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability
AAMI / ANSI / ISO 60601-2-47:2012, medical electrical equipment -- part 2-47: particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. (Cardiovascular)
AAMI / ANSI EC57:2012 Testing and reporting performance results of cardiac rhythm and st-segment measurement algorithms. (Cardiovascular)
AAMI ANSI EC53:1995/(R) 2008 ECG cables and leadwires
ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices
AAMI ANSI IEC 62304:2006 Medical device software - Software life cycle processes
ISO 15223-1 Second Edition 2012-07-01 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
AAMI ANSI ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
IEC 60601-1:2005 (Third edition) Medical electrical equipment. Part 1: General requirements for basic safety and essential performance
IEC (EN) 61000-3-2:2005 (EQV) (61000-3-2:2006 +A1+A2) Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤16 A per phase)
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 flicker in public low-voltage supply systems, for equipment with rated current

Regulation Number and Section

§ 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).

Summary

0

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

2

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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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

| Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number and
Date | Title of Standard | FR
Publication
Date | Remarks |
|-----------------------|----------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 5-53 | IEC | 60601-1-2 Edition
3:2007-03 | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests | 08/05/2013 | Was tested and certified by
TÜV Rheinland Intercert
Kft.- Product Certification
Body
1132 Budapest Váci út 48
A-B Hungary |
| 5-85 | IEC | 60601-1-6 Edition
3.0 2010-01 | Medical electrical equipment --
Part 1-6: General requirements
for basic safety and essential
performance -- Collateral
Standard: Usability | 01/30/2014 | |
| 3-127 | AAMI / ANSI /
ISO | 60601-2-47:2012, | medical electrical equipment --
part 2-47: particular
requirements for the basic
safety and essential
performance of ambulatory
electrocardiographic systems.
(Cardiovascular) | 07/09/2014 | |
| 3-118 | AAMI / ANSI | EC57:2012 | Testing and reporting
performance results of cardiac
rhythm and st-segment
measurement algorithms.
(Cardiovascular) | 01/30/2014 | |
| 3-72 | AAMI ANSI | EC53:1995/(R)
2008 | ECG cables and leadwires | 01/30/2014 | |
| 5-40 | ISO | 14971 Second
edition 2007-03-
01 | Medical devices - Application of
risk management to medical
devices | 08/20/2012 | |
| 13-32 | AAMI ANSI
IEC | 62304:2006 | Medical device software -
Software life cycle processes | 08/20/2012 | |
| 5-73 | ISO | 15223-1 Second
Edition 2012-07-
01 | Medical devices - Symbols to
be used with medical device
labels, labelling, and
information to be supplied - Part
1: General requirements | 01/15/2013 | |
| 2-181 | AAMI ANSI
ISO | 14155:2011 | Clinical investigation of medical
devices for human subjects -
Good clinical practice | 03/16/2012 | |
| Voluntary | IEC | 60601-1:2005
(Third edition) | Medical electrical equipment.
Part 1: General requirements
for basic safety and essential
performance | 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 current
emissions (equipment input
current ≤16 A per phase) | 11/01/2006 | Was tested and certified by
TÜV Rheinland Intercert
Kft.- Product Certification
Body
1132 Budapest Váci út 48
A-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 flicker
in public low-voltage supply
systems, for equipment with
rated current Dr. Béla Kincs managing director