K Number
K160746
Device Name
CARDIOLINE touchECG
Manufacturer
Date Cleared
2016-11-02

(229 days)

Product Code
Regulation Number
870.2340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
touchECG is designed to check and diagnose cardiac function. However, a physician must validate the results of the analysis run by the ECG. touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use by health professional in emergencies (ambulances). touchECG is intended to be used in conjunction with CARDIOLINE HD+ device. - The device analyzes, displays and prints out electrocardiograms. The ECG's are acquired from CARDIOLINE HD+ device. - The device interprets the data for review by a physician. - The device must be used by a physician or by health professionals on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis. - The device's interpretation of the ECG analysis is only significant if used together with an additional analysis by the physician and by an assessment of all the patient's important data. - The device can be used on adults patients. - The device must not be used as a physiological monitoring of vital signs.
Device Description
touchECG is a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function. However, the results of the analysis run by the ECG must be validated by a Cardiologist. touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use in emergencies (ambulances). touchECG is intended to be used in conjunction with CARDIOLINE HD+ device (K150289). The CARDIOLINE HD+ device is the device that acquire the ECG signal and send it, via Bluetooth, to the PC in which the touchECG software is installed. touchECG software is designed to works solely with CARDIOLINE HD+ device. The analysis of ECG traces and the automatic interpretation are performed on the PC, and must always be validated by a Cardiologist. The device can't do diagnosis by itself, but only shows the results of interpretation according to Glasgow program. The device must be used by a doctor or by specialized staff on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis. touchECG is a 12-lead diagnostic electrocardiograph which displays, acquires, prints and stores ECG traces for adults. It also calculates the principal global ECG parameters. The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with specific criteria for patients of different age, sex and race. If this option is enabled, the algorithm can provide the physician of reference with an automatic interpretation generating diagnostic messages in the ECG report. For further information on the resting ECG interpretation algorithm, see the Instruction Manual for doctors for its use with adults. In the touchECG software, the subject device, the Glasgow Interpretation Algorithm is always loaded on the device. It can be enabled or not, depends on the customer request. Only Cardioline can enable or disable the Glasgow Algorithm. In case the Glasgow is disabled the text of the automatic interpretation is not printed, but the measurements on the ECG traces are executed by the Glasgow algorithm. The device installs on any PC, tablet or notebook with the minimum requisites shown below: Operating System - Windows 7, Windows 8.1, Windows 10 Processor - Intel 15 or higher RAM - 4GB or more Free space on Hard Disk - 3GB or more Monitor - 640 x 480 pixel or more Bluetooth - Bluetooth 2.1 +EDR Printer - Laser (colour/BW) Printing paper: A4, Letter Interpretation Algorithm: Glasgow algorithm Additional applications - Email application which supports the EML format (only required for the email File Upload feature) It prints out in the following formats: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channel in automatic mode, and 3, 6 or 12 printout channels of the rhythm strip. The device doesn't have other hardware components or accessories. touchECGis intended to be used in conjunction with CARDIOLINE HD+ device (K150289 that acquires the ECG signal and transmits it. touchECG is a software medical device provided on a CD support
More Information

No
The document mentions an "Interpretation Algorithm: Glasgow algorithm" which is a known, rule-based algorithm for ECG interpretation, not typically considered AI/ML. There is no mention of AI, ML, deep learning, neural networks, or training/test data sets which are common indicators of AI/ML use in medical devices.

No
The device is described as an "interpretative electrocardiograph designed to check and diagnose cardiac function" and "is not intended as the only means for determining the diagnosis." Its purpose is diagnostic, providing data for a physician's review, not to provide therapy itself.

Yes

Explanation: The device is described as "designed to check and diagnose cardiac function" and "a 12-lead diagnostic electrocardiograph." It analyzes, displays, and interprets electrocardiograms, providing an "automatic interpretation generating diagnostic messages" which are for "review by a physician."

No

The device description explicitly states that touchECG is intended to be used in conjunction with the CARDIOLINE HD+ device (K150289), which acquires the ECG signal and transmits it. While touchECG is software, its functionality is dependent on and integrated with a specific hardware device for data acquisition.

Based on the provided information, the touchECG device is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • touchECG Function: The touchECG device analyzes, displays, and prints electrocardiograms (ECGs). ECGs are recordings of the electrical activity of the heart, acquired directly from the patient's body using electrodes. This is an in vivo measurement, not an in vitro examination of a specimen.
  • Intended Use: The intended use clearly states it's designed to "check and diagnose cardiac function" by analyzing ECGs acquired from the CARDIOLINE HD+ device, which acquires the signal from the patient.
  • Lack of Specimen Handling: There is no mention of the device handling or analyzing any biological specimens.

Therefore, the touchECG device falls under the category of a medical device used for physiological measurement and analysis, but not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

touchECG is designed to check and diagnose cardiac function. However, a physician must validate the results of the analysis run by the ECG.

touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use by health professional in emergencies (ambulances).

touchECG is intended to be used in conjunction with CARDIOLINE HD+ device.

  • The device analyzes, displays and prints out electrocardiograms. The ECG's are acquired from CARDIOLINE HD+ device.

  • The device interprets the data for review by a physician.

  • The device must be used by a physician or by health professionals on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis.

  • The device's interpretation of the ECG analysis is only significant if used together with an additional analysis by the physician and by an assessment of all the patient's important data.

  • The device can be used on adults patients.

  • The device must not be used as a physiological monitoring of vital signs.

Product codes (comma separated list FDA assigned to the subject device)

DPS

Device Description

touchECG is a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function. However, the results of the analysis run by the ECG must be validated by a cardiologist.

touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use in emergencies (ambulances).

touchECG is intended to be used in conjunction with CARDIOLINE HD+ device (K150289). The CARDIOLINE HD+ device is the device that acquire the ECG signal and send it, via Bluetooth, to the PC in which the touchECG software is installed. touchECG software is designed to works solely with CARDIOLINE HD+ device. The analysis of ECG traces and the automatic interpretation are performed on the PC, and must always be validated by a Cardiologist. The device can't do diagnosis by itself, but only shows the results of interpretation according to Glasgow program.

The device must be used by a doctor or by specialized staff on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis.

touchECG is a 12-lead diagnostic electrocardiograph which displays, acquires, prints and stores ECG traces for adults. It also calculates the principal global ECG parameters.

The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with specific criteria for patients of different age, sex and race. If this option is enabled, the algorithm can provide the physician of reference with an automatic interpretation generating diagnostic messages in the ECG report.

For further information on the resting ECG interpretation algorithm, see the Instruction Manual for doctors for its use with adults.

In the touchECG software, the subject device, the Glasgow Interpretation Algorithm is always loaded on the device. It can be enabled or not, depends on the customer request. Only Cardioline can enable or disable the Glasgow Algorithm.

In case the Glasgow is disabled the text of the automatic interpretation is not printed, but the measurements on the ECG traces are executed by the Glasgow algorithm.

The device installs on any PC, tablet or notebook with the minimum requisites shown below:

Operating System - Windows 7, Windows 8.1, Windows 10

Processor - Intel 15 or higher

RAM - 4GB or more

Free space on Hard Disk - 3GB or more

Monitor - 640 x 480 pixel or more

Bluetooth - Bluetooth 2.1 +EDR

Printer - Laser (colour/BW)

Printing paper: A4, Letter

Interpretation Algorithm: Glasgow algorithm

Additional applications - Email application which supports the EML format (only required for the email File Upload feature)

lt prints out in the following formats: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channel in automatic mode, and 3, 6 or 12 printout channels of the rhythm strip.

The device doesn't have other hardware components or accessories. touchECGis intended to be used in conjunction with CARDIOLINE HD+ device (K150289 that acquires the ECG signal and transmits it.

touchECG is a software medical device provided on a CD support

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

adults patients

Intended User / Care Setting

hospitals, clinics and outpatient departments of any size. It is suited for use by health professional in emergencies (ambulances).
physician or by health professionals on behalf of an authorized doctor in clinical facilities.

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)

Performance test are performed following the standard IEC 60601-2-25. These declared performances are applied to the software touchECG because this device is intended to be used in conjunction with the device Cardioline HD+ (K150289) to execute functions stated in the intended use of touchECG.

Then the ECG performances are to be verified and validated also for the software device touchECG using the combination of HD+ and touchECG to verify the performances of the touchECG software.

All the performances are verified also by printing the screenshot taked by the touchECG. All these screenshot are present in the file 031_510_TR_PR_TouchECG3_1402_00_eng_attachments_cardioline_touchECG.PDF and the explanation of all printed test is present on file 536 IEC60601-2-25 results performances list, both attached to the submission. The performance tested tests were passed regarding:

  • Defibrillation Protection
  • Overload Tolerance
  • Requirements for amplitude measurements
  • Interval Measurements
  • Requirements for interval measurements on biological ECGs
  • Indication of Inoperable ECG
  • Leads
  • Minimum Lead Configuration
  • Wilson Leads
  • Input Impedance
  • Required Gains
  • Common Mode Rejection
  • Line Filter Response
  • Noise Level
  • Channel Crosstalk
  • High Frequency Response
  • Low Frequency Response
  • Linearity and Dynamic Range
  • Sampling and Amplitude Quantization
  • Record Identification
  • Patient Identification
  • Recording Speed
  • Time and Amplitude Ruling
  • Use with Cardiac Pacemakers

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120865, K152902

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).

0

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

Cardioline S.p.A % Alessandro Peluso Official Correspondent Studio Tecnico Ing. Peluso Via Prati 1/2 Zola Predosa-localita Ponte Ronca- Bologna, 40069 IT

Re: K160746

Trade/Device Name: Cardioline touchECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 14, 2016 Received: April 15, 2016

Dear Alessandro Peluso:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) 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" (21 CFR 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 yours.

Minda Jellison

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) K160746

Device Name Cardioline touchECG

Indications for Use (Describe)

touchECG is designed to check and diagnose cardiac function. However, a physician must validate the results of the analysis run by the ECG.

touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use by health professional in emergencies (ambulances).

touchECG is intended to be used in conjunction with CARDIOLINE HD+ device.

  • The device analyzes, displays and prints out electrocardiograms. The ECG's are acquired from CARDIOLINE HD+ device.

  • The device interprets the data for review by a physician.

  • The device must be used by a physician or by health professionals on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis.

  • The device's interpretation of the ECG analysis is only sigmificant if used together with an additional analysis by the physician and by an assessment of all the patient's important data.

  • The device can be used on adults patients.

  • The device must not be used as a physiological monitoring of vital signs.

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)

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3

510(k) SUMMARY touchECG – K160746

1. SUBMITTER

CARDIOLINE S.p.A Via Linz 19-20-21 38121 Z.I. Spini di Gardolo (TN), Italy

T +39 0463 850125 F +39 0463 850088

Contact Person: Mr Emanuele Ercoli Date preparated: February 29, 2016

2. DEVICE

Name of Device: Cardioline touchECG Common or Usual Name: touchECG Classification Name: Electrocardiograph Regulatory Class: II Product Code: CFR 870.2340 Electrocardiograph, DPS

3. PREDICATE DEVICE

Manufacturer nameApplicant NamePredicate Device510(k) Number
Cardioline S.p.A.Cardioline S.p.A.Mortara RScribe ElectrocardiographK120865
Cardioline S.p.A.Cardioline S.p.A.Shenzhen Mindray Bio-medical
Electronics Co., Ltd - Passport Series
Patient MonitorsK152902

4

4. LIST OF APPLICABLE STANDARDS

| IEC 60601-2-25:2011 | Medical Electrical Equipment - Part 2-25: Particular Requirements For
The Basic Safety And Essential Performance Of Electrocardiographs.
(Cardiovascular) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 14971:2007+R(2010) | Medical Devices - Applications Of Risk Management To Medical Devices. |
| IEC 62304:2015 | Medical Device Software - Software Life Cycle Processes. |
| IEC 62366:2014 | Medical Devices - Application Of Usability Engineering To Medical
Devices. |

Below a complete list of applicable recognized standards that touchECG is complied:

5. DEVICE DESCRIPTION

touchECG is a multichannel interpretative electrocardiograph designed to check and diagnose cardiac function. However, the results of the analysis run by the ECG must be validated by a cardiologist.

touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use in emergencies (ambulances).

touchECG is intended to be used in conjunction with CARDIOLINE HD+ device (K150289). The CARDIOLINE HD+ device is the device that acquire the ECG signal and send it, via Bluetooth, to the PC in which the touchECG software is installed. touchECG software is designed to works solely with CARDIOLINE HD+ device. The analysis of ECG traces and the automatic interpretation are performed on the PC, and must always be validated by a Cardiologist. The device can't do diagnosis by itself, but only shows the results of interpretation according to Glasgow program.

The device must be used by a doctor or by specialized staff on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis.

touchECG is a 12-lead diagnostic electrocardiograph which displays, acquires, prints and stores ECG traces for adults. It also calculates the principal global ECG parameters.

The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with specific criteria for patients of different age, sex and race. If this option is enabled, the algorithm can provide the physician of reference with an automatic interpretation generating diagnostic messages in the ECG report.

For further information on the resting ECG interpretation algorithm, see the Instruction Manual for doctors for its use with adults.

In the touchECG software, the subject device, the Glasgow Interpretation Algorithm is always loaded on the device. It can be enabled or not, depends on the customer request. Only Cardioline can enable or disable the Glasgow Algorithm.

In case the Glasgow is disabled the text of the automatic interpretation is not printed, but the measurements on the ECG traces are executed by the Glasgow algorithm.

5

The device installs on any PC, tablet or notebook with the minimum requisites shown below:

Operating System - Windows 7, Windows 8.1, Windows 10

Processor - Intel 15 or higher

RAM - 4GB or more

Free space on Hard Disk - 3GB or more

Monitor - 640 x 480 pixel or more

Bluetooth - Bluetooth 2.1 +EDR

Printer - Laser (colour/BW)

Printing paper: A4, Letter

Interpretation Algorithm: Glasgow algorithm

Additional applications - Email application which supports the EML format (only required for the email File Upload feature)

lt prints out in the following formats: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channel in automatic mode, and 3, 6 or 12 printout channels of the rhythm strip.

The device doesn't have other hardware components or accessories. touchECGis intended to be used in conjunction with CARDIOLINE HD+ device (K150289 that acquires the ECG signal and transmits it.

touchECG is a software medical device provided on a CD support

6

6. INDICATION FOR USE

touchECG is designed to check and diagnose cardiac function. However, a physician must validate the results of the analysis run by the ECG.

touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use by health professional in emergencies (ambulances).

touchECG is intended to be used in conjunction with CARDIOLINE HD+ device.

  • -The device analyzes, displays and prints out electrocardiograms. The ECG's are acquired from CARDIOLINE HD+ device.
  • -The device interprets the data for review by a physician.
  • -The device must be used by a physician or by health professionals on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis.
  • -The device's interpretation of the ECG analysis is only significant if used together with an additional analysis by the physician and by an assessment of all the patient's important data.
  • -The device can be used on adults patients.
  • -The device must not be used as a physiological monitoring of vital signs.

7

7. TABULAR COMPARISON WITH PREDICATE DEVICES

Below the comparison table between CARDIOLINE touchECG, Mortara Rscribe Electrocardiograph and Mindray Passport 17m (12m)

| FEATURES | CARDIOLINE touchECG | Mortara Rscribe Electrocardiograph | Shenzhen Mindray Bio-medical Electronics Co., Ltd
Passport Series Patient Monitors |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
use | touchECG is designed to check and diagnose cardiac
function. However, a physician must validate the
results of the analysis run by the ECG.

touchECG is intended for use in hospitals, clinics and
outpatient departments of any size. It is suited for
use by health professional in emergencies
(ambulances).

touchECG is intended to be used in conjunction with
CARDIOLINE HD+ device.

The device analyzes, displays and prints out
electrocardiograms. The ECG's are acquired
from CARDIOLINE HD+ device.

The device interprets the data for review by
a physician.

The device must be used by a physician or
by health professionals on behalf of an
authorized doctor in clinical facilities. It is
not intended as the only means for
determining the diagnosis.

The device's interpretation of the ECG
analysis is only significant if used together
with an additional analysis by the physician
and by an assessment of all the patient's
important data.

The device can be used on adults patients. | The proposed Mortara RScribe Electrocardiograph is a
non-invasive prescription device.

The device is indicated for use to acquire,
analyze, display, transmit and print
electrocardiograms.

The device is indicated for use to provide
interpretation of the data for; consideration by
a physician.

The device is indicated for use in a clinical
setting, by a physician or by trained personnel
who are acting on the orders of a licensed
physician. It is not intended as a sole means of
diagnosis.

The interpretations of ECG offered by the
device are only significant when used in
conjunction with a physician over-read as well
as consideration of all other relevant patient
data.

The device is indicated for use on adult and
pediatric populations.

The device is not intended to be used as a vital
signs physiological monitor. | Passport 12m and 17m Patient Monitors:
The Passport 17m and Passport 12m patient monitors are
intended for monitoring, displaying, reviewing, alarming,
and transferring of multiple physiological parameters
including ECG (3-lead , 5-lead or 12-lead selectable,
arrhythmia detection, ST segment analysis, QT analysis, and
heart rate (HR)), respiration rate (Resp), temperature
(Temp), pulse oxygen saturation (SpO2), pulse rate (PR),
non-invasive blood pressure (NIBP), invasive blood
pressure(IBP), pulmonary artery wedge pressure (PAWP),
cardiac output (C.O.), continuous cardiac output (CCO),
mixed/central venous oxygen saturation (SvO2/ScvO2),
carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG),
impedance cardiograph (ICG), bispectral index (BIS), and
respiration mechanics (RM). The equipment also provides
an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult,
pediatric, and neonatal patients with the exception of the
following:
The arrhythmia detection, ST Segment analysis of
Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2,
and PAWP monitoring are intended for adult and
pediatric patients only; ST Segment analysis of Mindray algorithm is
intended for adult patients only; C.O. monitoring is restricted to adult patients
only; ICG monitoring is only for use on adult patients
who meet the following requirements: height:
122 to 229cm, weight: 30 to 155kg. |
| | The device must not be used as a
physiological monitoring of vital signs | The device is not designed for out of hospital
transport.

The device is not designed for use in highly
invasive environments, such as an operating | The monitor is to be used in healthcare facilities by clinical |
| | | theatre. | professionals or under their guidance. It should only be
used by persons who have received adequate training in its
use. It is not intended for helicopter transport, hospital
ambulance, or home use. |
| Accessory | CARDIOILINE HD+
K150289 | MORTARA WAM (Wireless Acquisition Module) or
Mortara Acquisition Module
(AM1 2) patient cables. | T1 Transport Monitor/ Module as a multi-parameter
Module |
| Target
population | Adults | Adults and Pediatric | Adults, pediatric, and neonatal |
| Safety
standards | IEC 60601-2-25 | Not specified | IEC 60601-1, IEC 60601-2-25 |
| Sampling Rate | 500 samples/second/channel | 40,000 s/sec/channel used for pacemaker spike
detection;
1000 s/sec/channel used for recording and analysis | 500 samples/s (ECG algorithm) |
| Standard
Leads which can be
analyzed | I, II, III, aVR, aVL, aVF, V1,V2,V3,V4,V5,V6 | I, II, III, aVR, aVL, aVF, V1,V2,V3,V4,V5,V6 | I, II, III, aVR, aVL, aVF, V1 to V6 |
| A/D
Conversion | Provided by auxiliary HD+ see table below | Not specified | 500 samples/s (A/D) |
| Frequence
responce | 0.05 – 150 Hz | 0.05 – 300 Hz | Diagnostic mode: 0.05 to 150 Hz
Monitor mode: 0.5 to 40 Hz
Surgical mode: 1 to 20 Hz
ST mode: 0.05 to 40 Hz |
| Front-end
performance | ANSI/AAMI IEC 60601-2-25:2011 | Not specified | IEC 60601-2-25 |
| Data transfer | Bluetooth 2.0+ with “secure pairing” using external
hardware | Wireless | Not provided in Passport 17m device
Wi Fi in Passport 12m device |
| Operating
system | touchECG can be installed on a
PC/TABLET/NOTEBOOK with Windows 7, Windows
8.1, Windows 10 | Window 7 professional 32 or 64 bits | Proprietary system |
| Lead-fail
detection | Independent for all leads | Not specified | Not specified |
| Cardiac
frequency
range | 30 - 300 bpm | Not specified | 15 – 350 bpm |
| ECG
measurements | All leads, medians, corrected | Simultaneous acquisition of all 12 leads | Simultaneous acquisition of 3, 5, 12 leads |
| ECG
acquisition
mode | Automatic (12 leads), Manual (3/6 leads), Review (12
leads) | Not specified | 3-lead: I, II, III
5-lead: I, II, III, aVR, aVL, aVF, V
12-lead: I, II, III, aVR, aVL, aVF, V1 to V6 |
| Lead | Standard, Cabrera | Standard or Cabrera | Standard or Cabrera |
| configuration | | | |
| ECG
interpretation | Glasgow algorithm for adults, STEMI (included in
Glasgow algorithm) | Mortara VERITAS resting ECG interpretation algorithm
with age and gender specific criteria; connectivity with
bidirectional communication | Diagnostic 12-Lead ECG. Interpretation with Glasgow
Algorithm |
| | | | |
| | | | |
| Exported
formats | SCP-PDF-GDT: Standard format | Experience the benefits of bidirectional communication
with third party systems including EMR, HIS, and PACS
via XML, PDF, and DICOM®. RScribe 5 also integrates
with Athena, Mortara's multi-modality report repository,
enabling convenient storage of ECG data. | HL7 export |
| | HL7: Optional | | |
| | | | |
| Printing | Variable in relation to printer
Format: A4
Sensitivity: 5, 10, 20 mV/mm
Automatic print speed: 25, 50 mm/s
Automatic print: 3, 3+1, 6, 12 channels; Standard or
Cabrera;
Automatic print formats: 12x1, 6x2, 3x4, 3x4+1,
3x4+3
Manual print speed: 5, 10, 25, 50 mm/sec
Manual printing: 3, 6, 12 channels; Standard or
Cabrera;
Manual print formats: 12x1, 6+6, 3x1

Letter paper | HP 2055DN or HP Enterprise M601 with HPUPD PCL 5
driver or equivalent | Paper: A4, Letter |

8

9

FEATURES RELATED TO CARDIOLINE HD+, the accessory which is intended to be used in conjunction with the subject device touchECG

FEATURESCARDIOLINE HD+Mortara Rscribe ElectrocardiographShenzhen Mindray Bio-medical Electronics Co., Ltd Passport Series Patient Monitors
Accessory of subject deviceCARDIOILINE HD+
K150289MORTARA WAM (Wireless Acquisition Module) or
Mortara Acquisition Module
(AM1 2) patient cables.T1 Transport Monitor/ Module as a multi-parameter
Module
Target
populationAdultsAdults and PediatricAdults, pediatric, and neonatal
Safety
standardsIEC 60601-2-25Not specifiedIEC 60601-1, IEC 60601-2-25
ECG Leads12-leads (I, II, III, aVR-L-F, V1-6)12-leads (I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6)3-lead: I, II, III
5-lead: I, II, III, aVR, aVL, aVF, V
12-lead: I, II, III, aVR, aVL, aVF, V1 to V6
Sampling Rate500 samples/second/channel40,000 s/sec/channel used for pacemaker spike
detection;
1000 s/sec/channel used for recording and analysis500 samples/s (ECG algorithm)
Standard
Leads
AcquiredI, II, III, aVR, aVL, aVF, V1,V2,V3,V4,V5,V6I, II, III, aVR, aVL, aVF, V1,V2,V3,V4,V5,V6I, II, III, aVR, aVL, aVF, V1 to V6
A/D
ConversionNot provided by software touchECG.
Provided by auxiliary HD+ device: 24 bit, 32 KHzNot specified500 samples/s (A/D)
Frequency
responce0.05 – 150 Hz0.05 – 300 HzDiagnostic mode: 0.05 to 150 Hz
Monitor mode: 0.5 to 40 Hz
Surgical mode: 1 to 20 Hz
ST mode: 0.05 to 40 Hz
Defibrillator
ProtectionAAMI/IEC standardNot specifiedAHA, IEC
Pacemaker
detectionHardware detection coupled with digital convolution
filterHardware detectionPresent
Mains Power
SupplyBattery operated100 – 240 VAC at 50/60 Hz100 to 240 VAC, 50/60 Hz
2 batteries 11.1 Vdc, 4500 mAh
Front-end
performanceANSI/AAMI IEC 60601-2-25:2011Not specifiedIEC 60601-2-25
Data transferBluetooth 2.0+ with "secure pairing"WirelessNot provided in Passport 17m device
Wi Fi in Passport 12m device
Lead-fail
detectionIndependent for all leadsNot specifiedNot specified
Cardiac
frequency
range30 - 300 bpmNot specified15 – 350 bpm
AC filterAdaptive 50/60 Hz digital filter40 Hz and 150 Hz noise filters;50/60 Hz
Monitor, ST and surgical mode: Notch turns on
automatically.
Diagnostic mode: Notch is turned on/off manually
ECG
measurementsAll leads, medians, correctedSimultaneous acquisition of all 12 leadsSimultaneous acquisition of 3, 5, 12 leads
ECG
acquisition
modeAutomatic (12 leads), Manual (3/6 leads), Review (12 leads)Not specified3-lead: I, II, III
5-lead: I, II, III, aVR, aVL, aVF, V
12-lead: I, II, III, aVR, aVL, aVF, V1 to V6
Lead
configurationStandard, CabreraStandard or CabreraStandard or Cabrera

10

510(k) SUMMARY touchECG – K160746

11

8. PERFORMANCE DATA

Performance test are performed following the standard IEC 60601-2-25. These declared performances are applied to the software touchECG because this device is intended to be used in conjunction with the device Cardioline HD+ (K150289) to execute functions stated in the intended use of touchECG.

Then the ECG performances are to be verified and validated also for the software device touchECG using the combination of HD+ and touchECG to verify the performances of the touchECG software.

All the performances are verified also by printing the screenshot taked by the touchECG. All these screenshot are present in the file 031_510_TR_PR_TouchECG3_1402_00_eng_attachments_cardioline_touchECG.PDF and the explanation of all printed test is present on file 536 IEC60601-2-25 results performances list, both attached to the submission. The performance tested tests were passed regarding:

  • 트 Defibrillation Protection
  • " Overload Tolerance
  • 트 Requirements for amplitude measurements
  • Interval Measurements
  • 트 Requirements for interval measurements on biological ECGs
  • 트 Indication of Inoperable ECG
  • 트 Leads
  • Minimum Lead Configuration
  • Wilson Leads
  • I Input Impedance
  • 트 Required Gains
  • 트 Common Mode Rejection
  • 트 Line Filter Response
  • Noise Level
  • Channel Crosstalk
  • High Frequency Response
  • 트 Low Frequency Response
  • I Linearity and Dynamic Range
  • 트 Sampling and Amplitude Quantization
  • 트 Record Identification
  • 트 Patient Identification
  • 트 Recording Speed
  • Time and Amplitude Ruling
  • " Use with Cardiac Pacemakers

12

9. CONCLUSION

The performance of touchECG are basically similar to the predicate and are summarized in table above. Like Mortara RScribe, the subject device touchECG, has the same hardware/software architecture: the ECG acquisition is on the acquisition module (HD+ for touchECG and WAM or AM12 for RScribe), interpretation is on board of the software on the PC (or notebook and tablet for CARDIOLINE touchECG). The interpretation algorithm is the same used in the predicate device Mindray Passport Series, the Glasgow Interpretation algorithm.

touchECG has similar wireless communication method between the interpreter and the acquirer of the Mortara Rscribe

touchECG has the same interpretation algorithm of Mindray Passport Series, the Glasgow Interpretation algorithm.

The Standards Leads Acquired are the same for touchECG and both predicates devices.

The intended use of CARDIOLINE touchECG is the same of Mortara RScribe.

The conclusions drawn from the nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in the substantial equivalence. touchECG is a complete electrocardiograph with the acquisition device and with an analysis, diagnosis and monitoring features.