(229 days)
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.
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
The provided text describes the Cardioline touchECG, an interpretative electrocardiograph intended for use with the CARDIOLINE HD+ device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that performance tests were conducted following IEC 60601-2-25:2011, suggesting that compliance with this standard serves as the primary acceptance criterion. The text then lists specific performance aspects that "were passed."
| Acceptance Criteria (Derived from IEC 60601-2-25) | Reported Device Performance |
|---|---|
| Defibrillation Protection | Passed |
| Overload Tolerance | Passed |
| Requirements for amplitude measurements | Passed |
| Interval Measurements | Passed |
| Requirements for interval measurements on biological ECGs | Passed |
| Indication of Inoperable ECG | Passed |
| Leads | Passed |
| Minimum Lead Configuration | Passed |
| Wilson Leads | Passed |
| Input Impedance | Passed |
| Required Gains | Passed |
| Common Mode Rejection | Passed |
| Line Filter Response | Passed |
| Noise Level | Passed |
| Channel Crosstalk | Passed |
| High Frequency Response | Passed |
| Low Frequency Response | Passed |
| Linearity and Dynamic Range | Passed |
| Sampling and Amplitude Quantization | Passed |
| Record Identification | Passed |
| Patient Identification | Passed |
| Recording Speed | Passed |
| Time and Amplitude Ruling | Passed |
| Use with Cardiac Pacemakers | Passed |
2. Sample size used for the test set and the data provenance:
The document states: "Performance test are performed following the standard IEC 60601-2-25." It then mentions that these tests were verified by "printing the screenshot taked by the touchECG," and that "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."
- Sample Size for Test Set: The number of test cases or ECGs used for the performance verification is not explicitly stated in the provided text. It only refers to a "file 536 IEC60601-2-25 results performances list" which would presumably contain this detail.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. The testing appears to be primarily technical performance verification against a standard, not necessarily involving a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The performance tests described (e.g., defibrillation protection, noise level, linearity) are typically evaluated against technical specifications within the IEC 60601-2-25 standard, rather than requiring expert adjudication of clinical ground truth for each test case.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided as the performance tests outlined against IEC 60601-2-25 are typically objective measurements against technical criteria rather than consensus-based adjudication.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device's interpretation algorithm (Glasgow algorithm) is present, but no study on its comparative effectiveness with or without AI assistance for human readers is described. The device's interpretation is explicitly stated to always be validated by a cardiologist and is "not intended as the only means for determining the diagnosis," suggesting a human-in-the-loop workflow, but without a formal study on its impact.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document states: "The device interprets the data for review by a physician." and "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." This strongly implies that the device is not intended or validated for standalone performance in a diagnostic context. Its role is to provide an interpretation that a physician must validate. While the Glasgow algorithm provides an interpretation, its performance in isolation is not separately evaluated or presented as a standalone diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the technical performance verification against IEC 60601-2-25, the "ground truth" would be the technical requirements defined by the standard itself (e.g., a specific frequency response range, a maximum noise level).
For the embedded Glasgow interpretation algorithm, the document does not describe how its internal ground truth was established, only that it is the "same interpretation algorithm of Mindray Passport Series." The document does not provide details on the validation of the Glasgow algorithm itself, only the overall device's compliance with a technical standard.
8. The sample size for the training set:
The document mentions that the device uses the "Glasgow Interpretation Algorithm." However, no information is provided regarding the training set size for this algorithm, nor for any other machine learning component within the touchECG for which training would be applicable. The document focuses on the integrated device performance, not the internal development or training of the interpretation algorithm.
9. How the ground truth for the training set was established:
Since the document does not provide information on the training set for the Glasgow Interpretation Algorithm, it also does not describe how the ground truth for any such training set was established.
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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
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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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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 name | Applicant Name | Predicate Device | 510(k) Number |
|---|---|---|---|
| Cardioline S.p.A. | Cardioline S.p.A. | Mortara RScribe Electrocardiograph | K120865 |
| Cardioline S.p.A. | Cardioline S.p.A. | Shenzhen Mindray Bio-medicalElectronics Co., Ltd - Passport SeriesPatient Monitors | K152902 |
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4. LIST OF APPLICABLE STANDARDS
| IEC 60601-2-25:2011 | Medical Electrical Equipment - Part 2-25: Particular Requirements ForThe 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 MedicalDevices. |
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., LtdPassport Series Patient Monitors |
|---|---|---|---|
| Indication foruse | touchECG is designed to check and diagnose cardiacfunction. However, a physician must validate theresults of the analysis run by the ECG.touchECG is intended for use in hospitals, clinics andoutpatient departments of any size. It is suited foruse by health professional in emergencies(ambulances).touchECG is intended to be used in conjunction withCARDIOLINE HD+ device.The device analyzes, displays and prints outelectrocardiograms. The ECG's are acquiredfrom CARDIOLINE HD+ device.The device interprets the data for review bya physician.The device must be used by a physician orby health professionals on behalf of anauthorized doctor in clinical facilities. It isnot intended as the only means fordetermining the diagnosis.The device's interpretation of the ECGanalysis is only significant if used togetherwith an additional analysis by the physicianand by an assessment of all the patient'simportant data.The device can be used on adults patients. | The proposed Mortara RScribe Electrocardiograph is anon-invasive prescription device.The device is indicated for use to acquire,analyze, display, transmit and printelectrocardiograms.The device is indicated for use to provideinterpretation of the data for; consideration bya physician.The device is indicated for use in a clinicalsetting, by a physician or by trained personnelwho are acting on the orders of a licensedphysician. It is not intended as a sole means ofdiagnosis.The interpretations of ECG offered by thedevice are only significant when used inconjunction with a physician over-read as wellas consideration of all other relevant patientdata.The device is indicated for use on adult andpediatric populations.The device is not intended to be used as a vitalsigns physiological monitor. | Passport 12m and 17m Patient Monitors:The Passport 17m and Passport 12m patient monitors areintended for monitoring, displaying, reviewing, alarming,and transferring of multiple physiological parametersincluding ECG (3-lead , 5-lead or 12-lead selectable,arrhythmia detection, ST segment analysis, QT analysis, andheart rate (HR)), respiration rate (Resp), temperature(Temp), pulse oxygen saturation (SpO2), pulse rate (PR),non-invasive blood pressure (NIBP), invasive bloodpressure(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), andrespiration mechanics (RM). The equipment also providesan interpretation of resting 12-lead ECG.All the parameters can be monitored on single adult,pediatric, and neonatal patients with the exception of thefollowing:The arrhythmia detection, ST Segment analysis ofMortara algorithm, BIS, RM, CCO, SvO2/ScvO2,and PAWP monitoring are intended for adult andpediatric patients only; ST Segment analysis of Mindray algorithm isintended for adult patients only; C.O. monitoring is restricted to adult patientsonly; ICG monitoring is only for use on adult patientswho meet the following requirements: height:122 to 229cm, weight: 30 to 155kg. |
| The device must not be used as aphysiological monitoring of vital signs | The device is not designed for out of hospitaltransport.The device is not designed for use in highlyinvasive 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 beused by persons who have received adequate training in itsuse. It is not intended for helicopter transport, hospitalambulance, or home use. | ||
| Accessory | CARDIOILINE HD+K150289 | MORTARA WAM (Wireless Acquisition Module) orMortara Acquisition Module(AM1 2) patient cables. | T1 Transport Monitor/ Module as a multi-parameterModule |
| Targetpopulation | Adults | Adults and Pediatric | Adults, pediatric, and neonatal |
| Safetystandards | 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 spikedetection;1000 s/sec/channel used for recording and analysis | 500 samples/s (ECG algorithm) |
| StandardLeads which can beanalyzed | 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/DConversion | Provided by auxiliary HD+ see table below | Not specified | 500 samples/s (A/D) |
| Frequenceresponce | 0.05 – 150 Hz | 0.05 – 300 Hz | Diagnostic mode: 0.05 to 150 HzMonitor mode: 0.5 to 40 HzSurgical mode: 1 to 20 HzST mode: 0.05 to 40 Hz |
| Front-endperformance | ANSI/AAMI IEC 60601-2-25:2011 | Not specified | IEC 60601-2-25 |
| Data transfer | Bluetooth 2.0+ with “secure pairing” using externalhardware | Wireless | Not provided in Passport 17m deviceWi Fi in Passport 12m device |
| Operatingsystem | touchECG can be installed on aPC/TABLET/NOTEBOOK with Windows 7, Windows8.1, Windows 10 | Window 7 professional 32 or 64 bits | Proprietary system |
| Lead-faildetection | Independent for all leads | Not specified | Not specified |
| Cardiacfrequencyrange | 30 - 300 bpm | Not specified | 15 – 350 bpm |
| ECGmeasurements | All leads, medians, corrected | Simultaneous acquisition of all 12 leads | Simultaneous acquisition of 3, 5, 12 leads |
| ECGacquisitionmode | Automatic (12 leads), Manual (3/6 leads), Review (12leads) | Not specified | 3-lead: I, II, III5-lead: I, II, III, aVR, aVL, aVF, V12-lead: I, II, III, aVR, aVL, aVF, V1 to V6 |
| Lead | Standard, Cabrera | Standard or Cabrera | Standard or Cabrera |
| configuration | |||
| ECGinterpretation | Glasgow algorithm for adults, STEMI (included inGlasgow algorithm) | Mortara VERITAS resting ECG interpretation algorithmwith age and gender specific criteria; connectivity withbidirectional communication | Diagnostic 12-Lead ECG. Interpretation with GlasgowAlgorithm |
| Exportedformats | SCP-PDF-GDT: Standard format | Experience the benefits of bidirectional communicationwith third party systems including EMR, HIS, and PACSvia XML, PDF, and DICOM®. RScribe 5 also integrateswith Athena, Mortara's multi-modality report repository,enabling convenient storage of ECG data. | HL7 export |
| HL7: Optional | |||
| Printing | Variable in relation to printerFormat: A4Sensitivity: 5, 10, 20 mV/mmAutomatic print speed: 25, 50 mm/sAutomatic print: 3, 3+1, 6, 12 channels; Standard orCabrera;Automatic print formats: 12x1, 6x2, 3x4, 3x4+1,3x4+3Manual print speed: 5, 10, 25, 50 mm/secManual printing: 3, 6, 12 channels; Standard orCabrera;Manual print formats: 12x1, 6+6, 3x1Letter paper | HP 2055DN or HP Enterprise M601 with HPUPD PCL 5driver or equivalent | Paper: A4, Letter |
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FEATURES RELATED TO CARDIOLINE HD+, the accessory which is intended to be used in conjunction with the subject device touchECG
| FEATURES | CARDIOLINE HD+ | Mortara Rscribe Electrocardiograph | Shenzhen Mindray Bio-medical Electronics Co., Ltd Passport Series Patient Monitors |
|---|---|---|---|
| Accessory of subject device | CARDIOILINE HD+K150289 | MORTARA WAM (Wireless Acquisition Module) orMortara Acquisition Module(AM1 2) patient cables. | T1 Transport Monitor/ Module as a multi-parameterModule |
| Targetpopulation | Adults | Adults and Pediatric | Adults, pediatric, and neonatal |
| Safetystandards | IEC 60601-2-25 | Not specified | IEC 60601-1, IEC 60601-2-25 |
| ECG Leads | 12-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, III5-lead: I, II, III, aVR, aVL, aVF, V12-lead: I, II, III, aVR, aVL, aVF, V1 to V6 |
| Sampling Rate | 500 samples/second/channel | 40,000 s/sec/channel used for pacemaker spikedetection;1000 s/sec/channel used for recording and analysis | 500 samples/s (ECG algorithm) |
| StandardLeadsAcquired | 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/DConversion | Not provided by software touchECG.Provided by auxiliary HD+ device: 24 bit, 32 KHz | Not specified | 500 samples/s (A/D) |
| Frequencyresponce | 0.05 – 150 Hz | 0.05 – 300 Hz | Diagnostic mode: 0.05 to 150 HzMonitor mode: 0.5 to 40 HzSurgical mode: 1 to 20 HzST mode: 0.05 to 40 Hz |
| DefibrillatorProtection | AAMI/IEC standard | Not specified | AHA, IEC |
| Pacemakerdetection | Hardware detection coupled with digital convolutionfilter | Hardware detection | Present |
| Mains PowerSupply | Battery operated | 100 – 240 VAC at 50/60 Hz | 100 to 240 VAC, 50/60 Hz2 batteries 11.1 Vdc, 4500 mAh |
| Front-endperformance | ANSI/AAMI IEC 60601-2-25:2011 | Not specified | IEC 60601-2-25 |
| Data transfer | Bluetooth 2.0+ with "secure pairing" | Wireless | Not provided in Passport 17m deviceWi Fi in Passport 12m device |
| Lead-faildetection | Independent for all leads | Not specified | Not specified |
| Cardiacfrequencyrange | 30 - 300 bpm | Not specified | 15 – 350 bpm |
| AC filter | Adaptive 50/60 Hz digital filter | 40 Hz and 150 Hz noise filters; | 50/60 HzMonitor, ST and surgical mode: Notch turns onautomatically.Diagnostic mode: Notch is turned on/off manually |
| ECGmeasurements | All leads, medians, corrected | Simultaneous acquisition of all 12 leads | Simultaneous acquisition of 3, 5, 12 leads |
| ECGacquisitionmode | Automatic (12 leads), Manual (3/6 leads), Review (12 leads) | Not specified | 3-lead: I, II, III5-lead: I, II, III, aVR, aVL, aVF, V12-lead: I, II, III, aVR, aVL, aVF, V1 to V6 |
| Leadconfiguration | Standard, Cabrera | Standard or Cabrera | Standard or Cabrera |
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510(k) SUMMARY touchECG – K160746
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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
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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.
§ 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).