Who is the manufacturer of CARDIOLINE touchECG?

Cardioline S.P.A filed the 510(k) submission for CARDIOLINE touchECG (K160746).

What is the FDA product code for CARDIOLINE touchECG?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CARDIOLINE touchECG?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CARDIOLINE touchECG?

Mortara RScribe Electrocardiograph (K120865); Shenzhen Mindray Bio-medical Electronics Co., Ltd - Passport Series Patient Monitors (K152902).

Who can help prepare an FDA 510(k) submission like CARDIOLINE touchECG?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CARDIOLINE touchECG

K160746 · Cardioline S.P.A · DPS · Nov 2, 2016 · Cardiovascular

Device Facts

Record ID	K160746
Device Name	CARDIOLINE touchECG
Applicant	Cardioline S.P.A
Product Code	DPS · Cardiovascular
Decision Date	Nov 2, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	Software as a Medical Device

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 Story

Software-based 12-lead diagnostic electrocardiograph; operates on PC/tablet/notebook (Windows OS). Inputs: ECG signals acquired via Bluetooth from external CARDIOLINE HD+ device (K150289). Processing: Glasgow resting ECG interpretation algorithm (optional/configurable) performs automatic analysis and measurement of ECG traces. Output: Displayed and printed ECG reports with diagnostic messages. Usage: Clinical facilities/ambulances; operated by physicians or specialized staff. Physician validates all automated interpretations and measurements against patient data. Benefits: Facilitates cardiac function diagnosis; provides automated interpretation support for clinical decision-making.

Clinical Evidence

Bench testing only. Performance verified against IEC 60601-2-25 standards, including defibrillation protection, overload tolerance, amplitude/interval measurements, input impedance, common mode rejection, noise level, and pacemaker detection. No clinical data presented.

Technological Characteristics

Software-based ECG; requires CARDIOLINE HD+ acquisition module. Connectivity: Bluetooth 2.1+EDR. Platform: PC/tablet/notebook (Windows 7/8.1/10). Standards: IEC 60601-2-25, ISO 14971, IEC 62304, IEC 62366. Interpretation: Glasgow algorithm (rule-based/parameter-based). Printing: A4/Letter laser printer.

Indications for Use

Indicated for adult patients in hospitals, clinics, outpatient departments, and emergency settings (ambulances) to check and diagnose cardiac function via 12-lead ECG analysis. Not for use as a physiological monitor of vital signs.

Regulatory Classification

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.

Predicate Devices

Mortara RScribe Electrocardiograph (K120865)
Shenzhen Mindray Bio-medical Electronics Co., Ltd - Passport Series Patient Monitors (K152902)

Reference Devices

CARDIOLINE HD+ (K150289)

Related Devices

K173830 — MAC VU360 Resting ECG Analysis System · Ge Medical Systems Information Technologies, Inc. · Sep 18, 2018
K103640 — MIDMARK IQECG · Brentwood Medical Technology Corp. · Mar 22, 2011
K160840 — ECG100+, ECG200+ · Cardioline S.P.A · Aug 12, 2016
K974352 — CARDIOVIEW 3000 SOFTWARE · Micromedical, Inc. · Sep 8, 1998
K221321 — MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System · Ge Medical Systems Information Technologies, Inc. · Oct 18, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services. 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 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-medical Electronics Co., Ltd - Passport Series Patient Monitors | K152902 | {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…