ECG100+, ECG200+

K160840 · Cardioline S.P.A · DPS · Aug 12, 2016 · Cardiovascular

Device Facts

• Record ID: K160840
• Device Name: ECG100+, ECG200+
• Applicant: Cardioline S.P.A
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ECGxxx(z)(+) is a high-performance, multi-channel, interpretative resting electrocardiograph. The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer. ECGxxx(z)(+) is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician. ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and doctor's offices of any size. - The device is indicated for use to acquire, analyse, display and print electrocardiograms. - The device is intended to provide the physician with an automatic interpretation of the ECG to be reviewed 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 overread 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.

Device Story

ECG100+ and ECG200+ are 12-lead resting electrocardiographs. Input: 12-lead ECG signals via 10-wire patient cable. Processing: Real-time display on integrated LCD; optional Glasgow resting ECG interpretation algorithm (age/sex/race-specific criteria) provides diagnostic messages. Output: Printed ECG reports (thermal printer), stored traces (up to 1000), or digital export (USB/LAN/DICOM/HL7). Used in hospitals/clinics by physicians or trained personnel. Output supports physician diagnosis; requires mandatory physician overread. Benefits: Automated interpretation and standardized reporting for cardiac function assessment.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60601-2-25 (performance), and EN 60601-1-2 (EMC) verified. Performance testing included defibrillation protection, input impedance, CMRR, filter response, and pacemaker detection.

Technological Characteristics

12-lead resting ECG; 24-bit A/D conversion; 32 kHz sampling; 0.05-150 Hz bandwidth; >100 dB CMRR. Features: 4.3" or 7" color LCD, thermal printer (8 dot/mm), mechanical keypad. Connectivity: USB, LAN (optional). Power: AC/battery (NiMH). Standards: IEC 60601-1, IEC 60601-2-25, AAMI/ANSI/AHA/ACC.

Indications for Use

Indicated for adult and pediatric patients for the acquisition, analysis, display, and printing of 12-lead resting electrocardiograms in clinical settings (hospitals, clinics, doctor's offices). Not intended as a vital signs monitor or sole diagnostic tool; requires physician overread.

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

• ET MEDICAL DEVICES SPA AR 1200 (K051534)
• MORTARA INSTRUMENTS INC. ELI 250 (K101403)

Submission Summary (Full Text)

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DEPARTMENT

Public Health Service

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

August 12, 2016

Cardioline S.p.A Mr. Alessandro Peluso Official Correspondent Via Prati 1/2 Zola Predosa-localita Ponte Ronca-bologna, 40069 IT

Re: K160840 Trade/Device Name: ECG100+, ECG200+ Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: March 11, 2016 Received: April 6, 2016

Dear Mr. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160840

Device Name ECG100+, ECG200+

### Indications for Use (Describe)

ECGxxx(z)(+) is a high-performance, multi-channel, interpretative resting electrocardiograph.

The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer.

ECGxxx(z)(+) is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.

ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and doctor's offices of any size.

- The device is indicated for use to acquire, analyse, display and print electrocardiograms.

- The device is intended to provide the physician with an automatic interpretation of the ECG to be reviewed 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 overread 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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### K160840

#### 510(k) SUMMARY ECGxxx(z)(+)

### 1. SUBMITTER

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

T [phone] F [phone]

Contact Person: Mr Emanuele Ercoli Date preparated: September 15, 2015

# 2. DEVICE

Name of Device: Cardioline ECGxxx(z)(+) Common or Usual Name: ECGxxx(z)(+) Electrocardiograph Model name: ECG100+, ECG200+ 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. | ET MEDICAL DEVICES SPA | K051534 |
| Cardioline S.p.A. | Cardioline S.p.A. | MORTARA INSTRUMENTS INC. | K101403 |

#### 4. DEVICE DESCRIPTION

ECGxxx(z)(+) is a family of high-performance, multi-channel, interpretative resting electrocardiograph. ECG100+ and ECG200+ are two models of that electrocardiographs family.

The device is a 12-lead diagnostic electrocardiograph which displays, acquires, prints and stores EGG tracings for adults and children. It also calculates the main overall ECG parameters.

The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with specific criteria by age, sex and race. If this option is enabled, the algorithm can provide an over-reading physician with a second opinion generating diagnostic messages in the ECG report.

For further information on the resting ECG interpretation algorithm, see the Guidance for the physician on the application on adults and children (see accessories list)

The device can be configured with a larger memory, with bidirectional connectivity (LAN) and with DICOM® functionality.

The device can be powered by battery or the electrical mains.

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The printing formats supported include: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channels in automatic mode and 3, 6 or 12 (only for ECG200+) channels rhythm strip printing.

The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyze and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer.

ECGxxx(z)(+) is intended for control and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Cardiologist.

ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and offices of any size.

ECGxxx(z)(+) is a family of electrocardiographs which are a 12-lead diagnostic electrocardiographs and which are intended to displays, acquires, prints and stores ECG tracings for adults and children. It also calculates the main overall ECG parameters.

The devices have the following characteristics:

- mains and internal battery operation
- manual and automatic acquisition of the 12 Standards Leads
- simultaneous acquisition of the 12 Standards Leads
- internal storage up to 100 ECGs. Can storage up to 1000 ECGs optionally
- multichannel ECG printout on thermal paper:
- a) (for ECG100+) 3, 6 channels, 5/10/25/50 mm/s
- b) (for ECG200+) 3, 6 or 12 channels, 5/10/25/50 mm/s
- high resolution thermal printer:
- a) (for ECG100+) 8 dot/mm 108mm; Z-fold 100x150mm
- b) (for ECG200+) 8 dot/mm 216mm; A4 Z-fold
- for autoprint mode:
- a) (for ECG100+) Standard or Cabrera; 3, 3+1, 6 channels Patient Demographic, Global Measurements, Optional Interpretation (Glasgow University - Prof. MacFarlane) Adult, Paediatric, STEMI
- b) (for ECG200+) Standard or Cabrera; 3, 3+1, 6, 12 channels Patient Demographic, Global Measurements, Optional Interpretation (Glasgow University - Prof. MacFarlane) Adult, Pediatric, STEMI
- display:
- a) (for ECG100+) Backlit, colour LCD display, 4.3" ECG waveform real-time tracing
- b) (for ECG200+) 7" backlit LCD colour display, displays the ECG waves in real time
- Keyboard (for both devices): Mechanical keypad with alphanumeric keys and special function keys -
- filters (for both devices): diagnostic fully digital high pass filter; adaptive digital AC interference filter (50/60 Hz); digital low pass filter muscular filter 25 and 40 Hz (only for display and printing)
- connectivity (for both devices): USB device and LAN (optional)
- patient cable (for both devices): standard 15D, 10-wires
- -Data export (for both devices): SCP (standard format), XML-PDF-GDT (included in standard connectivity option), DICOM (included in DICOM connectivity option), HL7 (optional).

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More specifically, the equipment family is based on two model variants characterized by different print and display capabilities.

Both devices offers full ECG acquisition meeting the standards used in clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). When battery powered both devices have a duration of more than 500 ECGs and the recharging time is 4 hours to 85% of full charge.

The package includes (for both devices):

- 1. Patient cable
- 2. AC Power supply (100-240 VAC 50/60 Hz)
- 3. Paper
- 4. Pack of electrodes
- 5. Banana/clip adapter set
- 6. Guidance for the physician on the application on adults and children (with interpretative key)
- 7. User manual

The common family name is ECGxxx(z)(+). Where:

xxx = printer size

- + = model with network connectivity
- z = models with different interfaces

(refer to Technical File for more details)

The results of the analysis must always be validated by qualified, trained medical personnel and the devices are intended for use in a medical environment. ECG100+ and ECG200+ are intended to be used on adult and all pediatric patients. The devices must be handled with care by taking all the necessary precautions in order to prevent and avoid shocks, vibrations, heat sources, liquids and anything else that may damage it.

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# 5. INDICATION FOR USE

ECGxxx(z)(+) is a high-performance, multi-channel, interpretative resting electrocardiograph.

The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer.

ECGxxx(z)(+) is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.

ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and doctor's offices of any size.

- -The device is indicated for use to acquire, analyse, display and print electrocardiograms.
- । The device is intended to provide the physician with an automatic interpretation of the ECG to be reviewed 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.

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# 6. TABULAR COMPARISON WITH PREDICATE DEVICES

For the comparison below, are present two tables:

TABLE 1: the ECG100+ is compared with AR 1200 of ET MEDICAL and ELI 250 of MORTARA INSTRUMENTS INC.

TABLE 2: the ECG200+ is compared with AR 2100 of ET MEDICA and ELI 250 of MORTARA INSTRUMENTS INC.

| FEATURES | CARDIOLINE ECG100+ | AR 1200 | ELI 250 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>use | ECGxxx(z)(+) is a high-<br>performance, multi-channel,<br>interpretative resting<br>electrocardiograph.<br>The ECG signal is acquired with a<br>10-wires patient cable and is<br>displayed in real time on a LCD<br>screen integrated in the device.<br>The electrocardiograph can<br>analyse and store the ECG traces,<br>send them to an external<br>peripheral via network or via USB,<br>print the 12 lead ECG in automatic<br>or manual mode by means of a<br>thermal printer.<br>ECGxxx(z)(+) is intended for<br>assessment and diagnosis of<br>cardiac functions. In any case the<br>results of analysis performed by<br>the electrocardiograph must be<br>validated by a Physician.<br>ECGxxx(z)(+) is intended for use in<br>hospitals, in medical clinics and<br>doctor's offices of any size.<br>- The device is indicated<br>for use to acquire,<br>analyse, display and<br>print<br>electrocardiograms.<br>- The device is intended to<br>provide the physician<br>with an automatic<br>interpretation of the<br>ECG to be reviewed by a<br>physician.<br>- The device is indicated<br>for use in a clinical<br>setting, by a physician or<br>by trained personnel<br>who are acting on the<br>orders of a licensed<br>physician. It is not<br>intended as a sole<br>means of diagnosis.<br>- The interpretations of<br>ECG offered by the<br>device are only<br>significant when used in<br>conjunction with a<br>physician over-read as | CARDIOLINE AR 600 and AR 1200 and<br>AR 2100 are a family of<br>electrocardiograph recorders<br>provided with a program for<br>automated ecg analysis and with a<br>graphic LCD display.<br>The equipments are intended for use<br>in routine ecg recording in physician<br>practice and/or hospital. The<br>electrical heart activity is detected by<br>means of two or more<br>electrocardiograph electrodes and is<br>recorded on thermal paper.<br>Intended use for non interpretive<br>applications covers the full range of<br>patient population with no<br>limitations with respect to age, sex<br>and race of the patient.<br>The interpretation program is<br>intended to provide a diagnostic<br>support to the physician for the ecg<br>evaluation on rhythm and<br>morphology.<br>Interpretation Statements must be<br>overviewed and approved by trained<br>Physician's. Interpretation<br>statements just represent a partial<br>qualitative and quantitative<br>information of the general patient<br>cardiovascular condition: no therapy<br>or drugs can be subministrated<br>based solely on Interpretation<br>statements.<br>The equipments are intended to be<br>used by trained medical personnel or<br>physician's.<br>Indication for use of the modified<br>device has not been changed with<br>respect to the predicate device AB<br>CARDIETTE DAEDALUS VIEW base<br>and Hes K002074. | - The device is indicated for<br>use to acquire, analyze,<br>display and print<br>electrocardiograms.<br>- The device is indicated for<br>use to provide interpretation<br>of the data for consideration<br>by a physician.<br>- The device is indicated for<br>use in a clinical setting, by a<br>physician or by trained<br>personnel who are acting on<br>the orders of a licensed<br>physician. It is not intended<br>as a sole means of diagnosis.<br>- The interpretations of ECG<br>offered by the device are<br>only significant when used in<br>conjunction with a physician<br>over-read as well as<br>consideration of all other<br>relevant patient data.<br>- The device is indicated for<br>use on adult and pediatric<br>populations.<br>- The device is not intended to<br>be used as a vital signs<br>physiological monitor |
| | well as consideration of<br>all other relevant patient<br>data.<br>- The device is indicated<br>for use on adult and<br>pediatric populations.<br>- The device is not<br>intended to be used as a<br>vital signs physiological<br>monitor. | | |
| Target<br>population | Adults and pediatric patients<br>Adults and pediatric patients for<br>analisys | Adults and pediatric patients<br>Adults for analisys | Adults and pediatric patients<br>Adults and pediatric patients for<br>analisys |
| Safety<br>standards | IEC 60601-1<br>IEC 60601-2-25<br>CB scheme | IEC 60601-1<br>IEC 60601-2-25 | IEC 60601-1<br>IEC 60601-2-25 |
| EMC<br>standards | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| ECG Leads | 12 Leads Standard / Cabrera | 12 Leads Standard / Cabrera | 12 Leads Standard / Cabrera |
| Sampling<br>Rate | 500 samples/second/channel | 1000 samples/s/channel printing and<br>filters<br>500 samples/s/channel in calculation<br>and filters | 1000 s/sec/channel used for<br>recording and analysis |
| Leads<br>Connector | Single block | Single block | Single block |
| Standard<br>Leads<br>Acquired | I, II, III, aVR, aVL, aVF, V1, V2, V3,<br>V4, V5, V6 | I, II, III, aVR, aVL, aVF, V1, V2, V3, V4,<br>V5, V6 | I, II, III, aVR, aVL, aVF, V1, V2, V3,<br>V4, V5, V6 |
| A/D<br>Conversion | 24 bit, 32 KHz | 12 bit | 20 bit |
| Bandwidth | 0.05 - 150 Hz | 0,05 - 150 Hz | 0.05Hz - 300Hz |
| CMRR | >100 dB | >100 dB | Not specified |
| Defibrillator<br>Protection | AAMI/IEC standards | AAMI/IEC standards with proprietary<br>applied part | Defibrillation proof applied part |
| Pacemaker<br>detection | Hardware detection coupled with<br>convolution digital filtering | Recognize pacemaker impulse<br>according to IEC applicable standards | Not specified |
| Patient Cable | 10 wire single connector | 10 wire single connector | 10 wire cable single connector |
| Mains Power<br>Supply | Medical grade AC power supply<br>(100-240 VAC, 50/60 Hz); | Internal power supply 90-264 VAC,<br>47 – 63 Hz | Universal AC power supply (100-<br>240 VAC at 50/60 Hz) 50 VA…