(137 days)
Not Found
No
The document mentions an "interpretative resting ECG interpretation algorithm" (specifically the Glasgow algorithm), which is a rules-based system, not AI/ML. There is no mention of AI, ML, or related concepts like neural networks or training data.
No
The device is described as a diagnostic electrocardiograph, intended for "assessment and diagnosis of cardiac functions". It acquires, analyzes, displays, and prints ECG traces to provide information for diagnosis, not to provide therapy.
Yes
The device is explicitly stated as being intended for "assessment and diagnosis of cardiac functions" and is described as a "12-lead diagnostic electrocardiograph." It also provides "automatic interpretation of the ECG" and "diagnostic messages," which are all functions of a diagnostic device.
No
The device description explicitly details hardware components such as a patient cable, LCD screen, thermal printer, physical keyboard, and connectivity ports (USB, LAN). It also mentions being powered by battery or electrical mains. These are all physical components, not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ECGxxx(z)(+) device acquires, analyzes, displays, and prints electrocardiograms. This involves measuring electrical activity of the heart through electrodes placed on the body. It does not perform tests on samples taken from the body.
- Intended Use: The intended use is for the assessment and diagnosis of cardiac functions by acquiring and analyzing electrical signals from the patient's body.
- No Mention of Samples: The description and intended use do not mention the use of any biological samples.
Therefore, the ECGxxx(z)(+) device falls under the category of a medical device used for physiological measurement and analysis, not an In Vitro Diagnostic.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS, CFR 870.2340 Electrocardiograph
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.
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).
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):
-
- Patient cable
-
- AC Power supply (100-240 VAC 50/60 Hz)
-
- Paper
-
- Pack of electrodes
-
- Banana/clip adapter set
-
- Guidance for the physician on the application on adults and children (with interpretative key)
-
- 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.
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
Adult and pediatric populations.
Intended User / Care Setting
Intended for use in hospitals, in medical clinics and doctor's offices of any size.
Intended to be used by trained medical personnel or physician's.
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)
Full safety test according to IEC 60601-2 and IEC 60601-2-25 have been performed on the device. These test have shown full compliance with these device.
The device has been subjected to Electromagnetic Compatibility testing procedure according to EN 60601-1-2 standard. Tests have shown full compliance with this standard.
Performance are tested following the standard IEC 60601-2-25 second edition.
The performance tested are:
- Defibrillation protection
- Energy reduction test
- Overload tolerance
- Indication of inoperable electrocardiograph
- LEAD representation, nomenclature and definition
- Goldberg and Wilson LEADS
- Recovery time
- Input impedance
- Common mode rejection
- Filters
- Noise level
- Channel crosstalk
- High frequency response
- Low frequency (impulse) response
- Linearity and dynamic range
- 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.
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
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
1
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 (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,
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
2
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 +39 0463 850125 F +39 0463 850088
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.
4
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).
5
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):
-
- Patient cable
-
- AC Power supply (100-240 VAC 50/60 Hz)
-
- Paper
-
- Pack of electrodes
-
- Banana/clip adapter set
-
- Guidance for the physician on the application on adults and children (with interpretative key)
-
- 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.
6
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.
7
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 | |||
| 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 | CARDIOLINE AR 600 and AR 1200 and
AR 2100 are a family of
electrocardiograph recorders
provided with a program for
automated ecg analysis and with a
graphic LCD display.
The equipments are intended for use
in routine ecg recording in physician
practice and/or hospital. The
electrical heart activity is detected by
means of two or more
electrocardiograph electrodes and is
recorded on thermal paper.
Intended use for non interpretive
applications covers the full range of
patient population with no
limitations with respect to age, sex
and race of the patient.
The interpretation program is
intended to provide a diagnostic
support to the physician for the ecg
evaluation on rhythm and
morphology.
Interpretation Statements must be
overviewed and approved by trained
Physician's. Interpretation
statements just represent a partial
qualitative and quantitative
information of the general patient
cardiovascular condition: no therapy
or drugs can be subministrated
based solely on Interpretation
statements.
The equipments are intended to be
used by trained medical personnel or
physician's.
Indication for use of the modified
device has not been changed with
respect to the predicate device AB
CARDIETTE DAEDALUS VIEW base
and Hes K002074. | - The device is indicated for
use to acquire, analyze,
display 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 |
| | 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. | | |
| Target
population | Adults and pediatric patients
Adults and pediatric patients for
analisys | Adults and pediatric patients
Adults for analisys | Adults and pediatric patients
Adults and pediatric patients for
analisys |
| Safety
standards | IEC 60601-1
IEC 60601-2-25
CB scheme | IEC 60601-1
IEC 60601-2-25 | IEC 60601-1
IEC 60601-2-25 |
| EMC
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
Rate | 500 samples/second/channel | 1000 samples/s/channel printing and
filters
500 samples/s/channel in calculation
and filters | 1000 s/sec/channel used for
recording and analysis |
| Leads
Connector | Single block | Single block | Single block |
| Standard
Leads
Acquired | 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, V2, V3,
V4, V5, V6 |
| A/D
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
Protection | AAMI/IEC standards | AAMI/IEC standards with proprietary
applied part | Defibrillation proof applied part |
| Pacemaker
detection | Hardware detection coupled with
convolution digital filtering | Recognize pacemaker impulse
according to IEC applicable standards | Not specified |
| Patient Cable | 10 wire single connector | 10 wire single connector | 10 wire cable single connector |
| Mains Power
Supply | Medical grade AC power supply
(100-240 VAC, 50/60 Hz); | Internal power supply 90-264 VAC,
47 – 63 Hz | Universal AC power supply (100-
240 VAC at 50/60 Hz) 50 VA |
| Internal
battery | Internal rechargeable battery
(NiMH), 12Vdc 2200 mAh | Rechargeable battery pack NiMH
10x1.2 Vdc; 1800 mAh | Internal rechargeable battery |
| Writing
system | Thermal head, 8 dot/mm -
108mm; Z-fold 100x150mm | Thermal head 108mm 8 dots/mm | Computer-controlled dot array;
1 dot/ms horizontal, 8 dots/mm
vertical |
| Printed
channels | Manual: 3, 6 channels
Automatic: 3, 3+1, 6 channels,
Patient Demographic, Global
Measurements, Optional
Interpretation (Glasgow University - Prof. MacFarlane)
Adult, Paediatric, STEMI | 3/4/6 channels | 3, 6 or 12 channel with configurable
lead groups |
| Paper speed | 5/10/25/50 mm/s | 5 mm/s ±10%
25 – 50 mm/s ±5% | 5, 10, 25, or 50 mm/s |
| Paper type | Z-FOLD 100X150 | DOTCARD 120mm | Perforated Z-fold thermal paper, A4
or 8.5 x 11" wide, 250 sheets |
| Mode
of
operation | Manual and automatic | Manual and automatic recording | Automatic |
| Display | Size: 4.3" colour LCD monitor
N° of displayed channels: 3, 6
Traces speed: 50/25/10/5
mm/sec | Size: 120 x 320 pixels / 240 x 320
pixels
N° of displayed channels: 3, 6, 12
Traces speed: 12,5 / 25 / 50 mm/sec | Size: Backlit, 1/4 VGA color LCD
(320 x 240)
N° of displayed channels: 3, 4, 6
Traces speed: not specified |
| Connectivity | USB device, LAN | Infrared digital interface | RS232, LAN, WLAN, Modem |
| ECG | Glasgow ECG system | Hannover ECG System (HES) | Mortara VERITAS resting |
Table 1
8
9
| interpretation | interpretation algorithm (adult and pediatric) [optional] | interpretation program | interpretation algorithm (adult and pediatric) [optional] |
|---|---|---|---|
| Where used | |||
| Used By | Hospitals, Medical Clinics. | ||
| Nurse, Physician and trained medical personnel | Hospitals, Clinics | ||
| Physician and trained medical personnel | Hospitals, Clinics | ||
| Physician and trained medical personnel |
Table 2
| FEATURES | CARDIOLINE ECG200+ | AR 2100 | ELI 250 |
|---|---|---|---|
| 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 anddoctor'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 | CARDIOLINE AR 600 and AR 1200 and
AR 2100 are a family of
electrocardiograph recorders
provided with a program for
automated ecg analysis and with a
graphic LCD display.
The equipments are intended for use
in routine ecg recording in physician
practice and/or hospital. The
electrical heart activity is detected by
means of two or more
electrocardiograph electrodes and is
recorded on thermal paper.
Intended use for non interpretive
applications covers the full range of
patient population with no
limitations with respect to age, sex
and race of the patient.
The interpretation program is
intended to provide a diagnostic
support to the physician for the ecg
evaluation on rhythm and
morphology.
Interpretation Statements must be
overviewed and approved by trained
Physician's. Interpretation
statements just represent a partial
qualitative and quantitative
information of the general patient
cardiovascular condition: no therapy
or drugs can be subministrated
based solely on Interpretation
statements.
The equipments are intended to be
used by trained medical personnel or
physician's.
Indication for use of the modified
device has not been changed with
respect to the predicate device AB
CARDIETTE DAEDALUS VIEW base
and Hes K002074. | - The device is indicated for
use to acquire, analyze,
display 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 |
| | 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. | | |
| Target
population | Adults and pediatric patients
Adults and pediatric patients for
analysis | Adults and pediatric patients
Adults for analysis | Adults and pediatric patients
Adults and pediatric patients for
analysis |
| Safety
standards | IEC 60601-1
IEC 60601-2-25
CB scheme | IEC 60601-1
IEC 60601-2-25 | IEC 60601-1
IEC 60601-2-25 |
| EMC
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
Rate | 500 samples/second/channel | 1000 samples/s/channel printing and
filters
500 samples/s/channel in calculation
and filters | 1000 s/sec/channel used for
recording and analysis |
| Leads
Connector | Single block | Single block | Single block |
| Standard
Leads
Acquired | 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, V2, V3,
V4, V5, V6 |
| A/D
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
Protection | AAMI/IEC standards | AAMI/IEC standards with proprietary
applied part | Defibrillation proof applied part |
| Pacemaker
detection | Hardware detection coupled with
convolution digital filtering | Recognize pacemaker impulse
according to IEC applicable standards | Not specified |
| Patient Cable | 10 wire single connector | 10 wire single connector | 10 wire cable single connector |
| Mains Power
Supply | Medical grade AC power supply
(100-240 VAC, 50/60 Hz); | Internal power supply 90-264 VAC,
47 - 63 Hz | Universal AC power supply (100-
240 VAC at 50/60 Hz) 50 VA |
| Internal
battery | Internal rechargeable battery
(NiMH), 12Vdc 2200 mAh | Rechargeable battery pack NiMH
10x1.2 Vdc; 1800 mAh | Internal rechargeable battery |
| Writing
system | Thermal head, 8 dot/mm
216mm; A4 Z-fold | Thermal head 210mm 8 dots/mm | Computer-controlled dot array;
1 dot/ms horizontal, 8 dots/mm
vertical |
| Printed
channels | Manual: 3, 6, 12 channels
Automatic: 3, 3+1, 6, 12 channels
Patient Demographic, Global
Measurements, Optional
Interpretation (Glasgow University
Prof. MacFarlane) Adult,
Paediatric, STEMI | 3/4/6/12 channels | 3, 6 or 12 channel with configurable
lead groups |
| Paper speed | 5/10/25/50 mm/s | 5 mm/s ±10%
25 - 50 mm/s ±5% | 5, 10, 25, or 50 mm/s |
| Paper type | A4 Z-fold | DOTCARD 210mm | Perforated Z-fold thermal paper, A4
or 8.5 x 11" wide, 250 sheets |
| Mode of
operation | Manual and automatic | Manual and automatic recording | Automatic |
| Display | Size: 7" backlit LCD colour display | Size: 120 x 320 pixels / 240 x 320 | Size: Backlit, 1/4 VGA color LCD |
10
11
| N° of displayed channels: 3, 6, 12 | pixels | (320 x 240) | |
|---|---|---|---|
| Traces speed: 50/25/10/ 5 | |||
| mm/sec | N° of displayed channels: 3, 6, 12 | N° of displayed channels: 3, 4, 6 | |
| Traces speed: 12,5 / 25 / 50 mm/sec | Traces speed: not specified | ||
| Connectivity | USB device, LAN | Infrared digital interface | RS232, LAN, WLAN, Modem |
| ECG | |||
| interpretation | Glasgow resting | ||
| interpretation algorithm (adult | |||
| and pediatric) [optional] | Hannover ECG System (HES) | ||
| interpretation program | Mortara VERITAS resting | ||
| interpretation algorithm (adult and | |||
| pediatric) [optional] | |||
| Where used | Hospitals, Medical Clinics. | Hospitals, Clinics | Hospitals, Clinics |
| Used By | Nurse, Physician and trained | ||
| medical personnel | Physician and trained medical | ||
| personnel | Physician and trained medical | ||
| personnel |
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Full safety test according to IEC 60601-2 and IEC 60601-2-25 have been performed on the device. These test have shown full compliance with these device.
The device has been subjected to Electromagnetic Compatibility testing procedure according to EN 60601-1-2 standard. Tests have shown full compliance with this standard.
Performance are tested following the standard IEC 60601-2-25 second edition.
The performance tested are:
- ▶ Defibrillation protection
- A Energy reduction test
- ► Overload tolerance
-
Indication of inoperable electrocardiograph
-
LEAD representation, nomenclature and definition
-
Goldberg and Wilson LEADS
- A Recovery time
- ► Input impedance
- A Common mode rejection
- 》 Filters
- ▷ Noise level
- A Channel crosstalk
- ▶ High frequency response
- A Low frequency (impulse) response
-
Linearity and dynamic range
- ► Recording speed
- ▸ Time and amplitude ruling
-
Use with cardiac pacemakers
12
8. CONCLUSION
The safety features of the CARDIOLINE ECGxxx(z)(+) are identical to those of the predicate devices ET MEDICAL CARDIOLINE AR and MORTARA ELI 250.
The performance of ECGxxx(z)(+) are basically similar to the predicate and are summarized in table above. Like predicate devices CARDIOLINE AR, the subject devices ECGxxx(z)(+), have parameters computation and interpretation program implemented on device and uses the same paper format.
Like Mortara ELI 250, is designed to acquire and analyze ECG data for pediatric populations. Like Mortara ELI 250 has the network connectivity.
The Standards Leads Acquired are the same to both predicate devices.
The intended use of CARDIOLINE ECGxxx(z)(+) is the same both devices
The conclusions drawn from the nonclinical and clinical tests demonstrates 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.