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

AI/ML Overview

The provided document is a 510(k) premarket notification for the Cardioline ECG100+ and ECG200+ electrocardiographs. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's diagnostic algorithm performance.

Therefore, many of the requested details about acceptance criteria, specific study designs, and ground truth establishment for an AI performance study are not present in this document. The document describes the device's physical and functional performance, as well as its safety and EMC compliance, but not the clinical performance of its automatic interpretation algorithm in a standalone or MRMC study.

Here's a breakdown of what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical accuracy or diagnostic performance for the ECG interpretation algorithm. Instead, it demonstrates compliance with relevant safety and performance standards for electrocardiographs.

The performance aspects highlighted are related to the physical and electrical functioning of the device, not the diagnostic accuracy of its interpretation algorithm.

Acceptance Criteria (Standards Compliance)	Reported Device Performance
Safety:
IEC 60601-1	Full compliance
IEC 60601-2-25	Full compliance
CB scheme	Full compliance
Defibrillation protection	Compliant
Energy reduction test	Compliant
Overload tolerance	Compliant
Indication of inoperable ECG	Compliant
LEAD representation, nomenclature & def.	Compliant
Goldberg and Wilson LEADS	Compliant
Recovery time	Compliant
Input impedance	Compliant
Common mode rejection	Compliant
Filters	Compliant
Noise level	Compliant
Channel crosstalk	Compliant
High frequency response	Compliant
Low frequency (impulse) response	Compliant
Linearity and dynamic range	Compliant
Recording speed	Compliant
Time and amplitude ruling	Compliant
Use with cardiac pacemakers	Compliant
EMC:
EN 60601-1-2 standard	Full compliance

Information Not Found in the Document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not contain information about a dedicated test set for evaluating the diagnostic performance of the interpretation algorithm. The "performance data" section focuses on hardware and electrical aspects, not clinical algorithm accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no dedicated test set for diagnostic accuracy is described. The document states that the interpretations must be validated by a Physician/Cardiologist.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no specific test set requiring adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study is mentioned. The device's interpretation algorithm (Glasgow ECG system) is presented as an "optional interpretation" intended to "provide the physician with an automatic interpretation of the ECG to be reviewed by a physician." It explicitly states: "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." This indicates it's an assistive tool, but no study on its effectiveness in improving human reader performance is provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies the algorithm provides an interpretation, but no standalone performance study results (e.g., sensitivity, specificity for specific conditions) are provided. Its role is clearly defined as "not intended as a sole means of diagnosis" and requiring "a physician over-read."
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified for the interpretation algorithm's development or validation.
The sample size for the training set:
- The document mentions the device can be supplied with the "optional 12-lead Glasgow resting ECG interpretation algorithm." The training set size for this pre-existing algorithm (developed by Glasgow University - Prof. MacFarlane) is not discussed in this submission.
How the ground truth for the training set was established:
- As with the training set size, the method for establishing ground truth for the Glasgow algorithm is outside the scope of this 510(k) submission and not detailed here.

Summary of what the document does provide regarding the interpretation algorithm:

Algorithm Name: Glasgow resting ECG interpretation algorithm (adult and pediatric).
Provider: Glasgow University - Prof. MacFarlane.
Function: Provides a "second opinion" or "diagnostic support" to the physician.
Limitation: "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." Also, "It is not intended as a sole means of diagnosis." and "must be validated by a Physician."
Target Population: Adult and pediatric.

This 510(k) submission focuses on demonstrating that the new Cardioline ECG devices are substantially equivalent to existing, legally marketed ECG devices in terms of general function, safety, and physical performance, including the capability to run a similar interpretation algorithm. It does not provide the detailed validation study of the embedded Glasgow interpretation algorithm itself.

Summary

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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

{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

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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)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 +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.

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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
1. AC Power supply (100-240 VAC 50/60 Hz)
1. Paper
1. Pack of electrodes
1. Banana/clip adapter set
1. Guidance for the physician on the application on adults and children (with interpretative key)
1. 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.

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 foruse	ECGxxx(z)(+) is a high-performance, multi-channel,interpretative restingelectrocardiograph.The ECG signal is acquired with a10-wires patient cable and isdisplayed in real time on a LCDscreen integrated in the device.The electrocardiograph cananalyse and store the ECG traces,send them to an externalperipheral via network or via USB,print the 12 lead ECG in automaticor manual mode by means of athermal printer.ECGxxx(z)(+) is intended forassessment and diagnosis ofcardiac functions. In any case theresults of analysis performed bythe electrocardiograph must bevalidated by a Physician.ECGxxx(z)(+) is intended for use inhospitals, in medical clinics anddoctor's offices of any size.- The device is indicatedfor use to acquire,analyse, display andprintelectrocardiograms.- The device is intended toprovide the physicianwith an automaticinterpretation of theECG to be reviewed by aphysician.- The device is indicatedfor use in a clinicalsetting, by a physician orby trained personnelwho are acting on theorders of a licensedphysician. It is notintended as a solemeans of diagnosis.- The interpretations ofECG offered by thedevice are onlysignificant when used inconjunction with aphysician over-read as	CARDIOLINE AR 600 and AR 1200 andAR 2100 are a family ofelectrocardiograph recordersprovided with a program forautomated ecg analysis and with agraphic LCD display.The equipments are intended for usein routine ecg recording in physicianpractice and/or hospital. Theelectrical heart activity is detected bymeans of two or moreelectrocardiograph electrodes and isrecorded on thermal paper.Intended use for non interpretiveapplications covers the full range ofpatient population with nolimitations with respect to age, sexand race of the patient.The interpretation program isintended to provide a diagnosticsupport to the physician for the ecgevaluation on rhythm andmorphology.Interpretation Statements must beoverviewed and approved by trainedPhysician's. Interpretationstatements just represent a partialqualitative and quantitativeinformation of the general patientcardiovascular condition: no therapyor drugs can be subministratedbased solely on Interpretationstatements.The equipments are intended to beused by trained medical personnel orphysician's.Indication for use of the modifieddevice has not been changed withrespect to the predicate device ABCARDIETTE DAEDALUS VIEW baseand Hes K002074.	- The device is indicated foruse to acquire, analyze,display and printelectrocardiograms.- The device is indicated foruse to provide interpretationof the data for considerationby a physician.- The device is indicated foruse in a clinical setting, by aphysician or by trainedpersonnel who are acting onthe orders of a licensedphysician. It is not intendedas a sole means of diagnosis.- The interpretations of ECGoffered by the device areonly significant when used inconjunction with a physicianover-read as well asconsideration of all otherrelevant patient data.- The device is indicated foruse on adult and pediatricpopulations.- The device is not intended tobe used as a vital signsphysiological monitor
	well as consideration ofall other relevant patientdata.- The device is indicatedfor use on adult andpediatric populations.- The device is notintended to be used as avital signs physiologicalmonitor.
Targetpopulation	Adults and pediatric patientsAdults and pediatric patients foranalisys	Adults and pediatric patientsAdults for analisys	Adults and pediatric patientsAdults and pediatric patients foranalisys
Safetystandards	IEC 60601-1IEC 60601-2-25CB scheme	IEC 60601-1IEC 60601-2-25	IEC 60601-1IEC 60601-2-25
EMCstandards	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
SamplingRate	500 samples/second/channel	1000 samples/s/channel printing andfilters500 samples/s/channel in calculationand filters	1000 s/sec/channel used forrecording and analysis
LeadsConnector	Single block	Single block	Single block
StandardLeadsAcquired	I, II, III, aVR, aVL, aVF, V1, V2, V3,V4, V5, V6	I, II, III, aVR, aVL, aVF, V1, V2, V3, V4,V5, V6	I, II, III, aVR, aVL, aVF, V1, V2, V3,V4, V5, V6
A/DConversion	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
DefibrillatorProtection	AAMI/IEC standards	AAMI/IEC standards with proprietaryapplied part	Defibrillation proof applied part
Pacemakerdetection	Hardware detection coupled withconvolution digital filtering	Recognize pacemaker impulseaccording to IEC applicable standards	Not specified
Patient Cable	10 wire single connector	10 wire single connector	10 wire cable single connector
Mains PowerSupply	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
Internalbattery	Internal rechargeable battery(NiMH), 12Vdc 2200 mAh	Rechargeable battery pack NiMH10x1.2 Vdc; 1800 mAh	Internal rechargeable battery
Writingsystem	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/mmvertical
Printedchannels	Manual: 3, 6 channelsAutomatic: 3, 3+1, 6 channels,Patient Demographic, GlobalMeasurements, OptionalInterpretation (Glasgow University- Prof. MacFarlane)Adult, Paediatric, STEMI	3/4/6 channels	3, 6 or 12 channel with configurablelead 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, A4or 8.5 x 11" wide, 250 sheets
Modeofoperation	Manual and automatic	Manual and automatic recording	Automatic
Display	Size: 4.3" colour LCD monitorN° of displayed channels: 3, 6Traces speed: 50/25/10/5mm/sec	Size: 120 x 320 pixels / 240 x 320pixelsN° of displayed channels: 3, 6, 12Traces speed: 12,5 / 25 / 50 mm/sec	Size: Backlit, 1/4 VGA color LCD(320 x 240)N° of displayed channels: 3, 4, 6Traces 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

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interpretation	interpretation algorithm (adult and pediatric) [optional]	interpretation program	interpretation algorithm (adult and pediatric) [optional]
Where usedUsed By	Hospitals, Medical Clinics.Nurse, Physician and trained medical personnel	Hospitals, ClinicsPhysician and trained medical personnel	Hospitals, ClinicsPhysician and trained medical personnel

Table 2

FEATURES	CARDIOLINE ECG200+	AR 2100	ELI 250
Indication foruse	ECGxxx(z)(+) is a high-performance, multi-channel,interpretative restingelectrocardiograph.The ECG signal is acquired with a10-wires patient cable and isdisplayed in real time on a LCDscreen integrated in the device.The electrocardiograph cananalyse and store the ECG traces,send them to an externalperipheral via network or via USB,print the 12 lead ECG in automaticor manual mode by means of athermal printer.ECGxxx(z)(+) is intended forassessment and diagnosis ofcardiac functions. In any case theresults of analysis performed bythe electrocardiograph must bevalidated by a Physician.ECGxxx(z)(+) is intended for use inhospitals, in medical clinics anddoctor's offices of any size.- The device is indicatedfor use to acquire,analyse, display andprintelectrocardiograms.- The device is intended toprovide the physicianwith an automaticinterpretation of theECG to be reviewed by aphysician.- The device is indicatedfor use in a clinicalsetting, by a physician orby trained personnelwho are acting on theorders of a licensedphysician. It is notintended as a solemeans of diagnosis.- The interpretations ofECG offered by thedevice are onlysignificant when used in	CARDIOLINE AR 600 and AR 1200 andAR 2100 are a family ofelectrocardiograph recordersprovided with a program forautomated ecg analysis and with agraphic LCD display.The equipments are intended for usein routine ecg recording in physicianpractice and/or hospital. Theelectrical heart activity is detected bymeans of two or moreelectrocardiograph electrodes and isrecorded on thermal paper.Intended use for non interpretiveapplications covers the full range ofpatient population with nolimitations with respect to age, sexand race of the patient.The interpretation program isintended to provide a diagnosticsupport to the physician for the ecgevaluation on rhythm andmorphology.Interpretation Statements must beoverviewed and approved by trainedPhysician's. Interpretationstatements just represent a partialqualitative and quantitativeinformation of the general patientcardiovascular condition: no therapyor drugs can be subministratedbased solely on Interpretationstatements.The equipments are intended to beused by trained medical personnel orphysician's.Indication for use of the modifieddevice has not been changed withrespect to the predicate device ABCARDIETTE DAEDALUS VIEW baseand Hes K002074.	- The device is indicated foruse to acquire, analyze,display and printelectrocardiograms.- The device is indicated foruse to provide interpretationof the data for considerationby a physician.- The device is indicated foruse in a clinical setting, by aphysician or by trainedpersonnel who are acting onthe orders of a licensedphysician. It is not intendedas a sole means of diagnosis.- The interpretations of ECGoffered by the device areonly significant when used inconjunction with a physicianover-read as well asconsideration of all otherrelevant patient data.- The device is indicated foruse on adult and pediatricpopulations.- The device is not intended tobe used as a vital signsphysiological monitor
	conjunction with aphysician over-read aswell as consideration ofall other relevant patientdata.The device is indicatedfor use on adult andpediatric populations.The device is notintended to be used as avital signs physiologicalmonitor.
Targetpopulation	Adults and pediatric patientsAdults and pediatric patients foranalysis	Adults and pediatric patientsAdults for analysis	Adults and pediatric patientsAdults and pediatric patients foranalysis
Safetystandards	IEC 60601-1IEC 60601-2-25CB scheme	IEC 60601-1IEC 60601-2-25	IEC 60601-1IEC 60601-2-25
EMCstandards	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
SamplingRate	500 samples/second/channel	1000 samples/s/channel printing andfilters500 samples/s/channel in calculationand filters	1000 s/sec/channel used forrecording and analysis
LeadsConnector	Single block	Single block	Single block
StandardLeadsAcquired	I, II, III, aVR, aVL, aVF, V1, V2, V3,V4, V5, V6	I, II, III, aVR, aVL, aVF, V1, V2, V3, V4,V5, V6	I, II, III, aVR, aVL, aVF, V1, V2, V3,V4, V5, V6
A/DConversion	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
DefibrillatorProtection	AAMI/IEC standards	AAMI/IEC standards with proprietaryapplied part	Defibrillation proof applied part
Pacemakerdetection	Hardware detection coupled withconvolution digital filtering	Recognize pacemaker impulseaccording to IEC applicable standards	Not specified
Patient Cable	10 wire single connector	10 wire single connector	10 wire cable single connector
Mains PowerSupply	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
Internalbattery	Internal rechargeable battery(NiMH), 12Vdc 2200 mAh	Rechargeable battery pack NiMH10x1.2 Vdc; 1800 mAh	Internal rechargeable battery
Writingsystem	Thermal head, 8 dot/mm216mm; A4 Z-fold	Thermal head 210mm 8 dots/mm	Computer-controlled dot array;1 dot/ms horizontal, 8 dots/mmvertical
Printedchannels	Manual: 3, 6, 12 channelsAutomatic: 3, 3+1, 6, 12 channelsPatient Demographic, GlobalMeasurements, OptionalInterpretation (Glasgow UniversityProf. MacFarlane) Adult,Paediatric, STEMI	3/4/6/12 channels	3, 6 or 12 channel with configurablelead 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, A4or 8.5 x 11" wide, 250 sheets
Mode ofoperation	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

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	N° of displayed channels: 3, 6, 12	pixels	(320 x 240)
	Traces speed: 50/25/10/ 5mm/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
ECGinterpretation	Glasgow restinginterpretation algorithm (adultand pediatric) [optional]	Hannover ECG System (HES)interpretation program	Mortara VERITAS restinginterpretation algorithm (adult andpediatric) [optional]
Where used	Hospitals, Medical Clinics.	Hospitals, Clinics	Hospitals, Clinics
Used By	Nurse, Physician and trainedmedical personnel	Physician and trained medicalpersonnel	Physician and trained medicalpersonnel

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

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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.

Regulation Number and Section

§ 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).