(117 days)
Not Found
No
The document describes an "automated ecg analysis program" and an "Interpretation Program Hannover Ecg System (HES)" which provides diagnostic support. While this involves automated analysis, the description and the reference to a 1991 publication suggest a rule-based or algorithmic approach rather than modern AI/ML techniques. There is no mention of AI, ML, deep learning, or training/test sets in the context of machine learning.
No
The device is an electrocardiograph recorder, which is used for diagnostic purposes (recording and analyzing heart activity) and explicitly states that "no therapy or drugs can be subministrated based solely on Interpretation statements." This indicates it is not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states, "The interpretation program is intended to provide a diagnostic support to the physician for the ecg evaluation on rhythm and morphology." This directly indicates a diagnostic purpose.
No
The device description clearly outlines hardware components such as electrocardiograph electrodes, thermal paper, a graphic LCD display, a thermal printer, and an infrared serial interface. While it includes software for analysis and interpretation, it is integrated into a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The CARDIOLINE AR 600, AR 1200, and AR 2100 are electrocardiographs. They detect and record the electrical activity of the heart using electrodes placed on the body surface. This is a non-invasive procedure and does not involve analyzing specimens taken from the body.
- Intended Use: The intended use is for routine ECG recording and providing diagnostic support to the physician based on the electrical signals of the heart. This is consistent with the function of an electrocardiograph, not an IVD.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of in vivo diagnostic devices rather than in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
CARDIOLINE AR 600, AR 1200 and AR 2100 is a family of electrocardiographs providing the following characteristics:
- Mains and internal battery operation
- Manual acquisition of the 12 Standard Leads
- Simultaneous acquisition of the 12 Standard Leads
- Storage of 10 seconds of acquired ecg signal
- Storage of up to 40 ecg recordings (optional)
- Multichannel Ecg printout on thermal paper
- Copy function of the stored ecg
- High resolution digital thermal printer
- Digital filters for AC interference suppression and base-line drift
- Time and date printout
- Possibility to send acquisition data to a Personal Computer or Workstation via Infrared serial interface
- Interpretation Program Hannover Ecg System (HES) providing the following additional informations (optional):
- Representatives Templates of each lead including markers on fiducial A points
- Summary of mean measurements A
- Summary of measurements performed on each lead A
- A Rythm Analysys Statements
- Rythm graphical representation A
- Signal noise detection and information A
- A Specific findings on QRS complex
- A Conduction statements
- QRS T Diagnostic Statements A
- Summary of measurements performed on each lead
- Arrhythmia monitoring detection
- A Heart Rate Variability
- graphic LCD display for user interface and ECG visualisation
- Patient input data for Interpretation, identification and filing purposes
More specifically, the equipments family is based on 3 model variants characterized by different print and display capabilities. Table 5.8.1 summarizes all model variants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
full range of patient population with no limitiations with respect to age
Intended User / Care Setting
physician practice and/or hospital.
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)
The correct implementation of the measurements and interpretation program has also been tested and validated.
The measurements and interpretation program has not been changed. It has been intensively tested and validated by the developer Medizinische Hochschule Hannover. Test results have been published on the New England Journal of Medecine 325:1767-1773 December 19, 1991 under the title: The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms.
The results shown in this study have demonstrated the quality and accuracy of the HES program with respect to other commercially availabe programs.
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
OCT 5 - 2005
et medical devices spa
FDA DOCUMENT NUMBER: k (515-34
1/5
Summary of Safety and Effectiveness 5.
CARDIOLINE AR 600, AR 1200, AR 2100
- 5.1 Date of application: 06/07/2005
- 5.2 Applicant's name and address: et medical devices spa Via De Zinis 6 38011 Cavareno (Trento) ITALY
| 5.3 Contact person: | Mr. Attilio Castelli |
|---|---|
| Tel: | (+39) 0463850125 |
| Fax: | (+39) 0463850088 |
| E-mail: | a.castelli@etmed.biz |
- 5.4 Device Trade Name CARDIOLINE AR 600, AR 1200, AR 2100
5.5 Device Common Name ECG Interpretive Electrocardiograph
- 5.6 Device Classification Name CFR 870.2340 Electrocardiograph Class II 74 DPS
5.7 Unmodified (Predicate) Device
The legally marketed device which has been modified is:
| Manufacturer Name | Applicant Name | Predicate Device | 510(k) Number |
|---|---|---|---|
| Elettronica Trentina | |||
| spa (*) | H&C Medical | ||
| Devices spa (*) | AB CARDIETTE | ||
| Daedalus View | |||
| base and Hes | K002074 |
(*) name changed into et medical devices spa in year 2003.
(°) merged into et medical devices spa in year 2003.
The safety features of the CARDIOLINE AR 600, AR 1200 and AR 2100 are identical to those of the predicate Daedalus View. The performances of CARDIOLINE AR 600, AR 1200 and AR 2100 are basically similar to the predicate Daedalus View and are summarized in table 5.7.1. The Parameters computation and Interpretation Program implemented in CARDIOLINE AR 600 and AR 1200 and AR 2100 is equivalent to the one implemented in the predicate Daedalus View Hes.
CARDIOLINE AR 600, AR 1200, AR 2100 special 510(K) SUBMISSION DOCUMENT Page 8 of 32
1
FDA DOCUMENT NUMBER:
Summary of Safety and Effectiveness (con't)
Intended use of CARDIOLINE AR 600 and AR 1200 and AR 2100 is identical to that of AB CARDIETTE Daedalus View base and Hes.
| Parameter | AR 600 | AR 1200 | AR 2100 | AB CARDIETTE
DAEDALUS VIEW
Base and Hes |
|--------------------------------|----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|------------------------------------------------------|
| RECORDER | | | | |
| Input dynamic
range | +/-300mV @ DC
+/- 5.0 mV within
the bandpass | +/-300mV @ DC
+/- 10.0 mV within
the bandpass | +/-300mV @ DC
+/- 10.0 mV within
the bandpass | +/-300mV @ DC
+/- 25 mV within the
bandpass |
| Frequency
response | 0.05 – 150 Hz (-3dB) | 0.05 – 150 Hz (-3dB) | 0.05 – 150 Hz (-3dB) | 0.05 – 150 Hz (-3dB) |
| A/D
conversion | 11 bits | 12 bits | 12 bits | 14 bits |
| Leads | 12 Standard / 12
Cabrera | 12 Standard / 12
Cabrera | 12 Standard / 12
Cabrera | 12 Standard / 12
Cabrera |
| Sensitivity | 2.5 5 10 20
mm/mV +/-5% | 2.5 5 10 20 mm/mV
+/-5% | 2.5 5 10 20 mm/mV
+/-5% | 1.25 2.5 5 10 20 40
mm/mV +/-5% |
| Writing
system | Thermal head 48
mm 8 dots/mm | Thermal head 108
mm 8 dots/mm | Thermal head 210
mm 8 dots/mm | Thermal head 210
mm 8 dots/mm |
| Printed
channels | 1/2/3 | 3/4/6 | 3/4/6/12 | 3/4/6/12 |
| Paper speed | 25 50mm/s +/-5% | 5 mm/s +/-10% 25
50mm/s +/-5% | 5 mm/s +/-10% 25
50mm/s +/-5% | 1.25 2.5 5 10 12.5
mm/s +/-10% 25
50mm/s +/-5% |
| Thermal
paper | DOTCARD 65 mm | DOTCARD 120 mm | DOTCARD 210 mm | DOTCARD 210 mm |
| Mode of
operation | Manual and
Automatic
recording | Manual and
Automatic recording | Manual and
Automatic recording | Manual, Manual
delayed and
Automatic recording |
| Input/output | Infrared digital
interface | Infrared digital
interface | Infrared digital
interface | RS 232 standard
digital port |
| DISPLAY | | | | |
| Size | 120 x 32 pixels | 120 x 32 pixels / 240
x 320 pixels | 120 x 32 pixels / 240
x 320 pixels | VGA 640 x 480
pixels |
| Nº of
displayed
channels | none | 3/6 | 3/6/12 | 3/6 |
| Traces speed | N/a | 12.5 25 50 mm/s | 12.5 25 50 mm/s | 1.25 2.5 5 10 12.5
25 50 mm/s |
| Sensitivity | N/a | 5 10 20 mm/mV | 5 10 20 mm/mV | 1.25 2.5 5 10 20 40
mm/mV |
Table 5.7.1
CARDIOLINE AR 600, AR 1200, AR 2100 special 510(K) SUBMISSION DOCUMENT Page 9 of 32
2
FDA DOCUMENT NUMBER:
Summary of Safety and Effectiveness (con't)
5.8 Device description
CARDIOLINE AR 600, AR 1200 and AR 2100 is a family of electrocardiographs providing the following characteristics:
- · Mains and internal battery operation
- · Manual acquisition of the 12 Standard Leads
- · Simultaneous acquisition of the 12 Standard Leads
- · Storage of 10 seconds of acquired ecg signal
- · Storage of up to 40 ecg recordings (optional)
- · Multichannel Ecg printout on thermal paper
- · Copy function of the stored ecg
- · High resolution digital thermal printer
- · Digital filters for AC interference suppression and base-line drift
- · Time and date printout
- Possibility to send acquisition data to a Personal Computer or Workstation via Infrared serial interface
- Interpretation Program Hannover Ecg System (HES) providing the following additional informations (optional):
- Representatives Templates of each lead including markers on fiducial A points
- Summary of mean measurements A
- Summary of measurements performed on each lead A
- A Rythm Analysys Statements
- Rythm graphical representation A
- Signal noise detection and information A
- A Specific findings on QRS complex
- A Conduction statements
- QRS T Diagnostic Statements A
-
Summary of measurements performed on each lead
-
Arrhythmia monitoring detection
- A Heart Rate Variability
- · graphic LCD display for user interface and ECG visualisation
- · Patient input data for Interpretation, identification and filing purposes
More specifically, the equipments family is based on 3 model variants characterized by different print and display capabilities. Table 5.8.1 summarizes all model variants.
CARDIOLINE AR 600, AR 1200, AR 2100 special 510(K) SUBMISSION DOCUMENT Page 10 of 32
3
4/5-
FDA DOCUMENT NUMBER:
Summary of Safety and Effectiveness (con't)
Table 5.8.1
| Model variant | Thermal head | LCD display | Interpretation |
|---|---|---|---|
| AR 600 | 50 mm | YES (alpha-num.) | YES |
| AR 1200 | 108 mm | YES (graphic) | YES |
| AR 2100 | 210 mm | YES (graphic) | YES |
5.9 Intended use
CARDIOLINE AR 600, AR 1200 and AR 2100 is a family of electrocardiographs characterized as basic standard electrocardiographs with program for automated ecq analysis.
Intended use is equivalent to the intended use of the predicate Daedalus View. More specifically:
The equipment 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 can be visualized on a digital display and recorded on thermal paper.
Intended use for non interpretive applications covers the full range of patient population with no limitiations 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 rythm and morphology.
5.10 Comparison of technological characteristics
CARDIOLINE AR 600 and AR 1200 and AR 2100 electrocardiographs are based on the same technological characteristics of the predicate device AB CARDIETTE Daedalus View base and Hes.
5.11 Non clinical tests used for Substantial Equivalence Determination
Full safety tests according to EN60601-1 and IEC 601-2 25 have been performed on all model variants. Tests have shown full compliance with these standards. The equipments have been subject to Electromagnetic Compatibility testing procedures according to EN60601-1-2 standard. Tests have shown full compliance with this standard.
The correct implementation of the measurements and interpretation program has also been tested and validated.
The measurements and interpretation program has not been changed. It has been intensively tested and validated by the developer Medizinische Hochschule
CARDIOLINE AR 600, AR 1200, AR 2100 special 510(K) SUBMISSION DOCUMENT Page 11 of 32
4
FDA DOCUMENT NUMBER:
Hannover. Test results have been published on the New England Journal of Medecine 325:1767-1773 December 19, 1991 under the title:
The Diagnostic Performance of Computer Programs for the Interpretation of Electrocardiograms.
The results shown in this study have demonstrated the quality and accuracy of the HES program with respect to other commercially availabe programs.
Moreover, the equipments are marketed worldwide since 2001 under the name CARDIETTE AR 600, AR 600 ADV, and AR 1200 ADV, AR 1200 VIEW, AR 2100, AR 2100 VIEW.
No adverse working conditions have been claimed and filed up to date. All equipments are CE marked according to 93/42/CEE Medical Device Directive.
5.12 Risk Analysis
Comparative risk analysis has been performed with respect to the umodified (predicate) device (see Att. A) demonstrating that all means adopted for risk reduction were identical to those adopted for the umodified equipment. The safety and the risk related to the use of the modified equipment are identical to the unmodified equipment.
5.13 Conclusions
Based on the above, et medicale devices belives that CARDIOLINE AR 600, AR1200 and AR 2100 electrocardiographs are substantially equivalent to AB CARDIETTE Daedalus View base and Hes.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 - 2005
et medical devices SpA c/o Mr. Attilio Castelli Via De Zinis, 6 38011 Cavareno (TN) ITALY
Re: K051534
Trade Name: Cardioline AR 600, AR 1200 and AR 2100 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: August 31, 2005 Received: September 6, 2005
Dear Mr. Castelli:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
6
Page 2 - Mr. Attilio Castelli
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimima for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K051534
et medical devices spa
Indications for Use:
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.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Simmon
of Cardlovascular Devices 510(k) Number ರಿ.