(60 days)
Not Found
No
The document describes an "Interpretation program Hanover ECG System (HES)" which provides various analysis statements. While this is automated analysis, the description does not use terms like AI, ML, or deep learning, nor does it provide details about training or test sets which are typical for AI/ML submissions. The analysis appears to be based on predefined rules and algorithms rather than learned patterns.
No
The device is intended for measuring, recording, displaying, and interpreting ECGs, which are diagnostic functions. It explicitly states that "no therapy or drugs can be administered based solely on the interpretation statements," indicating it does not provide therapeutic intervention.
Yes
The device is intended for measuring and displaying electrocardiograms, and its software provides interpretation suggestions and diagnostic statements, supporting physicians in evaluating a patient's cardiovascular condition.
No
The device description explicitly lists hardware components such as a colour LCD display, alphanumeric keyboard, colour ink-printer, and internal database storage, indicating it is not a software-only device.
Based on the provided information, the CorScreen device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD involves the examination of specimens such as blood, urine, or tissue to provide information about a physiological state, health, or disease.
- CorScreen directly measures a physiological signal from the body. The device acquires a surface electrocardiogram (ECG) by placing electrodes on the patient's skin. This is a direct measurement of electrical activity within the heart, not an analysis of a sample taken from the body.
- The intended use describes direct patient measurement. The intended use clearly states it is for "measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient."
Therefore, CorScreen falls under the category of an active medical device that performs a direct physiological measurement, rather than an In Vitro Diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
CorScreen is an active medical device and is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
CorScreen can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. CorScreen is intended for use in routine ECG recording by trained physicians in the office or hospital. CorScreen is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatic patients with an age below 16 years and for pacemaker patients.
The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm.
Intended use is equivalent to the intended use of the predicate device AB Cardiette Daedalus View Hes.
A qualified physician has to reassess all CorScreen measurements. An interpretation by CorScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CorScreen represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
CorScreen is an electrocardiograph providing the following characteristics:
- Mains operation .
- Simultaneous acquisition of the 12 standard leads
- Colour LCD display for user interface and ECG visualisation .
- Alphanumerical keyboard .
- Colour ink-printer for printouts of ECG and interpretation reports in US-letter and DIN A4 size .
- Digital filters for base-line drift and mains interference suppression .
- Interpretation program Hanover ECG System (HES) providing the following additional . information:
- Representatives templates of each lead including markers on fiducial points .
- Summary of mean measurements .
- Summary of measurements performed on each lead .
- Rhythm Analysis Statements .
- . Signal noise detection and information
- . Specific findings on QRS complex
- Conduction statements .
- QRS T Diagnostic statements .
- . Arrhythmia monitoring detection
- Heart Rate Variability .
- . Storage of 10 seconds of acquired ECG signal
- . Patient information and ECGs are stored in an internal database
- Data can be stored on an SD memory card
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
4 years and older and a weight of 20 kg or higher. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
Intended User / Care Setting
trained physicians in the office or hospital
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)
Both devices, CorScreen and the predicate device AB CARDIETTE View Base and Daedalus View Hes, have been tested according to EN 60601-1 and IEC 601-2-25. Furthermore, CorScreen has been tested according to the standards listed in chapter 9 of this 510(k) and has shown full compliance to the standards.
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
K070614/S1
P1/5
5. 510(K) SUMMARY
General Information
MAY - 4 2007
APPLICANT 5.1
Date:
Viasys Healthcare GmbH Name:
Address: Leibnizstrasse 7 D-97204 Hoechberg Germany
Contact person in the U.S .: Yvette Lloyd Viasys Respiratory Care - YL Address 22705 Savi Ranch Parkway Yorba Linda, CA 92887-4668 714 -- 919 - 3247 Telephone: 714 – 919 - 3247 FAX: E-Mail: Yvette.Lloyd@viasyshc.com
Contact person in Germany: Detlef Grotheer Telephone: FAX: E-Mail:
01149 931 4972 - 111 01149 931 4972 — 62111 Detlef. Grotheer@viasyshc.com
5.2 TRADE NAME
CorScreen
Signature:
5.3 Common Name or Classification Name
ECG Interpretive Electrocardiograph
Establishment Registration Number 5.4
9615102
Facility Address રું રે
Viasys Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg Germany
1
K070614/S1
P2/5
Device Classification 5.6
5.6.1 Classification
This is a class II device
5.6.2 Classification panel
Panel: Circular System Devices Panel (74), ECG Product Code DPS
5.6.3 Regulation Number0
870.2340
5.7 Reason for Premarket Notification
Approval of new ECG-device and interpretive software in combination with existing monitor (Viasys Flowscreen, K932744)
5.8 Predicate Devices Descriptions
5.8.1 Name
AB CARDIETTE Daedalus View Hes
5.8.2 Predicate Device Company
H&C Medical Devices spa Italy
5.8.3 Predicate Device 510(k)#
5.9 Device Description
CorScreen is an electrocardiograph providing the following characteristics:
- Mains operation .
- Simultaneous acquisition of the 12 standard leads ◆
- Colour LCD display for user interface and ECG visualisation .
- Alphanumerical keyboard .
- Colour ink-printer for printouts of ECG and interpretation reports in US-letter and DIN A4 size .
- Digital filters for base-line drift and mains interference suppression .
- Interpretation program Hanover ECG System (HES) providing the following additional . information:
- Representatives templates of each lead including markers on fiducial points .
- Summary of mean measurements .
- Summary of measurements performed on each lead .
- Rhythm Analysis Statements .
- . Signal noise detection and information
- . Specific findings on QRS complex
- Conduction statements .
2
K070614/S1
P 3/5
- QRS T Diagnostic statements .
- . Arrhythmia monitoring detection
- Heart Rate Variability .
- . Storage of 10 seconds of acquired ECG signal
- . Patient information and ECGs are stored in an internal database
- Data can be stored on an SD memory card
Promotional material and "Instructions for Use" are submitted as annex A and annex B.
5.10 Intended Use Statement
CorScreen is an active medical device and is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
CorScreen can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. CorScreen is intended for use in routine ECG recording by trained physicians in the office or hospital. CorScreen is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all CorScreen measurements. An interpretation by CorScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CorScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The intended use is equivalent to the intended use of the predicate device AB Cardiette Daedalus View Hes.
5.11 Required Components
- CorScreen-monitor .
- CorScreen ECG-amplifier
- Disposable ECG-electrodes
- User manual
5.12 Summary Table of Comparisons
| No. | Parameter | CorScreen | Predicate Device
AB CARDIETTE DAEDALUS
VIEW Base and Hes |
|-----|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended Use | CorScreen is an active medical
device and is intended for
measuring a 3/6- or 12-channel
surface electrocardiogram
(ECG) of a patient. The acquired
ECG can be recorded and
displayed on a screen or printed
on paper. 12-channel ECGs are
analysed automatically and
suggestions for the interpretation
of the 12-channel ECG can be | AB Cardiette Daedalus View
Base and Hes are two
electrocardiographs
characterized as follows:
Daedalus View Base is a basic
standard electrocardiograph.
Daedalus View Hes is equivalent
to the base version but provided
with an additional program for
automated ECG analysis. |
3
| K070614/5
| p4/5 | |
|---|---|
| made by the software. | |
| CorScreen can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. CorScreen is intended for use in routine ECG recording by trained physicians in the office or hospital. CorScreen is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients. | Intended use is equivalent to the intended use of the predicate Interp 1000. |
| More specifically: both 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 can be visualized on a digital display and recorded on thermal paper. | |
| The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm. | Intended use for non interpretive applications (both versions View Base and Hes) cover the full range of patient population with no limitations with respect to age, sex, and race of the patient. |
| A qualified physician has to reassess all CorScreen measurements. An interpretation by CorScreen is only significant | The interpretation program is intended to provide a diagnostic support to the physician for the ecg evaluation on rhythm and morphology. |
| | | 1144 81 1148811911 881 481 14
not intended for intracardial use.
Automatic interpretation of the
ECG is not possible for pediatric
patients with an age below 16
years and for pacemaker
patients. | auther in accuracy are invally of
two or more electrocardiograph
electrodes and can be visualized
on a digital display and recorded
on thermal paper.
Intended use for non interpretive |
|-----|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | The interpretation software is
intended to support the
physician in evaluating the ECG
in terms of morphology and
rhythm. | applications (both versions View
Base and Hes) cover the full
range of patient population with
no limitations with respect to
age, sex, and race of the patient. |
| | | A qualified physician has to
reassess all CorScreen
measurements. An interpretation
by CorScreen is only significant
if it is considered in connection
with other clinical findings. ECG
interpretation statements made
by the CorScreen represent
partial qualitative and
quantitative information on the
patient's cardiovascular
condition and no therapy or
drugs can be administered
based solely on the
interpretation statements. | The interpretation program is
intended to provide a diagnostic
support to the physician for the
ecg evaluation on rhythm and
morphology. |
| | 2. ECG interpretation
software | Based on Hes (Hanover ECG
System)
Among other features:
Representatives templates on
each lead including markers on
fiducial points | Based on Hes (Hanover ECG
System)
Among other features:
Representatives templates on
each lead including markers on
fiducial points |
| ని. | Input dynamic range | +/- 300mV @ DC | +/-300mV @ DC |
| 4. | Frequency
response
bandwidth | 0,05-150Hz / according to EC11 0,05 - 150 Hz
and IEC 60601-2-51 | |
| ട്. | A/D conversion | 24 bits | 14 bits |
| 6. | Leads | 12 Standard | 12Standard / 12 Cabrera |
| 7. | Paper Speed | 25, 50 mm/s +/-5%
According to EC11 | 1.25 2.5 5 10 12.5 mm/s +/-5% |
| 8. | Recorder Sensitivity | 5, 10 , 20 mm/mV
According to EC11 | 1.25 2.5 5 10 20 40 mm/mV |
| ். | Writing System | Ink-printer US-letter and DIN-A4
size | Thermal
head
210
8
mm
dots/mm |
| | 10. Printed Channels | 1/2/6/12 | 3/4/6/12 |
| | 11. Paper | US-Letter and DIN-A4 | Thermal Paper DOTCARD 210mm |
| | 12. Mode of operation | Manual | Manual, Manual delayed and Automatic recording |
| | 13. Input/output | SD Memory card | RS232 standard digital port |
| | 14. Display | | |
| | 15. Size | 320 x 240 pixels | VGA 640 x 480 pixels |
| | 16. N o of displayed channels | 1/3/6/12 | 3/6 |
| | 17. Traced speeds | 5 10 25 50 mm/s | 1.25 2.5 5 10 12.5 25 50 mm/s |
| | 18. Sensitivity | 5 10 20 40 mm/mV | 1.25 2.5 5 10 20 40 mm/mV |
4
The differences in technological characteristics between CorScreen and the predicate device AB CARDIETTE View Base and Daedalus View Hes can be summarized as follows:
- Use of an external ECG-amplifier / analog-digital converter instead of an internal .
- Use of an ink-printer versus thermal printer
- Data can be stored on an SD memory card
- CorScreen has four different sensitivities of the recorder, compared to six different sensitivities of the predicate device. This is not relevant for safety and effectiveness, because the two missing low sensitivities would lead to a compressed ECG signal (height). These signals would be more difficult to read.
- CorScreen has four different trace speeds instead of seven speeds. This is not relevant for safety and effectiveness, because the two missing low speeds lead to highly compressed ECG-recordings that are difficult to read. This is only an issue for saving paper.
- The CorScreen display is smaller than the display of the predicate device. This is not relevant for safety and effectiveness, because diagnosis is intended to be performed by means of the paper report produced by the CorScreen. The display is used only for controlling the ECGmeasurement process and is therefore sufficient for the intended use.
5.13 Summary of Device Testing
Both devices, CorScreen and the predicate device AB CARDIETTE View Base and Daedalus View Hes, have been tested according to EN 60601-1 and IEC 601-2-25. Furthermore, CorScreen has been tested according to the standards listed in chapter 9 of this 510(k) and has shown full compliance to the standards.
5.14 Conclusions
Based on the above, VIASYS HEALTHCARE GMBH concludes, that CorScreen is substantially equivalent to a legally marketed predicate device and is safe and effective for its intended use, and performs as well as or better than the predicate device.
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, represented by curved lines. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Viasys Respiratory Care - YL
MAY - 4 2007
c/o Yvette Lloyd Senior Regulatory Affairs Specialist 22705 Savi Ranch Parkway Yorba Linda, CA 92887-4668
Re: K070614
Trade/Device Name: CorScreen Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 24, 2007 Received: April 27, 2007
Dear Ms. Lloyd:
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 - Ms. Lloyd
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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
suma R. lochner
Ca Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
KOZOG 14 510(k) Number (if known):
Device Name: CorScreen
Indications for Use:
CorScreen is an active medical device and is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
CorScreen can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. CorScreen is intended for use in routine ECG recording by trained physicians in the office or hospital. CorScreen is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatic patients with an age below 16 years and for pacemaker patients.
The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm.
Intended use is equivalent to the intended use of the predicate device AB Cardiette Daedalus View Hes.
A qualified physician has to reassess all CorScreen measurements. An interpretation by CorScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CorScreen represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
Federal U.S. law restricts this device to sale by or on the order of a physician.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
una R. de Lunes
(Division Sign-Off) Division of Cardiovascular Devices
5 "K) Number_Ko 70614
Page 1 of