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.

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.

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

AI/ML Overview

The provided document is a 510(k) premarket notification for the CorScreen electrocardiograph. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/ML device.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics for the interpretive software, nor does it report specific performance outcomes like sensitivity, specificity, or accuracy against a ground truth. Instead, the submission focuses on demonstrating that the CorScreen, including its interpretive software (Hanover ECG System - HES), is substantially equivalent to a legally marketed predicate device (AB CARDIETTE Daedalus View Hes) which also uses HES.

The "performance" is implicitly demonstrated through the comparison table (Section 5.12) which shows that the CorScreen either matches the predicate device's specifications or has differences that are deemed "not relevant for safety and effectiveness."

Parameter	CorScreen Specification / Performance	Predicate Device Specification (AB CARDIETTE Daedalus View Hes)	Implied Acceptance / Justification
Intended Use	Measuring 3/6- or 12-channel surface ECG, automatic analysis, suggestions for interpretation for patients 4+ years, 20+ kg (non-interpretive), 16+ years (interpretive), not for intracardial use or pacemakers. Interpretation software supports physician in evaluating morphology and rhythm. Qualified physician reassesses all measurements; interpretation is only significant with other clinical findings. Not for sole basis of therapy.	Equivalent to predicate (AB Cardiette Daedalus View Hes), which provides automated ECG analysis to provide diagnostic support to the physician for ECG evaluation on rhythm and morphology.	Deemed substantially equivalent to the predicate device's intended use. The interpretative outputs are clearly stated as supportive and explicitly not for sole diagnosis or treatment.
ECG Interpretation Software	Based on Hanover ECG System (HES). Includes representative templates, fiducial points, etc.	Based on Hanover ECG System (HES). Includes representative templates, fiducial points, etc.	Direct Equivalence: Since both devices use the same interpreted software (HES), their interpretation capabilities are considered equivalent. No specific "performance" difference is claimed or tested.
Input Dynamic Range	+/- 300mV @ DC	+/-300mV @ DC	Matching specification.
Frequency Response Bandwidth	0.05-150Hz / according to EC11 and IEC 60601-2-51	0.05-150Hz	Matching specification.
A/D Conversion	24 bits	14 bits	Better Performance: 24 bits is superior to 14 bits, indicating better signal resolution, which is considered a positive difference that doesn't raise new questions of safety or effectiveness.
Leads	12 Standard	12 Standard / 12 Cabrera	Similar capability.
Recorder Sensitivity	5, 10, 20 mm/mV (According to EC11)	1.25, 2.5, 5, 10, 20, 40 mm/mV	Acceptable Difference: Fewer low sensitivities. Justified as "not relevant for safety and effectiveness" because missing low sensitivities would lead to compressed/difficult-to-read ECG signals.
Trace Speeds	5, 10, 25, 50 mm/s	1.25, 2.5, 5, 10, 12.5, 25, 50 mm/s	Acceptable Difference: Fewer low speeds. Justified as "not relevant for safety and effectiveness" because missing low speeds lead to highly compressed/difficult-to-read ECG recordings.
Display Size	320 x 240 pixels (Color LCD)	VGA 640 x 480 pixels	Acceptable Difference: Smaller display. Justified as "not relevant for safety and effectiveness" because diagnosis is intended from paper printouts; the display is for controlling the measurement process.
Overall Safety and Effectiveness	CorScreen has been tested according to EN 60601-1, IEC 601-2-25, and other standards listed in chapter 9.	Predicate device also tested to EN 60601-1 and IEC 601-2-25.	Compliance: The device meets relevant electrical safety and performance standards for an electrocardiograph, similar to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical study with a "test set" in the context of evaluating interpretive software performance. There's no mention of a separate dataset of ECGs analyzed by the CorScreen and compared against a ground truth.

The "testing" mentioned in Section 5.13 ("Summary of Device Testing") refers to compliance with electrical safety and performance standards (EN 60601-1, IEC 601-2-25), not clinical performance for the interpretive software itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical "test set" or performance validation study for the interpretive software is described, there's no mention of experts establishing a ground truth. The justification for the interpretive software's performance relies on it being the same software (Hanover ECG System - HES) as used in the legally marketed predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical performance study for the interpretive software with a test set is described.

5. 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 such MRMC study is mentioned. This type of study is more common for AI/ML diagnostic aids where the objective is to show the clinical benefit of the AI "assistance" to human readers. Here, the interpretive software is presented as a component of the ECG device, equivalent to that of the predicate.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study for the HES interpretive software is presented in this document. The submission hinges on the fact that the HES software is already commercially available and integrated into an equivalent predicate device. The device is explicitly designed to support physicians, stating "A qualified physician has to reassess all CorScreen measurements" and "An interpretation by CorScreen is only significant if it is considered in connection with other clinical findings." This indicates an "AI-in-the-loop" design where the software provides suggestions rather than making final diagnoses independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not discussed, as no specific clinical performance study requiring a ground truth for the interpretive software is detailed.

8. The sample size for the training set

The document does not provide any information about a training set for the Hanover ECG System (HES). This is likely because the HES software itself is a pre-existing, established technology, not a novel algorithm being developed and trained for this particular 510(k) submission.

9. How the ground truth for the training set was established

Not discussed, as no training set information is provided.

In summary:

This 510(k) submission for the CorScreen relies heavily on demonstrating substantial equivalence to a predicate device (AB CARDIETTE Daedalus View Hes). The key argument regarding the interpretive software is that it uses the same underlying software (Hanover ECG System - HES) as the predicate. Therefore, the submission does not present new clinical performance studies or specific acceptance criteria for the interpretive algorithm's accuracy, sensitivity, or specificity. Instead, it focuses on general device specifications and compliance with electrical safety standards, asserting that any differences are not relevant to safety or effectiveness.

Summary

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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

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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)#

K002074

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 .

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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

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 DeviceAB CARDIETTE DAEDALUSVIEW Base and Hes
1.	Intended Use	CorScreen is an active medicaldevice and is intended formeasuring a 3/6- or 12-channelsurface electrocardiogram(ECG) of a patient. The acquiredECG can be recorded anddisplayed on a screen or printedon paper. 12-channel ECGs areanalysed automatically andsuggestions for the interpretationof the 12-channel ECG can be	AB Cardiette Daedalus ViewBase and Hes are twoelectrocardiographscharacterized as follows:Daedalus View Base is a basicstandard electrocardiograph.Daedalus View Hes is equivalentto the base version but providedwith an additional program forautomated ECG analysis.

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K070614/5p4/5
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 14not intended for intracardial use.Automatic interpretation of theECG is not possible for pediatricpatients with an age below 16years and for pacemakerpatients.	auther in accuracy are invally oftwo or more electrocardiographelectrodes and can be visualizedon a digital display and recordedon thermal paper.Intended use for non interpretive
		The interpretation software isintended to support thephysician in evaluating the ECGin terms of morphology andrhythm.	applications (both versions ViewBase and Hes) cover the fullrange of patient population withno limitations with respect toage, sex, and race of the patient.
		A qualified physician has toreassess all CorScreenmeasurements. An interpretationby CorScreen is only significantif it is considered in connectionwith other clinical findings. ECGinterpretation statements madeby the CorScreen representpartial qualitative andquantitative information on thepatient's cardiovascularcondition and no therapy ordrugs can be administeredbased solely on theinterpretation statements.	The interpretation program isintended to provide a diagnosticsupport to the physician for theecg evaluation on rhythm andmorphology.
	2. ECG interpretationsoftware	Based on Hes (Hanover ECGSystem)Among other features:Representatives templates oneach lead including markers onfiducial points	Based on Hes (Hanover ECGSystem)Among other features:Representatives templates oneach lead including markers onfiducial points
ని.	Input dynamic range	+/- 300mV @ DC	+/-300mV @ DC
4.	Frequencyresponse bandwidth	0,05-150Hz / according to EC11 0,05 - 150 Hzand 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/mVAccording to EC11	1.25 2.5 5 10 20 40 mm/mV
்.	Writing System	Ink-printer US-letter and DIN-A4size	Thermalhead2108mmdots/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

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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.

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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.

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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

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Indications for Use

KOZOG 14 510(k) Number (if known):

Device Name: CorScreen

Indications for Use:

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.

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

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).