ECScope 200 portable, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 200 will acquire and record 12 ECG leads simultaneously.

The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm.

Interpretation results must be overviewed and approved by trained physicians. Interpretation just represents partial qualitative and quantitative information of the general patient cardiovascular conditions. No therapy or drugs can be administered based solely on the interpretation statements.

The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.

Device Description

ECScope 200 is designed to acquire, display and record ECG signals from surface electrodes. The device consists of two basic components: the processing unit and the patient acquisition module.

ECScope 200 is a multi channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads i.e L1, L2, L3, aVR, aVF, V1, V2, V3, V4, V5 & V6, featuring alphanumeric display and keyboard. This product has an option to print ECG data through inbuilt 2 inch thermal printer or through external USB printer. The ECG data can also be transferred in image format to USB Key or to the computer through USB Cable.

ECScope 200 can record and store in its database up to 30 ECGs. Each ECG record includes patient data, doctor's information and ECG measurements. Stored ECG can be printed directly on inbuilt Thermal Printer or through external USB printer.

ECScope 200 has optional ECG interpretative software which gives statements and measurements that represents partial qualitative and quantitative information of the patient's general cardiovascular conditions.

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 .
. Rhythm Graphical Statements
t Signal noise detection and information
. Specific findings on QRS complex
Conduction statements .
. QRS T Diagnostic statements
Summary of measurement performed on each lead .

AI/ML Overview

The provided 510(k) summary for the DyAnsys ECScope 200 (K091397) focuses on safety and performance testing against regulatory standards, particularly ANSI/AAMI EC11:1991 Guidance Document. However, it does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria, particularly concerning the performance of the optional ECG interpretative software.

Here's a breakdown of the information available and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The submission states that "The ECScope 200 was subjected to safety and performance tests against regulatory standards. Final testing for the product included various performance tests as per ANSI/AAMI EC11: 1991 Guidance Document." However, specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the ECG interpretation software or the device's ability to diagnose cardiovascular complications are not detailed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. There is no mention of a specific test set, its size, or the country of origin of any data used for evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. There is no mention of experts involved in establishing ground truth for any test data.

4. Adjudication Method

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The document explicitly states that the "interpretation program Hanover ECG System (HES) providing...partial qualitative and quantitative information" and "These are not intended for any specific clinical diagnosis and No therapy or drugs can be administered based solely on the interpretation statements." It also emphasizes that "Interpretation results must be overviewed and approved by trained physicians." This suggests the AI is an assistive tool, but no study on its effectiveness in improving human performance is detailed.

6. Standalone (Algorithm Only) Performance

While the document describes the "optional ECG interpretative software," it does not provide any specific standalone performance metrics for this algorithm (e.g., sensitivity, specificity, accuracy against a recognized ground truth). The statement "Interpretation just represents partial qualitative and quantitative information of the general patient cardiovascular conditions" and the requirement for physician approval indicate that the algorithm is not intended for standalone diagnostic use.

7. Type of Ground Truth Used

This information is not provided in the document. Without details on a specific test set or clinical study, the type of ground truth used (e.g., expert consensus, pathology, outcomes data) cannot be determined.

8. Sample Size for the Training Set

This information is not provided in the document. There is no mention of a training set or its size for the ECG interpretative software.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document.

In summary, the 510(k) summary for the DyAnsys ECScope 200 (K091397) primarily addresses the device's technical specifications, intended use, and its substantial equivalence to predicate devices based on safety and performance tests against regulatory standards like ANSI/AAMI EC11:1991. It provides very little detail about the analytical validation of its optional interpretative software's accuracy or clinical performance metrics as would be expected for an AI-based diagnostic tool. The emphasis is on the device's ability to acquire, display, and record ECG signals, with the interpretative software positioned as a supportive tool for physicians, not a standalone diagnostic.

Summary

{0}------------------------------------------------

DyAnsys

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of Safe Medical Devices Act (SMDA) 1990 and 21 CFR 807.92.

510(k) Number: K091397

JUL - 8 2009

Applicant Information:

Name:

Date Prepared: . 1 5t March 2009

DyAnsys, Inc., Address: c/o Emery & Howard, 577, Airport Boulevard, Suite 610, Burlingame, CA 95032 Phone: 650.579.7100 Fax: 650.579.7313

Contact Person:	Srini Nageshwar
Tel.:	408.354.8447
Fax:	650.579.7313

Device Information:

Classification:	Class II
Trade Name:	ECScope 200
Common Name:	ECG Monitor
Classification Name:	Electrocardiograph, CFR 870.2340
Product Code:	74 DPS

Predicate Devices:

a. K Number: K070614 Model Name: CorScreen Manufacturer: Viasys
b. K Number: K002074 Model Name: AB Cardiette Daedalus View Hes Manufacturer: H & C Medical Devices spa
c. K Number: K080036 Model Name: Portable ECScope 12i Manufacturer: DyAnsys, Inc

{1}------------------------------------------------

Zof 3 K091397

Image /page/1/Picture/1 description: The image contains the word "DyAnsys" next to a graphic. The graphic is a stylized image of a candy cane next to a greater than sign. The text is in a simple, sans-serif font.

Device Description:

ECScope 200 is designed to acquire, display and record ECG signals from surface electrodes. The device consists of two basic components: the processing unit and the patient acquisition module.

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 .
. Rhythm Graphical Statements
t Signal noise detection and information
. Specific findings on QRS complex
Conduction statements .
. QRS T Diagnostic statements
Summary of measurement performed on each lead .

Intended Use:

ECScope 200 is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. The optional ECG interpretative statements and measurements represent partial qualitative and quantitative information of the general patient cardiovascular conditions.

DyAnsys, Inc

Page 2 of 3

{2}------------------------------------------------

ീ DyAnsys

K091397 PS 30f3

These are not intended for any specific clinical diagnosis and No therapy or drugs can be administered based solely on the interpretation statements.

The clinical significance of ECG tracings, interpretative statements and measurements must be determined by the physician in conjunction with clinician's knowledge of patient, the results of other physical examination and clinical findings.

Summary of Safety and Effectiveness

Comparison to Predicate Device(s)

The ECScope 200 is substantially equivalent to the following predicate devices:

a. K Number: K070614 Model Name: CorScreen Manufacturer - Viasys
b. K Number: K002074 Model Name: AB Cardiette Daedalus View Hes Manufacturer - H & C Medical Devices spa
c. K Number: K080036, Model Name: Portable ECScope 12i Manufacturer - DyAnsys, Inc

ECScope 200 battery operated Multi channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. ECScope 200 will acquire and record Multi channel ECG signal. ECScope 200 can store in its database up to 30 ECG signal records. The device features a 10 lead ECG.
The ECScope 200 has the same intended use as the legally marketed predicate devices. The intended use of the ECScope 200 is the same as the predicates.

Summary of Device Testing

The ECScope 200 was subjected to safety and performance tests against regulatory standards. Final testing for the product included various performance tests as per ANSI/AAMI EC11: 1991 Guidance Document.

DyAnsys, Inc

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2009

DyAnsys, Inc. c/o Underwriters Laboratories Inc. 333 Pfingsten Road Northbrook, IL 60062 Attn: Ned Devine

Re: K091397

Trade/Device Name: ECScope 200 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 19, 2009 Received: June 23, 2009

Dear Mr. Devine:

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 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

{4}------------------------------------------------

Page 2 - Mr. Ned Devine

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 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 yours,

Duna D. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K 0 91397

Device Name: ECScope 200

Indications for Use:

ECScope 200 portable, battery operated 12 channel electrocardiographs is intended to be used for the diagnosis of cardiovascular system complications. ECScope 200 will acquire and record 12 ECG leads simultaneously.

The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm.

The equipments are intended to be used by trained medical personnel or physicians.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of | (Posted November 13, 2003)

uar D. Vacher

(Division Sign-Off) (Division Sign-Oil)
Division of Cardiovascular Devices

510(k) Number K091397

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).