IQmark EZ Stress is intended to be used under the supervision of a physician, in hospitals, clinics and physician's office, to acquire, display, process, record, analyze and print the patient's electrocardiograms from the human body surface during stress induced from exercise devices such as a treadmill, a bicycle ergometer or drug induced (pharmacological) stress.
The device may provide interfaces with external devices, such as a treadmill or an ergometer, non-invasive blood pressure equipment, and computer communication equipment.
The device is not intended to be used as a vital signs physiological monitor.

Device Description

The IQmark EZ Stress test system is a computer-based diagnostic electrocardiograph that is designed for exercise stress test. The IQmark stress runs on the Microsoft Windows environments and can control a treadmill or an ergometer through a serial port. The IQmark EZ Stress provides real time ECG data acquisition, waveform display, and ORS detection. It calculates the heart rate, detects ventricular ectopic beats, generates the average beats, measures the ST segment levels and slopes, generates the test reports, and stores the reports in the database. The IQmark EZ Stress system also provides reports and FCG strip printing and review and editing capabilities for trained personnel to manage the patient`s report.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text for the IQmark EZ Stress device:

Acceptance Criteria and Study Details for IQmark EZ Stress

This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than establishing novel performance metrics. Therefore, the "acceptance criteria" for the IQmark EZ Stress are largely defined by its ability to meet the same technical specifications and features as the predicate devices and conform to relevant industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission focuses on substantial equivalence, the "acceptance criteria" are implied by the comparison to predicate devices and adherence to standards. The "reported device performance" is described as meeting these criteria.

Acceptance Criteria (Implied by Predicate Comparison & Standards)	Reported Device Performance (IQmark EZ Stress)
Functional Equivalence to Predicate Devices:	The IQmark EZ Stress has many identical or similar technical specifications and features to the two predicate devices (Q-Stress and CASE 8000), including operating system, ECG lead capacity, signal processing capabilities, QRS detection, ST segment measurements, editing, and report generation.
Technical Specifications (e.g., ECG analysis frequency, frequency response, filters) equivalent to predicate devices.	- ECG analysis frequency: 500Hz- ECG frequency response (-3 dB): 0.05-150Hz- High pass filter: 0.05Hz- Low pass filter: 40, 150Hz- Line Filter: 50, 60Hz(Matches or is comparable to predicate devices where specified).
Conformance to AAMI/ANSI EC11: 1991 (ECG hardware).	ECG hardware is designed in conformance with AAMI/ANSI EC11: 1991.
Meeting EMC requirements of EN60601-1-2:2001.	ECG hardware meets the EMC requirements of EN60601-1-2:2001.
Performance of Heart Rate Calculation and ST Segment Measurements according to AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998.	Performance of heart rate calculation and ST segment measurements tested according to appropriate sections of AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998.
Software meets design specifications and user-level requirements.	Software Verification Procedure executed to confirm correct implementation of design. Software Validation Procedure executed to challenge completeness and correctness of user-level requirements.
Implementation of risk reduction activities identified in System Risk Analysis.	Traceability Analysis demonstrated implementation of prescribed risk reduction activities.
Safe and Effective as predicate devices.	Test results demonstrated the device is as safe and effective as the two predicate devices.

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

The document does not specify a distinct "test set" with a particular sample size for external clinical data. Instead, the validation primarily relies on:

Internal Verification & Validation Tests: These were performed for the "entire development effort" and for "user level requirements" but no specific case numbers are provided.
Beta Tests: The device underwent "beta tests in a physician's office." No sample size or data provenance (e.g., country of origin, retrospective/prospective) for these beta tests is explicitly stated.

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

Not applicable. The document does not describe the establishment of a "ground truth" by experts for an external test set in the conventional sense of a clinical study. The validation relies on internal testing against design specifications, compliance with industry standards, and comparison to predicate devices, implying that the "ground truth" for these tests would be the expected output based on these specifications and standards.

4. Adjudication Method for the Test Set

Not applicable. No external test set requiring expert adjudication is described in the provided text.

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 MRMC comparative effectiveness study is mentioned. This device is a stress test system, not an AI-powered diagnostic reader, so such a study would not be directly applicable in the context of human reader improvement.

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

Yes, aspects of algorithm-only performance were tested:

The QRS detection, heart rate calculation, and ST segment measurement algorithms (derived from Brentwood's ST and Arrhythmia Analysis library) were tested according to the appropriate sections of AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998. These are industry standards for ambulatory electrocardiographs and stress monitors, implying a standalone performance evaluation against defined criteria.

7. The Type of Ground Truth Used

The "ground truth" for the various tests mentioned appears to be:

Industry Standards: For QRS detection, heart rate, and ST segment measurements (AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998). These standards define expected performance characteristics and often include reference data or methods for assessing accuracy.
Design Specifications: For the general software functionality and user-level requirements, the ground truth would be the documented design specifications and requirements.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional medical device (stress test system) whose algorithms are derived from an existing library (Brentwood's ST and Arrhythmia Analysis library, K013717). It does not mention machine learning or AI models requiring a "training set" in the modern sense.

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

Not applicable, as no training set for a machine learning model is mentioned.

Summary

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This 510(k) Summary is prepared in accordance with 21 CFR 807.92.

1. BASIC INFORMATION

1.1 SUBMITTER

Name:	Brentwood Medical Technology Corp
Address:	3300 Fujita StreetTorrance, CA 90505
Contact Person:	Ruomei Zhang, PhD
Phone Number:	(310) 530-5955 x7210
Fax Number:	(310) 530-1421
Preparation Date:	January 17, 2006

1.2 DEVICE NAME

The trade name and the proprietary name of the device is the IQmark EZ Stress. (The remainder of this submission refers to the device as the "IOmark EZ Stress"). The common name of the device is Stress Test System. Classification names and Product Classification Codes are as follows:

Classification	Code	Description
870.2340, II	DPS	Electrocardiograph
870.2340, II	MLC	Non-alarming ST Segment Monitor
870.2300, II	DRT	Cardiac Monitor(including cardiotachometer and rate alarm)

1.3 IDENTIFICATION OF LEGALLY MARKETED DEVICE

Substantial equivalence is claimed to a legally marketed device cleared under the names:

1. Q-Stress. Quinton Instrument Inc. 510(k) Number: K001492.
1. CASE 8000 exercise testing system. GE Medical Systems. 510(k) Number: K991014.

1,4 DEVICE DESCRIPTION

The block diagram below shows the overall configuration of a stress testing system using the IOmark EZ Stress software.

Image /page/0/Figure/15 description: This image shows a diagram of an IQmark Diagnostic Workstation. The diagram shows a 10-lead patient connection connected to an IQmark Digital ECG Module via a patient cable. The ECG module is connected to a Windows PC, which is connected to a printer. A treadmill is also shown in the diagram.

IQmark EZ Stress Software

Figure 1. IQmark EZ Stress test system configuration

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The IQmark EZ Stress test system uses the same ECG data acquisition hardware as the IQmark Digital ECG (formerly Brentwood PCECG, 510K number: K955023). The ECG devices have been in market for more than 7 years. The QRS detection and ST analysis algorithm used in the IQmark EZ Stress is derived from Brentwood Real Time ST and Arrhythmia Analysis Software Library (STAR) (510K number: K013717).

1.5 INTENDED USE

The IQmark EZ Stress is intended to be used under the supervision of a physician, in hospitals, clinics and physician's office, to acquire, display, process, record, analyze and print the patient's electrocardiograms from the human body surface during stress induced from exercise devices such as a treadmill, a bicycle ergometer or drug induced (pharmacological) stress.

The device may provide interfaces with external devices, such as a treadmill or an ergometer, non-invasive blood pressure equipment, and computer communication equipment.

The device is not intended to be used as a vital signs physiological monitor.

1.6 COMPARISON TO CLEARED DEVICE

The IQmark EZ Stress device and the predicate devices have equivalent indications for use, intended use environment, and technical specifications and features. Table 1 compares the indications for use and intended use environment. Table 2 compares the technical specifications and features of the proposed device to the predicate devices.

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Indications	IQmark EZ Stress	CASE 8000	Q-Stress
for Use		(K991014)	(K001492)
IntendedUse	To acquire, display,process, record,analyze and print thepatient'selectrocardiogramsfrom the human bodysurface during stressinduced from exercisedevices such as atreadmill, a bicycleergometer or druginduced(pharmacological)stress.	To acquire, process,record, archive,analyze, and outputdata during a periodof physiologic stressor during a restingECG condition.	To acquire, process,record, archive,analyze, and outputelectrocardiographicdata duringphysiologic stresstesting.
InterfaceWithExternalDevices	Not intended to beused as a vital signsphysiological monitor.May provideinterfaces withexternal devices,such as a treadmill oran ergometer, non-invasive bloodpressure equipment,and computercommunicationequipment.	Not intended to beused as a vital signsphysiological monitor.Treadmill orergometer andcommunications withcentralized electronic/digital storagesystem.	Not intended to beused as a vital signsphysiological monitor.Treadmill orergometer fordynamic exerciseevaluation, non-invasive bloodpressure equipment.and computercommunicationsequipment.
IntendedUseEnvironment	Under the supervisionof a physician, inhospitals, clinics andphysician's office	Hospital basedexercise testinglaboratories, but canbe used in clinics,physician offices,outreach centers orwherever exercisetesting is performed.	Clinical setting bytrained personnel whoare acting on theorders of a licensedphysician
PatientPopulation	Not specified	Not specified.	Adult populations.typically symptomatic.
Feature	IQmark EZStress	CASE 8000(K991014)	Q-Stress(K001492)
Microsoft Windows Operating Systems	Yes	Yes	Yes
Computer communication and datastorage (network)	Optional	Optional	Optional
Maximum ECG leads	12	15	12
ECG analysis frequency	500Hz	500Hz	Not specified
ECG frequency response (-3 dB)	0.05-150Hz	0.01-150Hz	Not specified
High pass filter	0.05Hz	0.01Hz	Not Specified
Low pass filter	40, 150Hz	20,40,100,150Hz	Not specified
Line Filter	50, 60Hz	50, 60Hz	50, 60Hz
Baseline correction	Yes	Yes	Yes
CRT ECG display	3/6/12 configurable	3/6/12 configurable	3/6/12 configurable
ECG display speed	12.5, 25, 50 mm/sec	25, 50 mm/sec	5,25,50 mm/sec
Average beat display	Yes	Yes	Yes
Real time QRS detection and heart ratedisplay	Yes	Yes	Yes
Ectopic beat detection and display	Yes	Yes	Yes
ST measurements (ST level, ST slope)based on average beat	Yes	Yes	Yes
J and post-J point	Manual orcomputerselected	Manual orcomputerselected	Manual orcomputerselected
ST trending	Yes	Yes	Yes
Automatic treadmill control interface	Yes	Yes	Yes
Standard and customizable exerciseprotocols	Yes	Yes	Yes
Average beat summary report, rhythmstrip report	Yes	Yes	Yes
Reanalysis	Yes	Yes	Yes
12-lead Resting ECG Analysis	Yes	Yes	Yes
Pacemaker analysis (Resting ECG)	Yes	Yes	No

Table 1: Indications For Use Comparison of IQmark EZ Stress to Predicate Devices

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Table 2: Technical Specifications and Features Comparison of IQmark EZ Stress to Predicate Devices

Table 2 demonstrates that the proposed 10mark EZ Stress has many identical or similar technical specifications and features to the two predicate devices. They all run on Microsoft Windows with IBM compatible PC, use maximum 12 or more ECG leads. have similar signal processing capabilities, can detect (RS wave (and heart rate), and can perform ST segment measurements. They also have similar editing and report generating functionalities. The technical specifications and features listed in Table 2 and in the product specification documents of the IQmark E7. Stress have been verified and validated. The feature comparison in Table 2 and the verification and validation results

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demonstrated that the IQmark EZ Stress system is as effective, as the two predicate devices.

2. DEVICE SAFETY AND EFFECTIVENESS

The IQmark EZ Stress System Risk Analysis document identified the potential patient safety hazards associated with use of the Stress Test. The document also identified the risk reduction activities whose correct implementation must be validated to ensure safety. The Software Validation Procedure prescribed Traceability Analysis as the method to ensure the implementation of those risk reduction activities. The Software V&V Report contains a copy of the Traceability Analysis report, which demonstrates the implementation of the prescribed risk reduction activities. The Risk Analysis document concludes that the IOmark EZ Stress is a safe device if the prescribed risk reduction activities are implemented.

The IQmark EZ Stress uses the same ECG data acquisition hardware as the IQmark Digital ECG (formerly Brentwood PCECG, 510K number: K955023). The ECG hardware is designed in conformance with the AAMI/ANSI EC11: 1991 and meets the EMC requirements of the EN60601-1-2 :2001. The ORS detection, heart rate calculation, and ST segment measurement algorithms are delivered from Brentwood's ST and Arrhythmia Analysis library (510K number: K013717). The performance of the heart rate calculation and ST segment measurements are also tested according to the appropriate sections of the AAMI/ANSI EC13: 1992 and AAMI/ANSI EC38: 1998.

In conclusion, our test results have demonstrated that the I()mark E.Z. Siress is as safe and as effective as the two predicate devices.

3. VERIFICATION AND VALIDATION TEST

Verification and validation tests were performed for the entire development effort. A Software Verification Procedure was created and executed to confirm that the software development effort was performed as planned and to prescribe testing to challenge the correct implementation of the design. A software Validation Procedure was created and executed to challenge the completeness and correctness of the implementation of the user level requirements specified by the Software Requirements Specification and to confirm the implementation of the risk reduction activities prescribed by the System Risk Analysis. The IQmark EZ Stress has also undergone beta tests in a physician's office.

The results of execution of the test procedures and the beta tests are described in the Software Verification and Validation Report. The test results have demonstrated that the Quark EZ Siress meets its design specifications and is as safe and as effective as the two predicate devices. Q-Stress by Quinton Instrument, and CASE 8000 by GE.

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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 features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

MAK 2 8 ZUOb

Brentwood Medical Technology Corp. c/o Mr. Neil E. Devine

Intertek Testing Services NA, Inc. 70 Codman Hill Rd. Boxborough, MA 01719

Re: K052898

Trade Name: IQMark EZ Stress Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: March 09, 2006 Received: March 10, 2006

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 for are cased in 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 – Mr. Neil E. Devine

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

ﻌﺼﺮ ﻋﺪ ﻣ - - - -

: …

510(k) Number (if known):
Device Name:	IQmark EZ Stress
Indications for Use:	IQmark EZ Stress is intended to be used under the supervision of a physician, in hospitals, clinics and physician's office, to acquire, display, process, record, analyze and print the patient's electrocardiograms from the human body surface during stress induced from exercise devices such as a treadmill, a bicycle ergometer or drug induced (pharmacological) stress.The device may provide interfaces with external devices, such as a treadmill or an ergometer, non-invasive blood pressure equipment, and computer communication equipment.The device is not intended to be used as a vital signs physiological monitor.
Prescription Use(Part 21 CFR 801 Subpart D)	X AND/OR 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)
(Division Sign-Off)Division of Cardiovascular Devices	Page of
510(k) Number	K052898

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).