K Number

Device Name

IQMARK EZ STRESS

Manufacturer

BRENTWOOD MEDICAL TECHNOLOGY CORP.

Date Cleared

2006-03-28

(165 days)

Product Code

DPS

Regulation Number

870.2340

Intended 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.

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K001492, K991014

Reference Devices

K955023, K013717

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ECG analysis techniques (QRS detection, heart rate calculation, ST segment analysis) and does not mention any AI/ML specific terms or methodologies.

Therapeutic

No
The device is described as a "diagnostic electrocardiograph" intended to "acquire, display, process, record, analyze and print the patient's electrocardiograms" during stress tests. Its function is to provide information for diagnosis, not to treat a condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states the device is used to "acquire, display, process, record, analyze and print the patient's electrocardiograms" during stress testing. The "Device Description" section explicitly calls it a "computer-based diagnostic electrocardiograph."

SaMD (Software as a Medical Device)

The device description explicitly states it is a "computer-based diagnostic electrocardiograph" and mentions controlling external hardware like treadmills and ergometers through a serial port, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the IQmark EZ Stress is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
IQmark EZ Stress Function: The IQmark EZ Stress acquires, displays, processes, and analyzes electrocardiograms (ECGs) directly from the human body surface. It does not analyze specimens taken from the body.

The device is a diagnostic electrocardiograph used for exercise stress tests, which is a type of in vivo diagnostic procedure (performed on a living organism).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

DPS, MLC, DRT

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.
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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human body surface

Indicated Patient Age Range

Not specified (for IQmark EZ Stress). Predicate device Q-Stress states "Adult populations, typically symptomatic."

Intended User / Care Setting

Under the supervision of a physician, in hospitals, clinics and physician's office

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

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.
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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K001492, K991014

Reference Device(s)

K955023, K013717

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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 Street
Torrance, 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

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.

Indications	IQmark EZ Stress	CASE 8000	Q-Stress
for Use		(K991014)	(K001492)
Intended
Use	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.	To acquire, process,
record, archive,
analyze, and output
data during a period
of physiologic stress
or during a resting
ECG condition.	To acquire, process,
record, archive,
analyze, and output
electrocardiographic
data during
physiologic stress
testing.
Interface
With
External
Devices	Not intended to be
used as a vital signs
physiological monitor.
May provide
interfaces with
external devices,
such as a treadmill or
an ergometer, non-
invasive blood
pressure equipment,
and computer
communication
equipment.	Not intended to be
used as a vital signs
physiological monitor.
Treadmill or
ergometer and
communications with
centralized electronic/
digital storage
system.	Not intended to be
used as a vital signs
physiological monitor.
Treadmill or
ergometer for
dynamic exercise
evaluation, non-
invasive blood
pressure equipment.
and computer
communications
equipment.
Intended
Use
Environment	Under the supervision
of a physician, in
hospitals, clinics and
physician's office	Hospital based
exercise testing
laboratories, but can
be used in clinics,
physician offices,
outreach centers or
wherever exercise
testing is performed.	Clinical setting by
trained personnel who
are acting on the
orders of a licensed
physician
Patient
Population	Not specified	Not specified.	Adult populations.
typically symptomatic.
Feature	IQmark EZ
Stress	CASE 8000
(K991014)	Q-Stress
(K001492)
Microsoft Windows Operating Systems	Yes	Yes	Yes
Computer communication and data
storage (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 rate
display	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 or
computer
selected	Manual or
computer
selected	Manual or
computer
selected
ST trending	Yes	Yes	Yes
Automatic treadmill control interface	Yes	Yes	Yes
Standard and customizable exercise
protocols	Yes	Yes	Yes
Average beat summary report, rhythm
strip 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

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

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.

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.

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

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