Who is the manufacturer of IQMARK EZ STRESS?

Brentwood Medical Technology Corp. filed the 510(k) submission for IQMARK EZ STRESS (K052898).

What is the FDA product code for IQMARK EZ STRESS?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for IQMARK EZ STRESS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IQMARK EZ STRESS?

Q-Stress (K001492); CASE 8000 exercise testing system (K991014).

Who can help prepare an FDA 510(k) submission like IQMARK EZ STRESS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IQMARK EZ STRESS

K052898 · Brentwood Medical Technology Corp. · DPS · Mar 28, 2006 · Cardiovascular

Device Facts

Record ID	K052898
Device Name	IQMARK EZ STRESS
Applicant	Brentwood Medical Technology Corp.
Product Code	DPS · Cardiovascular
Decision Date	Mar 28, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	3rd-Party Reviewed

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 Story

Computer-based diagnostic electrocardiograph; acquires, displays, processes, records, and prints ECG data during stress testing. Inputs: 10-lead patient ECG signals; treadmill/ergometer control signals. Operation: Windows-based PC software performs real-time QRS detection, heart rate calculation, ventricular ectopic beat detection, ST segment level/slope measurement, and report generation. Used in hospitals, clinics, and physician offices by trained personnel. Output: ECG waveforms, heart rate, ST segment analysis, and test reports. Clinical utility: assists physicians in evaluating cardiac response to stress. Benefits: enables standardized stress testing, automated analysis, and digital record management.

Clinical Evidence

Bench testing only. Verification and validation performed per Software Verification Procedure and Software Validation Procedure. Performance of heart rate calculation and ST segment measurements tested against AAMI/ANSI EC13:1992 and AAMI/ANSI EC38:1998 standards. System risk analysis and traceability analysis conducted. Beta testing performed in a physician's office.

Technological Characteristics

Windows-based PC software; 12-lead ECG acquisition; 500Hz analysis frequency; 0.05-150Hz frequency response; 50/60Hz line filter; baseline correction. Hardware conforms to AAMI/ANSI EC11:1991 and EN60601-1-2:2001. Connectivity via serial port for treadmill/ergometer control. Software algorithm class: rule-based/signal processing library.

Indications for Use

Indicated for patients undergoing stress testing (exercise or pharmacological) in clinical settings under physician supervision to acquire and analyze ECG data.

Regulatory Classification

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.

Predicate Devices

Q-Stress (K001492)
CASE 8000 exercise testing system (K991014)

Reference Devices

IQmark Digital ECG (formerly Brentwood PCECG) (K955023)
Brentwood Real Time ST and Arrhythmia Analysis Software Library (STAR) (K013717)

Related Devices

K022618 — X-SCRIBE II · Mortara Instrument, Inc. · Sep 6, 2002
K121638 — ST80I STRESS TEST SYSTEM · Philips Health Care · Jul 18, 2012
K082173 — Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S · Cardiac Science Corporation · Aug 26, 2008
K961009 — STRESSWRITER EXERCISE TESTING SYSTEM · Hewlett-Packard Co. · Jun 17, 1996
K952417 — QUEST EXERCISE STRESS SYSTEM · Burdick, Inc. · May 22, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ 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. - 2) 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 {1}------------------------------------------------ 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). #### 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. {2}------------------------------------------------ | 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ # 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 |