IQMARK DIGITAL HOLTER

K031466 · Brentwood Medical Technology Corp. · MLO · Jun 11, 2003 · Cardiovascular

Device Facts

• Record ID: K031466
• Device Name: IQMARK DIGITAL HOLTER
• Applicant: Brentwood Medical Technology Corp.
• Product Code: MLO · Cardiovascular
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The intended use of the IQmark Digital Holter is for evaluation of the recorded ambulatory ECG for patients who need ambulatory monitoring, such as, but not limited to, those have complaints of chest pain, palpitations, dizziness, shortness of breath, or those have pacemaker implanted. The evaluation includes measurements and statistics of arrhythmia, R-R variability and ST segment changes in the recorded ECG data. The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report. The IOmark Digital Holter is intended to be used only by physicians or on the order of a physician.

Device Story

IQmark Digital Holter is a PC-based software program for analyzing pre-recorded ambulatory ECG data; inputs include raw ECG signals and pacemaker pulse detection data from Holter recorders. Software performs automated analysis to generate statistical reports on arrhythmia, R-R variability, and ST segment changes; provides review/editing tools for trained medical personnel to verify results. Device does not provide diagnostic interpretation. Used in clinical settings by physicians or under physician order; output assists clinicians in patient diagnosis by providing quantified ECG metrics and event statistics. Benefits include efficient review of long-term ambulatory monitoring data.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and functional verification of the software analysis algorithms against the predicate device.

Technological Characteristics

PC-based software; 3-channel ECG input; PCMCIA interface; GUI for data review/editing; network storage capability; supports re-analysis of data; includes pacemaker evaluation tools.

Indications for Use

Indicated for patients requiring ambulatory ECG monitoring, including those with chest pain, palpitations, dizziness, shortness of breath, or implanted pacemakers.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• Rhythmscan Precision 6000 (K914577)
• Syneview™ Holter ECG System (K990727)

Submission Summary (Full Text)

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510(k) Number: K031466 IQmark Digital Holter Device Name:

# 510(k) Summary

Submitter:

Ruomei Zhang, PhD, Chief Technical Officer Brentwood Medical Technology Corp. 3300 Fujita Street Torrance, CA 90505 Fax: [phone] Telephone: [phone] x 7210 E-mail: [e-mail] Ruomei Zhang Contact: Date of Summary: May 27, 2003

| Name of Device: | IQmark Digital Holter |
|----------------------|----------------------------------------------------------------------------------|
| Common/Usual Name: | Holter Analyzer |
| Classification Name: | Electrocardiograph, ambulatory, with analysis algorithm<br>(Per 21 CFR 870.2800) |

Legally marketed devices to which Substantial Equivalence is claimed:

Rhythmscan Precision 6000 - 510(k) K914577, May 08, 1992 Syneview™ Holter ECG System (510(k) K990727, ELA Medical Inc.)

## DESCRIPTION OF DEVICE:

The IOmark Digital Holter is a software program that analyzes recorded ambulatory ECG (Holter) then creates statistical reports based on analyzed data. The ambulatory ECG, as well as pacemaker pulse detection data, is pre-recorded onto data storage mediums by Holter recorders. The IQmark Digital Holter software reads these raw data into computers then performs analysis to generate statistical reports.

The IQmark Digital Holter software provides review and editing tools that allow trained medical personnel to review and edit the initial analysis results to diagnose patients. The IQmark Digital Holter software does not provide diagnostic interpretation.

The IQmark Digital Holter software also provides statistical results of pacing events for pacemaker patients. Like other features in the software, Holter scanning operators can review and edit, if necessary, any analysis results.

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## INTENDED USE OF DEVICE:

The intended use of the IQmark Digital Holter is for evaluation of the recorded ambulatory ECG for patients who need ambulatory monitoring, such as, but not limited to, those have complaints of chest pain, palpitations, dizziness, shortness of breath, or those have pacemaker implanted. The evaluation includes measurements and statistics of arrhythmia, R-R variability and ST segment changes in the recorded ECG data. The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report.

The IOmark Digital Holter is intended to be used only by physicians or on the order of a physician.

The intended use of the IQmark Digital Holter as described in its labeling has not changed from the cleared device, Rhythmscan Precision 6000 (K914577).

## COMPARISON TO CLEARED DEVICES

The IQmark Digital Holter is originated from Rhythmscan Precision 6000 Holter software, with a new trade name and feature modifications. The modified Holter software has not changed the intended use of the device and has not changed the fundamental scientific technology of the device. Both devices have identical heartbeat categories: Ventricular Ectopics, Supraventricular Ectopics, Asystole (Pause) events and Normal heartbeats. Both devices generate statistical results based on an identical set of analysis results. Both devices do not generate diagnostic interpretation. Analysis results are expected to be reviewed by physicians. Physicians or scanning operators can use provided review and editing tools to verify ECG strips in all categories as well as their measurements and statistics.

| Holter Analyzer<br>Devices | IQmark Digital<br>Holter | Rhythmscan<br>Precision 6000 | ELA Syneview<br>Holter ECG System |
|---------------------------------|---------------------------------------|-------------------------------|-----------------------------------|
| Company | Brentwood Medical<br>Technology Corp. | Brentwood Medical<br>Products | ELA Medical Inc. |
| 510(k) Number | K031466 | K914577 | K990727 |
| Raw Data Reader | Digital | Digital / Tape | Digital |
| ECG Channels | 3 | 2 or 3 | 2 or 3 |
| PC Based | Yes | Yes | Yes |
| PCMCIA Interface | Yes | Yes | Yes |
| Graphic User<br>Interface (GUI) | Yes | Yes | Yes |
| Network Storage | Yes | Yes | Yes |
| Re-analysis | Yes | Yes | No |

Comparison Table between IQmark Digital Holter and predicate devices:

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KC31466
page 3 of 3

| Arrhythmia<br>Classification | | | |
|------------------------------|-----|-----|-----|
| Events Editing | Yes | Yes | Yes |
| ST Segment | Yes | Yes | Yes |
| Templates | Yes | Yes | Yes |
| Pacemaker<br>Evaluation | Yes | No | Yes |
| Reports Editing | Yes | Yes | Yes |
| Reports Selection | Yes | Yes | Yes |
| Archiving | Yes | Yes | Yes |
| Printing ECG Strips | Yes | Yes | Yes |
| Printing Full<br>Disclosure | Yes | Yes | Yes |
| Full Disclosure<br>Storage | Yes | Yes | Yes |

:

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

Brentwood Medical Technology Corporation c/o Ruomei Zhang, Ph.D. Chief Technical Officer 3300 Fujita Street Torrance, CA 90505

Re: K031466

Trade Name: IQmark Digital Holter Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MLO Dated: May 27, 2003 Received: May 29, 2003

Dear Dr. Zhang:

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.

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

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Page 2 - Ruomei Zhang, Ph.D.

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 (OS) 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 [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

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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# K031466

510(k) Number (if known):

DEVICE NAME: IQmark Digital Holter

INDICATIONS FOR USE:

The intended use of the IQmark Digital Holter is for evaluation of the recorded ambulatory ECG for patients who need ambulatory monitoring, such as, but not limited to, those have complaints of chest pain, palpitations, dizziness, shortness of breath, or those have pacemaker implanted. The evaluation includes measurements and statistics of arrhythmia, R-R variability and ST segment changes in the recorded ECG data. The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report.

The IOmark Digital Holter is intended to be used only by physicians or on the order of a physician.

The intended use of the IOmark Digital Holter as described in its labeling has not changed from the cleared device, Rhythmscan Precision 6000 (K914577).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) X

OR

Over-The-Counter-Use (Optional Format 1-2-96)