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).

Device Description

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.

AI/ML Overview

The provided 510(k) summary for the IQmark Digital Holter (K031466) primarily focuses on demonstrating substantial equivalence to a predicate device (Rhythmscan Precision 6000, K914577), rather than presenting a detailed study with explicit acceptance criteria and performance data for the IQmark Digital Holter itself.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement are not explicitly stated in the provided document. The 510(k) process for this device relies on the existing clearance of the predicate device and asserts that the changes in the IQmark Digital Holter do not alter the fundamental scientific technology or intended use.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for the IQmark Digital Holter's performance. The primary "acceptance" is based on demonstrating substantial equivalence to the predicate device, Rhythmscan Precision 6000 (K914577), by showing that its intended use and fundamental scientific technology have not changed.

Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are presented for the IQmark Digital Holter. The document states that "Both devices generate statistical results based on an identical set of analysis results" and that the modified software "has not changed the fundamental scientific technology of the device." This implies that the performance is considered equivalent to the predicate device without needing re-validation of specific metrics for the new device.

Metric (Implied)	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Unchanged from predicate device (Rhythmscan Precision 6000)	"The intended use of the IQmark Digital Holter as described in its labeling has not changed from the cleared device, Rhythmscan Precision 6000 (K914577)."
Fundamental Scientific Technology	Unchanged from predicate device	"The modified Holter software has not changed the intended use of the device and has not changed the fundamental scientific technology of the device."
ECG Analysis Capabilities (e.g., heartbeat categories, ST segment, R-R variability)	Identical to predicate 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."
Pacemaker Evaluation (for IQmark Digital Holter)	Functional and reviewable by operators	"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."

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

The document does not describe a distinct "test set" and corresponding sample size for evaluating the IQmark Digital Holter's performance as a standalone product. The submission relies on the substantial equivalence to the predicate device, implying that the predicate's performance, which was presumably validated using appropriate data, is considered applicable.

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

Not applicable, as a specific "test set" for the IQmark Digital Holter with associated ground truth established by experts is not described in this 510(k) summary. The document mentions that "intended users are expected to review the report" and "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," indicating that human expertise is part of the clinical workflow, but not establishing a ground truth for a performance study within this submission.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as a specific "test set" requiring adjudication for ground truth establishment is not described.

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 study is mentioned or implied. The device is described as an analysis software that provides statistical reports, which are then reviewed and edited by "trained medical personnel" or "physicians or scanning operators." It's not presented as an AI-powered diagnostic aid that improves human reader performance in a controlled study scenario. The core functionality is automated analysis followed by human review/editing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device performs automated analysis and generates statistical reports, the document explicitly states:

"The IQmark Digital Holter software does not provide diagnostic interpretation."
"The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report."
"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."

This strongly indicates that the device's performance is intended to be used with human-in-the-loop review and editing, and no standalone performance study without human intervention is described as part of this 510(k) submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

No specific ground truth type is mentioned because a dedicated independent performance study for the IQmark Digital Holter is not described. The presumption is that the predicate device's performance was established using appropriate ground truth, likely expert interpretation of ECGs, given the nature of Holter analysis.

8. The Sample Size for the Training Set

Not applicable. The document does not describe a machine learning algorithm or a "training set" in the context of this 510(k) summary. The device is a "software program that analyzes recorded ambulatory ECG (Holter)" and is based on the "fundamental scientific technology" of its predicate. This suggests a rule-based or conventional signal processing algorithm rather than a data-driven machine learning model requiring a training set.

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

Not applicable, as no training set or machine learning algorithm requiring such ground truth is mentioned.

Summary

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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: (310) 530-1421 Telephone: (310) 530-5955 x 7210 E-mail: rzhang@brentwoodmed.com 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(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:

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INTENDED USE OF DEVICE:

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 AnalyzerDevices	IQmark DigitalHolter	RhythmscanPrecision 6000	ELA SyneviewHolter ECG System
Company	Brentwood MedicalTechnology Corp.	Brentwood MedicalProducts	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 UserInterface (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

ArrhythmiaClassification
Events Editing	Yes	Yes	Yes
ST Segment	Yes	Yes	Yes
Templates	Yes	Yes	Yes
PacemakerEvaluation	Yes	No	Yes
Reports Editing	Yes	Yes	Yes
Reports Selection	Yes	Yes	Yes
Archiving	Yes	Yes	Yes
Printing ECG Strips	Yes	Yes	Yes
Printing FullDisclosure	Yes	Yes	Yes
Full DisclosureStorage	Yes	Yes	Yes

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized image of a bird or abstract human figures, composed of three curved lines.

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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 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

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

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
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.(b)
Classification. Class II (performance standards).