(34 days)
Not Found
No
The document describes a software program that performs statistical analysis of ECG data and provides review and editing tools. There is no mention of AI, ML, or related concepts. The analysis is described as "computer-generated results" and "statistical reports," which are typical of traditional algorithms, not necessarily AI/ML.
No
The device is a software program that analyzes recorded ambulatory ECG data to create statistical reports and aid in diagnosis, but it does not provide therapy or treatment.
No
The device explicitly states it "does not contain diagnostic interpretation" and does "not provide diagnostic interpretation." It performs analysis and generates statistical reports from recorded ECG data, with users expected to review the report and medical personnel able to review and edit analysis results to diagnose patients.
Yes
The device description explicitly states that the IQmark Digital Holter is a "software program that analyzes recorded ambulatory ECG (Holter) then creates statistical reports based on analyzed data." It clarifies that the ECG data is "pre-recorded onto data storage mediums by Holter recorders," indicating the software processes existing data and does not include the hardware for recording.
Based on the provided information, the IQmark Digital Holter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- IQmark Digital Holter Function: The IQmark Digital Holter analyzes recorded ambulatory ECG data. This data is collected from the patient's body using a Holter recorder, but the analysis itself is performed on the electrical signals recorded from the heart, not on a biological specimen taken from the body.
- Intended Use: The intended use is for the evaluation of recorded ECG data to assist physicians in diagnosing patients based on cardiac electrical activity. This is distinct from analyzing biological samples.
Therefore, the IQmark Digital Holter falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used only by physicians or on the order of a physician.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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:
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.
1
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
Devices | IQmark Digital
Holter | Rhythmscan
Precision 6000 | ELA Syneview
Holter ECG System |
|---------------------------------|---------------------------------------|-------------------------------|-----------------------------------|
| Company | Brentwood Medical
Technology Corp. | Brentwood Medical
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
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
| Classification | |||
|---|---|---|---|
| Events Editing | Yes | Yes | Yes |
| ST Segment | Yes | Yes | Yes |
| Templates | Yes | Yes | Yes |
| Pacemaker | |||
| 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 | |||
| Disclosure | Yes | Yes | Yes |
| Full Disclosure | |||
| Storage | Yes | Yes | Yes |
:
3
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
4
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
5
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)