(30 days)
No
The summary describes standard ECG analysis software and does not mention AI or ML. Performance testing is against established databases, not a training/test set for an AI/ML model.
No
The device is used for the assessment and diagnosis of cardiac conditions, not for treatment. It analyzes recorded ECG data to provide reports and tools for trained medical personnel to diagnose patients.
Yes
The intended use explicitly states "Assessment of symptoms that may be related to rhythm disturbances of the heart" and "Cardiac data provided by 2010 Plus Holter for Windows is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns." This clearly indicates its role in diagnosing medical conditions.
No
The device description explicitly states that the software analyzes ECG data that is "pre-recorded onto one of several data storage mediums, which is fed into the Holter 2000." This indicates a dependency on a hardware component (Holter 2000 and data storage mediums) for data acquisition, making it a system that includes hardware, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is a Holter monitor system that analyzes electrocardiogram (ECG) data, which is a recording of the electrical activity of the heart. This data is collected externally from the patient's body using electrodes placed on the skin.
- Lack of Biological Sample Analysis: The device does not analyze biological samples taken from the body. It analyzes electrical signals from the body.
Therefore, while it is a medical device used for diagnosis, it falls under the category of a non-invasive diagnostic device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Assessment of symptoms that may be related to rhythm disturbances of the heart in patients from pediatric to adult age. Patients with palpitations.
- Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
- Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
- Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
- Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's angina.
- Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the following parameters.
-
- Ages: 33 to 82 years
-
- Heights: 147 to 185 cm (58 to 73 in)
-
- Weights: 53 to 118 kg (117 to 261 lb)
-
- Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.)
-
Product codes
74 MLO
Device Description
The 2010 Plus Holter for Windows is a device that analyzes recorded cardiac ECG and creates reports from the recorded data. The ECG is pre-recorded onto one of several data storage mediums, which is fed into the Holter 2000. The 2010 Plus Holter for Windows software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data that is analyzed is individual ECG waveforms and patterns of consecutive waveforms. Cardiac data provided by 2010 Plus Holter for Windows is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns. The Zymed system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, derived 12 lead ST analysis multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool. The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Choice of Cassette Tape or Digital Input Laser Printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
pediatric to adult age (for general assessment of rhythm disturbances); 33 to 82 years (for EASI derived 12-lead ST measurements)
Intended User / Care Setting
trained medical personnel
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)
Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European I enormance results were typical for the Holter as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database (00), positive proched for QRS, Ventricular, Couplets, Short runs and Long runs. Separate Episode and measured for Qres, Venerious, Decalictivity (E+P), Duration Sensitivity (DSE) and Duration Bositive Predictivity (D+P) were examined for the European ST-T (EST) database and measured for ST analysis. High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm, and performance in the presence of noise indicates the new system is equivalent to the old system when looking at baseline, electrode or muscle as the cause of noise. In summary, performance data between the two systems were nearly identical, and therefore, supports a claim of Substantial Equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivities (SE), positive predictivity (+P), and false positive rate (FPR). Episode and measured for Qres, Venerious, Decalictivity (E+P), Duration Sensitivity (DSE) and Duration Bositive Predictivity (D+P).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zymed Holter Scanner Model Holter 2000 - 510(k) K990170
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Zymed's EasiView Telemetry System - 510(k) K984089
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
KOO3763
7 med
JAN - 5 2001
Zymed Inc.
1201-B N. Rice Ave. Oxnard, California 93030 800.235.5941 - 805.604.0457 Fax 805.604.0493
510(k) Summary
Submitter:
| Gretel Lumley, Quality Assurance Engineer | |
|---|---|
| Zymed Medical Instrumentation | |
| 1201 B North Rice Avenue | |
| Fax: | 805-604-0493 |
| Phone: | 800-235-5941 (7417) |
| Date of Summary: | 12-5-00 |
| Contact: | G. Lumley - see above |
2010 Plus Holter for Windows Trade Name: Common Name: Holter Analyzer Electrocardiograph, ambulatory, with analysis algorithm Classification Name: (per 21 CFR 870.2800)
Legally marketed device to which S.E. is claimed.
Zymed Holter Scanner Model Holter 2000 - 510(k) K990170 Zymed's EasiView Telemetry System - 510(k) K984089
Description: The 2010 Plus Holter for Windows is a device that analyzes recorded cardiac ECG and creates reports from the recorded data. The ECG is pre-recorded onto one of several data storage mediums, which is fed into the Holter 2000. The 2010 Plus Holter for Windows software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data that is analyzed is individual ECG waveforms and patterns of consecutive waveforms. Cardiac data provided by 2010 Plus Holter for Windows is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns.
The Zymed system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, derived 12 lead ST analysis multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool.
The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Choice of Cassette Tape or Digital Input Laser Printer
1
Indications for Use:
- Assessment of symptoms that may be related to rhythm disturbances of the heart in patients . from pediatric to adult age. Patients with palpitations.
- Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with . ASSessment of risk in Patenas With of the of the cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
- Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, . reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
- Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, . detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
- Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's . angina.
- Assessment of EASI derived 12-lead ST measurements is recommended for patients that . meet the following parameters.
-
- Ages: 33 to 82 years
-
- Heights: 147 to 185 cm (58 to 73 in)
-
- Weights: 53 to 118 kg (117 to 261 lb)
-
- Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.) .
Review of Technology characteristics compared to the predicate device:
| Specification/Feature | Current Holter
Holter Scanner Holter 2000 | Modified Holter
2010 Plus Holter for
Windows |
|-----------------------|---------------------------------------------------------|----------------------------------------------------|
| Platform: | | |
| Type | IBM PC AT Compatible | Same |
| CPU | Pentium II 400 MHz
Or greater | Same |
| RAM | 128 Mbytes or greater | Same |
| Hard Disk | 6 Gbytes or greater | Same |
| Floppy Disk | 1.44 Mbytes | Same |
| Display | Direct Draw Capable,
1024 x 768 pixels, 16 bit Color | Same |
| Mouse | Yes | Same |
| USB | USB 1.2 or greater | Same |
| Software: | | |
| Operating System | Windows 98, Windows NT | Same |
2
| Hardware and Software
| Diagnostics | Included | Same |
|---|---|---|
| Data Acquisition: | ||
| Number of Channels | ||
| Resolution | ||
| Sampling Frequency | ||
| Playback Speed | ||
| Digital Input | 2 or 3 | |
| 8 bit | ||
| 192 samples per second | ||
| 240 times real time | ||
| Yes | Same | |
| Same | ||
| Same | ||
| Same | ||
| Same |
The only difference between the two Zymed systems is the extension of ST analysis from 3 channels to the derived 12 lead.
Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European I enormance has mees aresults were typical for the Holter as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database (00), positive proched for QRS, Ventricular, Couplets, Short runs and Long runs. Separate Episode and measured for Qres, Venerious, Decalictivity (E+P), Duration Sensitivity (DSE) and Duration Bositive Predictivity (D+P) were examined for the European ST-T (EST) database and measured for ST analysis. High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm, and performance in the presence of noise indicates the new system is equivalent to the old system when looking at baseline, electrode or muscle as the cause of noise.
In summary, performance data between the two systems were nearly identical, and therefore, supports a claim of Substantial Equivalence.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized abstract design, resembling an eagle or a symbol of human services. The text is arranged in a circular pattern around the emblem.
JAN - 5 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Gretel Lumley Zymed Corp. 1201 "B" N. Rice Ave. Oxnard, CA 93030
K003763 Re: Trade Name: 2010 Plus Holter For Windows Regulatory Class: II (two) Product Code: 74 MLO Dated: December 5, 2000 Received: December 6, 2000
Dear Ms. Lumley:
We have reviewed your Section 510(k) notification of intention market we nave revrenced your boose and we have determined the device is the device fererenced above and a indications for use stated in the substantially equivalence to the redicate devices marketed in encrosure) co regarif maries in the enactment date of the Incelstate Commerce prob or to devices that have been reclassified redical beview imending, with Federal Food, Drug, and In accordance with the provisions of therefore, market the device, which controle the general controls provisions of the Act. The general controls che general ocherozo include requirements for annual registration, provisions of thes, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your a viol as III (Premarket Approval), it may be subject to such controls) or Grace - Existing major regulations affecting your device aan be found in the Code of Federal Regulations, Title 21, Parts 800 can be round in the equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral rogarderen od Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this concerning your download notification submission does not affect any response of your have under sections 531 through 542 of the Act
4
Page 2 - Ms. Gretel Lumley
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described InIs lecter will afrow you co boyin in the FDA finding of substantial In your Stormance to a legally marketed predicate device equivalence of your device of a region and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advarse additionally 809.10 for in vitro regulation (21 CFR Fare contact the Office of Compliance at draghoser devices), promally, for questions on the promotion and (301) 39 4010. Hautevice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (21CFR 807) by reference to premarket notification" (21CFR 807.927) -MISDIanding by reference co-proir responsibilitities under the Acc may Ocher general Information of Small Manufacturers Assistance at its be obtained from the brives.
toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
A Stipt Rhodes
E. Dillard III Director Division of Cardiovascular · and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K003763 510(k) Number:
Device Name: Zymed Holter 2000
Indications for Use:
- Assessment of symptoms that may be related to rhythm disturbances of the heart in patients . from pediatric to adult age. Patients with palpitations.
- Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with . r woodsteens or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
- Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, . reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
- Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, . detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
- Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's . angina.
- Assessment of EASI derived 12-lead ST measurements is recommended for patients that . meet the following parameters.
-
- Ages: 33 to 82 years
-
- Heights: 147 to 185 cm (58 to 73 in)
-
- Weights: 53 to 118 kg (117 to 261 lb)
-
- Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.)
-
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE (F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stup Rhodes
Division of Cardiovascular & Respiratory Devices
510(k) Number K003763
Prescription Use A (CFR21 CFR 801.109) Over-The-Counter Use
or