HOLTER 2000

K990170 · Zymed Medical Instrumentation · MLO · Apr 13, 1999 · Cardiovascular

Device Facts

• Record ID: K990170
• Device Name: HOLTER 2000
• Applicant: Zymed Medical Instrumentation
• Product Code: MLO · Cardiovascular
• Decision Date: Apr 13, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended 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 symptomatic 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 Antiarrhythmic 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.

Device Story

Holter 2000 analyzes pre-recorded cardiac ECG data from cassette or digital storage. System processes 2 or 3-channel ECG waveforms to generate reports on cardiac rhythm patterns and performance. Clinical tools include individual ECG printouts, multi-channel automatic ST analysis, and multi-channel morphology analysis. Used by trained medical personnel in clinical settings to diagnose cardiac rhythm disturbances, assess arrhythmia risk, evaluate pacemaker function, and detect myocardial ischemia. Output assists clinicians in therapeutic decision-making and monitoring patient cardiac performance. System operates on an IBM PC AT compatible platform with Windows NT, providing automated analysis of ECG waveforms and consecutive patterns.

Clinical Evidence

Bench testing only. Performance validated against industry-standard AHA, MIT, and European ST-T (EST) databases. Metrics included sensitivity (SE), positive predictivity (+P), and false positive rate (FPR) for QRS, ventricular, couplets, and short/long runs. ST analysis validated using Episode Sensitivities (ESE), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE), and Duration Positive Predictivity (D+P). System performance demonstrated equivalence to the predicate in high heart rate scenarios (exceeding 300 bpm) and in the presence of baseline, electrode, or muscle noise.

Technological Characteristics

IBM PC AT compatible platform; 200 MHz Pentium Pro CPU; 64 MB RAM; 540 MB hard disk; SVGA display. Data acquisition: 2 or 3 channels, 8-bit resolution, 192 Hz sampling frequency. Input: Cassette tape or digital. Output: Laser printer. Software: Windows NT operating system. Performs multi-channel automatic ST analysis and morphology analysis.

Indications for Use

Indicated for pediatric to adult patients requiring assessment of cardiac rhythm disturbances, arrhythmia risk (including idiopathic hypertrophic cardiomyopathy and post-MI left ventricular dysfunction), antiarrhythmic therapy efficacy, pacemaker function, or myocardial ischemia (e.g., Prinzmetal's angina).

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

• Zymed Holter Scanner Model 2010 Plus (K955015)

Submission Summary (Full Text)

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APR 13 1999

K990170

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## 510(k) Summary

Submitter:

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Gretel Lumley, Quality Assurance Engineer Zymed Medical Instrumentation 20 North Aviador Street Camarillo, CA 93010 805-987-9532 Fax: [phone] (417) Phone: 2-19-99 Date of Summary: G. Lumlev - see above Contact:

Zymed Holter 2000 Trade Name: Common Name: Holter Analyzer Arrhythmia detector/medical cathode - ray tube display Classification Name: (per 21 CFR 870.2450)

Legally marketed device to which S.E. is claimed. Zymed Holter Scanner Model 2010 Plus - 510(k) K955015

Description: The Holter 2000 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 Holter 2000 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 Holter 2000 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, 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

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Indications for Use:

- 1. Assessment of symptoms that may be related to Rhythm Disturbances of the Heart in patients from pediatric to adult age. Patients with palpitations.
- 2. Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
- 3. Assessment of Efficacy of Antiarrhythmic Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
- 4. 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.
- 5. Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's angina.

| Platform | Holter 2000 (New)<br>Holter | Holter Scanner Model 2010 (Old)<br>Holter |
|---------------------|--------------------------------|-------------------------------------------|
| Type | IBM PC AT Compatible | Same |
| CPU | 200 Mhz Pentium Pro or greater | Same |
| RAM | 64 M Bytes Minimum | 16 M Bytes Minimum |
| Hard Disk | 540 M Bytes Minimum | 540 M Bytes Minimum |
| Display | SVGA | Same |
| Data Acquisition | | |
| Number of Channels | 2 or 3 | Same |
| Resolution | 8 bits | Same |
| Sampling Frequency | 192 samples per second | Same |
| Digital Input | Yes | Same |
| Software | | |
| Operating System | Windows NT | DOS |
| ST Segment Analysis | Yes | Same |

Review of Technology characteristics compared to the predicate device:

The only difference between the two Zymed systems is the operating system environment.

Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases. Results were typical for the Holter as targeted. Scparate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database

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and measured for QRS, Ventricular, Couplets, Short runs and Long runs. Separate Episode Sensitivities (ESE), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE) and Duration Positive 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 shows nearly identical data, and therefore, supports a claim of Substantial Equivalence.

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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 features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 1999

Ms. Gretel Lumley Quality Assurance Engineer Zymed, Inc. 20 North Aviador Street Camarillo, CA 93010-8348

Re: K990170 Holter 2000 II (two) Requlatory Class: Product Code: MLO Dated: March 18, 1999 Received: March 22, 1999

Dear Ms. Lumley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially 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 inspections, the Food and 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 response to your premarket notification submission does not affect any

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obligation you might have under sections 531 through 542 of the Act 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 in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, ² Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: K990170

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 . symptomatic 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Cardiovascular. Respirato and Neurological Dev 510(k) Number

Prescription Use
(CFR21 CFR 801.109)

or

Over-The-Counter Use