MODIFICATION TO ZYMED HOLTER 2000

K992197 · Zymed Medical Instrumentation · MLO · Jul 28, 1999 · Cardiovascular

Device Facts

• Record ID: K992197
• Device Name: MODIFICATION TO ZYMED HOLTER 2000
• Applicant: Zymed Medical Instrumentation
• Product Code: MLO · Cardiovascular
• Decision Date: Jul 28, 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. Paticnts with chest pain suggestive of Prinzmetal's angina.

Device Story

Holter 2000-Software converts user-provided PC hardware into ambulatory ECG scanner; analyzes pre-recorded cardiac ECG data from storage media. Software performs multi-channel automatic ST analysis, morphology analysis, and arrhythmia detection; generates clinical reports. Used by trained medical personnel in clinical settings to diagnose cardiac rhythm patterns, evaluate pacemaker function, and assess antiarrhythmic therapy efficacy. Output includes individual ECG waveforms, consecutive waveform patterns, and diagnostic reports. Clinical benefit includes improved diagnostic accuracy for cardiac arrhythmias and ischemia, and monitoring of pacemaker performance.

Clinical Evidence

Bench testing only. Performance validated against industry-standard AHA, MIT, and European ST-T databases. Metrics included sensitivity, positive predictivity, and false positive rates for QRS, ventricular ectopy, couplets, and short/long runs. ST analysis validated via episode and duration sensitivity/predictivity. Performance in high heart rates (>300 bpm) and presence of noise (baseline, electrode, muscle) demonstrated equivalence to predicate.

Technological Characteristics

Software-based ECG analysis system. Requires IBM PC AT compatible hardware (min. 200 MHz Pentium Pro, 64MB RAM, 540MB HDD, SVGA). Supports 2 or 3-channel data acquisition at 192 samples/sec, 8-bit resolution. Operating system: Windows NT. Features 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 (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

• Holter 2000 (K990170)

Submission Summary (Full Text)

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JUL 28 1999

7 ymed

K992197

Zemed Inc. 9) North Aviador Street Camarillo, California 93063.838 800 .. 35.50 .! - 805.98 - gol 1.11 8015.95-115 3.

510(k) Summary

Submitter:

Gretel Lumley, Quality Assurance Engineer Zymed Medical Instrumentation 20 North Aviador Street Camarillo, CA 93010 805-987-9532 Fax: Phone: [phone] (417) 6-29-99 Date of Summary: G. Lumley - see above Contact:

Zymed Holter 2000 - Software Trade Name: Holter Analyzer Common Name: Electrocardiograph, Ambulatory, with Analysis Algorithm Classification Name: (per 21 CFR 870.2800)

Legally marketed device to which S.E. is claimed. Holter 2000 - 510(k) 990170

Description: The Holter 2000-Software is a device that when installed onto a user's Hardware platform, will convert their system into a Holter scanner analyzes recorded cardiac ECG and creates reports from the recorded data. The patient's ECG is pre-recorded onto one of several data storage mediums, which is fed into user's Holter system whereby 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 Zymed's Holter 2000-Software is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns.

The Zymed software 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 Digital Input

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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. Paticnts with chest pain suggestive of Prinzmetal's angina.

Review of Technology characteristics compared to the predicate device:

| Platform | Holter 2000 (Predicate) | Holter 2000-Software |
|---------------------|---------------------------------------------------------------------|----------------------|
| | Holter | Holter |
| Type | IBM PC AT Compatible | Same |
| CPU | 200 Mhz Pentium Pro or greater | Same |
| RAM | 64 M Bytes Minimum | Same |
| Hard Disk | 540 M Bytes Minimum | Same |
| 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 | Same |
| ST Segment Analysis | Yes | Same |
| | Hardware Supplied<br>by User to published minimum<br>specification. | |

The only difference between the two Zymed systems is that one system is supplied as a complete system while the other is a software only package.

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Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases. Results were typical for the Holter as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database and measured for ORS. 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 1999

Ms. Gretel Lumley Quality Assurance Engineer Zymed, Inc. 20 North Aviador Street Camarillo, CA 93010-8302

Re: K992197 Modification to Zymed Holter 2000 Requlatory Class: II (two) Product Code: MLO Dated: June 29, 1999 Received: June 30, 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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

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concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 diaqnostic 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, 2Misbranding 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. 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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## K9921977 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 . 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)

Q.K. Miller

(Division Sign-Off)

of Cardiovascular, Respiratory,

K992197

Prescription Use
(CFR21 CFR 801.109)

Or

Over-The-Counter Use