2010 PLUS HOLTER FOR WINDOWS

K003940 · Agilent Technologies · MLO · Feb 8, 2001 · Cardiovascular

Device Facts

• Record ID: K003940
• Device Name: 2010 PLUS HOLTER FOR WINDOWS
• Applicant: Agilent Technologies
• Product Code: MLO · Cardiovascular
• Decision Date: Feb 8, 2001
• 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 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.

Device Story

2010 Plus Holter for Windows analyzes pre-recorded cardiac ECG data from cassette or digital storage. System performs multi-channel automatic ST analysis, frequency domain heart rate variability, and multi-channel morphology analysis. Operated by trained medical personnel in clinical settings to generate reports and review cardiac performance. Output includes ECG printouts and diagnostic reports used to identify rhythm patterns, assess pacemaker function, and evaluate ischemia. Benefits include improved diagnostic capability for cardiac rhythm disturbances and therapy monitoring.

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), false positive rate (FPR), duration sensitivity (DSE), and duration positive predictivity (D+P) for arrhythmias, couplets, runs, and ST analysis. Performance in high heart rates (>300 bpm) and noise conditions (baseline, electrode, muscle) was comparable to the predicate system.

Technological Characteristics

PC-based Holter analyzer (Pentium II, 128MB RAM, Windows 98/NT). Data acquisition: 2 or 3 channels, 8-bit resolution, 192 Hz sampling frequency. Connectivity: USB 1.2. Software-based analysis of ECG waveforms. Includes frequency domain heart rate variability, multi-channel ST analysis, and morphology analysis.

Indications for Use

Indicated for pediatric to adult patients requiring assessment of cardiac rhythm disturbances, arrhythmia risk (including hypertrophic cardiomyopathy and post-MI), antiarrhythmia therapy efficacy, pacemaker function, and myocardial ischemia detection.

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 Holter 2000 (K990170)
• Zymed Holter Scanner Model 1610 (K895208)
• Biosensor's Holter Monitor System (K974192)

Submission Summary (Full Text)

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## KOO3940

# FEB = 8 2001

#### Zymed Inc.

1201-B N. Rice Ave. Oxnard, California 93030 800.235.5941 - 805.604.0457 Fax [phone]

#### 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: | 12-20-00 |
| Contact: | G. Lumley - see above |

Trade Name: Common Name: Classification Name: 2010 Plus Holter for Windows Holter Analyzer Electrocardiograph, ambulatory, with analysis algorithm (per 21 CFR 870.2800)

Legally marketed device to which S.E. is claimed.

Zymed Holter Scanner Model Holter 2000 -- 510(k) K990170 Zymed Holter Scanner Model 1610 - 510(k) K895208 Biosensor's Holter Monitor System - 510(k) K974192

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 2010 Plus Holter for Windows. 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, frequency domain Heart Rate Variability, 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:

- 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.

Review of Technology characteristics compared to the predicate device:

| Specification/Feature | Current Holter<br>Holter Scanner Holter 2000 | Modified Holter<br>2010 Plus Holter for<br>Windows |
|--------------------------------------|---------------------------------------------------------|----------------------------------------------------|
| Platform: | | |
| Type | IBM PC AT Compatible | Same |
| CPU | Pentium II 400 MHz<br>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,<br>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 |
| Hardware and Software<br>Diagnostics | Included | Same |
| Data Acquisition: | | |
| Number of Channels | 2 or 3 | Same |
| Resolution | 8 bit | Same |

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Sampling Frequency Playback Speed Digital Input

192 samples per second 240 times real time Yes

Same Same Same

The only difference between the two Zymed systems is the addition of Frequency Domain Heart Rate Variability to the 2010 Plus for Windows System.

Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) Overall Holter performance was mesal Results were typical for the Holter as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each Schartives (DD), positive production Couplets, Short runs and Long runs. Separate database and measured for Ques, Veneroitive 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 whill 1000mmended gaudent 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.

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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 stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB = 8 2001

Ms. Gretel Lumley Quality Assurance Engineer Zymed Inc. 1201-B North Rice Avenue Oxnard, CA 93030

Re: K003940

Trade Name: 2010 Plus Holter for Windows Regulatory Class: II (two) Product Code: MLO Dated: January 26, 2001 Received: January 29, 2001

Dear Ms. Lumley:

We have reviewed your Section 510(k) notification of intent to market the device referenced
for the indically of the last to the last the last interestively for the indicati We have reviewed your Section 910(x) notificantially equivalent (for the indications for use above and we nave delemined the devices marketed in interstate comments, or to devices th stated in the enclosure) to legally marked preaced is al Device Amendments, or to devices that
prior to May 28, 1976, the enactment date of the Federal Food, Drug, and prior to May 26, 1970, the chaomicn auto of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control Cosmetic Act (Act). Tourmay, merciolo, manuel as act include requirements for annual provisions of the Act. "The general control provisions of the receing, and prohibitions against
registration, listing of devices, good manufacturing practice, labeling, and p misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classifica (see abovo) into such additional controls. Existing major regulations (Premarket Apploval), it may be subject to saal and in the Code of Federal Regulations, Title Courset Good allecting your device can be round in also somes compliance with the Current Good 893. A substantially Cqurvaicht decommination the Quality System Regulation (OS) for Manufacturing I Tactice requirements, as certe Part 820) and that, through periodic QSS
Medical Devices: General regulation (21 CFR Part 820) and that, through personalisms, Medical Devices. General regulation (FDA) will verify such assumptions. Failure to mspections, the Food and Drag i may result in regulatory action. In addition, comply with the Unit Tegulation may result in regared in the Federal Register. Please FDA may publish luruler announcements contoning Jour affect any obligation you

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Page 2 - Ms. Lumley

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, "Misbranding by reference to premarket notification" (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,

Stypt Rhodes

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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#### 510(k) Number:

Device Name: 2010 Plus Holter for Windows

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)

Atut Rhodes

Division of Cardiovascular & Respiratory Devices
510(k) Number K003940

Prescription Use (CFR21 CFR 801.109)

or

Over-The-Counter Use