2010 PLUS HOLTER FOR WINDOWS

K003763 · Agilent Technologies · MLO · Jan 5, 2001 · Cardiovascular

Device Facts

• Record ID: K003763
• Device Name: 2010 PLUS HOLTER FOR WINDOWS
• Applicant: Agilent Technologies
• Product Code: MLO · Cardiovascular
• Decision Date: Jan 5, 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 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: 1. Ages: 33 to 82 years 2. Heights: 147 to 185 cm (58 to 73 in) 3. Weights: 53 to 118 kg (117 to 261 lb) 4. Height to Weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb.)

Device Story

2010 Plus Holter for Windows analyzes pre-recorded cardiac ECG data from cassettes or digital media; provides reports on cardiac rhythm patterns and performance. Used by trained medical personnel in clinical settings to diagnose cardiac conditions. System features include individual ECG printouts, multi-channel automatic ST analysis, derived 12-lead ST analysis, and multi-channel morphology analysis. Input consists of 2 or 3-channel ECG data; output includes diagnostic reports and cardiac rhythm visualizations. Clinicians use these outputs to assess arrhythmia, pacemaker function, and myocardial ischemia, facilitating clinical decision-making regarding patient therapy and risk management.

Clinical Evidence

Bench testing only. Performance validated using industry-standard databases: AHA, MIT, and European ST-T (EST). Metrics included sensitivity (SE), positive predictivity (+P), false positive rate (FPR), episode sensitivity (ESE), episode positive predictivity (E+P), duration sensitivity (DSE), and duration positive predictivity (D+P). Results demonstrated performance nearly identical to the predicate device. High heart rate performance (up to 300 bpm) and noise robustness (baseline, electrode, muscle) were verified as equivalent to the predicate.

Technological Characteristics

IBM PC AT compatible platform; Pentium II 400 MHz CPU; 128 MB RAM; 6 GB hard disk; Windows 98/NT OS. Data acquisition: 2 or 3 channels, 8-bit resolution, 192 samples/second sampling frequency, 240x real-time playback. Connectivity via USB 1.2. Derived 12-lead ST analysis algorithm. Standard clinical workstation form factor.

Indications for Use

Indicated for pediatric to adult patients requiring assessment of cardiac rhythm disturbances, palpitations, arrhythmia risk (including cardiomyopathy and post-MI), antiarrhythmia therapy efficacy, pacemaker function, and myocardial ischemia (Prinzmetal's angina). EASI derived 12-lead ST measurements indicated for patients aged 33-82, height 147-185 cm, weight 53-118 kg, and specific height-to-weight ratios.

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's EasiView Telemetry System (K984089)

Submission Summary (Full Text)

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KOO3763

# 7 med

# JAN - 5 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: | 12-5-00 |
| 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

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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 . 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.
- 1. Ages: 33 to 82 years
- 2. Heights: 147 to 185 cm (58 to 73 in)
- 3. 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<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 |

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| Hardware and Software<br>Diagnostics | Included | Same |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------|
| Data Acquisition:<br>Number of Channels<br>Resolution<br>Sampling Frequency<br>Playback Speed<br>Digital Input | 2 or 3<br>8 bit<br>192 samples per second<br>240 times real time<br>Yes | Same<br>Same<br>Same<br>Same<br>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.

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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

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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 [phone]. 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 [phone] or [phone] 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

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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.
- 1. Ages: 33 to 82 years
- 2. Heights: 147 to 185 cm (58 to 73 in)
- 3. Weights: 53 to 118 kg (117 to 261 lb)
- 4. Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.)

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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

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