HOLTER 2000 by ZYMED MEDICAL INSTRUMENTATION

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 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

AI/ML Overview

Here's an analysis of the provided text to extract information about the device's acceptance criteria and the study used to demonstrate it, structured as requested:

Device: Zymed Holter 2000

1. Table of Acceptance Criteria and Reported Device Performance

The documentation does not explicitly state numerical acceptance criteria. Instead, it describes performance targets as "typical for the Holter as targeted" and states that "performance data between the two systems shows nearly identical data." The acceptance for the Zymed Holter 2000 is based on demonstrating Substantial Equivalence to the predicate device, the Zymed Holter Scanner Model 2010 Plus.

Performance Metric Category	Specific Metrics Examined	Acceptance Criteria (Implicit)	Reported Device Performance (Zymed Holter 2000)
Arrhythmia Analysis	Sensitivities (SE)	Equivalent to predicate device/typical for Holter	Typical for Holter; nearly identical to predicate
	Positive Predictivity (+P)	Equivalent to predicate device/typical for Holter	Typical for Holter; nearly identical to predicate
	False Positive Rate (FPR)	Equivalent to predicate device/typical for Holter	Typical for Holter; nearly identical to predicate
	(for QRS, Ventricular, Couplets, Short runs, Long runs)
ST Analysis	Episode Sensitivities (ESE)	Equivalent to predicate device/typical for Holter	Typical for Holter; nearly identical to predicate
	Episode Positive Predictivity (E+P)	Equivalent to predicate device/typical for Holter	Typical for Holter; nearly identical to predicate
	Duration Sensitivity (DSE)	Equivalent to predicate device/typical for Holter	Typical for Holter; nearly identical to predicate
	Duration Positive Predictivity (D+P)	Equivalent to predicate device/typical for Holter	Typical for Holter; nearly identical to predicate
High Heart Rates	Performance for rates in excess of 300 bpm (e.g., pediatric patients)	Within recommended guidelines	Demonstrated to be within recommended guidelines
Noise Performance	Performance in presence of baseline, electrode, or muscle noise	Equivalent to predicate device	New system is equivalent to the old system

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a numerical sample size of patients or recordings. Instead, the performance was measured against "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases."
Data Provenance: The databases used (AHA, MIT, EST) are generally recognized as public, retrospective datasets of ECG recordings. The specific country of origin for each database isn't detailed in this document but these are widely known and generally include data from various geographical locations historically. The nature of these established databases means the data is retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts or their qualifications for establishing the ground truth of the AHA, MIT, and EST databases. These databases are standardized and their ground truth (annotations) would have been established independently, often by multiple expert cardiologists/technicians, prior to their general acceptance for benchmarking.

4. Adjudication Method for the Test Set

The document does not detail the adjudication method for the test sets (the AHA, MIT, and EST databases). The annotations within these databases are pre-established and considered the reference standard for performance evaluation.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or reported in this document. The study focuses on comparing the new device's automated analysis performance against a predicate device and established databases.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done. The document states, "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." This refers to evaluating the automated analysis software of the Holter 2000 independent of human interaction during the analysis phase (though human review of results is part of clinical workflow).

7. The type of ground truth used

The ground truth used was expert annotated data from industry-accepted databases (AHA, MIT, European ST-T databases). These databases contain ECG recordings with pre-established annotations (e.g., QRS complexes, ventricular events, ST segment changes) considered as the reference standard.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This type of submission (510(k)) for substantial equivalence, especially in 1999, often focused on validating the performance of the final device against benchmarks, rather than detailing the internal development (training) process. Given the nature of the device as an "analyzer" rather than a deep learning model, it's possible that a "training set" in the modern AI sense wasn't applicable, or it certainly wasn't documented in this submission.

9. How the ground truth for the training set was established

Since no training set information is provided, how its ground truth was established is also not detailed.

Summary

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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: 800-235-5941 (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.
1. 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.
1. Assessment of Efficacy of Antiarrhythmic Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
1. 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.
1. Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's angina.

Platform	Holter 2000 (New)Holter	Holter Scanner Model 2010 (Old)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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Over-The-Counter Use

Regulation Number and Section

§ 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).