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 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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Zymed 2010 Plus Holter for Windows, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or target performance format. Instead, it frames the performance by comparing it to industry standards and the predicate device, aiming for "nearly identical" results. The table below summarizes the reported findings in relation to these implicit criteria.

Feature/Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Overall Holter Performance	Typical for Holter systems (compared to AHA and MIT databases)	"Results were typical for the Holter as targeted."
Ventricular Ectopic Beat Detection	Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) meeting standards (specific values not provided in document).	"Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each type of beat...and measured for QRS, Ventricular, Couples, Short runs and Long runs." (Implies results were acceptable, as substantial equivalence was claimed).
ST Analysis Performance	Separate sensitivities (DSE) and positive predictivity (D+P) for ST events meeting standards.	"Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. "Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs." The phrasing suggests both DSE and DPs were evaluated against the European ST-T (EST) database, implying acceptable performance.
High Heart Rate Performance	Within recommended guidelines in excess of 300 bpm (to include pediatric patients).	"High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm."
Performance in Presence of Noise	Equivalent to the predicate system (Holter 2000) for baseline, electrode, or muscle noise.	"Performance in the presence of noise was identical to the old system when looking at baseline, electrode or muscle as the cause of noise."

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

Sample Size: The document does not explicitly state the sample size (number of patients or recordings) used for the test set. It refers to "industry accepted AHA (AHA), MIT (MIT)" databases for overall Holter performance and the "European ST-T (EST) database" for ST analysis.
Data Provenance: The data provenance is implied by the use of "industry accepted AHA (AHA), MIT (MIT)" and "European ST-T (EST) database." These are well-known, publicly available databases, suggesting the data is likely retrospective and compiled from various sources. The country of origin for the AHA and MIT databases would primarily be the US, while EST would be Europe.

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

The document does not provide details on the number of experts or their qualifications used to establish the ground truth within the AHA, MIT, or EST databases. These databases typically have established ground truths generated by expert cardiologists or technicians following standardized protocols, but the specifics are not in this submission.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing or validating the ground truth in the test sets. It relies on the pre-established ground truths within the referenced industry-accepted databases.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on comparing the new device's algorithmic performance to industry standards and the predicate device, not on how human readers' performance is altered by using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The document states, "Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) databases" and "Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each type of beat... and measured for QRS, Ventricular, Couples, Short runs and Long runs." This indicates the algorithm's performance was evaluated directly against the established ground truth in these databases, without human intervention in the analysis process itself.

7. The Type of Ground Truth Used

The ground truth used was based on established, "industry accepted" databases:

Expert Consensus: The AHA and MIT databases are widely known to have rhythm annotations verified by expert consensus.
Pathology/Clinical Outcomes: While the document doesn't explicitly link to pathology or outcomes for the ground truth, the "European ST-T (EST) database" is used for ST analysis, which implies ground truth related to ischemic events, likely from clinical annotations.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set. It only discusses the evaluation of the device's performance (i.e., the test set).

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established, as details about a training set are not included in this submission. This document focuses on demonstrating substantial equivalence through performance testing against established benchmarks.

Summary

{0}------------------------------------------------

KOO3940

FEB = 8 2001

Zymed Inc.

1201-B N. Rice Ave. Oxnard, California 93030 800.235.5941 - 805.604.0457 Fax 805.604.0493

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.

{1}------------------------------------------------

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 HolterHolter Scanner Holter 2000	Modified Holter2010 Plus Holter forWindows
Platform:
Type	IBM PC AT Compatible	Same
CPU	Pentium II 400 MHzOr 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,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 SoftwareDiagnostics	Included	Same
Data Acquisition:
Number of Channels	2 or 3	Same
Resolution	8 bit	Same

{2}------------------------------------------------

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.

{3}------------------------------------------------

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

{4}------------------------------------------------

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 (301) 594-4645. 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, "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 (800) 638-2041 or (301) 443-6597 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

{5}------------------------------------------------

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

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).