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.
Assessment of EASI derived 12-lead ST measurements is recommended for patients that . meet the following parameters.
- 1. Ages: 33 to 82 years
- 1. Heights: 147 to 185 cm (58 to 73 in)
- 1. Weights: 53 to 118 kg (117 to 261 lb)
- 1. Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.)
QT measurements can be used by the physician in risk assessment process indicated for . patients with and without symptoms of arrhythmia. OT measurement is intended to be used by competent health professionals in hospital or clinic environment. Composite QT measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

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.

AI/ML Overview

Here's an analysis of the Agilent 2010 Plus Holter for Windows, outlining its acceptance criteria and the study that demonstrates its performance, based on the provided text.

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the same way a PMA or a more recent 510(k) would. As such, some of the requested information (like specific numerical acceptance criteria for performance metrics) is inferred from the overall claim of substantial equivalence and the comparison to industry-standard databases, rather than explicitly stated as acceptance criteria in the document.

Description of the Device and its Purpose

The Agilent 2010 Plus Holter for Windows is a device that analyzes recorded cardiac ECG data to generate reports on various cardiac data, including individual ECG waveforms and patterns of consecutive waveforms. This information is used by trained medical personnel for diagnosing patients with various cardiac rhythm patterns. Its primary function is to provide clinical tools such as ECG report generation, review of patient cardiac performance, multi-channel automatic ST analysis, frequency domain Heart Rate Variability, multi-channel morphology analysis, QT analysis, and custom reports. The key addition in this "Plus" version compared to its predicate is QT analysis.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms (e.g., "sensitivity must be > X%"). Instead, the document frames the acceptance criteria as demonstrating "Substantial Equivalence" to predicate devices, particularly the Zymed Holter Scanner Model Holter 2000, and meeting expected performance against industry-accepted databases. The core assertion is that the performance data between the new system and previous systems were "nearly identical," supporting substantial equivalence.

Performance Metric/Feature	Acceptance Criteria (Inferred from Substantial Equivalence and Study Design)	Reported Device Performance
Overall Holter Performance (against standard databases)	Performance "typical for the Holter as targeted" when measured against industry-accepted databases. This implies meeting or exceeding general benchmarks for arrhythmia detection, ST analysis, and noise immunity that would be expected for a Holter system seeking market clearance.	- Results were "typical for the Holter as targeted." - Sensitivities (SE), Positive Predictivity (+P), and False Positive Rate (FPR) were examined for each arrhythmia product (PVCs, short runs, long runs) against AHA and MIT databases. - Duration Sensitivity (DSE), Duration Positive Predictivity (D+P) were examined for the European ST-T (EST) database for ST analysis.
Arrhythmia Analysis (PVCs, short runs, long runs)	Performance comparable to the predicate device and expected levels for specific arrhythmia detections when tested against standard databases (AHA, MIT). The implicit criterion is that SE, +P, and FPR are within acceptable ranges for clinical use and are not significantly worse than predicate.	Examined for each arrhythmia product (PVCs, short runs, long runs) against AHA and MIT databases. Performance was deemed "nearly identical" to the predicate.
ST Analysis	Performance comparable to the predicate device and expected levels for ST analysis when tested against standard databases (European ST-T). The implicit criterion is that DSE and D+P are within acceptable ranges.	Examined against European ST-T (EST) database. Performance was deemed "nearly identical" to the predicate.
High Heart Rate Performance	Demonstrated ability to handle high heart rates, including those seen in pediatric patients (> 300 bpm).	Demonstrated mediator of 31 million in excess of 300 bpm (this phrasing is ambiguous, likely means it could process data with heart rates up to 300bpm, or that it was tested on 31 million beats, with some exceeding 300bpm). The performance in this scenario was consistent with the old system (predicate).
Noise Immunity	Performance in the presence of noise (baseline, electrode, or muscle artifact) within recommended guidelines should be comparable to the predicate device.	Performance in the presence of noise (baseline, electrode, or muscle as the cause of noise) was consistent with the old system (predicate).
QT Analysis (New feature)	While "performance" of the QT analysis as a diagnostic tool isn't discussed (as it's specifically stated "not intended to produce any interpretation or diagnosis"), the system's ability to measure the interval must be robust and produce consistent, objectively verifiable measurements. The implicit criterion is that the QT measurements themselves are accurate and reliable for aggregation and review by a competent health professional, enabling their risk assessment process. Accuracy of the measurements would be assumed to be validated.	The major difference between the new system and the Zymed 2000 is the addition of QT analysis. No specific performance metrics for QT measurement accuracy are provided in this summary, but its inclusion implies that the measurement function itself was deemed acceptable for its stated use (interval measurement only). The document states "Composite QT measures the interval only."
Overall Equivalence	Performance data between the two systems (new and predicate) must be 'nearly identical' such that it supports a claim of Substantial Equivalence.	Performance data between the two systems were "nearly identical."

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

Sample Size for Test Set: Not explicitly stated as a number of patients or ECG recordings. However, the study utilized "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." These databases contain standardized ECG recordings with known arrhythmias and ST changes.
Data Provenance: The data came from established, publicly available, and industry-accepted databases (AHA, MIT, European ST-T). These databases typically contain retrospective ECG recordings from a variety of patient populations. The countries of origin for these specific databases are generally North America and Europe.

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

Number of Experts: Not specified in the provided text.
Qualifications of Experts: The ground truth for the AHA, MIT, and European ST-T databases is established by expert cardiologists and technicians who have meticulously annotated the recordings. While the document doesn't detail their qualifications for this specific submission, the "industry accepted" nature of these databases implies that their ground truth was established by highly qualified and experienced professionals in the field of cardiac electrophysiology.

4. Adjudication Method for the Test Set

The document does not describe the specific adjudication method used for the pre-existing ground truth within the AHA, MIT, and European ST-T databases. However, for such widely recognized and "industry-accepted" databases, it is common that the ground truth has undergone rigorous review, often involving multiple experts and some form of consensus building or majority vote (e.g., 2+1 or 3+1 methods implicitly or explicitly during their creation). The 510(k) summary focuses on the device's performance against this established ground truth, rather than the methods used to create the ground truth itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not describe an MRMC comparative effectiveness study involving human readers. The study focuses purely on the standalone performance of the algorithm and compares it to a predicate device and established databases. There is no mention of comparing human reader performance with and without AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The performance evaluation discussed in the document ("Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases") describes the algorithm's performance in analyzing ECG data independently. The output of the 2010 Plus Holter for Windows is then used by "trained medical personnel to diagnosis patients," indicating the algorithm's standalone analysis provides the foundation for subsequent human interpretation.

7. The Type of Ground Truth Used

The ground truth used was expert consensus / annotated data from industry-standard databases, specifically:

AHA (American Heart Association) database
MIT (Massachusetts Institute of Technology) database
European ST-T database

These databases are meticulously annotated by cardiologists/experts with confirmed cardiac events (arrhythmias, ST changes), serving as the gold standard for testing ECG analysis algorithms.

8. The Sample Size for the Training Set

The document does not explicitly specify the sample size for the training set. It describes the device as inheriting much of its core functionality from existing Zymed systems ("The only difference between the two Zymed systems is the addition of QT Analysis to the 2010 Plus for Windows System"). This suggests that much of the underlying algorithm was likely trained or developed using extensive datasets over time, prior to this specific iteration. The performance testing against the noted databases would likely be part of a validation or test phase, rather than a training phase for this specific 510(k) submission.

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

As the document does not explicitly detail a training set for this specific submission, it also does not describe how its ground truth was established. However, for a device relying on previously developed algorithms (as implied by the substantial equivalence claim to an older model), the ground truth for any initial training of those algorithms would have been established through methods similar to the test set: expert cardiologists annotating large volumes of diverse ECG data.

Summary

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SEP 2 8 2001 KO10949

Agilent Technologies, Inc. 1201-B N. Rice Avenue Oxnard, California 93030 800 235 5941 telephone 805 988 7000 telephone 805 604 0493 facsimile

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Agilent Technologies

Innovating the HP Way

510(k) Summary

Submitter:

Gretel Lumley, Quality Assurance Engineer
Agilent Technologies
1201 B North Rice Avenue
Fax: 805-604-0493
Phone: 800-235-5941 (7417)
Date of Summary: 6-29-01
Contact: G. Lumley - see above

2010 Plus Holter for Windows 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.

Zymed Holter Scanner Model Holter 2000 – 510(k) K990170 Marquette Medical System's QT Guard Analysis System - 510(k) 981024

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, QT 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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p. 2/3

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.
Assessment of EASI derived 12-lead ST measurements is recommended for patients that . meet the following parameters.
- 1. Ages: 33 to 82 years
- 1. Heights: 147 to 185 cm (58 to 73 in)
- 1. Weights: 53 to 118 kg (117 to 261 lb)
- 1. Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.)
QT measurements can be used by the physician in risk assessment process indicated for . patients with and without symptoms of arrhythmia. OT measurement is intended to be used by competent health professionals in hospital or clinic environment. Composite QT measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

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

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K010949

MouseUSB	YesUSB 1.2 or greater	SameSame
Software:Operating SystemHardware and SoftwareDiagnostics	Windows 98, Windows NTIncluded	SameSame
Data Acquisition:Number of ChannelsResolutionSampling FrequencyPlayback SpeedDigital Input	2 or 38 bit192 samples per second240 times real timeYes	SameSameSameSameSame

The only difference between the two Zymed systems is the addition of QT Analysis to the 2010 Plus for Windows System.

Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) Overan Hotel performance was mesults were typical for the Holter as targeted. Separate and Edropean ST-1 (251) databases: Tresults (+P), and false positive rate (FPR) were examined for each softshivities (197, post: 10 products, Short runs and Long runs and Long runs. Separate database and modistivities (ESE), Follars 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 mediator of 31 milling in excess of 300 bpm, and performance in the presence of noise whilin recommended gardent 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right. The profiles are arranged in a way that they appear to be interconnected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the central image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2001

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

Re: K010949

Trade Name: 2010 Plus Holter for Windows Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MLO Dated: June 29, 2001 Received: July 2, 2001

Dear Ms. Lumley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Gretel Lumley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally presticated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

V. Decker Tell III

James 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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K010949 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 . i woosiment of not in it is it is no a 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.
- Ages: 33 to 82 years 1.
- Heights: 147 to 185 cm (58 to 73 in) 2.
- Weights: 53 to 118 kg (117 to 261 lb) 3.
- Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/Ib.) 4.
QT measurements can be used by the plysician in risk assessment process indicated for patients with . and without symptoms of arrhythmia. QT measurement is intended to be used by competent health professionals in hospital or clinic environment. Composite QT measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K010949

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).