Assessment of symptoms that may be related to rhythm disturbances of the heart: Patients with . palpitations; The evaluation of arrhythmia's in patients from pediatric to adult age.
Assessment of risk in patients with or without symptoms of arrhythmia.
Assessment of efficacy of Antiarrhythmic therapy. .
. Assessment of Pacemaker Function.
Assessment of real time ST segment analysis .
. Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing.
Assessment is for single-hospital environment.
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 2611b)
- 1. Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/b.)

Device Description

A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 (12 lead derived), and laser printer. The Zymed central monitor supports up to eight patients for real time cardiac monitoring. The system displays each patient's ECG continuously on the screen while performing real time ECG waveform analysis for all eight patients. This analysis permits immediate detection and classification of abnormal beats, cardiac rhythm disturbances and variations.

Each ECG transmitter's frequency can be programmed to operate at any frequency within the entire VHF band. For US domestic sites, the transmitters will comply with FCC band allocations (174-216 Mbz). In addition to ECG data, the transmitters also detect and transmit cardiac pacemaker information. Other information including transmitter status and individual lead impedance is also transmitted to the Zymed system for overall system safety and efficacy.

The Zymed system presents the user with a number of clinical tools such as visual and audible alarms and derived 12 lead display for the diagnosis of patients with various heart conditions. The system also provides tools to review a patient's cardiac performance. On-line review mechanisms as well as detailed analysis screens have been designed into the system to facilitate and to enhance the patient's diagnosis and treatment. Features such as individual ECG printouts, multi-channel automatic ST analysis, trend data analysis, and Full Disclosure data further enhance the system's qualities as a valuable and practical clinical tool.

The system has the following options available:
Choice of 4, 6, or 8 bed central monitor
Full disclosure screen and printout (full resolution programmable from 0 to 168 hours)
Choice of 6 lead sets, based on transmitter capability
Full arrhythmia analysis to include multi-channel automatic ST Analysis
12 lead ECGD
Laser Printer, print server options
Strip Chart
Networking

AI/ML Overview

Here's an analysis of the provided text regarding the Zymed Telemetry System, Model EasiView:

Device: Zymed Telemetry System: Model EasiView Telemetry Central Station Monitor

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail manner. Instead, it states that "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases. Results were typical for the real time monitoring environment for the EasiView as targeted." It then lists the types of metrics examined.

Given this, the table below will present the types of performance metrics used and a general summary of the findings as described in the submission.

Metric Category	Specific Metrics Examined	Reported Performance
Arrhythmia Analysis (QRS, Ventricular, Couplets, Short runs, Long runs)	Sensitivity (SE), Positive Predictivity (+P), False Positive Rate (FPR)	"Results were typical for the real time monitoring environment for the EasiView as targeted."
ST Analysis (European ST-T database)	Episode Sensitivities (ESE), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE), Duration Positive Predictivity (D+P)	"Results were typical for the real time monitoring environment for the EasiView as targeted."
High Heart Rates (incl. pediatric)	Performance at high heart rates	"Demonstrated to be within recommended guidelines in excess of 300 bpm."
Noise Presence	Performance in the presence of baseline, electrode, or muscle noise	"Indicates the new system is equal to or better than the old system."
Overall Comparison to Predicate	N/A (implicit comparison across all performance aspects)	"Performance data between the two systems shows nearly identical data, and therefore, supports a claim of Substantial Equivalence."

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

Sample Size for Test Set: The document refers to "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." However, it does not explicitly state the specific number of cases or recordings from these databases used for testing this particular device.
Data Provenance: The document implies the use of pre-existing, standardized databases (AHA, MIT, EST). It does not specify the country of origin of the data within these databases or whether the data was retrospective or prospective. Given they are "industry accepted databases," it's highly likely they contain a mix of retrospective data collected over time from various sources.

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

The document does not provide any information about the number or qualifications of experts used to establish the ground truth for the test sets (AHA, MIT, EST databases). For standardized databases like these, the ground truth is typically established by multiple expert cardiologists or arrhythmia technicians through a consensus process, but this submission does not detail that process for these specific databases.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the ground truth of the test set. For pre-existing, standardized databases, the adjudication would have been part of the database creation process, but it's not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses solely on the device's algorithmic performance against established databases and a comparison of its features and performance to a predicate device, not on human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was done. The entire section describing "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases" focuses on the algorithm's performance in detecting QRS, Ventricular events, Couplets, Short/Long runs, and ST analysis, without human intervention in the interpretation process.

7. The Type of Ground Truth Used:

The type of ground truth used was based on the annotations provided within the industry-accepted AHA, MIT, and European ST-T databases. These databases typically contain expert-adjudicated annotations for cardiac events (e.g., QRS complexes, arrhythmias) and ST segment changes, effectively representing expert consensus.

8. The Sample Size for the Training Set:

The document does not specify the sample size for the training set. It only discusses the performance evaluation against established test databases.

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

The document does not provide information on how the ground truth for the training set (if any distinct training was performed using Zymed's own data) was established. It only refers to using "industry accepted databases" for performance testing. If the device was trained using these same databases, the ground truth would be from those databases, which is typically expert consensus.

Summary

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510(k) Summary

Submitter:

Dudley Harris, Director of Regulatory Affairs/QA Zymed Medical Instrumentation 20 North Aviador Street Camarillo, CA 93010 805/987-9532 Fax: 800/235-5941 (401) Phone: Date of Summary: 12-3-98 D. Harris - see above Contact:

Trade Name: Common Name: Classification Name: (per 21 CFR 870.1025) Zymed Telemetry System: Model EasiView Telemetry Central Station Monitor Detection and Alarm, Arrhythmia

Legally marketed device to which S.E. is claimed. Zymed Telemetry System: Model EasiView - 510(k) K 980186

Description: A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 (12 lead derived), and laser printer. The Zymed central monitor supports up to eight patients for real time cardiac monitoring. The system displays each patient's ECG continuously on the screen while performing real time ECG waveform analysis for all eight patients. This analysis permits immediate detection and classification of abnormal beats, cardiac rhythm disturbances and variations.

The system has the following options available:

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Choice of 4, 6, or 8 bed central monitor Full disclosure screen and printout (full resolution programmable from 0 to 168 hours) Choice of 6 lead sets, based on transmitter capability Full arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Laser Printer, print server options Strip Chart Networking

Intended use:

Assessment of symptoms that may be related to rhythm disturbances of the heart: Patients with . palpitations; The evaluation of arrhythmia's in patients from pediatric to adult age.
Assessment of risk in patients with or without symptoms of arrhythmia.
Assessment of efficacy of Antiarrhythmic therapy. .
. Assessment of Pacemaker Function.
Assessment of real time ST segment analysis .
. Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing.
Assessment is for single-hospital environment.
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 2611b)
- 1. Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/b.)

A review of the technological characteristics compared to the predicate devices are:

Platform	Easi View (New)telemetry system	EasiView (Old)telemetry system
Type	IBM PC AT Compatible	Same
CPU	200 Mhz Pentium Pro	Same
RAM	64 M Bytes	Same
Hard Disk	1.6 G Bytes	Same
Display	SVGA	Same
Transmitters:
3 channel	yes	yes
Tunable frequencies	174-216 Mhz	Same

Software:

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Number of patients	4, 6, or 8	Same
Operating System	Windows NTDOS Compatible	Same
Data Storage	24 hrs of EKG/Channel	Same
Number of leads for Analysis: 3
Automatic ST Analysis	yes, 12 derived leads	yes, 3 leads
Manual ST Analysis	no	no

The only difference between the two Zymed systems is the extension of automatic ST Analysis to the derived 12 lead.

Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases. Results were typical for the real time monitoring environment for the EasiView as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database 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 bom, and performance in the presence of noise indicates the new system is equal to or better than 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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TRUTHFUL AND ACCURATE STATEMENT

PREMARKET NOTIFICATION AND ACCURATE STATEMENT (As required by 21 CR 807.87(1))

I certify that, in my capacity as Director of Regulatory Affairs/Quality Assurance, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Dudley Harvista

J. Dudley Harris

11/13/98

Dated

J. Dudley Harris Director Regulatory Affairs Quality Assurance Phone: 800/235-5941 Fax: 805/987-9532

msoff/wword/zymed/ra-qa/truthacc.doc

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 1999

Mr. Dudley Harris Director Requlatory Affairs/Quality Assurance Zymed Inc. 20 North Aviador Street Camarillo, CA 93010-8348

Re: K984089 Zymed Telemetry System, Model Easi View Trade Name: Regulatory Class: III Product Code: DSI Dated: November 13, 1998 November 16, 1998 Received:

Dear Mr. Harris:

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 leqally 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 obligation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Mr. Dudley Harris

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) 594-4586. 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,

Thomas J. Callahan

Thomas J. Callaha 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: K984089

Device Name: EasiView Telemetry Monitoring System

Indications for Use:

Assessment of symptoms that may be related to rhythm disturbances of the heart; Patients . with palpitations; The evaluations of arrhythmia's in patients from pediatric to adult age.
Assessment of risk in patients with or without symptoms of arrhythmia. .
Assessment of efficacy of Antiarrhythmia therapy. .
Assessment of Pacemaker Function. .
Assessment of real time ST segment analysis.
Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease . and arrhythmias analysis during exercise testing.
Assessment is indicated for single-hospital environment. .
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.)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K984089

Prescription Use
(CFR21 CFR 801.109) ✓

Over-The-Counter Use

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.