(260 days)
- Assessment of symptoms that may be related to rhythm disturbances of the hear. Parients with . palpitations; The evaluation of arrhythmia's in parients from pediatric to adult age.
- Assessment of risk in pariems 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 ◆
A Zymed Telement monitoring system consists of a series of interface devices to include ECG transmitters, a central Telementy monitoring computerized until a surin chart recorder, Easi 5 (12 lead derived), and laser printer. The Zymed central monutor supports up to eight parients for real time curdial monitoring. The system displays each patient's ECG community on the screen while performing real time ECG wave form analysis for all eight patients. Thus 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 Mich. In addition to ECG data, the transmitters also detect and transmit cardiac pacemaker information. Other information including transminer status and individual lead impediated is the Zyned 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 parients with various heart conditions. The system also provides tools to review a patient's cardiac performance. Con-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 printous, multi-channel automatic ST analysis, trend data analysis, and Full Disclosure data further enhance the system's qualities as a valuable and practical clinical
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study (Zymed EasiView Telemetry System)
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "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." While specific numerical acceptance criteria (e.g., minimum sensitivity or specificity values) are not explicitly provided in the text, the study implies that the device met the generally understood "typical" performance for real-time monitoring against established cardiac databases. The document also states that performance data between the two Zymed systems (the new EasiView and the predicate) shows "nearly identical data."
Based on the provided text, the criteria are implicitly derived from the established performance on these benchmark databases.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| QRS detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." Separate SE, +P, and FPR were "examined for each database and measured for QRS." "Performance data between the two systems shows nearly identical data." |
| Ventricular arrhythmia detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." Separate SE, +P, and FPR were "examined for each database and measured for... Ventricular." "Performance data between the two systems shows nearly identical data." |
| Couplets detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." Separate SE, +P, and FPR were "examined for each database and measured for... Couplers." "Performance data between the two systems shows nearly identical data." |
| Short runs detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." Separate SE, +P, and FPR were "examined for each database and measured for... Short runs." "Performance data between the two systems shows nearly identical data." |
| Long runs detection performance (Sensitivity, Positive Predictivity, False Positive Rate) against AHA, MIT, and EST databases. | "Results were typical for the real time monitoring environment for the EasiView as targeted." Separate SE, +P, and FPR were "examined for each database and measured for... Long runs." "Performance data between the two systems shows nearly identical data." |
| High heart rate performance (including pediatric patients). | "High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm." "Performance data between the two systems shows nearly identical data." |
| Performance in the presence of noise (baseline, electrode, muscle). | "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." "Performance data between the two systems shows nearly identical data." |
| ST Segment Analysis/Alarm (Implicitly, that its performance is acceptable for the new feature and maintains overall system performance at par with the predicate). | The only explicit discussion of this feature is that the "only difference between the two Zymed systems is the addition of automatic Multi-channel ST Analysis/alarm to the algorithm." The statement that overall "performance data between the two systems shows nearly identical data" implies that the ST Analysis feature did not negatively impact the device's overall performance to an unacceptable degree, and it's considered "substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The document only mentions using "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." The exact number of patients or ECGs from these databases used in the test set is not provided.
- Data provenance: The data came from "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." These are well-known, publicly available, and extensively used retrospective ECG databases from various institutions. The specific countries of origin for each database are not mentioned in this document, but they are generally international in scope (e.g., MIT/BIH Arrhythmia Database from the US, European ST-T Database primarily from Europe). The data is retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. For established public databases like AHA, MIT, and EST, the ground truth is typically established through a consensus of multiple cardiologists or expert reviewers, but the specific number and qualifications are not mentioned in this document.
4. Adjudication method for the test set
Not explicitly stated. For established public databases, the adjudication method for ground truth is usually a consensus process (e.g., multiple experts reviewing and agreeing, often with a tie-breaker if needed), but this document does not detail it.
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, a multi-reader, multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done. This device is a "Telemetry Central Station Monitor" performing "real time ECG wave form analysis" for "immediate detection and classification of abnormal beats, cardiac rhythm disturbances and variations." The study compared the device's performance against established databases and against its predicate device, not the performance of human readers 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, "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." This describes the algorithm's direct performance against annotated databases, without human intervention in the loop during the measurement of these specific metrics (SE, +P, FPR for various beat types and conditions). The comparison to the predicate device also focuses on the algorithmic performance.
7. The type of ground truth used
The ground truth used for the test sets (AHA, MIT, EST databases) would be expert consensus annotations. These databases are meticulously reviewed and labeled by cardiology experts to establish the "true" events (e.g., QRS complexes, ventricular beats, ST segment changes) against which algorithms are benchmarked.
8. The sample size for the training set
Not explicitly stated. The document refers to the evaluation being performed against the AHA, MIT, and EST databases, which are typically used for testing and benchmarking rather than for training a new algorithm. It's possible the new "automatic Multi-channel ST Analysis/alarm" algorithm was trained on proprietary data or a subset of these large databases, but the training set size is not provided.
9. How the ground truth for the training set was established
Not explicitly stated. Given that the training set size is not provided and the primary databases mentioned are benchmark testing databases, the ground truth establishment method for training data is unknown from this document. However, for medical algorithms, ground truth for training data would typically be established by expert review (e.g., cardiologists annotating ECG recordings).
{0}------------------------------------------------
FROM-ZYMED INC. OCT-06-98 04:57PM
805-987-9532
ﻠﺴﻬ
OCT 7 1998
7 ymed
Lymed Inc 20 North Aviador Street Camarillo. Culiforais 93010-83. 800 :: 35 5941 - 805.987.9811 Fax 845.987.9532
510(k) Summary
Submitter
| Dudley Harris, Director of Regulatory Affairs/QA | |
|---|---|
| Zymed Medical Instrumentation | |
| 20 North Aviador Street | |
| Camarillo, CA 93010 | |
| Fax: | 805/987-9532 |
| Phone: | 800/235-5941 (401) |
| Date of Summary: | 10-06-98 |
| Contact: | D. Harris - see above |
| Trade Name: | Zymed Telemetry System: Model EasiView |
| Common Name: | Telemetry Central Station Monitor |
| Classification Name: | Detection and Alarm, Arrhythmia |
| (per 21 CFR 870,1025) |
Legally markered device to which S.E. is claimed.
Zymed Telemetry System: Model EasiView - 510(k) K 951370
Zymed Holter Scanning System: Model 2010 - 510(k) K 930806
Description: A Zymed Telement monitoring system consists of a series of interface devices to include ECG transmitters, a central Telementy monitoring computerized until a surin chart recorder, Easi 5 (12 lead derived), and laser printer. The Zymed central monutor supports up to eight parients for real time curdial monitoring. The system displays each patient's ECG community on the screen while performing real time ECG wave form analysis for all eight patients. Thus 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 Mich. In addition to ECG data, the transmitters also detect and transmit cardiac pacemaker information. Other information including transminer status and individual lead impediated is the Zyned 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 parients with various heart conditions. The system also provides tools to review a patient's cardiac performance. Con-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 printous, multi-channel automatic ST analysis, trend data analysis, and Full Disclosure data further enhance the system's qualities as a valuable and practical clinical ശി
{1}------------------------------------------------
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 transminer capability Full arthythmus analysis to include multi-channel automanc ST Analysis 12 lead ECGD Laser Printer, print server options Suip Chart Networking
Intended use:
- Assessment of symptoms that may be related to rhythm disturbances of the hear. Parients with . palpitations; The evaluation of arrhythmia's in parients from pediatric to adult age.
- Assessment of risk in pariems 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 ◆
| Platform | Easi View (New)telemetry system | Easi View (Old)telemetry system | Holterholter system |
|---|---|---|---|
| Type | IBM PC AT Compatible | Same | |
| CPU | 200 Mhz Pentium Pro | 486/66 Mhz | |
| RAM | 64 M Bytes | 64 M Bytes | |
| Hard Disk | 16 G Bytes | 1.2 G Bytes | |
| Display | SVGA | Same | |
| Transmitters:3 channel | yes | yes | |
| Tunable frequencies | 174-216 Mhz | Same | |
| Software | |||
| 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 | Same | |
| Automatic ST Analysis | yes | no | no |
| Manual ST Analysis | no | no | yes |
A review of the technological characteristics compared to the predicate devices are:
{2}------------------------------------------------
The only difference between the rwo Zymed systems is the addition of automanc Multi-channel ST Analysis/alarm to the algorithm.
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 EasilView as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive nate (FPR) were examined for each database and measured for QRS, Venricular, Couplers, Short nuns and Long nuns. High heart rates to include pediatic patients were demonstrated to be within recommended guidelines in excess of 300 bygm, 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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 OCT
Mr. J. Dudley Harris Zymed Inc. 20 North Aviador Street Camarillo, CA 93010-8348
Re: K980186 EasiView Telemetry Monitoring System - Modified with ST-Segment Analysis Requlatory Class: III (three) Product Code: 74 DSI Dated: July 20, 1998 Received: July 21, 1998
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 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 In addition, FDA may publish further announcements requlatory action. 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 under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. J. Dudley Harris
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, "Misbranding by reference to premarket notification"(21 CFR 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. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number. K980186
Device Name: Easiview Telement Monitoring System
Indications For Use
- Assessment of symploms that may be related to rhythm disturbances of the heart: Patients with . palpitations; The evaluation of arthythmus's in parients from podiatric to adult age.
- Assessment of risk in patients with or without symptoms of arrhythmia. ♥
- Assessment of efficacy of Antianty through therapy. .
- Assessment of Pacemaker Function.
- Assessment of real time ST segment analysis. .
- Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart discase and . arrhythmia analysis during exercise testing.
- Assessment is indicated for single-hospital environment. ◀
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
mer
Mark K(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number_**_
| Labels | Values |
|---|---|
| Prescription Use (CFR21 CFR 801.109) | \checkmark |
| Over-The-Counter Use |
§ 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.