(92 days)
K 980186
Not Found
No
The document describes standard real-time ECG waveform analysis and detection of abnormal beats and rhythms, which are typical functions of traditional cardiac monitoring systems and do not explicitly mention or imply the use of AI/ML. The performance evaluation against standard databases (AHA, MIT, EST) is also common for non-AI/ML arrhythmia detection algorithms.
No.
The device is used for assessment and monitoring of cardiac rhythm disturbances and heart conditions, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "Assessment of symptoms that may be related to rhythm disturbances of the heart," "Evaluation of arrhythmia's," "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," and to "evaluate for, ischemic heart disease and arrhythmia analysis." These descriptions clearly indicate that the device is used to identify, analyze, and characterize medical conditions, which falls under the definition of a diagnostic device. The "Device Description" also mentions tools for "diagnosis of patients with various heart conditions."
No
The device description explicitly mentions hardware components such as ECG transmitters, a central Telemetry monitoring computerized unit, a strip chart recorder, and a laser printer.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The device description clearly states that the system monitors ECG data from patients in real-time using ECG transmitters. This is a direct measurement of physiological signals from the body, not the analysis of a sample (like blood, urine, or tissue) taken from the body.
- The intended use focuses on monitoring and analyzing electrical activity of the heart. The indications for use and device description describe the assessment of heart rhythm disturbances, arrhythmia, pacemaker function, and ST segment analysis based on ECG signals. These are all related to the electrical activity of the heart within the body.
Therefore, this device falls under the category of a medical device that monitors physiological signals, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
-
- Ages: 33 to 82 years
-
- Heights: 147 to 185 cm (58 to 73 in)
-
- Weights: 53 to 118 kg (117 to 2611b)
-
- Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/b.)
-
Product codes
DSI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
pediatric to adult age (generalized), 33 to 82 years (for EASI derived 12-lead ST measurements)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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. 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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zymed Telemetry System: Model EasiView - 510(k) K 980186
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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:
1
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.
-
- Ages: 33 to 82 years
-
- Heights: 147 to 185 cm (58 to 73 in)
-
- Weights: 53 to 118 kg (117 to 2611b)
-
- 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:
2
| Number of patients | 4, 6, or 8 | Same |
|---|---|---|
| Operating System | Windows NT | |
| DOS 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.
3
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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
4
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
5
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
6
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.
-
- Ages: 33 to 82 years
-
- Heights: 147 to 185 cm (58 to 73 in)
-
- Weights: 53 to 118 kg (117 to 261 lb)
-
- 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