(120 days)
K 980186, K930004/A
Not Found
No
The document describes standard real-time ECG waveform analysis and classification of abnormal beats and rhythms, which is typical for traditional cardiac monitoring systems and does not explicitly mention or imply the use of AI or ML. The performance evaluation against standard databases (AHA, MIT, EST) is also common for such devices and doesn't necessarily indicate AI/ML.
No.
The device is for monitoring and assessment, providing tools for diagnosis and treatment enhancement, but it does not directly administer therapy or provide therapeutic effects.
Yes
The "Intended Use / Indications for Use" section explicitly states purposes like "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," and "Assessment of real time ST segment analysis," all of which are diagnostic functions. The "Device Description" also mentions providing "clinical tools such as visual and audible alarms for the diagnosis of patients with various heart conditions."
No
The device description clearly outlines a system that includes hardware components such as ECG transmitters, multi-parameter transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 lead, and a laser printer. It is not solely software.
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 (like blood, urine, tissue) in vitro (outside the body). The device description clearly states that this system monitors physiological parameters in vivo (within the body) through sensors attached to the patient (ECG transmitters, etc.).
- The intended use focuses on monitoring and assessing physiological signals (ECG, SpO2, blood pressure, temperature, respiration) directly from the patient. This is characteristic of patient monitoring systems, not IVDs.
- The performance studies are based on analyzing ECG waveforms and other physiological data, not on analyzing biological samples.
Therefore, this device falls under the category of a patient monitoring system, not an In Vitro Diagnostic.
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 of transferred SpO2 level date from an MDE Escort Bedside monitor to EasiView for display and alarm.
- . Assessment of transferred Invasive and Non-Invasive blood pressure, both systolic and diastolic, data from an MDE Escort Bedside monitor to EasiView for display and alarm.
- Assessment of transferred temperature parameter data from an MDE Escort Bedside monitor to ● EasiView for display and alarm.
- Assessment of transferred respiration data from an MDE Escort Bedside monitor to Easi View for display.
- Assessment is for single-hospital environment.
Product codes (comma separated list FDA assigned to the subject device)
DSI
Device Description
A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, multi-parameter transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 lead 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 will also display each patient's Oxygen Saturation, Respiration, Non-Invasive Blood Pressure, Invasive Blood Pressure and Temperature.
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 Mhz). 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 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 Zymed system presents the user with a number of clinical tools such as visual and audible alarms for multi-parameter monitoring of the patient. The Zymed system provides a means to monitor multiple patients from a central monitoring station for ECG, Oxygen Saturation, Non-Invasive Blood Pressure, Invasive Blood Pressure, Temperature, and Respiration.
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 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
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
Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases.
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 Easi View 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 Durative 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 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), Episode Sensitivities (ESE), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE) and Durative Predictivity (D+P)
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.
K 980186, K930004/A
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.
0
MAY 1 1 1999
7 vmed
1
Zymed Inc. 20 North Aviador Street Camarillo, California 93010-8348 800.235.5941 - 805.987.9611 Fax 805.987.9532
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: 1-8-99 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 Medical Data Electronics: Escort 100/300 Series B Patient Monitor System - 510(k) K930004/A
Description: A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, multi-parameter transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 lead 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 will also display each patient's Oxygen Saturation, Respiration, Non-Invasive Blood Pressure, Invasive Blood Pressure and Temperature.
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 Mhz). 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 for the diagnosis of patients with various heart conditions. The system also provides tools to review a patient's
1
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 Zymed system presents the user with a number of clinical tools such as visual and audible alarms for multi-parameter monitoring of the patient. The Zymed system provides a means to monitor multiple patients from a central monitoring station for ECG, Oxygen Saturation, Non-Invasive Blood Pressure, Invasive Blood Pressure, Temperature, and Respiration.
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 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 of transferred SpO2 level date from an MDE Escort Bedside monitor to EasiView for display and alarm.
- . Assessment of transferred Invasive and Non-Invasive blood pressure, both systolic and diastolic, data from an MDE Escort Bedside monitor to EasiView for display and alarm.
- Assessment of transferred temperature parameter data from an MDE Escort Bedside monitor to ● EasiView for display and alarm.
- Assessment of transferred respiration data from an MDE Escort Bedside monitor to Easi View for display.
- Assessment is for single-hospital environment.
A review of the technological characteristics compared to the predicate devices are:
2
| Platform | EasiView (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: | | |
| 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 | Same |
| Automatic ST Analysis | yes | Same |
| Manual ST Analysis | no | no |
| Platform | EasiView (New)
telemetry system | MDE Escort Monitor System (Old)
monitoring system |
| Temperature: | | |
| Range | 20-50 degrees C | Same |
| Alarms | 0-150 F (0-65 C) | 0.1-44.0 C |
| Non-Invasive BP | | |
| Measurement Method | Oscillometric | Same |
| Alarms | | |
| Systolic | 0-300 mmHg | 25-240 mmHg |
| Mean | NA | 15-200 mmHg |
| Diastolic | 0-200 mmHg | 10-180 mmHg |
| Invasive BP | | |
| Number of Channels | 1 or 2 | Same |
| Alarms | | |
| Systolic | 0-300 mmHg | 0-240 mmHg |
| Mean | NA | 0-200 mmHg |
| Diastolic | 0-200 mmHg | 0-180 mmHg |
| SpO2 | | |
| Range | 20- 100% | Same |
| Alarms | 0-100% by 1%
0-100% by 1 % | 70-100% high limit
50-99% low limit |
| Respiration | | |
| Range | 4-200 | Same |
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 Easi View 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
3
Sensitivities (ESE), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE) and Durative 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 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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1999
Mr. Dudley Harris Director of RA/QA Zymed, Inc. 20 North Aviador Street Camarillo, CA 93010-8348
Re: K990093 Easiview Telemetry Central Station Monitor Regulatory Class: III (three) Product Code: DSI Dated: April 20, 1999 Received: April 21, 1999
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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
5
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.
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, 2Misbranding by reference to premarket notification² (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.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number: K990093
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 of transferred SpO2 level data from an MDE Escort Bedside monitor to ● EasiView for display and alarm.
- Assessment of transferred invasive and Non-invasive blood pressure, both systolic and . diastolic, data from an MDE Escort Bedside monitor to EasiView for display and alarm.
- Assessment of transferred temperature parameter data from an MDE Escort Bedside monitor . to EasiView for display and alarm.
- Assessment of transferred respiration data from an MDE Escort Bedside monitor to EasiView . for display.
- 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)
F.K. Jones for the
Prescription Use
(CFR21 CFR 801.109)
Over-The-Counter Use