ZYMED TELEMETRY SYSTEM

{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)<br>telemetry system | Easi View (Old)<br>telemetry system | Holter<br>holter 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:<br>3 channel | yes | yes | | | Tunable frequencies | 174-216 Mhz | Same | | | Software | | | | | Number of patients | 4, 6, or 8 | Same | | | Operating System | Windows NT<br>DOS 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. {4}------------------------------------------------ ## 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***_****_* | <strong>Labels</strong> | <strong>Values</strong> | |--------------------------------------|----------------------------------------| | Prescription Use (CFR21 CFR 801.109) | \checkmark | | Over-The-Counter Use | <strong><em>_</em></strong> <em>_</em> |