MT-200

{0}------------------------------------------------ K973751 AUG 25 1998 # 510 K Summary accordina to 21 CFR 807,92 #### A1 Address SCHILLER America, Inc. 3002 Dow Avenue, #138 Tustin, CA 92780 Contact Name; Tel: Date: Mr. Markus Martz 1619) 635 6023 22" September 1997 #### A2 Device Name | 1. Trade Name: | Microvtt MT-200 | |-------------------------|------------------------------------| | 2. Common Names: | Holter System, Holter Analyzer | | 3. Classification Name: | Computer, Diagnostic, Programmable | Panel Code: DEK ICV 74 Classification Class: # Computer Diagnostic Programmable Class 2 ## A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared: Brentwood Rhythmscan Precision CS-6000 (K914577) ### Description of Submitted Device A4 The ECG Holter evoluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter EOG recordings. The Holter iscoralings are used for the diagnostics of symptomatic and asymptomatic arrhythings, i.e. bradyeardia, tachycardia, diagnastic of arthythinias in pattents with coraniary artery disease, in cardiomopathy, high blood pressure, long QT syndrome, A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of aliziniess or for controlling medical theraples, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic Ischemics. The software runs on Windows™ 95. {1}------------------------------------------------ # ITZEHL # A5 Intended Use The ECG Holter Analyzer MT-200, Is a ECG analyzing software for the diagnostics of symptomatic and asymptomatic artnythmias and of Ischernic episodes. hurnan beings without restrictions of age, sex or race. 1. Patient Population: 2. Difference to the Predicate Device: no differences. #### Table of Comparison A6 Predicate device: Brentwood Rhytmsoan Precision CS-6000 (K914577) | | Precision CS-6000 | MT-200 | |---------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Recording Medium | Tape cassette and Solid<br>state recorder DL, 700 | Solid state recorder<br>MT-200 | | Channels | 2 or 3 | 2 | | System requirements | | | | CPU | IBM compatible PC<br>386, 33 MHz<br>8 Mbytes RAM<br>80 Mbytes Hard-drive<br>Windows™ 3.11 or 95 | IBM compatible PC<br>486, 66 MHz<br>16 Mbytes RAM<br>100 Mbytes Hard-drive<br>Windows™ 95 | | Monitor | VGA Color Monitor | SAME | | Printer | HP Laser Jet Series | SAME | #### Non-Clinical Tests B1 # Data related to software quality SCHILLER has reviewed the MT-200 Analyzer Software development process following the quideline "reviewer quidance for computer controlled medical devices undergoing 510 (k) review". All tests are passed. #### B2 Clinical Tests To evaluate the performance of arthythmia detection of the MT-200 program, the AHA and MIT data bases were used and the annotations in the databases compared with the automatic analysis carried out by the MI-200 program. # Method A normal analysis of the AHA and MIT records was carried out by the MT-200. The classifications given by the MT-200 were then compared with the annotated classifications of the data bases. The results of the comparison were alven in tabular form. The procedure and limits described In ANSVAAMI EC 38-1994 were used. {2}------------------------------------------------ # SCHILLER ITZERLAND For the evaluation of the ST-T analysis the ESC ST.T. database was used. The STsegment deviations measured by the MT-200 were compared to the deviations measured by two independent observers. The limits set up for test were not violated. The absolute difference between paired values (reader MT-200) is less than 0.1 mV. The total number of differences greater than 0.1 mW Is less than or equal to 2% of the total number of measurements. All tests are passed #### ВЗ Conclusions from Tests The fulfillment of the above standards ensures the safely and effectiveness of the submitted device. We consider the submitted device to be as safe and effective as the Predicate Brentwood Rhytmscan Precision CS-6000 (K914577) Device. All tests are passed. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 25 1998 Mr. Markus Maritz Schiller America, Inc. 3002 Dow Avenue, Suite 138 Tustin, CA 92780 Re: K973751 Microvit MT-200 Requlatory Class: II (two) Product Code: 74 DQK Dated: May 29, 1998 Received: June 2, 1998 Dear Mr. Maritz: 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 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 under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ ## Page 2 - Mr. Markus Maritz 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. 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 {5}------------------------------------------------ WELCH ALLYN 07 : 31 : 98 14:58 07/31/98 13:04 FAX ID:619-621-6610 201 143 3101 AUG 04, 98 FD3-051 DECS Page I of I 610(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name:Holter Evaluation Software MT-200 ## Indications For Use: The ECG Holter evaluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter ECG recordings. The Holter recordings are used for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | |--------------------------------------------------------| |--------------------------------------------------------| Dalla Tilla (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K97375/ **Prescription Use** (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Pormat 1-2-90)