MATRIX HOLTER SYSTEM, MODEL M12

{0}------------------------------------------------ # SEP 2 6 2005 # 12. Premarket Notification [510(k)] Summary ## Submitted By: Global Instrumentation LLC 8104 Cazenovia Road Manlius, NY 13104 Telephone: 315-682-0272 ext 213 Fax: 315-682-0278 Contact Person: Craig Sellers Prepared June 24th, 2005 | Common Name: | Electrocardiograph, Ambulatory, With Analysis Algorithm | |--------------|---------------------------------------------------------| |--------------|---------------------------------------------------------| - Trade Name: Matrix Holter System - Classification: 21 CFR 870.2800 - Predicate Device: The legally marketed medical devices which are substantially equivalent are: Mortara H-Scribe Holter Analysis System (K004017) Mortara H12+ Holter Recorder (K021373) Burdick PC Holter Scanning System (K945985) Burdick Altair-Disc Recorder (K942565) Confidential Material {1}------------------------------------------------ # 051730 #### Description: The M12 Matrix Holter System is a Holter system consisting of the Matrix Holter recorder (M12R) and the PC-based Matrix Holter System Application (M12A). The complete system is referred to as the M12 Matrix Holter System. The Matrix recorder is a Holter Recorder (ambulatory electrocardiograph) designed to be used with the PC-based Matrix Holter System Application. The Matrix recorder acquires ECG data, converts the data to digital format and stores the digital data. The data is not analyzed by the Matrix recorder. The Matrix recorder uses a 7 or 10 lead electrode hookup and placement to obtain data for use by the Matrix Holter System Application. The Matrix Holter System Application is a PC-based application which is used to analyze, view, print, and edit the data collected by the Matrix recorder. The ambulatory electrocardiograph data recorded by the Matrix recorder is transferred to the Holter System Application, where it is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The Matrix Holter recorder acquires up to 12 leads of ECG data continuously for a period of up to 48 hours. The data is stored in digital format and is intended to be retrieved from the recorder by the Matrix Holter System Application for data review and analysis. The Matrix Holter recorder contains a keypad to provide means to configure the recorder, check hookup lead quality, and start the recording. The patient can use the keypad to enter patient activated event marks into the recording. The Matrix recorder has a display which provides operational status information to the hook-up technician and to the patient. This information includes hook-up lead quality and system status. Page 39 of 41 #### Confidential Material {2}------------------------------------------------ The Matrix recorder uses two AA batteries for power supply. Data is stored on a removable memory card. The data is transferred from the Matrix recorder to the Matrix Holter System Application by removing the memory card from the recorder and inserting the card into the memory card interface of the PC running the application. An optional wireless communication interface can also be used to transfer data from the recorder to the Matrix Holter System Application. The Matrix Holter System Application is a PC-based application. This application runs on a conventional PC system with a processing/data storage module, a graphical color display, a user interface keyboard, a printer, memory card interface and communication interfaces. #### Intended Use: The M12 Matrix Holter System is intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over periods up to 48-hours. The Matrix Holter System is intended for use under the supervision of a Physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia. This procedure is commonly called a Holter procedure which captures ECG rhythm abnormalities which may be infrequent or provoked by activities outside of the physician office. The M12 Matrix Holter System is comprised of the Matrix Holter Recorder (M12R) and the Matrix Holter System Application (M12A). The Matrix Holter Recorder component of the system will be worn by the patient and is used to record ambulatory electrocardiograph data from the patient. The Matrix Holter System Application is used to analyze the data recorded by the Matrix Holter Recorder. The subject Devices will provide the following diagnostic functions: - Acquiring, viewing, storing and printing ambulatory ECG waveforms from . patients using the Matrix Holter Recorder and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body. - Using optional Holter algorithms to generate measurements, data presentations . and graphical presentations on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings. - Using optional interpretive algorithms to generate measurements, data . presentations, graphical presentations, and interpretive statements on an advisory Page 40 of 41 Confidential Material {3}------------------------------------------------ basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings. . Page 41 of 41 {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular fashion around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 26 2005 Global Instrumentation, LLC c/o Mr. Craig Sellers Manager of Regulatory Affairs 8104 Cazenovia Road Manlius. NY 13104 Re: K051730 Trade Name: Matrix Holter System Regulation Number: 21 CFR 870.2800 Regulation Name: Electrocardiograph, Ambulatory, With Analysis Algorithm Regulatory Class: Class II (two) Product Code: MLO Dated: September 9, 2005 Received: September 12, 2005 Dear Mr. Sellers: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ Page 2 - Mr. Craig Sellers Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I DTP of localites complies with other requirements of the Act that IDA has made a decemination administered by other Federal agencies. You must of ally it cachar statutes and regaranents and limited to: registration and listing (21 comply with an the Her Stequirements, we see manufacturing practice requirements as set CTN Fat 807, adomig (21 OF RT 820), government (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control pro herens (seeins (seting your device as described in your Section 510(k) I mis letter will anow you to oegin maining of substantial equivalence of your device to a legally premarket notineation: The PDF Intamisgsification 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), please If you desire specific acries in 1984 (240) 276-0295. Also, please note the regulation entitled, Contact the Ories of Collier of Collier of Collication" (21CFR Part 807.97) you may obtain. Missuranding of reference to promazionsibilities under the Act may be obtained from the Other general information on your respectional and Consumer 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, Bfimmermanfor Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## 11. Statement of Indications For Use Page 1 of 1 510(k) Number (if known): K051730 Matrix Holter System Device Name: Indications For Use: The M12 Matrix Holter System is intended for use by trained operators in health facilities. The subject Device will provide the following diagnostic functions: - Acquiring, viewing, storing and printing Ambulatory ECG waveforms for up to twelve . (12) leads of patient ECG waveforms through surface electrodes adhered to the body. - Using optional algorithms to generate measurements, data presentations, and graphical . presentations on an advisory basis for the subject patients. These are presented for review probentation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG tracings, and other clinical findings. Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) or Bhimmar Eulian Slan Off (Optional Format 3-10-98)