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The "Intended Uses" of the modified 300-2W is exactly the same as the predicate device (model 300-2). The intended use is to acquire, record, and store one or more davs of multi-lead ECG data for patients undergoing continuous ambulatory electrocardiography. The 300-2 performs no cardiac analysis by itself and is intended to be used only with the DMS Premier II Holter system (K062088), as is the predicate 300-2 device. The "Indications for Use" of the modified DMS 300-2W recorder is indicated for use in a clinical setting by qualified medical professionals only for recording multi-lead ECG data of patients during a minimum ambulatory time period of 24-hours. It is not a life supporting system, and is not connected to an AC power source. Ambulatory 24-hour electrocardiography is used for the below indications: - . Evaluation of patients with symptoms suggesting arrhythmias. - Evaluation of patients with pacemakers. . - Evaluation of patients heart rate changes. - . Evaluation of patients QRS interval changes. - · Evaluation of patients response to drug therapy treatment. The "Indications for Use" for the modified 300-2W is exactly the same as the predicate 300-2 device.

The 300-2W is a Holter Recorder that records the ECG signal in the exact same manner as the predicate 300-2 device. The 300-2W transfers the Holter ECG from its memory in the exact same manner as the predicate 300-2. The 300-2W uses the same USB cable as is used by the predicate 300-2 to transfer the Holter file from the Holter Recorder to the Holter PC. The Holter PC program processes the 300-2W Holter ECG recording with the exact same software program as is used by the 300-2 predicate device. All of the Holter ECG screen displays and print pages are exactly the same when using either the 300-2W device or the 300-2 predicate device. The Holter report from which the physician makes a diagnosis is the exact same format when using either the 300-2W device or the 300-2 predicate device. The 300-2W uses the same firmware as the predicate 300-2 to record the Holter ECG data and to transfer the Holter recording to the Holter PC. The ECG signal in the 300-2W is the same ECG signal as the predicate 300-2. The Intended Uses of the 300-2W and the predicate 300-2 are the same. The Indications for Use of the 300-2W and the predicate 300-2 are the same. The Design Controls and Performance Standards for the 300-2W and the predicate 300-2 are from the same source processes. The manufacturing process has ISO 13485 certification. The 300-2W and the predicate 300-2 are multi-day Holter recorders. Both the 300-2W and the predicate 300-2 use the same alkaline or lithium batteries that are off-the-shelf AA batteries. Both the 300-2W and the predicate 300-2 use off-the-shelf commercial memory chips. The 300-2W uses a larger capacity memory chip, and both recorders operate with the memory chip in the same manner. The larger commercial memory chips are now larger capacity and cost less money than 300-2 Holter ECG recorder of 2006. All Holter ECG recorders have auxiliary real-time ECG outputs. These auxiliary outputs have no effect on the safety, performance, Intended Use, or Indications for Use with either the 300-2W or the predicate 300-2. Both the 300-2W and the predicate 300-2 have two (2) auxiliary outputs. The traditional uses of these auxiliary outputs is to view the quality of the electrode application to the patient prior to leaving the doctor's office, or to see the operational ECG of the Holter recording. The 300-2W and the predicate 300-2 have the same USB auxiliary output. The 300-2W has a WiFi auxiliary output and the predicate 300-2 has a transtelephonic auxiliary output.

The "Indications for Use" of the modified DMS 300-2, 300-3 and 300–4 recorders are indicated for use in a clinical setting, by qualified medical professionals only, for recording multi-lead ECG data of patients during a minimum ambulatory time period of 24-hours. It is not a life supporting system, and is not connected to an AC power source. The "Intended Uses" of the modified 300-2, 300-3, and 300-4 Holter ECG Recorders are exactly the same as the predicate devices (DMS 300-7 and 300 ECG Recorder).Ambulatory multi-day electrocardiography is used for the below indications: . Evaluation of patients with symptoms suggesting arrhythmias. - . Evaluation of patients with pacemakers. . Evaluation of patient heart rate changes and QRS interval changes. . Evaluation of patient response to drug therapy treatment.

The modified DMS 300-2 Holter ECG Recorder is intended for use as a part of a Holter ECG analysis system for continuous and cardiac event monitoring, and is designed to be used with the DMS Premier Holter system. The DMS 300-2 provides three (3) leads of continuous ECG recording. With its memory built into its circuit board, the 300-2 can store up to thirty (30) days of Long-Term Ambulatory ECG, whether it be continuous ECG or patient symptomatic event ECG data. The 300-2 acquires, digitizes, and stores ECG data that can be later analyzed by the Premier Holter system. Short-term, two-minute ECG's can also be phone transmitted from the Holter recorder to a host PC for symptomatic ECG's. The Premier Holter system processes pre-recorded patient ECG data that has been stored in the DMS 300-2. The cardiac data provided by the 300-2 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhvthm patterns. The modified DMS 300-3 Holter ECG Recorder is intended for use as a part of a Holter analysis system, and is designed to be used with the DMS Premier Holter system. The DMS 300-3 provides three (3) channels of continuous ECG recording. With its memory built into its circuit board, the 300-3 can store up to two (2) days of continuous Holter ECG data. The 300-3 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes pre-recorded patient ECG data that has been stored in the DMS 300-3. The cardiac data provided by the 300-3 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns. The modified DMS 300-4 Holter ECG Recorder is intended for use as a part of a Holter analysis system, and is designed to be used with the DMS Premier Holter system. The DMS 300-4 provides twelve (12) leads of continuous ECG recording. With its memory built into its circuit board, the 300-4 can store up to two (2) days of continuous Holter ECG data. The 300-4 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes nre-recorded patient ECG data that has been stored in the DMS 300-4. The cardiac data provided by the 300-4 and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns.

The "Intended Use" of the Premier 11 software is the same as the predicate devices. The intended use is for evaluation of the recorded ECG for patients who are subject to physician ordered Holter ECG monitoring environments; such as, palpitations, dizziness, chest pains, shortness of breath, pacemaker function, and drug therapy follow-up. The evaluation includes the standard Holter software measurements and reporting of arrhythmia, ST changes, R-R Variability, QRS interval changes, and heart rate trends. The PC computer-generated results do not contain diagnostic interpretation. The data can be edited, and only the qualified physicians are intended to review the ECG data and to make a diagnosis. The Premier 11 Holter is intended to be used only by physicians, or on the order and supervision of a physician. Indications For Use: The indications for use for 24-hour ambulatory ECG for this modified Premier ll software and the listed predicate devices are for ECG evaluation of, but limited, to typical symptoms of chest pains, palpitations, dizziness, shortness of breath, and pacemaker. More specifically, indications for use include the following: - . Assessment of symptoms that may be related to rhythm disturbances of the heart in patients from pediatric to adult age; such as, palpitations. - . Assessment of risk in patients with or without symptoms or arrhythmia; such as, patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patients with left ventricular dysfunction. - . Assessment of efficacy of anti-arrhythmic therapy. - . Assessment of pacemaker function. - . Detection of transient ST Depression, as well as Prinzmetal ST Elevation.

The Premier 11 Holter is a software program that analyzes recorded ambulatory ECG (Holter), then creates ECG print-outs and numerical reports based on the analyzed data. The ambulatory ECG, as well as pacemaker pulse data, is prerecorded onto data storage mediums by Holter ECG recorders. The Premier 11 Holter software reads these raw data into standard PC computers, and then performs analysis to generate numerical reports. The Premier 11 Holter software provides review and editing tools that allow trained medical personnel to review and edit the initial analysis of the recorded Holter ECG data. This data processing is performed on a standard PC computer, such as an XP Home or Professional operating platform. The cardiac data that is processed by the Premier 11 Holter is both individual ECG waveforms and patterns of consecutive ECG waveforms. The Premier 11 Holter software does not provide diagnostic interpretation of the ECG data. Only the trained physician can provide such diagnosis. The cardiac data processed by the Premier 11 Holter is used by trained medical professionals to assist them to perform diagnosis on patients with various cardiac rhythm patterns. The Premier 11 provides the standard Holter ECG processing features; such as individual ECG print-outs, Full Disclosure ECG print-outs, multi-channel morphology and ST analysis, heart rate analysis, manual markers for measuring the QRS width in both filtered and unfiltered modes, editing of arrhythmias, editing of ECG strips. editing of abnormal ECG events, selection of desired page prints for the Holter report, PageScanning of 100% of the 24-hour ECG, and storage of the Holter ECG file for future review of the data.

The DMS 300-7 Holter ECG recorder is intended to acquire, record, and store up to 24-hours of three (3) channel ECG data for patients undergoing continuous ambulatory electrocardiography. The DMS 300-7 performs no cardiac analysis by itself and is intended to be used with the DMS Premier Holter system. In turn, the cardiac data and analysis provided by the Premier Holter system will be used by trained medical personnel in the diagnosis of patients with various rhythm patterns. The DMS 300-7 is indicated for use in a clinical setting, by qualified medical professionals only, for recording 3-channel ECG data of patients requiring ambulatory 24-hour monitoring. Holter ECG is appropriate for the indications below: .Evaluation of adult patients with symptons suggesting arrhythmia .Evaluation of adult patients with pacemakers .Evaluation of patients with suspected abnormal heart rate changes .Evaluation of patients with suspected abnormal QRS interval changes .Evaluation of patient response to drug therapy treatment

The modified DMS 300-7 Holter ECG recorder is intended for use as a part of a Holter analysis system and is designed to be used with the DMS Premier Holter system. The DMS 300-7 provides three (3) channels of continuous ECG recorded over a 24-hour time period. The DMS 300-7 acquires, digitizes, and stores data to be later analyzed by the Premier Holter system. The Premier Holter system processes pre-recorded patient 3-channel ECG data that has been stored in the DMS 300-7. The cardiac data provided by the DMS 300-7 recorder and the Premier Holter system is used by trained medical personnel to assist in the diagnosis of patients with various ECG rhythm patterns. The DMS 300-7 is a 3-channel ECG recorder that uses either a five (5) or seven (7) electrode ECG cable, as is the same with the predicate Model 300 ECG Recorder. The five (5) electrode ECG cable records a modified V1, V3, Lead II ECG recording. The seven (7) electrode ECG cable records three (3) bipolar leads, and can be used for an XYZ recording. A patient activated ECG Event button can be pressed by the patient to flag a symptomatic cardiac event ECG, as is the same with the predicate Model 300 ECG Recorder. The DMS 300-7 uses a single AA alkaline battery as its power source, and stores acquired ECG data on a removable, non-volatile memory compact flash card. Stored ECG data is then downloaded to the hard disk drive of the Premier Holter system via a standard PCMCIA reader interface. The recorded data will remain in memory until it has been cleared by the clinician.