(30 days)
The CardioPerfect Workstation software and associated accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various diseases and/or treatment regimens. The CardioPerfect Workstation software also provides non-diagnostic functions such as patient management, data security, search tools for patient and/or test records and support for exporting data to Electronic Medical Record systems.
The CardioPerfect Workstation and associated accessories are intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients, subject to any specific contraindications identified below.
Electrocardiograph - Stress: Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms. Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.
Electrocardiograph - Resting: The same as defined for stress ECG plus the ability to use optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis for patients sixteen (16) years of age and above. These are presented for review and interpretation by the clinician.
Ambulatory Blood Pressure: Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history. Indications for ambulatory blood pressure measurement (as listed in Journal of Hypertension 2003, 21:821-848, E. O'Brien et. al.) include, but are not limited to, the following: Suspected "white coat" hypertension, Suspected nocturnal hypertension, To establish dipper status, Resistant hypertension, Elderly patient, To monitor antihypertensive drug treatment, Type 1 diabetes, Hypertension of pregnancy, Evaluations of hypotension, Autonomic failure, Masked hypertension.
Spirometry: Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. Normal values and comparative results are not calculated for children under the age of six. Indications for spirometry include, but are not limited to, the following: Shortness of breath, Chronic cough, Occupational exposure to dust or chemicals, Assist in the diagnosis of Bronchitis, Assist in the diagnosis of Asthma, Wheezing, Assist in the monitoring of bronchodilator.
CardioPerfect Workstation software is used to create a computer platform on which ECG, ABP, & Spirometry applications can operate within inherent capabilities of an off-the-shelf desktop or laptop personal computer utilizing a Windows or DOS based operating system.
The provided text is a 510(k) Premarket Notification for the Welch Allyn CardioPerfect Workstation Software Version 1.5.0 and Accessory Product. It describes the device, its indications for use across various modules (Resting ECG, Stress ECG, ABP, and Spirometry), and regulatory information.
However, the document does not contain specific details regarding acceptance criteria, study methodologies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC) as requested in the prompt. It focuses on the regulatory submission, equivalence to predicate devices, and indications for use.
Therefore, I cannot extract the requested information from the provided text. The document is primarily a regulatory filing for market clearance, not a detailed technical report on device performance validation.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).