(311 days)
The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to 168 hours (7 days) during activities of daily living. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, dizziness, anxiety, fatigue, syncope, presyncope, light-headedness, shortness of breath and where a software-assisted analysis of the potential causes of these symptoms is desirable.
The Stealth™ Monitor is a small, lightweight, patch-style, single-use cardiac monitor designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 168 hours (7 days) and ECG signal characterization. It is worn on the patient's chest similar to an adhesive bandage. The housing is constructed of a foam material making the device very lightweight (less than 9 grams). A software application is installed at a physician's office to receive the data from the monitor using a direct connection. Data retrieved from the monitor may be printed or saved and stored for later viewing. The DSD software has the ability to generate reports as well as the ability to save a full disclosure ECG file for viewing.
Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and studies:
Device Name: Stealth™ Monitor (S200, K142468)
Device Type: Prescription only single-use, continuous recording ECG monitor
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for the device's performance in terms of diagnostic accuracy or specific metrics (e.g., sensitivity, specificity for detected arrhythmias). Instead, it focuses on the performance of the device's components and system in meeting regulatory standards and functional requirements.
The "Summary of Performance Testing" section lists various documentation provided, indicating that general safety and functional performance were evaluated. However, specific numerical acceptance criteria for arrhythmia detection or other clinical performance metrics are absent from this summary.
Therefore, based solely on the provided text, a table of acceptance criteria and reported device performance related to clinical accuracy cannot be constructed. The document primarily addresses the substantial equivalence to predicate devices based on indications for use and technological characteristics, along with adherence to software and safety standards.
Further analysis of the document indicates: No clinical studies demonstrating diagnostic performance (e.g., sensitivity, specificity for specific arrhythmias) with specific acceptance criteria are presented or referenced in this 510(k) summary. The "Stealth™ System S200" is listed with "Arrhythmias and/or statistics" of "Normal, fastest heart rate, slowest heart rate, average heart rate, pauses, bradycardia (run), tachycardia (run)," but there are no performance metrics provided for these detections. This 510(k) seems to rely on substantial equivalence to predicate devices for its claims, rather than new clinical performance data for arrhythmia detection.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).