(154 days)
The proposed device is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.
The CV3000 Holter Analysis System is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.
The CV3000 Holter Analysis System is consisting of Holter recorder and the PC-based CV3000 Analysis Software.
The Holter recorder is an ambulatory electrocardiograph designed to be used with the PC-based CV3000 Analysis Software. It is intended to acquire, record and store up to 24 hours of ECG data from the patient. It performs no cardiac analysis by itself and is intended to be used with the CV3000 analysis software. ECG data prerecorded by the Holter recorder is analyzed by the CV3000 analysis software.
The provided text describes a 510(k) summary for the CV3000 Holter Analysis System. However, it does not contain specific acceptance criteria or details of a study that directly proves the device's performance against such criteria.
The document focuses on demonstrating substantial equivalence (SE) to a predicate device (TLC5000 Holter Analysis System, K101273) through non-clinical tests that verify the device meets design specifications and complies with various safety and performance standards (IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC38, ANSI/AAMI EC57).
The comparison table provided (Table 3-1) lists technical characteristics of the proposed device and the predicate device, emphasizing their similarities ("Same" or "Similar"). It also mentions that the proposed device "Have measurement function" which is "Same" as the predicate. This comparison is to support the claim of substantial equivalence, not to present a direct study demonstrating the proposed device's performance against specific acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document's purpose is to establish substantial equivalence for regulatory clearance, not to detail a clinical performance study with specific metrics like sensitivity, specificity, or reader improvement.
§ 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).