(64 days)
The 3M™ Littmann® Scope to-Scope Software System is intended to provide and control the real time data transfer of body sounds between two 3M™ Littmann® Electronic Stethoscopes, Model 3200 over a data network. It can be used on any person undergoing a physical assessment.
The 3M™ Littmann® Scope-to-Scope Software System consists of software on a CD working with two 3M Littmann® Model 3200 Electronic Stethoscopes (cleared under K083903), such that when the software program is installed onto a PC, the software provides and controls real time data transfer of body sounds between two 3M Littmann® Model 3200 Electronic Stethoscopes over a data network. The sound captured by the stethoscope at the Patient site can be heard equivalently at both the Patient and Consulting sites through the Model 3200 headsets. The Scope to Scope Software System can be used on any person underqoing a physical assessment. thereby enabling health care professionals in remote clinics to obtain a second opinion from clinicians in a different location. Both sites' Model 3200 electronic stethoscopes are connected to Microsoft Windowsbased PC's via a Bluetooth wireless link. The two PC's are then connected to each other over a TCP/IP data network. The software allows for the Consulting site to control the Patient site's filter settings remotely when connected. The software also provides for the ability to facilitate verbal communication usinq the stethoscope's 'talk-through' feature that utilizes an expanded frequency range to better capture voice audio. This allows the Consultant to provide verbal cues and/or directions to the Patient site.
The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.
The document is a 510(k) Premarket Notification for the 3M™ Littmann® Scope-to-Scope Software System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with quantitative acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document primarily describes the device, its intended use, and its classification, and confirms its substantial equivalence to a predicate device for regulatory approval.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).