(43 days)
The Tel-Echo System is intended to acquire echocardiographic images during a cardiac ultrasound exam and transfer them to another location for viewing. This system is intended for tele-echocardiography applications.
The Tel-Echo System is designed specifically to transmit cardiac ultrasound (echocardiographic) exams over telephone lines for remote review. This application is usually referred to as tele-echocardiography.
A Tel-Echo System may send complete exams from a remote clinic to the main clinic. It may also send selected images to a physician's home or office for "on call" coverage. The Tel-Echo System acquires echocardiographic images in parallel with the VCR(Video Cassette Recorder) or other recording method. This VCR tape or equivalent digital media comprise the exam record and not the Tel-Echo system, which is for communication only.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it describes a 510(k) submission for the "Tel-Echo System," which is a tele-echocardiography device. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with defined acceptance criteria.
The 510(k) summary states, "The Tel-Echo System acquires echocardiographic images in parallel with the VCR(Video Cassette Recorder) or other recording method. This VCR tape or equivalent digital media comprise the exam record and not the Tel-Echo system, which is for communication only." This indicates the device is a communication tool, not a diagnostic one that would typically require validation of clinical performance (e.g., diagnostic accuracy metrics).
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study proving performance, as this information is not present in the provided text. The document is concerned with the functional equivalence of the communication capabilities rather than diagnostic performance.
However, I can extract information related to the comparison with predicate devices, which serves as the basis for its regulatory clearance:
Summary of Device Comparison and Regulatory Basis:
| Feature | Tel-Echo System (Innovative Medical Solutions) | Predicate Devices (Network Concepts Univision, VMI Technologies EchoVacs, MPACS EchoLink) |
|---|---|---|
| Intended Use | Acquire echocardiographic images and transfer them to another location for viewing; tele-echocardiography applications. | Perform tele-echocardiography applications (implied for all, explicitly stated for MPACS EchoLink). |
| Technology | Transmits cardiac ultrasound exams over telephone lines for remote review; uses MPEG standard compression. | Transmit exams for subsequent review over a wide area network; use MPEG standard compression. |
| Compression Ratios | Offers a choice of MPEG compression ratios to match data transfer speed with telecommunications bandwidth. | Network Concepts and VMI Technologies offer only one compression ratio. MPACS offers a choice. |
| Archive Capability | Does not offer archive capability; relies on user to keep current medical record (VCR tape or other media). | All predicate devices offer an archive capability to replace VCRs. |
| Function | Communication only; exam record is the VCR tape or equivalent digital media. | Communication and in some cases, archiving. |
Study Details (Not applicable as a performance study with acceptance criteria was not described):
As the provided text does not describe a performance study with specific acceptance criteria validating the device's clinical efficacy, most of the requested information is not available. The submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily focusing on its communication function and the technical aspects of data transfer and compression.
Given this, I cannot answer questions 1-9 directly as requested for a performance study. The 510(k) process for this device focused on functional comparison rather than a clinical performance study with acceptance criteria.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).