(45 days)
The CardioStream SonoAim is intended for capturing, transporting, and reporting patient cardiac study data.
The CardioStream SonoAim is a clinical assessment tool designed to automate the movement of clinical data through the clinical assessment process. The system is comprised of the following components: Data Harvester (DH) - Laptop (variations - desktop, pole-mounted LCD screens), Data Packager (DP) - Computer (tower), AIM Server - Archive and Image Manager - located at secure off-site data center. Data and images are captured in the clinical setting via an image capture device (DH), and a preliminary report is completed by the Sonographer. The preliminary report is immediately formatted (DP) and available on a secure webaccessed internet site. The physician with secure user name and password will then access/review the clinical images and preliminary report, and edit or add commentary as needed. The final report is then electronically signed and returned to the referring physician. The information is available on any web-accessible device.
The provided text is a 510(k) summary for the CardioStream SonoAim, a medical device. However, it does not contain any information regarding acceptance criteria, device performance studies, or quantitative data about the device's accuracy or efficacy.
The document primarily focuses on:
- Device Description: What the CardioStream SonoAim is and its components (Data Harvester, Data Packager, AIM Server).
- Intended Use: Capturing, transporting, and reporting patient cardiac study data.
- Substantial Equivalence: A comparison table showing features of the CardioStream SonoAim against a predicate device (Siemens KinetDX, K041029) to demonstrate functional and technical similarity.
- FDA Clearance Letter: Official communication from the FDA confirming the device's substantial equivalence and clearance to market.
Therefore, I cannot provide the requested table and details about acceptance criteria, study design, or performance metrics because this information is not present in the given input.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates that the clearance was based on similarity to an existing device rather than a new clinical performance study demonstrating efficacy against specific 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).