(82 days)
The Tomophase OCTIS (Optical Coherence Tomography Imaging System) is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.
The Tomophase OCTIS is an imaging tool for the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. The system consists of an Imaging Console and a detachable Probe.
The Imaging Console contains optical and electrical components to utilize NIR light to create high resolution real-time images; and has a user interface for acquiring, displaying, saving and reporting the images.
The Probe is a single-use, sterile device consisting of a sealed sheath and a flexible fiber optic mechanism.
Here's an analysis of the acceptance criteria and the study information based on the provided text for the Tomophase OCTIS 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) for a specific clinical task. Instead, the "acceptance criteria" are implied by the successful completion of various safety and bench tests, demonstrating the device's adherence to relevant standards and design objectives.
Therefore, the table below reflects what can be inferred as "acceptance criteria" from the provided document, focusing on safety and technical performance, rather than clinical diagnostic performance.
| Acceptance Criteria (Implied from successful test completion) | Reported Device Performance (as stated in the document) |
|---|---|
| Safety and Standards Compliance | |
| Risk Management per ISO 14971 | Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use. |
| Medical Electrical Equipment per IEC 60601-1 | Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use. |
| Electrical Safety per IEC 60601-1-1 | Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use. |
| Electromagnetic Compatibility per IEC 60601-1-2 | Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use. |
| Safety of Endoscopic Equipment per IEC 60601-2-18 | Tomophase OCTIS meets design criteria, performance objectives, and user requirements. Safe for intended use. |
| Laser Safety per IEC 60825-1 | Laser Safety Class 3R; Optical Radiation Emission Safety: |
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.