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510(k) Data Aggregation
(158 days)
Shenzhen Sophway Technology Co., Ltd.
Endoscopic Camera System is a camera control unit (CCU) for use with camera heads and video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.
The device consists of a camera control unit (CCU) and a camera head.
The device is intended to be used to connect with an optical endoscope during the endoscopic diagnosis and/or treatment/surgery, and to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.
There are 4 models of the device. The hardware configuration of the device of 4 models are same, and difference is different functions which opened up through software.
The provided FDA 510(k) clearance letter describes an Endoscopic Camera System (K250204) and its substantial equivalence to a predicate device (Image1 SPIES System, K160044). However, it does not provide detailed acceptance criteria or the specific results of a study (e.g., clinical study) that quantitatively proves the device meets strict performance thresholds.
The letter primarily focuses on the device's technical specifications and compliance with non-clinical performance tests relevant to the safety and fundamental function of an endoscopic camera system. It highlights that the device "met all its specifications" and that bench tests demonstrated the device's characteristics have been met, but it does not specify what those specifications or characteristics are in measurable terms related to clinical performance.
Based on the provided text, here's an attempt to answer your questions, highlighting what is available and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The bench test data for the Endoscopic Camera System demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications." and "The bench testing performed verified and validated that the Endoscopic Camera System has met all its design specification and is substantially equivalent to the predicate device, Image1 SPIES System."
However, the specific acceptance criteria (measurable thresholds) and the quantitative reported device performance for these specifications are NOT detailed in this public FDA 510(k) clearance letter.
The letter mentions "minor technology differences" in:
- Horizontal resolution
- Spatial frequency response
- Field of view
- Focal length
- Dimensions
- Weight of camera head
- Image delay
- Video output
- USB port of CCU
For these parameters, the letter ambiguously states that these differences "does not raise new issues of safety and effectiveness." It implies that the new device's performance for these characteristics is either equivalent or acceptably different without introducing new risks compared to the predicate, but specific numbers are not provided.
| Acceptance Criteria (Example/Inferred) | Reported Device Performance (Not Provided Quantitatively in Letter) |
|---|---|
| Horizontal Resolution = [X] | Met specification, equivalent to predicate K160044 |
| Spatial Frequency Response = [Y] | Met specification, equivalent to predicate K160044 |
| Field of View = [Z] | Met specification, equivalent to predicate K160044 |
| Focal Length = [A] | Met specification, equivalent to predicate K160044 |
| Image Delay |
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