(251 days)
ClearEndoclip is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
- (1) Endoscopic marking
- (2) Hemostasis for
- (a) Mucosal/sub-mucosal defects
ClearEndoclip is a sterile device consisting of a pre-loaded, single-use, endoscopic clipping device with two main components: the (clip-fixing) delivery system and the clip. Clip is preloaded in the clip fixing delivery system, connected with an operation wire. Clip will open when the slider of the clip fixing device is pushed, and closed when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel. HDPE outer sheath, and polypropylene stopper materials. The delivery system will allow for the device to rotate at the distal end. The ClearEndoclip is offered in 165cm and 230cm working lengths.
ClearEndoclip consists of two main components, first, the endoscopic clip, which gets physically deployed and placed as a hemostatic purpose clip in the patient's gastrointestinal tract and second, the delivery system, known as a clip fixing device used to deliver the endoscopic clip under the use of an endoscope.
The provided text describes Finemedix Co., Ltd.'s ClearEndoclip, a medical device for endoscopic clipping. However, it does not contain information about software or AI, nor does it discuss acceptance criteria and study results related to AI device performance. The document is a 510(k) summary for a physical medical device, focusing on its substantial equivalence to a predicate device, functional descriptions, indications for use, and performance data related to its MR (Magnetic Resonance) compatibility.
Therefore, I cannot fulfill your request as the necessary information regarding AI device performance, study types (MRMC, standalone), ground truth establishment, training set details, and expert involvement is not present in the provided text.
The "Performance Data" section specifically details tests for MR compatibility (e.g., magnetically induced displacement force, torque, image artifact, RF induced heating, and MR pull-off test), all of which relate to the physical properties of the clip in an MRI environment, not the performance of an AI algorithm.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.