(421 days)
The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the first trimester of pregnancy. It has an additional feature of visualization.
The Disposable Endoscopic Cannula is a sterile, single patient use device composed of transparent cover, suction orifice, dual-function cannula, handle, suction port, connection port, and data cable. The patient contacting components of this device are transparent cover, suction orifice and dual function cannula that are manufactured with polycarbonate.
The transparent cover contains a LED light source and CMOS camera at the distal end for visualization of the cervical canal and uterine cavity. This device has two channels, one for transcervical aspiration of the uterine cavity and the other for transmitting the image signal through a cable connected to the Endoscopic Workstation. The images captured by the camera are transmitted to the endoscopic workstation through the cable for display. When the embryo tissues are located, the operator sucks out the embryo tissues through the suction orifice connected to a vacuum source.
The Disposable Endoscopic Cannula is provided with five sizes based on outer cannula diameter: 5mm (RL1205 model), 6mm (RL1206 model), 7mm (RL1207 model), 8mm (RL1208 model), and 9mm (RL1209 model) (outer diameter). All models have a length of 170mm.
This document is a 510(k) premarket notification for a medical device called the "Disposable Endoscopic Cannula". It is not a study demonstrating machine learning algorithm performance. Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance in the context of AI/ML.
The document focuses on demonstrating substantial equivalence to a predicate device (Rigid Uterine Cannulae) for the purpose of FDA clearance. This involves comparing the new device's features, intended use, technology, and safety aspects to a legally marketed predicate device.
Here's what the document does provide regarding acceptance criteria and performance, but it's for a traditional medical device, not an AI system:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct table of acceptance criteria with corresponding performance values in the way you might expect for an AI algorithm's metrics (e.g., sensitivity, specificity). Instead, it states that the device is in "compliance with requirements" for various standards.
Here's a summary of the compliance stated:
| Parameter | Acceptance Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 | "demonstrated that the Disposable Endoscopic Cannula is in compliance with requirements" |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-18 | "data demonstrates that the device is in compliance" |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "data demonstrates that the device is in compliance" |
| Optical Performance | Compliance with ISO 8600-1, ISO 8600-3, ISO 8600-4, and ISO 8600-5 | "demonstrated that this device is in compliance" |
| Mechanical Performance | Safe and Effective (evaluated for tensile strength, vacuum integrity, and vacuum performance) | "The results demonstrated that the Disposable Endoscopic Cannula is safe and effective." |
| Light Source Safety | Can be assessed by "accepted electrical safety, EMC, thermal safety and photobiological safety testing methods" | "The electrical safety, EMC, thermal safety and photobiological safety testing showed that the Disposable Endoscopic Cannula is safe." |
| Imaging Function Performance | Optical performance data including image resolution, distortion, depth of view, field of view, direction of view | "supported by optical performance data" |
The remaining points (2-9) are not applicable because this document describes a hardware medical device, not an AI or machine learning system. There are no test sets, training sets, ground truth, experts for annotation, or multi-reader multi-case studies described. The "performance" referred to is about the physical and electrical integrity and functionality of the device, not the accuracy of an algorithm.
§ 884.5070 Vacuum abortion system.
(a)
Identification. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.(b)
Classification. Class II (performance standards).