Search Results

The Guidewire Locking Device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedures.

The Guidewire Locking Device is a sterile, single-use accessory to be used with endoscopic biliary devices, intended to be used to lock the wire guide(s) in place during ERCP procedures.

The Guidewire Locking Device is fitted on the duodenoscope to lock the guidewire and plug the working channel access. During the ERCP operation, the device and guidewire can be inserted into the endoscope through the opening of the guidewire locking device, the Guidewire Locking Device can lock up to two guidewires at the same time. During the insertion and exchange of the device, the guidwire can be locked and will not be moved, so the convenience of the operation can be improved.

The Guidewire Locking Device is composed with the guidewire locking assembly and the clamp seal assembly. The main materials of the proposed device include ABS, Silicone rubber, SUS304 and Polyurethane sponge.

This device should only be used by healthcare professional trained in ERCP. As an accessory of digestive endoscopy, the product shall be used by professionals familiar with the operation technique of digestive endoscopy.

There are 2 specifications which mainly differ in adaptive endoscope. MT-RGL-O-N is compatible for Olympus/ Fujinon Duodenoscope, and MT-RGL-P-N is compatible for Pentax Duodenoscope.

The proposed device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 6 months.

The provided document, K220247, describes a 510(k) premarket notification for a medical device called the "Guidewire Locking Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive clinical trials for software performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device. The device in question is a physical accessory used during ERCP procedures, and its performance evaluation involves engineering and biocompatibility testing, not an AI performance study with human readers or standalone algorithm analysis.

Here's why the requested information is absent:

• Device Type: The "Guidewire Locking Device" is a physical accessory to be used with endoscopic biliary devices to lock guidewires. It is a mechanical device, not an AI/software device that requires performance metrics like sensitivity, specificity, or reader studies.
• 510(k) Premarket Notification: This regulatory pathway (510(k)) is for demonstrating "substantial equivalence" to a predicate device. It typically relies on comparing technological characteristics and non-clinical performance data (e.g., bench testing, biocompatibility, sterilization) rather than novel clinical performance studies or AI validation studies.
• Performance Data Provided: Section 8, "Performance Data," lists several engineering tests (e.g., Slide Block Flexibility Test, Locking Retention Performance Test, Friction Resistance Test, Sealability Test, Wire Locking Force Test, Brush and Squeegee Performance Test, Connection Force Test). It also mentions shelf-life, sterilization validation, and biocompatibility testing. None of these are related to AI performance.
• Absence of Clinical/Animal Studies: Sections 9 and 10 explicitly state "No animal study is included in this submission" and "No clinical study is included in this submission," further confirming that this is not an AI or software-as-a-medical-device (SaMD) submission that would involve the type of performance evaluation requested.

In summary, the questions posed (regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the type of device and regulatory submission described in the provided document.

Ask a specific question about this device