(78 days)
The WallFlex Colonic Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.
The WallFlex Duodenal Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
The WallFlex Colonic Soft Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.
The WallFlex Duodenal Soft System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
The WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the anchor lock delivery system.
The proposed stent is manufactured of Ntinol. The stent will be offered in two diameters, 22mm with a 30mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The WallFlex Duodenal Stent will only be offered in the 22mm/27mm stent diameter (all lengths) preloaded on the 230cm Anchor Lock Delivery System. The WallFlex Colonic Stent will be offered in the 22mm/27mm and 25mm/30mm diameters (all lengths) preloaded on the 230cm or 135cm Anchor Lock Delivery System. The Anchor Lock delivery system consist of a coaxial tubing assembly that constrains the stent on the until the stent is released by retracting the exterior tube.
The WallFlex™ Colonic Soft Stem with Anchor Lock Delivery System and WallFlex™ Duodenal Soft Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the Anchor Lock Delivery System.
The stent is manufactured from Nitinol wires braided together to form a cylinder with a flared end. The wires are looped at both stent ends and welded at the non-flared end. The WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent will be offered in three diameters: 22 mm with a 27 mm flare, 20 mm flare, and 18 mm with a 23 mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The stent sizes that are shared between the WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent are identical in all aspects of their design; the only difference is in indication.
The stent is compressed on a flexible catheter for delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during deployment. There are 3 radiopaque marker bands on the diftate placement; the exterior tube marker band, the deployment limit marker band, and the post deployment marker band. The exterior tube marker band is located adjacent to the leading end the deployment limit marker band is located adjacent to the trailing end of the stent. The deployment limit marker band identifies the stent beyond which the stent cannot be reconstrained. The post deployment marker band, situated 4cm from the trailing end of the constrained stent, helps to facilitate accurate placement of the stent. The only design difference between product offerings is how the stent is loaded onto the delivery system. The colonic stent is loaded with the flare is distal to the operator, and the duodenal stent is loaded with the flare is proximal to the operator.
The Anchor Lock stent holder is located at the trailing end of the stent on the delivery system to aid in reconstrainment when repositioning the stent. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in. / 0.89 mm guidewire. The device may be inserted through the working channel of a 9 French endoscope (minimum channel diameter 3.2mm scope). The WallFlex Colonic/Duodenal Soft Stent with Anchor Lock Delivery System will be offered in 230cm.
The provided text pertains to a 510(k) premarket notification for a medical device, specifically the WallFlex Colonic and Duodenal Stent Systems. This document is a regulatory clearance letter from the FDA, asserting that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document does not describe the acceptance criteria and study proving a device meets those criteria for an AI/ML-enabled medical device. The product under review (WallFlex Stent Systems) is a physical, implantable medical device, not an AI/ML diagnostic or therapeutic system. Therefore, the concepts of "acceptance criteria for an AI/ML device," "test set sample size," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," "training set size," and "ground truth establishment for training" are not applicable to the content of this FDA clearance letter.
The letter focuses on demonstrating substantial equivalence to already cleared predicate devices based on:
- Intended Use/Indications for Use: The current devices have identical indications for use as their predicates, which are for palliative treatment of malignant colonic and duodenal strictures and large bowel obstructions.
- Technological Characteristics: The devices are stated to be identical to the predicates in terms of principles of operation, technical characteristics, performance, and materials (Nitinol stents with anchor lock delivery systems).
- Non-Clinical Tests: The documentation mentions compliance with FDA guidance for MR safety (ASTM F2503e2020), which is a standard non-clinical test for implantable devices, not an AI/ML algorithm validation.
In summary, this document is a 510(k) clearance for a conventional medical device and does not contain the information requested about acceptance criteria and study data for an AI/ML-enabled medical device.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”