§ 876.5983 Endoscopic suturing device for altering gastric anatomy for weight loss.

(a) Identification. An endoscopic suturing device for altering gastric anatomy for weight loss uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use and evaluate the following: (i) Weight change; and (ii) All adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Performance bench testing in a simulated use model must verify functional aspects of the device design and support device durability during clinical use; (ii) Dimensional specifications must be verified; and (iii) Tensile strength testing must be performed for all articulating components. (3) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life. (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Training must be provided so that, upon completion of the training program, the user can use the device correctly to approximate tissue to alter the gastric anatomy for the purpose of weight loss with minimal impact to the safety of the patient. (7) Labeling must include: (i) A summary of clinical performance testing with the device, including a discussion of adverse events and clinical benefit reported as percent total body weight loss; and (ii) A shelf life.