(a) Identification. An anchored esophageal sheath is a device used to provide an endoluminal pathway to facilitate insertion of an endoscope or other compatible device into the upper gastrointestinal tract. A distal anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other compatible device.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:

(i) Testing must verify all dimensions;

(ii) Testing must demonstrate that insertion and removal of any device from the anchored esophageal sheath does not damage the shaft wall or exert force that would cause tissue injury;

(iii) Testing must demonstrate that the anchoring component can be reliably actuated;

(iv) Testing must demonstrate compatibility with any other device that the anchored esophageal sheath is intended to be used with; and

(v) Testing must demonstrate device integrity and functionality in simulated gastric conditions under clinically anticipated forces.

(3) Simulated use testing using an anatomically accurate gastrointestinal model must demonstrate that:

(i) The device can be inserted and removed safely;

(ii) The device remains anchored in place;

(iii) The device can be safely withdrawn after releasing the anchor; and

(iv) The device location and anchoring status can be observed by the intended user.

(4) Performance data must demonstrate continued device functionality over the identified shelf life.

(5) Labeling must include:

(i) Information as to whether the device can be used for foreign body removal or with instruments alongside the endoscope;

(ii) Steps needed to prevent injury to the esophagus or gastroesophageal junction (GEJ) during placement, anchoring, and use of the device;

(iii) Any visualization steps required to confirm the device's placement prior to and after actuating the anchoring component at the GEJ;

(iv) A precaution to avoid excessive force during insertion;

(v) Identification of any endoscopes or other devices that have been validated for use with the anchored esophageal sheath; and

(vi) An expiration date or shelf life.