(a) Identification. An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity.

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

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of debridement of walled off pancreatic necrosis and all adverse events.

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

(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(4) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.

(5) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.

(6) 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) Testing of rotational speeds and vacuum pressure;

(ii) Functional testing including testing with all device components and the ability to torque the device; and

(iii) Functional testing in a relevant tissue model to demonstrate the ability to resect and remove tissue.

(7) Performance data must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.

(8) Software verification, validation, and hazard analysis must be performed.

(9) Training must be provided so that upon completion of the training program, the user can resect and remove tissue of interest while preserving non-target tissue.

(10) Labeling must include the following:

(i) A summary of the clinical performance testing conducted with the device;

(ii) Instructions for use, including the creation of a conduit for passage of endoscope and device into a walled off pancreatic necrotic cavity;

(iii) Unless clinical performance data demonstrates that it can be removed or modified, a boxed warning stating that the device should not be used in patients with known or suspected pancreatic cancer;

(iv) The recommended training for safe use of the device; and

(v) A shelf life for any sterile components.

[89 FR 72986, Sept. 9, 2024]