---
kind: "section"
citation: "21 C.F.R. § 876.4330"
title: "21"
number: "876.4330"
heading: "Endoscopic pancreatic debridement device."
url: "https://uscodex.org/cfr/21/876.4330"
---

# §876.4330. Endoscopic pancreatic debridement device.

- (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.**

## Notes

### Amendments

[89 FR 72986, Sept. 9, 2024]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[89 FR 72986, Sept. 9, 2024]