---
kind: "section"
citation: "21 C.F.R. § 876.4350"
title: "21"
number: "876.4350"
heading: "Fluid jet system for prostate tissue removal."
url: "https://uscodex.org/cfr/21/876.4350"
---

# §876.4350. Fluid jet system for prostate tissue removal.

- (a) **Identification.** A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must evaluate the following:
    - (i) All adverse events associated with the device, and
    - (ii) **Improvement in lower urinary tract symptoms (LUTS).**
  - (2) Physician training must be provided that includes:
    - (i) Information on key aspects and use of the device, and
    - (ii) **Information on how to override or stop resection.**
  - (3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.
  - (4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and
    - (ii) **High pressure fluid jet verification testing at target and non-target tissues.**
  - (5) Software verification, validation, and hazard analysis must be performed.
  - (6) The patient-contacting elements of the device must be demonstrated to be biocompatible.
  - (7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.
  - (8) Performance data must demonstrate the sterility of the patient-contacting components of the device.
  - (9) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
  - (10) Performance data must validate the instructions for reprocessing and reliability of reusable components.
  - (11) Labeling must include the following:
    - (i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;
    - (ii) A shelf life for single use components;
    - (iii) A use life for reusable components; and
    - (iv) **Reprocessing instructions for reusable components.**

## Notes

### Amendments

[83 FR 27897, June 15, 2018]

### 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

[83 FR 27897, June 15, 2018]