---
kind: "section"
citation: "21 C.F.R. § 878.5050"
title: "21"
number: "878.5050"
heading: "Surgical smoke precipitator."
url: "https://uscodex.org/cfr/21/878.5050"
---

# §878.5050. Surgical smoke precipitator.

- (a) **Identification.** A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Adverse tissue reaction must be mitigated through the following:
    - (i) **Chemical characterization and toxicological risk assessment of the treated surgical smoke.**
    - (ii) Demonstration that the elements of the device that may contact the patient are biocompatible.
  - (2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
  - (3) Software verification, validation, and hazard analysis must be performed.
  - (4) Performance data must demonstrate the sterility of the patient contacting components of the device.
  - (5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life.
  - (6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use.
    - (ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries.
    - (iii) Device must be demonstrated to be non-damaging to the site of use and animal subject.
  - (7) Labeling must identify the following:
    - (i) **Detailed instructions for use.**
    - (ii) **Electrical safety and electromagnetic compatibility information.**
    - (iii) **A shelf life.**

## Notes

### Amendments

[83 FR 4143, Jan. 30, 2018]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[83 FR 4143, Jan. 30, 2018]