---
kind: "section"
citation: "21 C.F.R. § 878.4371"
title: "21"
number: "878.4371"
heading: "Irrigating wound retractor device."
url: "https://uscodex.org/cfr/21/878.4371"
---

# §878.4371. Irrigating wound retractor device.

- (a) **Identification.** An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.
- (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 and evaluated for particulate matter.
  - (2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.
  - (3) Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life.
  - (4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:
    - (i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;
    - (ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;
    - (iii) Characterize the forces required to deploy the device;
    - (iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;
    - (v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and
    - (vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.
  - (5) The labeling must include or state the following information:
    - (i) Device size or incision length range;
    - (ii) Method of sterilization;
    - (iii) Flammability classification;
    - (iv) Non-pyrogenic;
    - (v) Shelf life; and
    - (vi) **Maximum flow rate and suction pressure.**

## Notes

### Amendments

[83 FR 24, Jan. 2, 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 24, Jan. 2, 2018]