§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.

(a) Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.

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

(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:

(i) Demonstrate that the device is able to achieve hemostasis;

(ii) Demonstrate that the device can be radiographically detected; and

(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.

(2) The device must be demonstrated to be biocompatible.

(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:

(i) In vitro clot assessment;

(ii) Particulate release testing;

(iii) Physical characterization, including swelling percent and particulate size;

(iv) Chemical characterization;

(v) Radiopacity testing; and

(vi) Mechanical integrity testing, including tensile strength and tear strength.

(4) Performance data must demonstrate the sterility of the device.

(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(6) Labeling must include the following:

(i) Instructions for use, including an instruction to remove all visible device components by irrigation;

(ii) The maximum amount of time the device may be left within the body;

(iii) A shelf life;

(iv) A contraindication for intravascular use of the device; and

(v) A warning regarding the potential for adhesion formation.

[83 FR 6794, Feb. 15, 2018]