21 CFR §884.1100

1. (a)Identification. An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).
2. (b)Classification. Class II. The special controls for this device are:
   1. (1)FDA's:
      1. (i)“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
      2. (ii)“510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
   2. (2)Labeling:
      1. (i)Indication: Only to evaluate the endometrium, and
      2. (ii)Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and
   3. (3)Design and testing:
      1. (i)The sampling component is covered within the vagina, and
      2. (ii)For adherence of the bristles and brush head.