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Labeling Requirements for Ultrasonic Surgical Aspirator Devices - Contraindication for Uterine Fibroid Procedures

This guidance applies to ultrasonic surgical aspirator devices with indications for laparoscopic surgery, open surgery, or gynecologic surgery. It specifically excludes devices indicated only for other surgical subspecialties like gastrointestinal, urological, or neurosurgery.

  1. Review current device labeling to determine if it falls within the scope of this guidance
  2. Add the specified contraindication statement to product labeling
  3. Review and update other sections of the labeling to ensure consistency with the contraindication
  4. Submit both current and revised labeling to CDRH within 120 days
  5. Provide updated labeling to existing device purchasers
  6. Consider posting updated labeling on company website and notifying purchasers
  7. For new 510(k) submissions, ensure inclusion of these labeling requirements
  8. Document all changes and communications related to this labeling update

Key Considerations

Labelling

  • Must include a specific contraindication stating: “This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids”
  • Other portions of labeling should be reviewed and updated to be consistent with this contraindication
  • Updated labeling must be provided to purchasers of already distributed devices

Safety

  • Recognition of potential tissue dissemination risk during use
  • Specific concern about unintended dissemination of cancerous cells in certain clinical circumstances

Other considerations


Original guidance

  • Labeling Requirements for Ultrasonic Surgical Aspirator Devices - Contraindication for Uterine Fibroid Procedures
  • HTML / PDF
  • Issue date: 2017-10-30
  • Last changed date: 2019-03-12
  • Status: FINAL
  • Official FDA topics: Medical Devices, Errors, Obstetrical & Gynecological, General & Plastic Surgery, and Problems, 510(k), Labeling, Premarket, Safety - Issues
  • ReguVirta summary file ID: 1ebe69eea62aee9555eb9922cad2d595
This post is licensed under CC BY 4.0 by the author.