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.
Recommended Actions
- Review current device labeling to determine if it falls within the scope of this guidance
- Add the specified contraindication statement to product labeling
- Review and update other sections of the labeling to ensure consistency with the contraindication
- Submit both current and revised labeling to CDRH within 120 days
- Provide updated labeling to existing device purchasers
- Consider posting updated labeling on company website and notifying purchasers
- For new 510(k) submissions, ensure inclusion of these labeling requirements
- 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
- Manufacturers have 120 days from guidance publication to implement changes
- Changes can be submitted as an amendment to existing 510(k) rather than a new 510(k)
- New 510(k) submissions should include these labeling recommendations
Relevant Guidances
- Device Labeling Requirements and Content for Premarket Approval Applications
- Labeling Requirements and Recommendations for Medical Devices
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.