Contains Nonbinding Recommendations 
Product Labeling for Certain 
Ultrasonic Surgical Aspirator Devices 
Guidance for Industry and  
Food and Drug Administration Staff 
Document issued on October 30, 2017. 
The draft of this document was issued on November 10, 2016. 
For questions about this document, contact the Obstetrics-Gynecology Devices Branch, 301-796-
7030 for gynecologic indications, or the General Surgery Devices Branch 2, 301-796-6970 for 
general surgical indications. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
  Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2016-D-3275. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies
 
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 
1500072 to identify the guidance you are requesting.
  Contains Nonbinding Recommendations 
Product Labeling for Certain 
Ultrasonic Surgical Aspirator Devices 
Guidance for Industry and  
Food and Drug Administration Staff  
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic. It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
I.  Introduction 
The Food and Drug Administration (FDA) is issuing this guidance to recommend the addition of 
a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices. 
Ultrasonic surgical aspirator devices are surgical tools intended to fragment, emulsify and 
aspirate hard and soft tissue. These devices can be used in many different surgical specialties for 
a wide range of procedures, including the debulking of malignant tumors. Ultrasonic surgical 
aspirators cause tissue fragmentation through the delivery of ultrasound energy to target tissue 
through an oscillating tip. Tissue fragments are aspirated through the inner lumen of the device. 
This mechanism of action creates the potential for tissue dissemination. The incorporation of 
suction/aspiration reduces but cannot eliminate this potential. 
In light of the risk of tissue dissemination from use of these devices, the FDA is providing a 
specific labeling recommendation in this guidance to promote the safe and effective use of 
ultrasonic surgical aspirator devices. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required.  
II.  Background 
Ultrasonic surgical aspirator devices may be indicated for use in a wide range of surgical 
applications, including but not limited to neurosurgery, plastic and reconstructive surgery, 
orthopedic surgery, laparoscopic surgery, open surgery, and gynecologic surgery. Because 
ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through 
1  Contains Nonbinding Recommendations 
the delivery of ultrasound energy to target tissue, there is the potential for tissue dissemination 
that is mitigated but not completely eliminated by the use of suction/aspiration. 
FDA is aware that ultrasonic surgical aspirator devices are sometimes used to treat advanced 
malignancy through cytoreduction (also known as debulking). In these cases, the device is used 
to remove a portion of a malignant tumor that cannot be completely excised, in an effort to 
enhance the effectiveness of ancillary treatments (such as radiation or chemotherapy). When 
used in advanced cancers, the risk of adverse clinical effects from tissue dissemination may be 
small compared to the devices potential benefits, such as more extensive tumor debulking, 
no/minimal collateral thermal damage, and the ability to avoid resection/removal of organs. 
However, in certain clinical circumstances, the unintended dissemination of cancerous cells may 
have a significant adverse effect that outweighs any demonstrated benefits. FDA is aware that 
labeling of certain ultrasonic surgical aspirator devices allows for use in the removal of uterine 
fibroids, although this use may not be explicitly stated in the labeling and FDA is not aware of 
these devices being used for this purpose.1 There are currently no reliable preoperative screening 
procedures to detect uterine sarcoma in women with presumed benign fibroids. Use of an 
ultrasonic surgical aspirator during treatment for symptomatic uterine fibroids on a woman with 
an occult uterine sarcoma could result in dissemination of this cancer. This risk of cancer 
dissemination outweighs any potential benefits in this patient population, particularly since there 
are alternative treatment options available. 
For these reasons, FDA recommends that the labeling of certain ultrasonic surgical aspirator 
devices include a contraindication against use of the devices for removal of uterine fibroids. 
III.  Scope 
Ultrasonic surgical aspirator devices may have general indications for use (e.g., laparoscopic 
surgery, open surgery) or specific indications for use (e.g., gynecologic surgery). This guidance, 
and the labeling recommendation below, applies to ultrasonic surgical aspirator devices with 
indications for use in laparoscopic surgery, open surgery, or gynecologic surgery as such 
surgeries can include gynecologic procedures. These devices are regulated under several 
different product codes, including LFL (Instrument, Ultrasonic Surgical) and NLQ (Scalpel, 
Ultrasonic, Reprocessed). Some devices regulated under these product codes may utilize 
different technology (e.g., they do not aspirate), and would not fall within the scope of this 
guidance. 
                                                           
1 On November 25, 2014, FDA issued the Immediately in Effect Guidance Document: Product Labeling for 
Laparoscopic Power Morcellators 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM424123.
pdf) to address new scientific information that represents a significant change to the benefit/risk profile for 
laparoscopic power morcellators (LPM). Specifically, FDA reviewed scientific information that suggests that the use 
of LPMs contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing 
laparoscopic gynecologic surgery for presumed fibroids. FDA is generally not aware of reports of dissemination or 
upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time. FDA is recommending 
the contraindication in this guidance, rather than the contraindication in the LPM guidance, in light of the fact that 
ultrasonic surgical aspirators are generally not intended nor used for the removal of uterine fibroids. 
2  Contains Nonbinding Recommendations 
This guidance does not apply to ultrasonic surgical aspirator devices with an indication for use 
only for other surgical subspecialties, e.g., gastrointestinal and affiliated organ surgery, 
urological surgery, neurosurgery. For example, this guidance would not apply to devices 
indicated only for neurosurgical fragmentation and aspiration.  
IV.  Recommended Labeling Statement 
FDA recommends that manufacturers of ultrasonic surgical aspirator devices with indications for 
use in laparoscopic surgery, open surgery, or gynecologic surgery prominently include the 
following Contraindication in their product labeling: 
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for 
and should not be used for the fragmentation, emulsification, and aspiration of uterine 
fibroids. 
In addition to including the above Contraindication in the product labeling, we recommend 
manufacturers review and update other portions of their labeling to be consistent with this 
Contraindication. For example, a manufacturer may revise the list of procedures in the labeling 
for which the ultrasonic surgical aspirator can be utilized. 
FDA believes accurate product labeling is important to make health care providers and patients 
aware of situations when these devices should not be used. FDA believes that the 
Contraindication is important for the safe and effective use of these ultrasonic surgical aspirator 
devices. 
Within 120 days of the publication of this guidance, a manufacturer with an existing 510(k) 
clearance should: 1) add the Contraindication to its labeling; 2) submit both the current labeling 
and revised labeling to the Center for Devices and Radiological Health (CDRH); and 3) provide 
updated labeling to purchasers of these ultrasonic surgical aspirator devices that have already 
been distributed.2 
If a manufacturer with an existing 510(k) clearance adds the Contraindication listed above, FDA 
does not intend to object if such labeling changes are submitted as an amendment (add to file) 
to the existing 510(k) rather than as a new 510(k). We recommend that manufacturers bundle 
510(k) amendments for these labeling changes as appropriate. 
In addition, manufacturers submitting a new 510(k) for a new or significantly modified device 
should include these labeling recommendations in the submission. 
                                                           
2 FDA recommends that a manufacturer provide updated labeling in a way to help ensure purchasers are aware of it, 
such as posting the updated labeling on the manufacturers website and notifying purchasers that they can access the 
updated labeling on that website. 
3