This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Minitouch 3.8 Era System (Minitouch System)
PMA Applicant: MicroCube, LLC
Address: 47853 Warm Springs Blvd, Fremont, CA 94539
Approval Date: July 28, 2023
Approval Letter: Approval Order

What is it?

The Minitouch 3.8 Era System is a global endometrial ablation device used to treat heavy menstrual bleeding. These types of devices use a cold or heat energy source to destroy (thermally ablate) the lining of the uterus (endometrium) as a whole.

How does it work?

A health care provider inserts the hand piece of the Minitouch 3.8 Era System into the uterus. The provider may need to dilate the cervix to allow insertion. After the handpiece is inserted into the uterus, microwave energy produces heat that is delivered for a few minutes to destroy the uterine lining. After energy delivery is completed, the hand piece is removed.

When is it used?

The Minitouch 3.8 Era System is intended for ablation of the endometrial lining of the uterus for the treatment of menorrhagia (heavy menstrual bleeding) caused by non-malignant conditions (benign causes) in pre-menopausal women who do not wish to become pregnant in the future.

What will it accomplish?

Eighty-nine-point five percent (89.5%) of people treated experienced a reduction in blood loss, moving from an excessive level of bleeding to more typical or less than typical levels. Based on safety outcomes from the clinical study, serious adverse events are expected to be rare.

When should it not be used?

The Minitouch 3.8 Era System should not be used for people:

• Who are pregnant or want to remain fertile. Pregnancy following the ablation can be dangerous for both mother and fetus.
• Who have known or suspected uterine cancer or pre-malignant conditions of the endometrium, including the unresolved pre-cancerous condition known as adenomatous hyperplasia.
• With any physical (anatomic) condition such as history of a previous classical cesarean section or transmural surgery to remove uterine fibroids (myomectomy), including hysteroscopic and/or laparoscopic myomectomy performed immediately prior to the Minitouch procedure, that could lead to weakening of the uterine smooth muscle (myometrium).
• With any condition requiring long term medical therapy (pathologic) that could lead to weakening of the uterus muscle.
• With a history of endometrial ablation and/or surgery (resection), including endometrial ablation/resection performed immediately before to the Minitouch procedure, regardless of the surgery method used. Repeat ablation may result in serious patient injury.
• Who have active genital or urinary tract infection or pelvic inflammatory disease.
• Who have an abnormal, blocked (obstructed), or torn (perforated) uterine cavity. Ablation in such cavities could result in serious injury.
• Who have intrauterine implants such as an intrauterine device (IUD).
• Who have undiagnosed vaginal bleeding.
• With uterine cavity length of less than 4 cm. The hand piece may not deploy adequately, and the system may not deliver energy.
• With abnormal uterine/pelvic physical anatomy, such as frozen pelvis.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Labeling 
• Labeling Part 2
• PMA Database entry