This is a brief overview of information related to FDA's clearance to market this product. See the links below to the 510(k) Summary and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s clearance.
Product Name: Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tk®)
Manufacturer: Hamilton Thorne Biosciences, Inc.
Address: 100 Cummings Center, Suite 465E, Beverly, MA 01915-6143
Clearance Date: November 4, 2004
Clearance Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k040045.pdf
What is it? The Hamilton Thorne ZILOS-tk® is a laser device that can be attached to an inverted microscope in an assisted reproduction lab for use in laser-assisted embryo hatching procedures.
In order for an embryo to implant in the uterine lining, the inner embryo (blastocyst) must “hatch” from its outer protective shell (zona pellucida). Laser-assisted hatching is a technique in which the zona pellucida of an embryo is weakened to help the embryo hatch and promote implantation in the uterine lining.
How does it work? The Hamilton Thorne ZILOS-tk® creates a single opening in or thins a region of the zona pellucida using a focused laser beam on the targeted area. Weakening the zona pellucida of an embryo can help the embryo hatch and promote implantation in the uterine lining.
When is it used? The Hamilton Thorne ZILOS-tk® is used in select assisted reproduction patient populations with a higher rate of embryo hatching and implantation problems. These populations include:
- women of advanced age,
- patients with prior failed in vitro fertilization attempts,
- patients with frozen embryos, or
- patients with embryos that have abnormal zona pellucida characteristics.
What will it accomplish? The Hamilton Thorne ZILOS-tk® will create a single opening in or thin a region of the zona pellucida to help the embryo hatch and promote implantation.
When should it not be used? The Hamilton Thorne ZILOS-tk® should not be used on embryos from all patients undergoing assisted reproductive procedures, because its effectiveness in patient populations outside those listed above has not been established.
This device also should not be used on more developed embryos (greater than 8-cell stage) as the effects of laser hatching on more developed embryos are not known.
In addition, this device is not indicated for use in diagnostic procedures, such as laser-assisted embryo biopsy for preimplantation genetic diagnosis procedures, because its safety and effectiveness for such procedures have not been established.