(34 days)
The Hamilton Thorne ZILOS-tk is to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as: Advanced maternal age Prior failed IVF Cryopreserved embryos Abnormal zona pellucida morphology
The Hamilton Thorne Zona Infrared Laser Optical System [ZILOS-tkTM] 1480 nm Diode Laser for Laser Assisted Hatching [LAH].
This appears to be a 510(k) clearance letter from the FDA for a medical device called the "Zona Infrared Laser Optical System [ZILOS-tk™] 1480nm Diode Laser for Laser Assisted Hatching [LAH]".
The document does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. This type of information is typically found in the 510(k) summary submitted by the manufacturer, not in the clearance letter itself.
The clearance letter primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to "indications for use" but does not detail performance criteria or study results that would demonstrate how those indications are met.
Therefore, I cannot provide the requested table and study details based on the provided text.
§ 884.6200 Assisted reproduction laser system.
(a)
Identification. The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.