(106 days)
No
The summary describes a laser system for manipulating the zona pellucida of embryos. While it mentions software changes for multi-pulse firing and image processing features like image capture, video recording, and measurement tools, there is no mention of AI, ML, or any related terms or concepts that would indicate the use of such technologies for tasks like image analysis, decision support, or automated control based on learned patterns. The performance studies focus on equivalence to predicate devices in terms of physical parameters and software functionality, not on the performance of any AI/ML algorithms.
Yes.
The device is intended to drill a hole in or thin the zona pellucida of the embryo to improve the prognosis for successful pregnancy outcomes in IVF patients, which is a direct therapeutic intervention aimed at improving patient health.
No
Explanation: The device is used to physically alter the zona pellucida of an embryo for procedures like assisted hatching or biopsy, not to diagnose a condition.
No
The device description clearly outlines a physical system involving an infrared laser, optical components, and integration with a microscope. While software is mentioned for controlling the laser (multi-pulse mode) and image processing, it is an integral part of a hardware-based medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to physically modify the zona pellucida of an embryo (drilling a hole or thinning it) to facilitate procedures like assisted hatching or biopsy for PGD. This is a manipulative procedure performed on the embryo itself, not a test performed on a sample taken from the patient or embryo to provide diagnostic information.
- Device Description: The device uses a laser to physically alter the embryo's structure. While it mentions image capture and measurement tools, these appear to be for guiding the laser and documenting the procedure, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Claims: There are no claims of diagnosing a disease, condition, or state based on the output of this device. It's a tool for performing a physical manipulation.
- Anatomical Site: The target is the zona pellucida of the embryo, which is a structure being manipulated, not a sample being analyzed for diagnostic purposes.
IVDs are typically used to examine specimens (like blood, urine, tissue, etc.) to provide information about a person's health status, diagnose diseases, or monitor treatment. This device does not fit that description. It's a tool used in the process of assisted reproductive technology.
N/A
Intended Use / Indications for Use
This system is intended 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 procedures, cryopreserved embryos, or abnormal zona pellucella morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.
Product codes
MRX
Device Description
There are two configurations offered. The ZILOS-tk has already been cleared [510(k) K063636], and the LYKOS is a new design version. The assembled Infrared Laser Optical System (ZILOS-tk) is the same length as a microscope 40x objective and can be fitted onto the turret of any inverted microscope. In addition a slightly different configuration is offered (Infrared Laser Optical System LYKOS system) in which the laser is integrated within a microscope 40X objective. As with Zilos-tk, it mounts on the turret of any inverted microscope and has the same intended use.
The ZILOS-tk and LYKOS are used in the reproductive laboratory for cutting a hatching hole in the zona pellucida (ZP) of embryos. The hole cut in the zona pellucida can be used to extract blastomere(s) for PGD. The devices can also be used to cut a herniated trophectoderm-cell biopsy from the embryo.
The devices use an infra-red [IR] laser beam [of wavelength in the range 1450
§ 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.
0
APR 2 4 2012
K120055
Pg. 10f3
Innovations to Rely On
Image /page/0/Picture/3 description: The image shows the logo for Hamilton Thorne. The logo consists of a stylized key on the left and the company name "HAMILTON THORNE" in bold, sans-serif font on the right. The key is black and white, while the company name is in black.
info@hamiltonthorne.com www.hamiltonthorne.com
April 5 2012
510(k) Summary for ZILOS-tk and LYKOS
A. Sponsor
Hamilton Thorne, Inc. 100 Cummings Center Suite 465E Beverly, MA 01915 Telephone: 978-921-2050 Fax: 978-921-0250
B. Contact Name
Primary Contact: Diarmaid Douglas-Hamilton Secondary Contact : Sudha Thimmaraju
C. Device Name
ZILOS-tk [Zona Infrared Laser Optical System - Turn Key] LYKOS
D. Product Code
ZILOS-tk: Assisted Reproduction Laser System, 884.6200: Product Code MRX LYKOS: Assisted Reproduction Laser System, 884.6200: Product Code MRX
E. Predicate Device(s)
Hamilton Thorne Infrared Laser Optical system (Zilos-tk) (K063636) Research Instruments Saturn 3 laser system (K060764)
F. Indications for Use
This system is intended 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 procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.
Homilton Thorne, Inc., 100 Cummings Center, Suite 465E, Beverly, MA 01915-6143 USA, 978.921.2050, Fax: 978.921 0250
France Office: 21 Rue Joseph Guillonneau, 14100 Usieux, France, Telephone/Fax: (33) 2.31.63.18.95 Singapare Office: 348 Kang Ching Road, 04-17 1, Singapore, 610348, (65) 9067.4755, Fax: (65) 6265.8638
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KI 20053-
pg. 2 of 3
G. Device Description
There are two configurations offered. The ZILOS-tk has already been cleared [510(k) K063636], and the LYKOS is a new design version. The assembled Infrared Laser Optical System (ZILOS-tk) is the same length as a microscope 40x objective and can be fitted onto the turret of any inverted microscope. In addition a slightly different configuration is offered (Infrared Laser Optical System LYKOS system) in which the laser is integrated within a microscope 40X objective. As with Zilos-tk, it mounts on the turret of any inverted microscope and has the same intended use.
The ZILOS-tk and LYKOS are used in the reproductive laboratory for cutting a hatching hole in the zona pellucida (ZP) of embryos. The hole cut in the zona pellucida can be used to extract blastomere(s) for PGD. The devices can also be used to cut a herniated trophectoderm-cell biopsy from the embryo.
The devices use an infra-red [IR] laser beam [of wavelength in the range 1450