ZILOS-TK

• K Number: K063636
• Device Name: ZILOS-TK
• Manufacturer: HAMILTON THORNE BIOSCIENCES
• Date Cleared: 2007-04-24 ( 138 days)
• Product Code: MRX
• Regulation Number: 884.6200

Intended 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.

Device Description

The ZILOS-tk uses an infra-red [IR] laser beam [of wavelength in the range 1450 < 1 < 1480 nm] to locally heat a small spot on the embryo zona pellucida. The IR beam is projected through the microscope objective in a direction opposite to the image light, so that it focuses on the embryo. This epi-irradiating IR beam is confocal with the visible beam, and the user adjusts the line-up of the target to treat the exact region of the zona desired. The beam power is typically 300 mW and the beam is pulsed on for typically 500 usec or less, with a 40x objective. The thermal effect of the beam is to liquefy the zona pellucida in a small region surrounding the focal point, and thereby provide access to the embryo itself. The hole drilled in this manner can be used either to aid hatching or for biopsy cell extraction. The assembled ZILOS-tk laser system is the same length as a microscope objective and can be fitted on to the turret of any inverted microscope. It can be controlled by a desktop or laptop computer.

Predicate Devices

K040045

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the laser technology and its mechanical effect on the zona pellucida, with no mention of AI or ML for image analysis, decision-making, or automation beyond basic computer control.

Therapeutic

Yes
The device is intended to drill a hole in the zona pellucida of the embryo to improve the prognosis of successful pregnancy, which constitutes a therapeutic intervention.

Diagnostic

No

The device is described as a system for drilling holes or thinning the zona pellucida of an embryo for therapeutic purposes (aiding hatching, biopsy cell extraction for PGD), not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a hardware component (IR laser beam, microscope objective, turret fitting) that performs a physical action (drilling/thinning the zona pellucida). While it is controlled by a computer, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The ZILOS-tk system is used to physically modify an embryo (drilling a hole in the zona pellucida) for procedures like assisted hatching or biopsy. It does not analyze a specimen to provide diagnostic information.
• The intended use describes a physical intervention on the embryo. The purpose is to facilitate other procedures (hatching or biopsy), not to diagnose a condition based on analyzing a sample.
• The device description details a laser system for physical manipulation. It focuses on the mechanism for creating a hole in the zona pellucida, not on analyzing biological markers or substances.

While the procedure it facilitates (biopsy for PGD) might lead to diagnostic testing, the ZILOS-tk itself is a tool for manipulating the embryo, not a diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.

Product codes

MRX

Device Description

The ZILOS-tk uses an infra-red [IR] laser beam [of wavelength in the range 1450

Regulation Number and Section

§ 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.

Summary

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p. 1 of2 KO63636

HAMILTON THORNE BIOSCIENCES

100 Cummings Center, Suite 465E, Beverly, MA 0.1915-6143 USA 978.921.2050, 800.323.0503, Fax: [phone] www.hamiltonthorne.com

5. 510(k) Summary

APR 2 4 2007

Owner: Address:

Hamilton Thorne Biosciences 100 Cummings center suite 465E Beverly, MA 01915 978-921-2050 tel [phone] fax Diarmaid H. Douglas-Hamilton November 30 2006

Contact person: Date

Trade Name: Common name: Classification Name ZILOS-tk, Laser drill. Assisted reproduction laser system (21 CFR 884.6200, code MRX)

Equivalent legally marketed device: ZILOS-tk

The ZILOS-tk uses an infra-red [IR] laser beam [of wavelength in the range 1450