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

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 < A < 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. 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.

Weakening or breaking the junction between the trophectoderm cells so that they can be aspirated into the biopsy micropipette is also facilitated by using multiple pulses. Therefore a software change was made to add a multi-pulse mode which will allow for sequential multiple-pulse firing of the laser by a single footswitch press.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ZILOS-tk and LYKOS devices, which are Assisted Reproduction Laser Systems. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way typically seen for a new diagnostic or AI-powered device.

Therefore, many of the requested elements (like human reader improvement, specific sample sizes for training/test sets, expert qualifications for ground truth in a clinical study, etc.) are not explicitly stated because the submission's purpose is different.

However, I can extract information related to the non-clinical testing performed to demonstrate equivalence.

Here's the breakdown of the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic. Instead, the "acceptance criteria" appear to be that the devices (ZILOS-tk and LYKOS) perform equivalently to their predicate devices in terms of physical and functional characteristics. The Reported Device Performance is essentially a statement of equivalence.

Acceptance Criteria (Demonstrated Equivalence to Predicates)	Reported Device Performance (Statement of Equivalence)
Functional Equivalence
Laser Wavelength, Power, Pulse Duration, Classification, Preset Pulse Durations	The LYKOS and ZILOS-tk systems demonstrated these laser characteristics are equivalent to the predicate ZILOS-tk (K063636).
Objective Magnification & Focal Length, Computer Generated Target, Isotherms at Laser Target	Demonstrated to be equivalent to the predicate ZILOS-tk (K063636).
Image Capture, Video Image Recording, Measurement Tools, Report Generation	Demonstrated to be equivalent to the predicate ZILOS-tk (K063636).
RED-i beam for laser beam target alignment	The RED-i visible directional beam is functionally equivalent to the pilot laser for alignment checking of the Predicate 2, Saturn 3 Laser System (K060764).
Software Mode (Validation) for Laser Beam Alignment	Demonstrated to be equivalent to the predicate ZILOS-tk (K063636).
Clinical/Biological Impact Equivalence
Zona Pellucida Penetration (thermal effect)	The thermal effect of the IR beam liquefies the zona pellucida, providing access to the embryo for aiding hatching or biopsy cell extraction. This mechanism is consistent with the predicate.
Multi-pulse mode impact on heating	The Multipulse Mode has been shown to result in similar or lower heating as the predicate single-pulse laser, to which it is therefore commensurate.
Overall Equivalence for the given Indications for Use	The LYKOS and modified ZILOS-tk share the same software code, have the same Indications for Use, and identical applications. Their operational principles are the same, and non-clinical testing verified and validated image quality, laser focus, zona pellucida penetration, and software, showing equivalence to predicates in laser pulse duration, power, mean power limits, RED-i directionality, and laser focus.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The "testing" mentioned is non-clinical and pertains to device specifications and functional equivalence rather than a clinical trial with a "test set" of patient data.
Data Provenance: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical engineering and functional testing. No human or patient data is described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. The ground truth for this submission is based on engineering specifications and the established performance of predicate devices, not expert human assessment of medical images or clinical outcomes.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as there is no human-read test set requiring adjudication mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This type of study is not described in the document. The submission is for an assisted reproduction laser system, not an imaging interpretation or diagnostic algorithm requiring human reader comparison.
Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable. The device is a tool used by human operators, but the submission doesn't assess the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: No, not in the typical sense of an algorithm. The ZILOS-tk and LYKOS are physical laser systems with integrated software. The "performance" assessment is of the device's technical specifications and functional output, not a standalone diagnostic algorithm. Non-clinical bench testing was performed to verify system parameters.

7. Type of Ground Truth Used

Ground Truth Type:
- Predicate Device Specifications: The primary "ground truth" for demonstrating substantial equivalence is the established performance and specifications of previously cleared predicate devices (Hamilton Thorne Infrared Laser Optical system (Zilos-tk) (K063636) and Research Instruments Saturn 3 laser system (K060764)).
- Engineering and Bench Test Standards: Electrical, optical, and mechanical specifications are tested against established engineering standards and validated performance. For example, "laser pulse duration, laser pulse power, laser mean power limits, RED-i directionality and laser focus have all been tested."

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/ML device in the sense of requiring a "training set" of data for an algorithm. The "training" in this context would refer to engineering development and calibration.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable for an AI/ML algorithm training set. The "ground truth" for the device's development and validation is based on established physics principles, engineering design, and functional requirements for assisted reproduction laser systems, benchmarked against the predicate devices.

Summary

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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

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

H. Substantial Equivalence

The Zilos-tk and the Lykos are substantially equivalent to the Hamilton Thorne Infrared Optical System (Zilos-tk) cleared via 510(k) K063636. These devices have the same Indication for Use and the same technological characteristics. Modifications to the Zilos-tk were detailed in this submission and evidence presented shows these devices are substantially equivalent. The modified ZILOStk and the LYKOS contain the RED-i visible directional beam for aiming the laser, which is substantially equivalent to the pilot laser for alignment checking of the Research Instruments Saturn 3 (K060764)

A comparison table is given below summarizing the features equivalent to the Predicates.

Features compared andFound Equivalent for Zilos-tkand Lykos Devices	Predicate 1Zilos-tk (K063636)	Predicate 2Saturn 3 LaserSystem (K060764)
Laser Wavelength	X
Laser Power	X

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K120053
Pg. 3 of 3

Features compared andFound Equivalent for Zilos-tkand Lykos Devices	Predicate 1Zilos-tk (K063636)	Predicate 2Saturn 3 LaserSystem (K060764)
Laser Pulse Duration	X
Laser Classification	X
Laser Preset Pulse Durations	X
RED-i beam for laser beamtarget alignment		X
Objective Magnification	X
Objective Focal Length	X
Computer Generated Target	X
Isotherms at Laser Target	X
Image Capture	X
Video Image Recording	X
Measurement Tools	X
Report Generation	X
Software Mode (Validation)for Laser Beam Alignment	X

I. Non Clinical Testing.

The LYKOS and ZILOS-tk image quality, laser focus, zona pellucida penetration and software have been verified and validated, and laser pulse duration, laser pulse power, laser mean power limits, RED-i directionality and laser focus have all been tested and shown to be equivalent to the predicates.

J Conclusions.

LYKOS and the modified ZILOS-tk are substantially equivalent to the predicate 1 ZILOS-tk:

1. They share the same software code.
1. They have the same Indications for Use and their applications are identical.
1. Their operational principles are the same.
1. The Multipulse Mode has been shown to result in similar or lower heating as the predicate single-pulse laser, to which it is therefore commensurate.
1. The use of the visible directional beam to indicate the target is functionally equivalent to Predicate 2, Saturn.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 2 4 2012

Mr. Diarmaid H. Douglas-Hamilton Senior V.P. of R&D Hamilton Thorne Inc. 100 Cummings Center, Suite 465E BEVERLY MA 01915

Re: K120055

Trade/Device Name: ZILOS-tk [Zona Infrared Laser Optical System - Turn Key] LYKOS

Regulation Number: 21 CFR§ 884.6200 Regulation Name: Assisted reproduction laser system Regulatory Class: II Product Code: MRX Dated: March 27, 2012 Received: March 28, 2012

Dear Mr. Douglas-Hamilton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The , general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin K. Kirk

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Indications for Use

510(k) Number (if known): K120055

Device Name:

ZILOS-tk [Zona Infrared Laser Optical System - Turn Key]

LYKOS

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Page | of |

ion Sign-Off) sion of Reproductive, Gastro-Renal, and oglical De

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.