The LYKOS Assisted Reproduction Laser with Dynamic Target System (DTS) is intended for in vitro fertilization (IVF) laboratory use in assisted reproduction procedures to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate assisted reproduction hatching procedures and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.

Device Description

The LYKOS with DTS is comprised of hardware, software and firmware. Hardware components include a laser control unit, communication cable, optional foot pedal, microscope mount(s) and a 40x objective. Fully integrated within the objective is the laser, a rotating mirror frame and motors that rotate the mirror and control the direction of the laser beam. The objective can be mounted on most commercially available inverted microscopes. The laser hardware interfaces with a computer and camera, providing a live image of the objective's field of view on the computer monitor. The system also records images and videos of the laser procedures.

The system includes three laser modes: Clinical, Multipulse, and Validation. The Clinical Mode includes laser settings recommended for zona thinning and embryo hatching procedures. The Multipulse Mode allows the use of a series of laser pulses and is intended for trophectoderm biopsy procedures. The Validation Mode is intended to validate the proper operation of the laser including RED-i and laser alignment.

Targeting of the laser beam (i.e., either aiming its direction or plotting its ablation path) may be performed in two modes: fixed direction or DTS. In the fixed direction mode of operation, the direction of the beam remains fixed and the embryo is manually guided to the laser by the user. In the DTS Mode, the embryo remains fixed and the direction of the laser is computer-controlled, navigating a user defined plot as drawn on the computer monitor. The system can be programmed to aim and fire the laser anywhere in the field of view or along a user-defined ablation path.

In both Manual and DTS modes, because the laser operates in the invisible infrared wavelength (lambda = 1460 mm), to aim and visually verify the position of the laser beam at all times prior to firing, the laser is concentrically aligned with a visible red LED beam (RED-i). Through an automated mapping and verification system using the X-Y coordinates of the computer monitor, the laser can be aimed and an ablation path plotted and verified by the user prior to each use.

AI/ML Overview

The provided text describes the Hamilton Thorne LYKOS™ Assisted Reproduction Laser with Dynamic Targeting System (DTS). However, it does not contain a detailed study report with specific acceptance criteria and device performance results in a table format, nor does it include information on sample sizes for test/training sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.

The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to a predicate device (SATURN 5™ Laser System). It outlines the device's intended use, technological characteristics, and a summary of performance testing performed.

Here's an attempt to answer your request based on the available information, with significant limitations due to the missing details:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Laser Performance Testing in accordance with the 2004 FDA guidance document 'Assisted Reproduction Laser Systems - Class II Special Controls Guidance Document for Industry and FDA Staff.'" It also lists specific validation tests. However, the specific acceptance criteria (e.g., "accuracy must be within X microns") and the reported device performance (e.g., "accuracy achieved Y microns") for these tests are not provided in the document.

The document states that the testing demonstrated the device is "substantially equivalent to the predicate device," implying that the performance met the necessary thresholds for equivalence, but without quantifying them.

Acceptance Criteria (Not explicitly stated in document, inferred)	Reported Device Performance (Not explicitly stated in document, inferred)
Accuracy of DTS single-pulse across the field of view (criteria not given)	"Validation of the accuracy and precision of DTS single-pulse across the field of view" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying acceptable performance. No specific numerical values are given.
Accuracy of DTS multiple-pulse across the field of view (criteria not given)	"Validation of the accuracy and precision of DTS multiple-pulse (linear or curved plots) across the field of view" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying acceptable performance. No specific numerical values are given.
RED-i target alignment (criteria not given)	"Validation of the RED-i target alignment feature" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying acceptable performance. No specific numerical values are given.
Electrical Safety (IEC 61010-1:20117; IEC 60825-1:2014 compliance)	"Electrical Safety Testing: IEC 61010-1:20117; IEC 60825-1:2014" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the standards.
Electromagnetic Compatibility (IEC 61326-1:2013 compliance)	"EMC Testing: IEC 61326-1:2013" was performed. The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the standard.
Software documentation (2005 FDA guidance compliance)	"Software documentation in accordance with the 2005 FDA guidance document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' to support device software with a moderate level of concern." The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the guidance.
Cybersecurity (2014 FDA guidance compliance)	"Cybersecurity information in accordance with the 2014 FDA guidance document 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'" The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the guidance.
Reprocessing Validation (2015 FDA guidance compliance)	"Reprocessing: Validation testing conducted in accordance with the 2015 FDA guidance document, 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.'" The results "demonstrate that the [device is] substantially equivalent to the predicate device," implying compliance with the guidance.

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The laser performance testing, validation of accuracy and precision, RED-i alignment, electrical safety, EMC, software, cybersecurity, and reprocessing validation are mentioned, but the specific sample sizes used for these tests are not disclosed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The nature of the device (a laser system for assisted reproduction procedures) suggests that "ground truth" might relate to the physical accuracy of the laser's targeting and ablation, rather than interpretation of biological data by experts in the typical clinical AI context.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study is not mentioned in the document. The performance testing outlined focuses on the device's technical specifications and functionality (e.g., laser accuracy, electrical safety, software compliance), rather than clinical outcomes or human reader performance with or without AI assistance. This device is an instrument used by a human, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable in the context of this device. The LYKOS DTS is an "assisted reproduction laser system," meaning it is a tool operated by a human user (e.g., an embryologist). Its "dynamic targeting system" (DTS) uses computer control to navigate the laser, but it's not described as an AI algorithm making independent decisions or diagnoses without human supervision. The performance testing focuses on the accuracy and precision of the laser's operation and mapping capabilities, which are functions of the system, not a standalone diagnostic algorithm.

7. The type of ground truth used

For the laser performance tests (accuracy and precision of single/multiple pulses, RED-i alignment), the "ground truth" would likely refer to physical measurements and precise calibrations of the laser's output and aiming mechanics, compared against known targets or reference points. It would not typically involve "expert consensus," "pathology," or "outcomes data" in the way these terms are used for diagnostic AI. For regulatory compliance (electrical safety, EMC, software, cybersecurity, reprocessing), the "ground truth" is compliance with the respective international standards and FDA guidance documents.

8. The sample size for the training set

This information is not provided in the document. As this device is a laser system and not a machine learning diagnostic algorithm, the concept of a "training set" in the sense of data used to train an AI model is unlikely to apply directly. However, if any internal models or algorithms were developed, the data used for their development is not disclosed.

9. How the ground truth for the training set was established

This information is not provided in the document, as the concept of "training set" and associated ground truth establishment for AI models is not directly addressed.

Summary

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July 2, 2021

Hamilton Thorne, Inc. Donald Fournier Director, Regulatory Affairs & Quality Assurance 100 Cummings Center, Suite 465E Beverly, MA 01915

Re: K202241

Trade/Device Name: LYKOS™ Assisted Reproduction Laser with Dynamic Targeting System (DTS) Regulation Number: 21 CFR§ 884.6200 Regulation Name: Assisted Reproduction Laser System Regulatory Class: II Product Code: MRX Dated: June 3, 2021 Received: June 4, 2021

Dear Donald Fournier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202241

Device Name

LYKOS™ Assisted Reproduction Laser with Dynamic Targeting System (DTS)

Indications for Use (Describe)

The LYKOS Assisted Reproduction Laser with Dynamic Target System (DTS) is intended for in vitro fertilization (IVF) laboratory use in assisted reproduction procedures to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate assisted reproduction hatching procedures and to biopsy trophectodern cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K202241

LYKOS™ Assisted Reproduction Laser with Dynamic Targeting System (DTS)

Submitter	Hamilton Thorne, Inc.100 Cummings Center, Suite 465EBeverly, MA 01915Tel: (978) 921-2050Fax: (978) 921-0250
Contact Person	Donald FournierDirector, Regulatory Affairs & Quality Assurance100 Cummings Center, Suite 465EBeverly MA 01915Tel: (978) 921-2050 Ext. 1726Fax: (978) 921-0250dfournier@hamiltonthorne.com
Date Prepared	June 30, 2021
Subject Device
Trade Name:Common Name:Regulation Name:Regulation Number:Product Code:Regulatory Class:	LYKOS™ Assisted Reproduction Laser with Dynamic Targeting System (DTS)Assisted Reproduction Laser SystemAssisted Reproduction Laser System21 CFR § 884.6200MRX (System, Assisted Reproduction Laser)Class II

Predicate Device

510(k) Number:	K141434
Device Name:	Saturn 5 ™ Laser System
Manufacturer:	Research Instruments Ltd

The predicate device has not been subject to a design-related recall.

Device Description

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In both Manual and DTS modes, because the laser operates in the invisible infrared wavelength (i) = 1460 mm), to aim and visually verify the position of the laser beam at all times prior to firing, the laser is concentrically aligned with a visible red LED beam (RED-i). Through an automated mapping and verification system using the X-Y coordinates of the computer monitor, the laser can be aimed and an ablation path plotted and verified by the user prior to each use.

Indications for Use

Substantial Equivalence Comparison

A comparison of the indications for use and technological characteristics of the subject and predicate devices are summarized in the table below:

Parameter	Subject Device	Predicate Device	Comparison
	LYKOS DTS	SATURN 5 – K141434
Indications for Use	The LYKOS AssistedReproduction Laser withDynamic Target System (DTS) isintended for in vitro fertilization(IVF) laboratory use in assistedreproduction procedures to ablatea small, tangential hole or thin thezona pellucida of select IVFembryos to facilitate assistedreproduction hatching proceduresand to biopsy trophectoderm cellsfrom blastocyst stage embryos forpurposes of preimplantationgenetic diagnosis or screening.	For use in assisted reproductionprocedures to ablate or thin thezona pellucida of an oocyte orembryo to facilitate assistedhatching or recovery of cells forpre-implantation geneticdiagnosis (blastomeres). Thedevice can also be used onblastocyst stage embryos forbiopsy of trophectoderm cellsfor preimplantation diagnosisprocedures, and blastocystcollapse prior to vitrificationprocedures.	Different: The indications foruse statements for the subjectand predicate devices aredifferent. Both the subject andpredicate devices are for use inablating or thinning the zonapellucida (ZP) to facilitateassisted hatching of embryosand can also be used fortrophectoderm biopsy.However, the predicate deviceis indicated for additional usesbeyond those of the subjectdevice, includingablation/thinning of the ZP ofoocytes and blastocyst collapseprior to vitrification, Thesedifferences represent a morelimited use of the subjectdevice and do not represent anew intended use. Therefore,the indented uses are the same.

System Configuration	• Laser control unit• 40X objective• Microscope adapters• Mirror module• Motor module• Laser application software• Computer user-interface• Camera• Foot switch (optional)	• Laser control unit• 40X objective• Microscope adapters• Mirror module• Motor module (Activeversion only)• Laser application software• Computer user-interface• Camera• Foot switch (optional)	Different: The subject andpredicate are comprised ofdifferent components. Thedifferences in devicecomponents do not raisedifferent questions of safetyand effectiveness (S&E).
Operating Modes	Fixed Direction – The direction ofthe laser beam is fixed; usermanually guides embryo.	Fixed Mode – The direction ofthe laser beam is fixed; usermanually guides embryo.	Similar
	DTS – The direction and path ofthe laser beam are computer-controlled; embryo is stationary.	Active Mode – The directionand path of the laser beam iscomputer-controlled; embryo isstationary.
Laser Modes	Clinical Mode: Allows a singleablation of the target (Fixed Modeand DTS Mode) or a series ofablations (DTS Mode)	Single Pulse: Allows a singleablation of the target (FixedMode and Active Mode)	Different: The subject andpredicate devices havedifferent laser modes. Thedifferences do not raisedifferent questions of S&E.
	Multipulse Mode: Allows the useof a series of laser pulses forbiopsy procedures (Fixed Modeonly)	Biopsy Mode: Allows to ablatea series of holes for biopsyprocedures (Active Mode only)
	Validation Mode: For validationof proper operation of the laser(Fixed Mode and DTS Mode)
Laser Specifications	$λ$ = 1460 nmPower: 3-300 mWPulse length: 0.1 to 3.0 ms	$λ$ = 1480 nmPower 400 mWPulse length 5-2000 μs	Different: The subject andpredicate devices havedifferences in laserwavelength, power and pulselengths. These differences donot raise different questions ofS&E.
Alignment Indicator	Yes - RED-i	Yes -Pilot laser	Similar
Laser Classification(U.S CFR 1040.10)	Class I	Class I	Same
Microscope Compatibility	Compatible with various modelsof inverted microscopes.	Compatible with various modelsof inverted microscopes.	Same
Laser Firing Mechanism	Mouse; foot pedal	Mouse; foot pedal	Same
Hole Size Indicator	Yes	Yes	Same

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As noted in the table above, there are differences in the indications for use statements and technological features of the subject and predicate devices. However, as stated in the table, the differences in indications for use do not represent a new intended use and the differences in technological features do not raise different questions of safety and effectiveness.

Summary of Performance Testing

The following performance data was provided in support of the substantial equivalence determination:

Laser Performance Testing in accordance with the 2004 FDA guidance document "Assisted Reproduction ● Laser Systems - Class II Special Controls Guidance Document for Industry and FDA Staff." Additional testing included the following:

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Validation of the RED-i target alignment feature -
-Validation of the accuracy and precision of DTS single-pulse across the field of view
-Validation of the accuracy and precision of DTS multiple-pulse (linear or curved plots) across the field of view
Electrical Safety and Electromagnetic Compatibility (EMC) Testing in accordance with: ●
- Electrical Safety Testing: IEC 61010-1:20117; IEC 60825-1:2014 -
- -EMC Testing: IEC 61326-1:2013
Software and Cybersecurity: ●
- Software documentation in accordance with the 2005 FDA guidance document "Guidance for the -Content of Premarket Submissions for Software Contained in Medical Devices" to support device software with a moderate level of concern.
- Cybersecurity information in accordance with the 2014 FDA guidance document "Content of -Premarket Submissions for Management of Cybersecurity in Medical Devices."
Reprocessing: Validation testing conducted in accordance with the 2015 FDA guidance document, ● "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

Conclusion

The results of the testing described above demonstrate that the substantially equivalent to the predicate device.

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.