Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details computer-controlled laser targeting based on user-defined plots and automated mapping, but does not mention any learning or adaptive capabilities characteristic of AI/ML.

Therapeutic

Yes.
The device facilitates assisted reproduction hatching and preimplantation genetic diagnosis by performing procedures on IVF embryos, which directly contributes to a medical treatment.

Diagnostic

No

The device is intended for therapeutic procedures (ablation, thinning, biopsy) related to in vitro fertilization, not for diagnosing a medical condition. While it mentions "preimplantation genetic diagnosis or screening," the device itself performs the biopsy for this purpose; it does not analyze or interpret data to provide a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the LYKOS with DTS is comprised of hardware, software, and firmware, and lists several hardware components.

IVD (In Vitro Diagnostic)

Based on the provided text, the LYKOS Assisted Reproduction Laser with Dynamic Target System (DTS) is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states "for in vitro fertilization (IVF) laboratory use in assisted reproduction procedures". IVF is a process performed outside of the body (in vitro) involving the manipulation of gametes and embryos.
Procedures Performed: The device is used to "ablate a small, tangential hole or thin the zona pellucida of select IVF embryos" and "biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening." These are procedures performed on biological samples (embryos) in a laboratory setting.
Care Setting: The intended user is an "in vitro fertilization (IVF) laboratory use".

While the device itself is a laser system, its intended use and the procedures it facilitates are directly related to the in vitro manipulation and analysis of biological samples (embryos) for diagnostic and reproductive purposes. This aligns with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

MRX

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 (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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

in vitro fertilization (IVF) laboratory use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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:
- 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."

Key Metrics

Not Found

Predicate Device(s)

K141434

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font below.

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.

1

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

2

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 465E
Beverly, MA 01915
Tel: (978) 921-2050
Fax: (978) 921-0250 |
|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Donald Fournier
Director, Regulatory Affairs & Quality Assurance
100 Cummings Center, Suite 465E
Beverly MA 01915
Tel: (978) 921-2050 Ext. 1726
Fax: (978) 921-0250
dfournier@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 System
Assisted Reproduction Laser System
21 CFR § 884.6200
MRX (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

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.

4

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 (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

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.

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 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.	For use in assisted reproduction
procedures to ablate or thin the
zona pellucida of an oocyte or
embryo to facilitate assisted
hatching or recovery of cells for
pre-implantation genetic
diagnosis (blastomeres). The
device can also be used on
blastocyst stage embryos for
biopsy of trophectoderm cells
for preimplantation diagnosis
procedures, and blastocyst
collapse prior to vitrification
procedures.	Different: The indications for
use statements for the subject
and predicate devices are
different. Both the subject and
predicate devices are for use in
ablating or thinning the zona
pellucida (ZP) to facilitate
assisted hatching of embryos
and can also be used for
trophectoderm biopsy.
However, the predicate device
is indicated for additional uses
beyond those of the subject
device, including
ablation/thinning of the ZP of
oocytes and blastocyst collapse
prior to vitrification, These
differences represent a more
limited use of the subject
device and do not represent a
new 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 (Active
version only)
• Laser application software
• Computer user-interface
• Camera
• Foot switch (optional)	Different: The subject and
predicate are comprised of
different components. The
differences in device
components do not raise
different questions of safety
and effectiveness (S&E).
Operating Modes	Fixed Direction – The direction of
the laser beam is fixed; user
manually guides embryo.	Fixed Mode – The direction of
the laser beam is fixed; user
manually guides embryo.	Similar
	DTS – The direction and path of
the laser beam are computer-
controlled; embryo is stationary.	Active Mode – The direction
and path of the laser beam is
computer-controlled; embryo is
stationary.
Laser Modes	Clinical Mode: Allows a single
ablation of the target (Fixed Mode
and DTS Mode) or a series of
ablations (DTS Mode)	Single Pulse: Allows a single
ablation of the target (Fixed
Mode and Active Mode)	Different: The subject and
predicate devices have
different laser modes. The
differences do not raise
different questions of S&E.
	Multipulse Mode: Allows the use
of a series of laser pulses for
biopsy procedures (Fixed Mode
only)	Biopsy Mode: Allows to ablate
a series of holes for biopsy
procedures (Active Mode only)
	Validation Mode: For validation
of proper operation of the laser
(Fixed Mode and DTS Mode)
Laser Specifications	$λ$ = 1460 nm
Power: 3-300 mW
Pulse length: 0.1 to 3.0 ms	$λ$ = 1480 nm
Power 400 mW
Pulse length 5-2000 μs	Different: The subject and
predicate devices have
differences in laser
wavelength, power and pulse
lengths. These differences do
not raise different questions of
S&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 models
of inverted microscopes.	Compatible with various models
of inverted microscopes.	Same
Laser Firing Mechanism	Mouse; foot pedal	Mouse; foot pedal	Same
Hole Size Indicator	Yes	Yes	Same

5

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:

6

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.