Who is the manufacturer of LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

Hamilton Thorne, Inc. filed the 510(k) submission for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (K202241).

What is the FDA product code for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

MRX. It is classified under 21 CFR 884.6200 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

Saturn 5™ Laser System (K141434).

Who can help prepare an FDA 510(k) submission like LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

K202241 · Hamilton Thorne, Inc. · MRX · Jul 2, 2021 · Obstetrics/Gynecology

Device Facts

Record ID	K202241
Device Name	LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
Applicant	Hamilton Thorne, Inc.
Product Code	MRX · Obstetrics/Gynecology
Decision Date	Jul 2, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6200
Device Class	Class 2

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.

Device Story

LYKOS with DTS is an assisted reproduction laser system for IVF laboratories; operated by embryologists. System inputs include live video feed from an inverted microscope; outputs include laser ablation of zona pellucida or trophectoderm biopsy. Hardware includes laser control unit, 40x objective, mirror/motor modules, and computer interface. Operation modes: Fixed Direction (manual embryo guidance) or DTS (computer-controlled laser path navigation). Laser is infrared (1460 nm) with concentric red LED (RED-i) for visual targeting. System records images/videos of procedures. Clinical benefits include precise, user-defined ablation paths for embryo hatching and biopsy, facilitating genetic screening.

Clinical Evidence

Bench testing only. Performance validation included laser accuracy/precision for single and multiple-pulse DTS modes, RED-i alignment verification, electrical safety (IEC 61010-1, IEC 60825-1), EMC (IEC 61326-1), software validation (moderate level of concern), cybersecurity, and reprocessing validation.

Technological Characteristics

Class II laser system. Infrared laser (1460 nm); power 3-300 mW; pulse length 0.1-3.0 ms. Components: laser control unit, 40x objective, mirror/motor modules, computer interface. Connectivity: USB/communication cable to PC. Standards: IEC 61010-1, IEC 60825-1, IEC 61326-1. Software: moderate level of concern.

Indications for Use

Indicated for IVF laboratory use in assisted reproduction procedures for zona pellucida ablation or thinning to facilitate hatching, and for trophectoderm biopsy of blastocyst stage embryos for preimplantation genetic diagnosis or screening.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Saturn 5™ Laser System (K141434)

Submission Summary (Full Text)

{0}------------------------------------------------ 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) | | |--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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.

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

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LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

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Indications for Use

Device Story

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Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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