The R:GEN is indicated for use by an ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment of Clinically Significant Macular Edema (CSME).

Device Description

The R:GEN is a surgical laser system for use by ophthalmic physicians for performing focal laser treatment, also referred to as selective retinal therapy for the treatment of various retinal diseases by wounding Retinal Pigmented Epithelium (RPE) cells. It is the product of continual technological evolution of the R:GEN technology described in the predicate device (K153769). It consists of the following main components: Main Body, LCD Monitor, Slit Lamp Set, Footswitch, and Real Time Feedback (RTF) Contact Lens which consists of the RTF Body (Real Time Feedback Body) and RTF Sensor (Real Time Feedback Sensor). The Main Body allows the proper operation of the entire system. It contains the laser and is attached to the Footswitch and optical fiber. The laser is a Q-switched Nd:YLF (Neodymium-doped Yttrium Lithium Fluoride) laser with an emission wavelength of 527 nm (produced by second-harmonic generation). The integrated software provides all the functions which are necessary to use the device. The Slit Lamp Set contains the laser delivery system. The laser beam emitted through the Slip Lamp Set is transmitted through the RTF Contact Lens (first through the RTF body and then through the RTF Sensor), and finally irradiated to the patient's retina.

AI/ML Overview

This document is a 510(k) Summary for the R:GEN ophthalmic laser system. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (K153769) and several reference devices (K122202, K121475, K123542).

The information provided does not include explicit acceptance criteria in the format of a table with reported device performance alongside it. Instead, it describes performance data from various types of studies (bench, animal, and clinical evidence) to support the device's safety and effectiveness and its substantial equivalence to the predicate.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not contain a discrete table of acceptance criteria and reported device performance. It generally states that the device "substantially conforms to the performance standards for light emitting products (21 CFR 1040)" and meets various IEC and ISO standards. It also mentions that animal studies "established that the use of subject device wounds RPE cells" and published clinical performance testing "established that the subject device performs as intended in the treatment of CSME."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Bench Testing: No specific sample sizes for test sets are mentioned. The testing was performed in accordance with standards (IEC, ISO, ASTM).
Animal Testing: No specific sample size is mentioned for the R:GEN animal study. It mentions "Additional published animal studies." Data provenance (country, retrospective/prospective) is not provided.
Clinical Evidence: Refers to "Published clinical performance testing," but does not provide specific sample sizes, country of origin, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the studies described (bench, animal, and "published clinical evidence") do not detail the use of experts for ground truth establishment in a diagnostic-like context. The device is a surgical laser system, so "ground truth" would likely refer to objective outcomes related to RPE wounding or CSME treatment, rather than expert interpretation of images or data to establish a diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the types of studies described (bench, animal, and general clinical performance) as there is no mention of expert consensus or adjudication for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The R:GEN is an ophthalmic laser system, not a diagnostic AI device that assists human readers.

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

This is not applicable as the R:GEN is a surgical laser system and not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the animal studies, the ground truth appears to be direct observation of "wounds to RPE cells."
For the clinical evidence, the ground truth is referred to as "performing as intended in the treatment of CSME," which implies clinical outcomes data related to CSME treatment. However, the specific metrics or methods for establishing this ground truth are not detailed.

8. The sample size for the training set

This is not applicable. The R:GEN is a hardware device (laser system) with integrated software. The document refers to "Software Verification and Validation," which implies software testing, but there is no mention of a "training set" in the context of machine learning.

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

This is not applicable, as there is no mention of a training set for machine learning.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

December 27, 2022

Lutronic Vision, Inc. % Dulciana Chan Principal Consultant Ram+ 2251 San Diego Avenue, Suite B-257 San Diego, California 92110

Re: K220974

Trade/Device Name: R:gen Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: November 23, 2022 Received: November 25, 2022

Dear Dulciana Chan:

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.

{1}------------------------------------------------

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 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-regulatory-information/postmarketing-safety-reportingcombination-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.

Alexander Date: 2022.12.27 Beylin -S 17:58:40 -05'00'

for Elvin Ng, Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220974

Device Name R:GEN

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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 K220974

DATE PREPARED

December 22, 2022

510(k) OWNER

Lutronic Vision Inc. 19 Fortune Drive Billerica, MA 01821 Telephone: Official Contact: Haelyung Hwang, CEO

REPRESENTATIVE/CONSULTANT

Dulciana Chan, MSE Allison C. Komiyama, Ph.D., R.A.C. RQM+ Telephone: +1 (412) 816-8253 Email: dchan@rqmplus.com, akomiyama@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name: R:GEN Common Name: Laser, Ophthalmic Regulation Number: 21 CFR § 886.4390 Class: II Product Code: HQF Premarket Review: OPEQ/OHT1/DHT1A/Retinal and Diagnostic Devices Review Panel: Ophthalmic

PREDICATE DEVICE IDENTIFICATION

The R:GEN is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K153769	R:GEN Laser System	✓

{4}------------------------------------------------

Lutronic submits the following information to demonstrate that the R:GEN has similar technology to the following legally marketed reference devices:

510(k) Number	Reference Device Name / Manufacturer	Reference Device
K122202	Ellex 2RT /Ellex Medical	✓
K121475	TxCell Scanning Laser Deliver System /IRIDEX Corporation	✓
K123542	Pascal Synthesis Ophthalmic Laser/ IRIDEX Corporation	✓

DEVICE DESCRIPTION

INDICATIONS FOR USE

INTENDED USE

The subject device has the same intended use as the predicate device which is to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye.

{5}------------------------------------------------

SUBSTANIAL EQUIVALENCE

	Subject Device	Predicate Device	Reference Device	Reference Device	Reference Device		2 x 2 Combo Pattern			Rotation	Triple Ring
IntendedUse	Lutronic VisionInc.R:GENK220974	LutronicCorporationR:GEN LaserSystemK153769	Ellex MedicalEllex 2RTK122202	IRIDEX CorporationTxCell Scanning LaserDelivery SystemK121475	IRIDEX CorporationPascal SynthesisOphthalmic LaserK123542					Arc	Arc
Indicationsfor Use	To produce a woundto the RetinalPigmentedEpithelium (RPE) ofthe retina of the eye	To produce a woundto the RetinalPigmented Epithelium(RPE) of the retina ofthe eye	To produce awound to theRetinal PigmentedEpithelium (RPE) ofthe retina of theeye	To deliver laser energy tovarious ocular targets	To deliver laser energy tovarious ocular targets					Triple Arc	Line (1-10 spots in a line)
Indicationsfor Use	The R:GEN isindicated for use byan ophthalmicphysician toproduce a wound tothe RetinalPigmentedEpithelium (RPE) ofthe retina of theeye, via focal lasertreatment, in thetreatment ofClinically SignificantMacular Edema(CSME).	The R:GEN LaserSystem is indicatedfor use by anophthalmic physicianto produce a woundto the RetinalPigmented Epithelium(RPE) of the retina ofthe eye, via focal lasertreatment, in thetreatment of ClinicallySignificant MacularEdema (CSME)	The 2RT (LR1532) isindicated for use bya trainedophthalmicphysician toproduce a woundto the RetinalPigmentedEpithelium (RPE) ofthe retina of theeye, via focal lasertreatment, in thetreatment ofClinically SignificantMacular Edema(CSME)	When the TxCell ScanningLaser Delivery System isconnected to the IQ 532(532 nm), the IQ 577 (577nm) or the IQ 810 (810nm) Laser Console, fromthe IRIDEXFamily of IQ Laser Systemsand used to deliver laserenergy in CW-Pulse,MicroPulse or LongPulsemode, it is intended to beused by a trainedophthalmologist for thetreatment of ocularpathology of both theanterior and posteriorsegments of the eye.532 nmIndicated for retinalphotocoagulation laser	The PASCAL® SynthesisOphthalmic Scanning LaserSystem is intended for use inthe treatment of ocularpathology in both the posteriorand anterior segments.Intended for use in theposterior segment to performretinal photocoagulation,panretinal photocoagulation.focal photocoagulation andgrid photocoagulation forvascular and structuralabnormalities of the retina andchoroid including:(532 nm)• proliferative and non-proliferative diabeticretinopathy• macular edema					Circle	Hexagon (6-sided array)
PatientPopulation	Adult	Adult	Adult	Adult	Adult						Octant (up to 4 rings divided
ProductCode /	HQF/ 21 CFR886.4390	HQF/ 21 CFR886.4390	HQF/ 21 CFR886.4390	GEX/ 21 CFR 878.4810	HQF/ 21 CFR 886.4390						into 8 radial segments)
				trabeculoplasty,iridotomy, iridoplastyincluding:Retinal photocoagulation(RPC) for the treatmentof:Diabetic retinopathy,including:NonproliferativeretinopathyMacular edemaProliferative retinopathyRetinal tears anddetachmentsLattice degenerationAge-related maculardegeneration (AMD) withchoroidalneovascularization (CNV)Sub-retinal (choroidal)neovascularizationCentral and branch retinalvein occlusionLaser trabeculoplasty forthe treatment of:Primary open angleglaucomaLaser iridotomy,iridoplasty for thetreatment of:Angle closure glaucoma	choroidalneovascularizationassociated with wet age-related maculardegeneration age-related maculardegeneration lattice degeneration retinal tears anddetachments(577nm) proliferative and non-proliferative diabeticretinopathy macular edema choroidalneovascularizationassociated with wet age-related maculardegeneration age-related maculardegeneration lattice degeneration retinal tears anddetachments Intended for use in thetreatment of ocular pathologyin the anterior segmentincluding:(532 nm and 577nm) iridotomytrabeculoplasty						Enhanced Octant (multiple
RegulationNumber											rings from 500-3000 μm
RegulationDescription	Ophthalmic Laser	Ophthalmic Laser	Ophthalmic Laser	Laser surgical instrumentfor use in general andplastic surgery and indermatology	Ophthalmic Laser						radius)
Laser Type	Q-switched Nd:YLFLaser	Q-switched Nd:YLFLaser	Q-switched Nd:YAGLaser, frequencydoubled	Frequency doubled solid-state	Pumped semiconductor(OPSL); solid-state						Circle (1-3 rings in full or partial
LaserWavelength	527 nm (green)	527 nm (green)	532 nm	532 nm, 577 nm, 810 nm	532 nm or 577 nm						circle)
Laser Energy	0.03 mJ to 0.35 mJ	0.03 mJ to 0.4 mJ	Minimum: 0.1 mJMaximum: 0.6 mJ0.10-0.30 in 0.02steps0.30-0.60 in 0.05steps	2W power	0.3mW-2000 mW power	Screen	Touch LCD Module	Touch LCD Module	Tablet	Unknown	Touchscreen LCD Module
PulseDuration	1.7 µs	1.7 µs	0.003 μsNo less than 500 msfor 20 continuousshots	Variable (≤100ms)	5-1000 ms	Emission	Footswitch	Footswitch	Footswitch	Footswitch	Footswitch
AimingBeam	635 nm	635 nm	635 nm	635 nm	635 nm	Control
Type ofDeliverySystem	Slit lamp adapterwith optical fiberconnected to aseparate lasersource	Slit lamp adapter withoptical fiberconnected to aseparate laser source	Slit lamp adapterwith optical fiberconnected to aseparate lasersource	Slit lamp adapter withoptical fiber connected toa separate laser source	Slit lamp adapter with opticalfiber connected to a separatelaser source	Laser	RTF Contact Lens	Laser Contact Lens	Laser Contact Lens	Laser Contact Lens not	Laser Contact Lens not
Single SpotSize	200 μm	200 μm	400 μm	50-500 μm	50, 100, 200, 400 μm	Contact Lens	provided	not provided	not provided	provided	provided
Multi-spotDeliverModes	YesSquare Pattern (2x2,3x3, or 4x4)Circle Pattern(radius 500-2000μm)	No	No	YesMulti-spot patterns (100-500 μm spot sizes)RadiusGrid (2x2, 3x3, 4x4, 5x5,6x6,7x7)	Yes Multi-spot patterns (40-400 µm spot sizes)Array (1x1 to 5x5 grid)Triple ArcWedge (3-sided 3x3x3 to6x6x6 segment)	Electrical	AC 100-240V, 50/60	AC 100-240V, 50/60	100-240 VAC,	100-240 VAC, 50/60 Hz	100 - 230 VAC,
Rating	Hz, Power	Hz, Power	50/60 Hz		50/60 Hz
	consumption 300VA	consumption 300VA

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The R:GEN that is the subject of this 510(k) employs the same mechanism of action as the predicate device and achieves its intended use with very similar technological characteristics when compared with the legally marketed predicate and reference devices. Differences in technological characteristics, do not raise difference safety or effectiveness questions and data demonstrates that the R:GEN is as safe and effective as the predicate device for the same intended use. The R:GEN is substantially equivalent to the predicate device based on the information summarized here:

The subject device has a similar design and dimensions, and identical materials as the device cleared in K153769.

The differences in technological characteristics from the predicate include using the same laser technology to provide additional treatment patterns and the use of the Real Time Feedback (RTF) Contact Lens. The subject device offers additional laser treatment patterns including single, square, circle and 2x2 Combo while the predicate device provided a single spot treatment pattern.

The maximum laser energy per pulse for the subject device is lower than the predicate device. The predicate device was designed to deliver a single pulse to the patient with no limitations on the number of pulses to be delivered during a treatment session. The subject device delivers a maximum of 15 pulses per treatment.

The R:GEN subject to this 510(k) has undergone testing to ensure the device is as safe and effective as the predicate for the intended use.

PERFORMANCE DATA

The R:GEN substantially conforms to the performance standards for light emitting products (21 CFR 1040). Bench testing was performed in accordance with IEC 60825-1 Safety of laser products - Part 1: Equipment classification, and requirement and IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

Bench Testing

The following tests were performed to demonstrate safety and performance based on current industry standards:

. Biocompatibility testing of patient contacting material in compliance to ISO 10993-1, ISO 10993-5, and ISO 10993-10
Sterilization testing and shelf life validation of the RTF Sensor in compliance to ISO . 11737-1, ISO 10993-7, ISO 11135, and ASTM F1980-16

{10}------------------------------------------------

Software Verification and Validation were conducted in compliance to IEC 60601-1 and ● IEC 62304. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Major" level of concern, since a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.
Electromagnetic Compatibility (EMC) and Electrical Safety testing in compliance to IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and IEC/EN 60601-1-2

Animal Testing

An animal studies were performed with the R:GEN that established that the use of subject device wounds RPE cells. Additional published animal studies showing the safety and effectiveness of the subject were provided.

Clinical Evidence

Published clinical performance testing established that the subject device performs as intended in the treatment of CSME.

CONCLUSION

Based on the testing performed, including biocompatibility, sterilization, shelf life validation, software verification and validation, EMC and electrical safety, bench performance testing, animal testing, and published clinical evidence, it can be concluded that the subject device is able to perform equivalently to the predicate device. The R:GEN has the same indications for use, and technological characteristics, that do not raise different questions of safety and effectiveness and therefore is assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.