in the creation of an anterior capsulotomy;
in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea;
in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea;
in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and
in the creation of partial thickness single-plane radial cuts/incisions in the cornea.

Device Description

The LLS-fs 3D with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The device is also intended for use in the creation of pocket cuts/incisions in the cornea in patients undergoing ophthalmic surgery, in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions.

Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket. flap, and tunnel cuts.

The LLS-fs 3D with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.

AI/ML Overview

Acceptance Criteria and Study for LENSAR Laser System - fs 3D (LLS-fs 3D)

The information provided describes the performance evaluation conducted for the LENSAR Laser System - fs 3D (LLS-fs 3D) to support its substantial equivalence, particularly concerning new indications for use related to corneal ring segments and radial incisions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Corneal Tunnel Depth Accuracy	Achieved depth was "well within the established requirements" for corneal tunnel depth.
Corneal Tunnel Incision Quality & Ease of Opening	Demonstrated "ease of opening and quality of incision quality that was acceptable."
Radial Incision Depth Accuracy (individual or with arcuate incisions)	Achieved depth was "well within the established requirements" for radial incision depth.
Radial Incision Quality & Ease of Opening (individual or with arcuate incisions)	Demonstrated "ease of opening and quality of incision quality that was acceptable."
Effect on Endothelial Cells from Partial Thickness Incisions	"No loss of endothelial cell density when a sufficiently large residual corneal bed is maintained."
Hazard Analysis	All potential hazards have "acceptable levels of probability/severity characteristics."
Software Verification and Validation	All criteria were met, demonstrating the software meets all performance specifications and requirements.

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

Sample Size: Not explicitly stated as a number of eyes, but the studies were conducted on porcine ex vivo eye models.
Data Provenance: The data is from pre-clinical testing on porcine ex vivo eye models. This indicates an in vitro or ex vivo setting, not human clinical data.

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

For the assessment of incision quality (corneal tunnel and radial incisions), a "trained biomedical scientist" was used.
No further details are provided regarding the number of scientists, their specific qualifications, or years of experience.

4. Adjudication Method for the Test Set

Not explicitly stated. For the incision quality assessment, it mentions "A trained biomedical scientist... assessed the acceptability," implying a single assessor or a consensus not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "The addition of the added indications for use and other minor changes... did not require clinical performance data to demonstrate substantial equivalence to the predicate device."
Therefore, there is no effect size of human readers improving with or without AI assistance.

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

The performance data presented focuses on the device's ability to create precise cuts and tunnels. While the device uses software and imaging for guidance (Iris Registration, IntelliAxis, CustomFrag), the performance evaluation described directly assesses the physical outcomes of the laser treatment on anatomical models. It does not describe a "standalone" algorithmic performance in the typical sense of an AI model making diagnostic or prescriptive decisions without human oversight or direct intervention. The device itself is a surgical tool controlled by a surgeon.

7. The Type of Ground Truth Used

Instrumental measurements: For depth accuracy, an optical coherence tomographer was used.
Expert assessment: For incision quality, a trained biomedical scientist performed the assessment.
Biological assessment: Evaluation of endothelial cells of ex vivo eyes for cell density loss.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for any training set. The performance data presented is for verification and validation testing, which often refers to testing on a held-out set after development. There is no information provided about how the device's algorithms or parameters (e.g., for depth placement, cut patterns, image analysis) were internally trained or developed.

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

This information is not provided in the document. As no training set size is stated, the method for establishing its ground truth is also absent. The document focuses on the validation studies performed to demonstrate the device meets specifications, rather than the internal development or training processes of its embedded software/algorithms.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

December 21, 2018

Lensar, Inc. Keith Peck Director, Quality Assurance 2800 Discovery Drive. Suite 100 Orlando, FL 32826

Re: K182795

Trade/Device Name: LENSAR Laser System - fs 3D (LLS-fs 3D) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: September 28, 2018 Received: October 1, 2018

Dear Keith Peck:

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/cdrl/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. 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bradley S. Cunningham -S

for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182795

Device Name LENSAR Laser System - fs 3D

Indications for Use (Describe)

The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: · in the creation of an anterior capsulotomy;

· in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
· in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
· in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea;
· in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea;
· in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and
· in the creation of partial thickness single-plane radial cuts/incisions in the cornea.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CER 801 Subpart C)

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510(K) SUMMARY

This 510(k) Summary has been prepared in accordance with the requirements of 21 CFR 807.92.

SUBMITTER INFORMATION 1.0

The submitter of this 510(k) Summary is:

Company:	Contact Person:
LENSAR, Inc.2800 Discovery Drive, Suite 100Orlando, FL 32826	Keith Peck(888) 575-6412 (Office(407) 386-7228 (Fax)

Summary Preparation Date: December 21, 2018

DEVICE INFORMATION 2.0

	Trade/Proprietary Name: LENSAR Laser System - fs 3D (LLS-fs 3D)
Common/Usual Name:	Ophthalmic Femtosecond Laser
Classification Name(s):	Ophthalmic Femtosecond Laser (21 CFR 886.4390)
Product Code(s):	OOE
Review Panel:	Ophthalmic
Regulatory Class:	II

3.0 PREDICATE DEVICE

The legally marketed (predicate) device to which LENSAR is claiming substantial equivalence to is:

510(k) Number	Device Name	Manufacturer
K181430	LENSAR Laser System - fs 3D (LLS-fs 3D)(for use in radial cuts/incisions)	LENSAR, Inc.
K141476	WaveLight® FS200 Laser System (for use intunnels for corneal ring segments)	Alcon Laboratories, Inc.

4.0 DEVICE DESCRIPTION

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initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions.

5.0 INDICATIONS FOR USE

The LENSAR Laser System – fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:

in the creation of an anterior capsulotomy; ●
in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens:
. in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea;
in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea;
. in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and
in the creation of partial thickness single-plane radial cuts/incisions in the cornea

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6.0 PREDICATE DEVICE

All elements of the proposed device remain unchanged from that cleared under K181430 except for the following technological difference:

addition of a new indication for use in patients undergoing surgery or other treatments . requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments: and
. addition of a new indication for the creation of partial thickness single-plane radial cuts/incisions in the cornea.

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Other changes unrelated to the requested change for the addition of the new indications are as follows:

. allowing arcuate incisions that are currently cleared to be completed with the curved contact patient interface device (PID) that is already cleared;
. the ability to manually adjust the location of the capsulotomy without compromising the safety limits to the iris that already exist; and
. the ability to fragment the lens closer to the anterior capsule only within the boundaries of the capsulotomy diameter.

The following table provides a comparative between the proposed LLS-fs 3D laser device with the addition of the new indications and the predicate laser devices.

Table 1: Summary of Technological Characteristics
Characteristics	Proposed DeviceLLS-fs 3D Laser System510(k) K182795	Predicate Device(Radial Cuts/Incisions)LLS-fs 3D Laser System510(k) K181430Cleared: 08/09/2018	Predicate Device(Tunnels for Corneal RingSegments)WaveLight FS200 Laser System510(k) K141476Cleared: 09/30/2014
Indication forUse	The LENSAR LaserSystem - fs 3D (LLS-fs3D) with Streamline™ isan ophthalmic surgicallaser indicated for use:in the creation of ananterior capsulotomy;in patients undergoingsurgery requiringlaser-assistedfragmentation of thecataractous lens;in the creation of fulland partial thicknesssingle-plane and multi-plane arc cuts/incisions in thecornea;in patients undergoingophthalmic surgery orother treatmentsrequiring pocketcuts/incisions in thecornea;in the creation of acorneal flap in patientsundergoing treatmentrequiring initiallamellar resection ofthe cornea;	The LENSAR LaserSystem - fs 3D (LLS-fs3D) with Streamline™ isan ophthalmic surgicallaser indicated for use:in the creation of ananterior capsulotomy;in patients undergoingsurgery requiringlaser-assistedfragmentation of thecataractous lens;in the creation of fulland partial thicknesssingle-plane and multi-plane arc cuts/incisions in thecornea;in patients undergoingophthalmic surgery orother treatmentsrequiring pocketcuts/incisions in thecornea;in the creation of acorneal flap in patientsundergoing treatmentrequiring initiallamellar resection ofthe cornea.	The WaveLight FS200 LaserSystem is an ophthalmic surgicallaser indicated for use:In the creation of a corneal flapin patients undergoing LASIKsurgery or other surgery ortreatment requiring initiallamellar resection of thecornea.In patients undergoing surgeryor other treatment requiringinitial lamellar resection of thecornea to create tunnels forplacement of corneal ringsegments.In the creation of a lamellarcut/resection of the cornea forlamellar keratoplasty.In the creation of a penetratingcut/incision for penetratingkeratoplasty and for cornealharvesting.In patients undergoingophthalmic surgery or othertreatment requiring arcuatecuts/ incisions in the cornea.In patients undergoingophthalmic surgery or othertreatment requiring pocketcuts/ incisions in the cornea.
Table 1: Summary of Technological Characteristics
Characteristics	Proposed DeviceLLS-fs 3D Laser System510(k) K182795	Predicate Device(Radial Cuts/Incisions)LLS-fs 3D Laser System510(k) K181430Cleared: 08/09/2018	Predicate Device(Tunnels for Corneal RingSegments)WaveLight FS200 Laser System510(k) K141476Cleared: 09/30/2014
	in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and in the creation of partial thickness single-plane radial cuts/incisions in the cornea.
OperatingPrinciple	Photodisruption andplasma mediated ablation	Photodisruption andplasma mediated ablation	Photodisruption and plasmamediated ablation
LensFragmentationRemoval	Provided by commerciallyavailable separatesystem of ultrasound;irrigation/ aspiration	Provided by commerciallyavailable separatesystem of ultrasound;irrigation/ aspiration	Provided by commerciallyavailable separate system ofultrasound; irrigation/ aspiration
Class/ ProductCode/Regulation	Class II/ OOE/ 886.4390	Class II/ OOE/ 886.4390	Class II/ OOE/ 886.4390
Patient ContactPortion ofDevice	Disposablepolycarbonate/ siliconepatient interfaceaccessory; suction ringassembly	Disposablepolycarbonate/ siliconepatient interfaceaccessory; suction ringassembly	Disposable patient contactconsumable accessory; suctionring assembly and applanatingcone.
SterilizationMethod (patientinterfaceaccessory)	Gamma irradiation (notincluding Curved ContactPID) or Ethylene Oxide(EO)	Gamma irradiation (notincluding Curved ContactPID) or Ethylene Oxide(EO)	Ethylene Oxide (EO)
Laser Type	Yb:YAG	Yb:YAG	Nd:Glass*
Wavelength	1030 nm	1030 nm	1030 nm
Pulsing	Mode-locked	Mode-locked	Mode-locked
Mode	Fundamental (TEM00)	Fundamental (TEM00)	Fundamental (TEM00)
Pulse Duration	$1.5 x10^{-12}$ sec	$1.5 x10^{-12}$ sec	$0.35 x 10^{-12}$ sec
Repetition Rate	20-80 kHz, adjustable	20-80 kHz, adjustable	200 kHz
Maximum PulseEnergy	15 µJ	15 µJ	2.4 µJ
Maximum PeakPower	9 MW	9 MW	7 MW
Table 1: Summary of Technological Characteristics
Characteristics	Proposed DeviceLLS-fs 3D Laser System510(k) K182795	Predicate Device(Radial Cuts/Incisions)LLS-fs 3D Laser System510(k) K181430Cleared: 08/09/2018	Predicate Device(Tunnels for Corneal RingSegments)WaveLight FS200 Laser System510(k) K141476Cleared: 09/30/2014
Biometrics	Scheimpflug Camera-based Imaging Systemwith 3D ConfocalStructured Illumination(3D-CSI)	Scheimpflug Camera-based Imaging Systemwith 3D ConfocalStructured Illumination(3D-CSI)	Opto-Mechanical referencing
Beam Targetingand Delivery	Computer-controlledscanner with F-theta lens	Computer-controlledscanner with F-theta lens	Computer-controlled scanner withF-theta lens
PhotodisruptiveFluenceThreshold inLens Tissue	4 J/cm²	4 J/cm²	3 J/cm²*
Intended Use forIris RegistrationFeature	• System provides ameans to assist thesurgeon during anteriorsegment ophthalmicsurgical procedures, tomake an incision.• Using standard pre-operative clinical data,together with surgeon-driven, onscreentemplates and guides,the System providesgraphical assistance tothe surgeon as desiredduring the surgery.• The system utilizessurgeon confirmation ateach step for planningand positioning ofguidance for incisionplacement.• The ocular rotationdifference between theupright position (asobserved duringpreoperativemeasurements) and thesupine position (asobserved during thesurgical event) isdetermined either bymanually marking theeye in the uprightposition and allowingthe surgeon to line up	• System provides ameans to assist thesurgeon during anteriorsegment ophthalmicsurgical procedures, tomake an incision.• Using standard pre-operative clinical data,together with surgeon-driven, onscreentemplates and guides,the System providesgraphical assistance tothe surgeon as desiredduring the surgery.• The system utilizessurgeon confirmation ateach step for planningand positioning ofguidance for incisionplacement.• The ocular rotationdifference between theupright position (asobserved duringpreoperativemeasurements) and thesupine position (asobserved during thesurgical event) isdetermined either bymanually marking theeye in the uprightposition and allowingthe surgeon to line up	• Not Applicable.
Table 1: Summary of Technological Characteristics
Characteristics	Proposed DeviceLLS-fs 3D Laser System510(k) K182795	Predicate Device(Radial Cuts/Incisions)LLS-fs 3D Laser System510(k) K181430Cleared: 08/09/2018	Predicate Device(Tunnels for Corneal RingSegments)WaveLight FS200 Laser System510(k) K141476Cleared: 09/30/2014
	the pre-marked eye inthe upright position tothat of the supineposition by way ofsoftware reticules, or bythe System's ability toanalyze and match irisfeatures betweenimages acquired ineach position.	the pre-marked eye inthe upright position tothat of the supineposition by way ofsoftware reticules, or bythe System's ability toanalyze and match irisfeatures betweenimages acquired ineach position.
Intended Use forthe CataractDensity ImagingFeature	• The imaging system ofthe LENSAR LaserSystem finds lenssurfaces in order tocorrectly place pulsesinto the lens. Uponfinding the lenssurfaces, the imagingsystem also determinesthe location and degreeof the nuclear cataractwithin the lens. Thesurgeon then has theability to pick from avariety of fragmentationpatterns as the surgeonsees fit. Additionally,the pattern itself can bealtered in size andthereby the number ofshots as the surgeonsees fit.• LENSAR Laser Systemprovides a mechanismfor the doctor to changethe size and type ofpattern as the surgeonsees fit. Forconvenience, theSystem is also providedwith an optionalmechanism for intra-operatively matchingthe nuclear cataractcondition to one of fivecategories for surgeonpre-selected	• The imaging system ofthe LENSAR LaserSystem finds lenssurfaces in order tocorrectly place pulsesinto the lens. Uponfinding the lenssurfaces, the imagingsystem also determinesthe location and degreeof the nuclear cataractwithin the lens. Thesurgeon then has theability to pick from avariety of fragmentationpatterns as the surgeonsees fit. Additionally,the pattern itself can bealtered in size andthereby the number ofshots as the surgeonsees fit.• LENSAR Laser Systemprovides a mechanismfor the doctor to changethe size and type ofpattern as the surgeonsees fit. Forconvenience, theSystem is also providedwith an optionalmechanism for intra-operatively matchingthe nuclear cataractcondition to one of fourcategories for surgeonpre-selected	• Not Applicable.
Table 1: Summary of Technological Characteristics
Characteristics	Proposed DeviceLLS-fs 3D Laser System510(k) K182795	Predicate Device(Radial Cuts/Incisions)LLS-fs 3D Laser System510(k) K181430Cleared: 08/09/2018	Predicate Device(Tunnels for Corneal RingSegments)WaveLight FS200 Laser System510(k) K141476Cleared: 09/30/2014
	fragmentation(CustomFrag).• The LENSAR LaserSystem utilizes surgeonconfirmation forplanning andpositioning of guidancefor laser shotplacement.	fragmentation(CustomFrag).• The LENSAR LaserSystem utilizes surgeonconfirmation forplanning andpositioning of guidancefor laser shotplacement.
Intended Use forthe CapsularIntelliAxis(IntelliCap)Feature	• Using standard pre-operative data, theSystem places lasermarks onto the lenscapsule as part of thecapsulotomy to identifythe astigmatic axis asprescribed by thesurgeon.	• Using standard pre-operative data, theSystem places lasermarks onto the lenscapsule as part of thecapsulotomy to identifythe astigmatic axis asprescribed by thesurgeon.	• Not Applicable.

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LENSAR estimate only (some WaveLight® parameters were not in the public domain as of this writing and, therefore, LENSAR estimates cannot be confirmed).

The laser parameters that differ slightly from the predicate device (K141476) are Pulse Duration, Repetition Rate, and Maximum Pulse Energy (listed in the table above). The settings for these parameters are based on pre-clinical testing results. Included in this process is the optimization of additional treatment parameters. Clinical safety and effectiveness of tunnels for corneal ring segments are qualified by: a) incision depth accuracy, b) ring tunnel depth regularity, c) ring tunnel incision quality, and whether the incision after the ICRS insertion is acceptable.

PERFORMANCE DATA 7.0

The following performance data were undertaken in support of the substantial equivalence determination.

Performance Evaluation:

Verification and validation testing were completed to demonstrate that the proposed device performance complies with specifications and requirements identified for the LENSAR Laser System - fs 3D. Each function and/or feature was verified through unit testing and system testing by means of the appropriate test case or test specification. The unit/system verification test reports provide the test cases, expected results for each test case, and the actual results obtained. All criteria for this testing were met and the results demonstrate that the LENSAR System with the new indications and other software changes meets all performance specifications and requirements. The objectives defined in the validation plan were achieved

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according to the validation results. The software on the proposed LLS-fs 3D System has been updated in support of the changes outlined above.

Performance data supporting substantial equivalence is summarized as follows:

The accuracy of the depth of the corneal tunnel was tested using a porcine ex vivo eve . model. The depth of the tunnel was measured using an optical coherence tomographer over various depths and compared to the intended depth. The study showed that the achieved depth was well within the established requirements for depth of the corneal tunnel.
For both the corneal tunnel and radial incisions in combination with arcuate incisions an . assessment of the incision quality was conducted. The study consisted of using the laser to cut corneal tunnel and radial incisions (individually or in combination with arcuate incisions) at various depths in porcine eyes. A trained biomedical scientist, using standard instruments, assessed the acceptability for each as it relates to ease of opening and incision quality. The results showed that the proposed device showed ease of opening and quality of incision quality that was acceptable.
. Evaluation (from a previous study) of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes showed that the laser method results in no loss of endothelial cell density when a sufficiently large residual corneal bed is maintained.
. The accuracy of the depth of the radial incisions in combination with arcuate incisions was tested using a porcine ex vivo eye model. The depth of the radial and arcuate incisions was measured using an optical coherence tomographer over various depths and compared to the intended depth. The study showed that the achieved depth was well within the established requirements for depth of the radial incision individually or in combination with the arcuate incision.
. A review of the hazard analysis of all potential hazards to the patient, surgeon and other system operators was performed to consider all changes to the proposed LLS-fs 3D device. The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics.

In all cases, the test results showed that the new indications and other minor changes meet the performance specifications and requirements. The comparison with the predicate devices shows that the proposed LENSAR Laser System – fs 3D is substantially equivalent to the WayeLight® FS200 Laser System (K141476) for the indication of use in the creation of corneal tunnels and to the LENSAR Laser System - fs 3D (LLS-fs 3D) for the indication of use in the creation of partial thickness single planed radial incisions.

The minor differences between the additional LENSAR device feature and the predicate device do not raise any new questions of safety or effectiveness.

Biocompatibility Testing:

The Patient Interface Device (PID) Kits have no changes to the material or assembly as part of this submission and thus remains unchanged from that used with the previously cleared device (K181430).

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The PID Ring Arm is multi-use and is sterilized by autoclaving. There were no changes to the material or assembly of the PID Ring Arm as part of this submission and thus remains unchanged from prior device files.

Software Verification and Validation Testing:

A complete software verification and validation testing was conducted covering all cited changes and updates since the prior clearance (K181430), and 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 in the software could directly result in serious injury to the patient or operator.

Summary of Clinical Studies:

The addition of the added indications for use and other minor changes as described in Section 6 above for use with the LENSAR Laser System did not require clinical performance data to demonstrate substantial equivalence to the predicate device.

CONCLUSIONS 8.0

The activities used to evaluate the LENSAR Laser System – fs 3D (LLS-fs 3D) and the information provided in this 510(k) submission do not identify any new issues of safety or effectiveness.

Based on the above supportive information, the proposed LENSAR Laser System - fs 3D (LLS-fs 3D) with the new indications are substantially equivalent with respect to safety and effectiveness and indication for use as cleared in:

the LENSAR Laser System - fs 3D (LLS-fs 3D) predicate device (K181430) as it relates to radial cuts and other minor changes; and
. the WaveLight® FS200 Laser System predicate device (K141476) as it relates to tunnels for placement of corneal ring segments.

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.