· In the creation of corneal cuts/incisions (single-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
· In the creation of corneal pockets for placement/insertion of a corneal inlay device and for creation of corneal tunnels for the placement of corneal rings.

Device Description

The LenSx Laser System is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create incisions and to separate tissue within the lens capsule, crystalline lens, and the cornea. A femtosecond light pulses is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. A computer-controlled scanning system directs the focused laser beam throughout a three-dimensional pattern to produce an incision. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation.
The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the LenSx Laser System, which is an ophthalmic surgical laser. The submission aims to seek clearance for additional indications for use: the creation of corneal tunnels and corneal pockets. The document states that the LenSx Laser System is "essentially the same device as the predicate LenSx Laser System" and that "All modifications were tested to show substantial equivalence to the predicate device as safe and as effective as the predicate device."

However, the provided text does not contain specific acceptance criteria, reported device performance metrics, or details about the study design elements such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The "Performance Data" section discusses that the accuracy and reproducibility of depths and geometry of treatment patterns were evaluated, but it does not provide the quantitative results or the acceptance criteria used for these evaluations.

Therefore, based solely on the provided text, I cannot complete the requested information, specifically:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The document mentions "acceptance criteria established for the predicate LenSx Laser" but does not state what those criteria are or the quantitative results achieved by the modified device against them.
Sample sized used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable. This device is a surgical laser, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical laser, not an AI algorithm. Its performance is intrinsic to its mechanical and optical capabilities in creating cuts.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): While it mentions evaluating "accuracy and reproducibility of the depths and geometry," it doesn't specify how these were measured to establish ground truth (e.g., using imaging, physical measurements, etc.).
The sample size for the training set: Not applicable. This is a hardware device with software controls, not a machine learning model requiring a training set in the typical sense.
How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary of what is present:

Device Name: LenSx Laser System
Purpose of Submission: Seek clearance for additional indications for use:
- Creation of corneal pockets for placement/insertion of a corneal inlay device.
- Creation of corneal tunnels for the placement of corneal rings.
Comparison to Predicate: The modified system is stated to be "substantially equivalent" to the primary predicate device (K163551) and additional predicate devices (K141852, K141476) in terms of indications for use, technological characteristics, and fundamental scientific technology.
Performance Data Mentioned (but no specifics): Evaluation of accuracy and reproducibility of depths and geometry of previously cleared and new treatment patterns.
Safety Standards Compliance: The device underwent medical electrical equipment testing and was found compliant with several IEC and ANSI AAMI standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 62304, IEC 62366).
Software Verification and Validation: Conducted according to FDA guidance for "major" level of concern software, demonstrating fulfillment of functional and safety critical requirements.

Conclusion: The provided document is a 510(k) summary focusing on substantial equivalence for a surgical laser, and while it mentions performance data were collected, it does not disclose the quantitative acceptance criteria or the specific results of those performance tests. It does not describe a study that would typically involve a test set with ground truth established by experts, as is common for diagnostic imaging AI devices, but rather focuses on engineering and functional performance of the laser itself.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 27, 2018

Alcon Laboratories, Inc. James Arganda Director Global Regulatory Affairs 20511 Lake Forest Dr Lake Forest, CA 92630

Re: K173660

Trade/Device Name: LenSx Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE, HOC, HNO Dated: February 15, 2018 Received: February 16, 2018

Dear James Arganda:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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,

Denise L. Hampton -S

for Malvina B. 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) K173660

Device Name LenSx Laser System

Indications for Use (Describe)

The LenSx Laser System is indicated for use:

· In the creation of corneal cuts/incisions (single-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
· In the creation of corneal pockets for placement/insertion of a corneal inlay device and for creation of corneal tunnels for the placement of corneal rings.

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

This 510(k) summary document has been prepared in accordance with section 21 CFR 807.92.

I. Submitter of the 510(k)

Company:	Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099, USA
Primary Contact Person:	James ArgandaAlcon Research, Ltd.20511 Lake Forest Dr.Lake Forest, CA 92630
Phone:	(949) 505-7038
Fax:	(949) 505-6237
Email:	james.arganda@alcon.com
Back up Contact Person:	Kim Regis
Phone:	(949) 505-7232
Fax:	(949) 505-6237
Email:	kim.regis@alcon.com
Date Prepared:	28 November 2017

II. Devices Subject to this 510(k)

Trade/Device Name:	LenSx Laser System
Regulation Number	21 CFR 886.4390
Regulation Name:	Ophthalmic Laser
Device Classification:	Class II
Product Code:	OOE, HQC, HNO

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	Primary Predicate Device	Additional Predicates
510(k)Clearance	K163551	K141852 K141476
Device Name	LenSx Laser System	iFS Laser SystemWaveLight FS200
Manufacture	Alcon Laboratories, Inc.	AMO ManufacturingUSA, LLCAlcon Laboratories, Inc.

III. Predicate Device

IV. Device Description

The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

Indications for Use v.

The following indications for use for the LenSx Laser System are unchanged from the previously cleared device (K163551):

In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.

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. In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
. In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.

VI. Comparison to Technological Characteristics with the Predicate Device

The modified LenSx Laser System is substantially equivalent to the primary predicate device (K163551) and additional predicate devices (K141852, K141476) in terms of indications for use, technological characteristics and fundamental scientific technology. The subject and predicate laser systems share the same design principle and mode of operation in that they all deliver femtosecond pulses through a computer-controlled delivery system to produce a pattern of photodisruption to create incisions in the ophthalmic tissue. The means of fixation of the patient contact portion of the devices are all substantially equivalent in that the suction vacuum affixes a suction ring to the corneal surface prior to use.

No changes to the LenSx Laser System's operating principles, system specifications or disposable Patient Interface were required to support the additional indications for use. Software updates were implemented to support the new functionality along with associated graphical user interface functionality. While no changes are proposed to the LenSx Laser system hardware, new painted skin colors that are intended to harmonize the appearance of the LenSx Laser console appearance with other Alcon commercial products are proposed.

Modifications proposed in this 510(k) premarket notification were tested to show substantial equivalence to the predicate device. The following summarizes the substantial equivalence between the modified device and the predicate device.

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TECHNOLOGICAL COMPARISON LENSX LASER SYSTEM – PREDICATE DEVICES

	SYSTEMPROPOSED	PRIMARY PREDICATE	ADDITIONAL PREDICATE	ADDITIONAL PREDICATE
510(k)Clearance		K163551	K141852	K141476
Device Name	LenSx Laser System	LenSx Laser System	iFS Laser System	WaveLight FS200
Manufacture	Alcon Laboratories	Alcon Laboratories	AMO ManufacturingUSA, LLC	Alcon Laboratories
Indicationfor Use	The LenSx LaserSystem is indicated foruse:□ In the creation ofcorneal cuts/incisions(single-plane, multi-plane, and arcuate),anterior capsulotomyand laserphacofragmentationduring cataractsurgery. Each ofthese procedures maybe performed eitherindividually orconsecutively duringthe same surgery.□ In the creation of acorneal flap inpatients undergoingLASIK surgery orother treatmentrequiring initial	The LenSx LaserSystem is indicated foruse:□ In the creation ofcorneal cuts/incisions(single-plane, multi-plane, and arcuate),anterior capsulotomyand laserphacofragmentationduring cataractsurgery. Each ofthese procedures maybe performed eitherindividually orconsecutively duringthe same surgery.□ In the creation of acorneal flap inpatients undergoingLASIK surgery orother treatmentrequiring initial	□ In patientsundergoing surgeryor other treatmentrequiring initiallamellar resection ofthe cornea□ In patientsundergoing surgeryor other treatmentrequiring initiallamellar resection ofthe cornea to createtunnels forplacement of cornealring segments□ In patientsundergoingophthalmic surgeryor other treatmentrequiring arcuatecuts/incisions in thecornea, penetratingand/or intrastromal	The WaveLight FS200Laser System is anophthalmic surgicallaser indicated for use:□ In the creation of acorneal flap inpatients undergoingLASIK surgery orother surgery ortreatment requiringinitial lamellarresection of thecornea.In patientsundergoing surgeryor other treatmentrequiring initiallamellar resection ofthe cornea to createtunnels forplacement of cornealring segments.
	SYSTEMPROPOSED	PRIMARY PREDICATE	ADDITIONAL PREDICATE	ADDITIONAL PREDICATE
	lamellar resection ofthe cornea.□ (New) In the creationof corneal pocketsforplacement/insertionof a corneal inlaydevice; and forcreation of cornealtunnels for theplacement of cornealrings.	lamellar resection ofthe cornea.	□ In lamellar IEK andcorneal harvesting□ In the creation of acorneal flap inpatients undergoingLASIK surgery orother treatmentrequiring initiallamellar resection ofthe cornea□ In the creation of alamellarcut/resection of thecornea for lamellarIEK and for thecreation of apenetratingcut/incision forpenetrating IEK□ In patientsundergoingophthalmic surgeryor other treatmentrequiring thecreation of cornealchannels forplacement/insertionof a corneal inlaydevice	□ In the creation of alamellarcut/resection of thecornea for lamellarkeratoplasty.□ In the creation of apenetratingcut/incision forpenetratingkeratoplasty and forcorneal harvesting.□ In patientsundergoingophthalmic surgeryor other treatmentrequiring arcuatecuts/incisions in thecornea.□ In patientsundergoingophthalmic surgeryor other treatmentrequiring pocketcuts/incisions in thecornea.
OperatingPrinciple	Femtosecond laserphotodisruption	Femtosecond laserphotodisruption	Femtosecond laserphotodisruption	Femtosecond laserphotodisruption
	SYSTEMPROPOSED	PRIMARY PREDICATE	ADDITIONAL PREDICATE	ADDITIONAL PREDICATE
Mechanismof Action	Cutting and resectionsurfaces are created byscanned patterns offemtosecond lasermicro-photodisruptionsin tissue	Cutting and resectionsurfaces are created byscanned patterns offemtosecond lasermicro-photodisruptionsin tissue	Cutting and resectionsurfaces are created byscanned patterns offemtosecond lasermicro-photodisruptionsin tissue	Cutting and resectionsurfaces are created byscanned patterns offemtosecond lasermicro-photodisruptionsin tissue
LaserWavelength	1030 nm	1030 nm	1053 nm	1030 nm
MaximumPulseEnergy	15 µJ for cataract2.6 µJ for cornealflaps, pockets andtunnels	15 µJ for cataract2.6 µJ for corneal flapsfor LASIK	2.5 µJ	2.4 µJ
AccessoryDesign	Cone with curvedcontact lens withintegrated suction ring	Cone with curvedcontact lens withintegrated suction ring	Cone with flat contactlens and separatesuction ring	Cone with flat contactlens and separatesuction ring

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VII. Performance Data

The performance data supporting substantial equivalence of the LenSx Laser with the above modifications include:

. Evaluation of the accuracy and reproducibility of the depths and geometry of the previously cleared treatment patterns using the modified LenSx Laser in comparison to acceptance criteria established for the predicate LenSx Laser.
. Evaluation of the accuracy and reproducibility of the depths and geometry of the proposed new corneal pocket treatment patterns using the modified LenSx Laser.
. Evaluation of the accuracy and reproducibility of the depths and geometry of the proposed new corneal tunnel treatment patterns using the modified LenSx Laser.

The LenSx Laser system underwent medical electrical equipment testing and was found in compliance with the following application safety standards:

ANSI AAMI ES 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Basic Safety and Essential Performance
. IEC 60601-1-2 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility
. 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
IEC 60825-1 Safety of Laser Products Part 1: Equipment Classification and . Requirements
IEC 62304 Medical Device Software Software Life Cycle Processes .
. IEC 62366 – Medical Devices - Application of Usability Engineering to Medical Devices

Verification and validation of the software updates were conducted in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005, and demonstrated that the functional and safety critical requirements are fulfilled.

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VIII. Software Verification and Validation

Software verification and validation testing were conducted 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 is considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

IX. Conclusions

The subject of this 510(k) Premarket Notification is to seek clearance for additional new indications for the creation of corneal tunnels and corneal pockets. The LenSx Laser System is essentially the same device as the predicate LenSx Laser System. All modifications were tested to show substantial equivalence to the predicate device as safe and as effective as 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.