The VICTUS Femtosecond Laser Platform is indicated for use for:
· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• for anterior capsulotomy during cataract surgery.
· the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

Device Description

The VICTUS Femtosecond Laser is a precision ophthalmic surgical laser indicated for use in patients undergoing ophthalmic surgery in the anterior segment of the eye. The VICTUS Femtosecond Laser system produces scanned patterns designed to create flaps, produce corneal incisions, arcuate incisions, capsulotomy cuts, and crystalline lens fragmentation patterns for use in cataract surgery. The patient is treated while supine on a patient bed that the physician can position electromechanically via simple controls. The physician controls the VICTUS laser system itself through a touchscreen display and other user controls. Laser emission and of PI suction vacuum are actuated by the physician using separate footswitch pedals.

The mode of operation for the VICTUS Platform is using Yb:KYW Femtosecond laser to produce Laser-Induced Optical Breakdown (LIOB) of the corneal tissue. Scanned patterns of laser pulses from the VICTUS are delivered through a sterile, disposable Patient Interface (PI). The PI consists of two components: (i) a contacting lens, and (ii) a suction clip. Together, the suction clip and contacting lens connect to make a single assembly during a VICTUS procedure. The surface of the contacting lens that contacts the eye is spherically curved to match the curvature of the human eye. The suction clip assembly gently immobilizes the eye with respect to the VICTUS laser beam and optical visualization systems. The PI contacting lens and suction clip together allow for proper optical coupling of the laser and optical paths into the patient's eye and create a precise opto-mechanical reference surface for depth control of the scanning laser beam.

AI/ML Overview

The provided text focuses on the 510(k) premarket notification for the VICTUS Femtosecond Laser Platform, specifically regarding modifications to its Patient Interface. It primarily discusses the technological comparison and non-clinical performance data to establish substantial equivalence to a previously cleared device. Therefore, the information regarding in-depth acceptance criteria and a standard study that proves the device meets those criteria (especially in the context of AI/ML performance) is not available in the provided document.

However, based on the non-clinical performance data section, we can infer some aspects related to acceptance criteria and the study performed, even though it's not presented in a typical AI/ML study format.

Here's an attempt to structure the answer based on the available information, noting where specific details are absent:

Acceptance Criteria and Study for VICTUS Femtosecond Laser Platform (Modified Patient Interface)

This submission describes changes to the Patient Interface (PI) of the VICTUS Femtosecond Laser Platform. The study's primary goal was to demonstrate that these modifications do not negatively impact the device's performance compared to the previously cleared version, thus establishing substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from study goals)	Reported Device Performance
Biocompatibility	Meet ISO 10993-1 requirements for patient-contacting material.	Test results satisfied the acceptance criteria as defined by the associated ISO standards. (Implies the modified PI is biocompatible).
Endotoxin Content	Limulus Amebocyte Lysate (LAL) Endotoxin testing: Endotoxin levels < 20 EU/medical device (non-intraocular).	Test results of < 1.0 EU/sample, which is below the defined endotoxin limit for a medical device (non-intraocular) of 20 EU/medical device.
Cut Pattern Fidelity	Cuts made with modified PI should be equivalent to those with cleared PI for all indications.	Bench testing results demonstrated equivalent performance between the modified and current 510(k)-cleared PI Kits. Cuts made using the modified PI Kit were shown to be equivalent in terms of cut pattern fidelity for all cleared cataract and corneal indications for use.
Cut Quality	Cuts made with modified PI should be equivalent to those with cleared PI for all indications.	Bench testing results demonstrated equivalent performance. Cuts made using the modified PI Kit were shown to be equivalent in terms of cut quality for all cleared cataract and corneal indications for use.
Docking Behavior (IOP Safety)	Equivalent Intraocular Pressure (IOP) safety between modified and cleared PI during docking.	The docking behavior in terms of IOP safety is equivalent between the current 510(k)-cleared and the modified (proposed) PI Kit models.
Docking Behavior (Limbal Suction Integrity)	Equivalent limbal suction integrity between modified and cleared PI during docking.	The docking behavior in terms of limbal suction integrity is equivalent between the current 510(k)-cleared and the modified (proposed) PI Kit models.
Electrical Safety & EMC	Comply with applicable safety standards (EN ISO 60601-1, -1-2, -2-22). (No new testing required for this submission, as previous compliance was established).	Previously undergone testing and complies with applicable safety standards EN ISO 60601-1: 2005 + A1, EN ISO 60601-1-2: 2007, and EN ISO 60601-2-22: 2007. This establishes that the platform itself (not the new PI specifically) meets these.

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

Sample Size: Not explicitly stated for each non-clinical test. The document mentions "All bench testing results" without detailing the number of tests performed or the quantities of PI kits/cuts analyzed for each criterion (fidelity, quality, docking behavior).
Data Provenance: The studies are described as "Non-Clinical Performance Data" and "bench testing." This implies internal laboratory studies conducted by the manufacturer (Technolas Perfect Vision GmbH). The country of origin is not specified but is likely within the company's operational regions (e.g., Munich, Germany or San Francisco, CA where the contact person is located). It is retrospective in the sense that it evaluates a modified component against an existing, cleared component.

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

Not Applicable / Not Mentioned: This type of information (number of experts, qualifications) is typically relevant for studies involving human interpretation or clinical endpoints, especially in AI/ML performance evaluation. The presented data is from bench testing, where "ground truth" would be established by objective measurements (e.g., precise measurements of cut parameters, biocompatibility assay results). Experts would be involved in interpreting the objective data, but not in establishing a subjective "ground truth" in the way radiologists might for medical images.

4. Adjudication Method for the Test Set

Not Applicable / Not Mentioned: Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies among multiple human readers. This was a non-clinical bench testing study comparing device performance metrics, not human expert assessments.

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

No: No MRMC or human-in-the-loop study was done. This notification is for a hardware modification (Patient Interface) of a laser platform, not an AI/ML algorithm requiring human reader performance evaluation. The document explicitly states: "There was no clinical study performed to support substantial equivalence of this premarket notification." Additionally, "No new software testing was performed to support this premarket notification."

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

No: This is not an AI/ML algorithm. The performance evaluation focuses on the mechanical and optical characteristics of a physical device component (Patient Interface).

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance data appears to be objective measurements and laboratory assays comparing the modified Patient Interface (PI) to the predicate PI. This includes:
- Quantitative measurements of cut pattern fidelity and quality (e.g., dimensions, regularity).
- Biocompatibility assay results (pass/fail criteria per ISO standards).
- Endotoxin concentration measurements.
- Measurements related to docking behavior outcomes (IOP, suction integrity).

8. The Sample Size for the Training Set

Not Applicable: This is not an AI/ML device, so there is no "training set."

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

Not Applicable: As there is no training set for an AI/ML algorithm involved, this question is not relevant.

Summary

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

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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

September 1, 2020

Technolas Perfect Vision GmbH % Ken Nehmer Director, Regulatory Affairs 351 Buena Vista Ave. E, Unit 501E San Francisco, CA 94117

Re: K200724

Trade/Device Name: VICTUS Femtosecond Laser Platform Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: OOE Dated: March 9, 2020 Received: March 19, 2020

Dear Ken Nehmer:

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. 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

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

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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 LT Charles Chiang 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) K200724

Device Name VICTUS Femtosecond Laser Platform

Indications for Use (Describe) The VICTUS Femtosecond Laser Platform is indicated for use for:

· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

• for anterior capsulotomy during cataract surgery.

· the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.

· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

X 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

I.	Submitter	Technolas Perfect Vision GmbHMesserschmittstr. 1 +380992 Munich, GermanyTel: 49 174 3494062
	Contact	Ken NehmerDirector, Regulatory AffairsTechnolas Perfect Vision GmbH351 Buena Vista Ave. EUnit 501ESan Francisco, CA 94117Ph: 415-297-0408Email: ken.nehmer@bausch.com
	Date Prepared	September 1, 2020

II. Device

Name of Device	VICTUS Femtosecond Laser Platform
Common Name	Ophthalmic Laser
Classification Name	Laser, Ophthalmic
Regulatory Class	Class II
Product Code	OOE (Ophthalmic Femtosecond Laser)
Regulation Number	21 CFR 886.4390
III. Predicate Device	VICTUS Femtosecond Laser Platform (K171014)This predicate has not been subject to a design-relatedrecall.

IV. Device Description

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

VICTUS laser system itself through a touchscreen display and other user controls. Laser emission and of PI suction vacuum are actuated by the physician using separate footswitch pedals.

Component	Description
Assistant workstation	Allows to perform the system tests, to enter and manage the patient data, to select and program procedures, to apply vacuum for patient interface and suction clip, to adjust the procedure according to the patient's eye and to export treatment records.
Chiller	Helps to ensure that the main components are kept at a steady temperature.
Controller	Checks the connectivity among all electronic components.
GUI PC	Interface between the user and the laser system.
Laser source	Generates the laser beam.
Optical unit	Controls the complete laser beam path.
Surgeon control screen	Shows a live camera image, a live OCT image, and all relevant parameters for the selected treatment.
Treatment illumination	Contains the laser ring light module. It illuminates the treatment area.
Video microscope	Used as part of treatment planning and shows the top view of the eye to be treated.
OCT	Fourier based integrated optical coherence tomography unit which is used to visualize and/or position the treatment as an overlay on the video image. The OCT is not used for diagnostic purposes.

The VICTUS Femtosecond Laser Platform main unit is composed of the following:

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

Additional feature	Description
Surgical microscope (optional feature)	Allows for centering the suction clip
Surgical microscope illumination (optional feature)	Provides a uniform and adjustable illumination
Patient Bed	Used to position a supine patient for treatment by the VICTUS Platform.

The following components are additional features to the main unit:

The following components are accessories to the main unit:

Accessory	Description
Patient Interface Kit (PIK)	The patient interface kit is sterile, single use kitcomposed of a contact lens component and a suctionclip component. The contact lens and suction clipassembly create a reference surface for depth controland fix the eye relative to the delivery of the laser beam.

V. Indications for Use

The VICTUS Femtosecond Laser Platform is indicated for use for:

· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
· for anterior capsulotomy during cataract surgery.
· the creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.
· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The indications for use remain unchanged from those previously cleared via K171014.

VI. Comparison of Technological Characteristics with the Predicate

Modifications to the VICTUS Femtosecond Laser described in this premarket notification are limited to the contacting lens component of the Patient Interface accessory and to the PI mating hardware (i.e. the Spacer Cone) that is permanently installed on the VICTUS laser. No other modifications are proposed to the cleared device.

A comparison of the technological characteristics for both the current and modified Patient Interface Kit components are provided in the following table.

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

CLEARED DEVICEK171014		PROPOSEDDEVICE
Trade Name –Laser System	VICTUS Femtosecond Laser Platform	Same
Indication for Use	The VICTUS Femtosecond Laser Platform isindicated for use for:the creation of a corneal flap in patientsundergoing LASIK surgery or othertreatment requiring initial lamellar resectionof the cornea.for anterior capsulotomy during cataractsurgery.the creation of cuts / incisions in the corneain patients undergoing cataract surgery orother ophthalmic treatment requiring cuts /incisions in the cornea.laser-assisted lens fragmentation of nuclearcataracts during cataract surgery, not forfragmentation of posterior subcapsular(PSC) and cortical cataracts	Same
Trade Name –Patient Interface Kit	VERAFIT Patient Interface Kit(SKU: 90000200TPV)	Patient Interface (PI) Kit(SKU: 90000145)
Function	Sterile, single use accessory designed to(i) provide reference surface for laser depthcontrol and (ii) affix eye for delivery of laserbeam	Same
Usage	Sterile, single use, disposable	Same
Accessory Design	Two components:contact lenssuction assembly: spring clip with suctionring, tubing, vacuum reservoir w/ consoleconnector	Same
Eye Fixation Method	Suction-fixated, curved contact	Same
Applanation Force	Shear Force: ≤ 2 NVertical Force:Cataract indications ("soft dock"): 0.2 – 1.0 NFlaps/incisions ("hard dock"): 2.0 – 5.0 N	Same
Sterilization Method	Gamma irradiation	Same
Suction Clip ComponentDesign	Limbal suction ring with spring clip	Same
Suction Method	Integrated suction ring with vacuum tubingand connector	Same
	CLEARED DEVICEK171014	PROPOSEDDEVICE
	Contacting Lens Component
Manufacturing method	Machinedpolymeric contacting lens	Injection moldedpolymeric contacting lens
Contact Lens Material	PMMA	COP Zeonex
Distal (eye-contacting)radius of curvature	9.5 mm	10.5 mm
Proximalradius of curvature	17 mm	Same
Index of refraction	1.49	1.53
Maximum treatmentdiameter	12.0 mm	11.7 mm
Outside diameter ofcontacting surface	15.6 mm	same

TECHNOLOGICAL COMPARISON OF THE CLEARED AND PROPOSED PATIENT INTERFACE KIT COMPONENTS

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

VII. Performance Data

Biocompatibility testing

Biocompatibility assessment for the modified Patient Interface contacting lens component of the PI Kit has been performed in accordance with the requirements of ISO 10993-1 to evaluate the impact of the patient contacting material modification. Test results satisfied the acceptance criteria as defined by the associated ISO standards.

Limulus Amebocyte Lysate (LAL) testing

The VICTUS Patient Interface (PI) Kit includes a patient interface contacting lens and the suction clip ring which contact the corneal surface only (non-intraocular). Limulus Amebocyte Lysate (LAL) Endotoxin testing had been performed with results of < 1.0 EU/sample. Results are below the defined endotoxin limit for a medical device (non-intraocular) of 20 EU/medical device.

Electrical safety and electromagnetic compatibility (EMC)

No new electrical safety or EMC testing was required to support this premarket notification. The VICTUS Femtosecond Laser Platform has previously undergone testing and complies with the applicable following safety standards:

STANDARD	TITLE
EN ISO 60601-1: 2005 + A1	Medical electrical equipment – Part I: General requirements for safety
EN ISO 60601-1-2: 2007	Medical electrical equipment – Part 1: General requirements for safety; 2. Collateral standard: electromagnetic compatibility; requirements and tests
EN ISO 60601-2-22: 2007	Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

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

The VICTUS Femtosecond Laser Platform has been found to perform equivalently to the predicate device. The VICTUS Femtosecond Laser Platform and the predicate device therefore have a similar performance profile.

Software Verification and Validation Testing

No new software testing was performed to support this premarket notification

Mechanical and acoustic testing

There was no mechanical or acoustical testing performed to support substantial equivalence of this premarket notification.

Animal Study

There was no animal study performed to support substantial equivalence of this premarket notification.

Non-Clinical Performance Data

Nonclinical performance testing was conducted to establish substantial equivalence between the Patient Interface (PI) Kit (SKU: 90000145) with the modified Patient Interface contacting lens and the PI Kit (SKU: 90000200TPV) cleared under K171014.

All bench testing results demonstrated equivalent performance between the modified and the current 510(k)-cleared PI Kits. Cuts made using the modified PI Kit were shown to be equivalent in terms of both cut pattern fidelity and cut quality to those produced with the current 510(k)cleared PI for all cleared cataract and corneal indications for use. The docking behavior in terms of IOP safety and limbal suction integrity are equivalent between the current 510(k)-cleared and the modified (proposed) PI Kit models.

Clinical Studies

There was no clinical study performed to support substantial equivalence of this premarket notification.

VIII. Conclusion

The minor modifications proposed in this 510(k) Premarket Notification did not impact the product design requirements or the conformance to applicable standards specific to this device. Any differences between the predicate and proposed devices do not affect the substantial equivalence of the device as demonstrated by the performance testing.

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.