Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a laser system with electromechanical controls and scanned patterns, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

Yes
The device is indicated for surgical procedures such as LASIK, cataract surgery, and creating corneal incisions, which are therapeutic interventions.

Diagnostic

No

The device is a surgical laser system used for creating cuts and fragmenting tissue in ophthalmic procedures, not for diagnosing conditions. While it uses imaging modalities (OCT, video microscope) for surgical guidance, its primary function is therapeutic/interventional.

SaMD (Software as a Medical Device)

No

The device is a complex hardware system that includes a laser, patient bed, touchscreen display, footswitch pedals, and a disposable patient interface with a contacting lens and suction clip. While it has software control, it is fundamentally a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The VICTUS Femtosecond Laser Platform is a surgical laser system used to perform procedures directly on the eye (an in-vivo procedure). It creates cuts and fragments tissue within the eye.
Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's eye.
Intended Use: The intended uses listed are all surgical procedures performed on the eye.

Therefore, the VICTUS Femtosecond Laser Platform is a surgical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Product codes

OOE

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.

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

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 following components are additional features to the main unit:

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 accessories to the main unit:

Patient Interface Kit (PIK): The patient interface kit is sterile, single use kit composed of a contact lens component and a suction clip component. The contact lens and suction clip assembly create a reference surface for depth control and fix the eye relative to the delivery of the laser beam.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior segment of the eye, eye, cornea, crystalline lens

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

VICTUS Femtosecond Laser Platform (K171014)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 GmbH
Messerschmittstr. 1 +3
80992 Munich, Germany
Tel: 49 174 3494062 |
|----|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact | Ken Nehmer
Director, Regulatory Affairs
Technolas Perfect Vision GmbH
351 Buena Vista Ave. E
Unit 501E
San Francisco, CA 94117
Ph: 415-297-0408
Email: 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-related
recall.

IV. 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

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.

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.

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 kit
composed of a contact lens component and a suction
clip component. The contact lens and suction clip
assembly create a reference surface for depth control
and 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 DEVICE
K171014 | | PROPOSED
DEVICE |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Trade Name –
Laser System | VICTUS Femtosecond Laser Platform | Same |
| Indication 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 | 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 depth
control and (ii) affix eye for delivery of laser
beam | Same |
| Usage | Sterile, single use, disposable | Same |
| Accessory Design | Two components:
contact lens
suction assembly: spring clip with suction
ring, tubing, vacuum reservoir w/ console
connector | Same |
| Eye Fixation Method | Suction-fixated, curved contact | Same |
| Applanation Force | Shear Force: ≤ 2 N
Vertical Force:
Cataract indications ("soft dock"): 0.2 – 1.0 N
Flaps/incisions ("hard dock"): 2.0 – 5.0 N | Same |
| Sterilization Method | Gamma irradiation | Same |
| Suction Clip Component
Design | Limbal suction ring with spring clip | Same |
| Suction Method | Integrated suction ring with vacuum tubing
and connector | Same |
| | CLEARED DEVICE
K171014 | PROPOSED
DEVICE |
| | Contacting Lens Component | |
| Manufacturing method | Machined
polymeric contacting lens | Injection molded
polymeric contacting lens |
| Contact Lens Material | PMMA | COP Zeonex |
| Distal (eye-contacting)
radius of curvature | 9.5 mm | 10.5 mm |
| Proximal
radius of curvature | 17 mm | Same |
| Index of refraction | 1.49 | 1.53 |
| Maximum treatment
diameter | 12.0 mm | 11.7 mm |
| Outside diameter of
contacting 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