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

· 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 Platform (VICTUS) is a precision ophthalmic surgical laser and is cleared for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for patients undergoing anterior capsulotomy during cataract surgery (via K120426). The VICTUS has additionally been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (K122386), primary/secondary corneal incisions (K132534), and laser-assisted lens fragmentation (K140615). This submission does not add to the indications previously cleared for the VICTUS Platform. With the exception of a new patient interface suction clip, the VICTUS Platform hardware and software remain unchanged from that described and cleared via K141379.

A new patient interface suction clip for the VICTUS platform is being introduced within this premarket submission, the new suction clip is smaller in diameter and contains a colorant to aid in positioning on the cornea of the eye. For all indications for use, laser pulses are delivered through a sterile disposable Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam. The contact lens portion of the patient interface remains unchanged from that previously cleared. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

The fundamental scientific technology and indications for use remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K141379.

AI/ML Overview

The provided text describes the Victus Femtosecond Laser Platform, which is regulated as an Ophthalmic Laser. The document is a 510(k) premarket notification summary, indicating substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly provide a table of quantitative acceptance criteria for device performance. Instead, it states that the device was found to perform "equivalently to the predicate device" and that "the acquired test data successfully verified that the various parameters meet their pre-defined acceptance criteria." This implies that specific performance metrics and their acceptance thresholds exist but are not detailed in this summary.

However, based on the non-clinical and clinical performance data, we can infer some performance aspects:

Feature/Parameter Tested	Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Performance
Consistency of lens fragmentation with new software (v3.2) vs. old software (v2.7 SP3)	Substantially equivalent results in lens fragmentation	Achieved substantially equivalent results.
Various parameters (e.g., cut quality, precision) across different materials (porcine eyes, agarose gel, PETG, PMMA)	Pre-defined acceptance criteria	Data successfully verified that parameters meet pre-defined acceptance criteria.
Clinical Performance
Intraoperative accuracy of biometry visualization (Lens Thickness, ACD, CCT) by VICTUS OCT vs. LENSTAR LS900	Correlation and agreement between VICTUS OCT and LENSTAR LS900 measurements	Results are "consistent" between VICTUS OCT and LENSTAR LS900.
Completion of laser-assisted capsulotomy without manual intervention	100% completion rate without manual intervention	All 113 laser-assisted capsulotomy procedures were completed fully without the need for manual intervention.
Absence of adverse events	No adverse or serious adverse events	No adverse or serious adverse events reported.
Absence of device malfunctions	No device malfunctions leading to adverse events	No device malfunctions reported which led or potentially led to adverse or serious adverse events.

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

Non-Clinical Test Set:
- Sample Size: Not explicitly stated as a number of distinct "test sets" but mentions "four different materials" (porcine eyes, agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)) were used for bench performance testing.
- Data Provenance: Retrospective (bench testing/lab data). Country of origin is not specified, but the applicant is based in Germany, so it's likely European or global.
Clinical Test Set:
- Sample Size:
  - Flap group: 58 eyes
  - Cataract group: 113 eyes
  - Total: 171 eyes
- Data Provenance: Prospective, single-center clinical study. The country of origin for the study is not specified but the applicant is based in Germany.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for either the non-clinical or clinical studies.

Non-Clinical: Ground truth for material testing (e.g., cut quality, precision) would likely be established by engineers or scientists performing the tests, comparing measurements to specifications.
Clinical: For biometry, the LENSTAR LS900 measurements served as a reference (ground truth proxy). For capsulotomy completion and adverse events, the operating surgeons/investigators would make those assessments, but their specific expert qualifications are not detailed beyond "multi-surgeon" and "investigators."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set data.

Biometry: The comparison was statistical ("correlation and agreement") between the VICTUS OCT and LENSTAR LS900.
Capsulotomy Completion/Adverse Events: These were reported by investigators, implying direct observation and recording without a separate adjudication process mentioned.

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, an MRMC comparative effectiveness study involving human readers improving with AI assistance was not conducted or described. This device is an ophthalmic laser for surgical procedures, not an AI diagnostic tool primarily interpreted by human readers. The clinical study focused on the device's accuracy for biometry and its effectiveness in performing specific surgical steps like capsulotomy and lens fragmentation. The "OCT subassembly" is part of the device's guidance system, not an AI assistance for human image interpretation.

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

The performance of the VICTUS Femtosecond Laser Platform itself, as a device performing surgical actions (cuts, fragmentation, imaging), is inherently standalone in its operation. However, surgical procedures always involve a human surgeon in the loop for planning, supervision, and execution. The "standalone" aspect, in this context, would relate to the laser's ability to precisely execute its programmed actions and measurements.

Non-Clinical Tests: These were standalone tests of the device's physical performance characteristics.
Clinical Studies: The study confirmed the "intraoperative accuracy of biometry visualization performed by VICTUS optical coherence tomography (OCT)" and the laser's ability to complete capsulotomy. This can be considered evaluating the standalone performance of the device's functions, although within the context of a surgical procedure where a surgeon operates the device.

7. The Type of Ground Truth Used

Non-Clinical: The ground truth for bench testing would typically be established through precise metrological measurements and adherence to predefined engineering specifications. For material like porcine eyes, histopathology might be used to confirm laser effects, though not explicitly stated.
Clinical:
- Biometry: The LENSTAR LS900 was used as the reference standard for axial optical resolution accuracy (lens thickness, anterior chamber depth, and central cornea thickness). This acts as a proxy for ground truth, assuming the LENSTAR LS900 is accepted as an accurate measurement device.
- Capsulotomy Completion: The ground truth was observed clinical outcome, specifically whether the capsulotomy was completed fully by the laser without manual intervention.
- Adverse Events: The absence of reported adverse events constitutes the ground truth for safety in the study.
- Cataract Grades: Clinical assessment (implicitly by ophthalmologists) was the ground truth for cataract grading.

8. The Sample Size for the Training Set

The document does not mention any "training set." This summary pertains to the evaluation of a physical medical device (femtosecond laser) whose functionality is based on established physics and pre-programmed parameters, not a machine learning or AI algorithm that requires a training dataset in the conventional sense. The "software version 3.2" is updated device control software, not a trainable AI model in the common "training set" connotation.

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

Since no training set for an AI/ML algorithm is mentioned, this question is not applicable based on the provided text. The device's "training" in a broad sense would be its design, calibration, and validation against engineering specifications during its development.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 24, 2015

Technolas Perfect Vision GmbH Mr. Ken Nehmer Senior Manager, Regulatory Affairs 351 Buena Vista Ave. E Unit 501 E San Francisco, California 94117

Re: K151161

Trade/Device Name: Victus Femtosecond Laser Platform Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE, HOF Dated: April 30, 2015 Received: May 1, 2015

Dear Mr. 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. 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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Page 2 - Mr. Ken Nehmer

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

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 comea in patients undergoing cataract surgery or other ophflaalmic treatment requiring cuts / incisions in the comea.

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

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

2 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."

FORM FDA 3881 (8/14)

Page 1 of 1

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ട. 510(k) Summary of safety and effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant:	Technolas Perfect Vision GmbHMesserschmittstr. 1 +380992 Munich, GermanyTel: 49 174 3494062
Contact:	Ken NehmerSr. Manager, Regulatory AffairsTechnolas Perfect Visionc/o 351 Buena Vista Ave. EUnit 501ESan Francisco, CA 94117Ph: 415-297-0408Email: ken.nehmer@bausch.com
Date of Summary:	April 30, 2015
Trade Name:	VICTUS Femtosecond Laser Platform
Common Name:	Ophthalmic Laser
ClassificationName:	Laser, Ophthalmic
DeviceClassification:	Class II
Product Code	OOE (Ophthalmic Femtosecond Laser)HQF (Laser, Ophthalmic)
Predicate Devices:	VICTUS Femtosecond Laser Platform (K132534)

Substantially Equivalent To

510(k) Number	Product Trade Name	Manufacturer
K141379	VICTUS Femtosecond Laser Platform	Technolas Perfect Vision GmbH
K140615	VICTUS Femtosecond Laser Platform	Technolas Perfect Vision GmbH

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Description of the Device Subject to Premarket Notification

The fundamental scientific technology and indications for use remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K141379.

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

Technical Characteristics Comparison

The design principle of the VICTUS Platform is the same as that previously cleared for VICTUS under K141379. The VICTUS Platform mode of operation and software version (version 3.2) is the same as that previously cleared for the VICTUS Platform via

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SECTION 5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K141379 which delivers femtosecond pulses to produce a pattern of photodisruption to create cuts / separation in ophthalmic tissue.

The means of fixation (suction clip) of the patient contact portion of the VICTUS Platform has been modified as described within this premarket submission. The VICTUS Platform uses vacuum to affix a suction ring to the corneal surface prior to use. There is no change to vacuum suction or force pressure related to the patient interface as compared to that previously described and cleared in K141379.

The VICTUS Platform mode of operation and the technology used to create the cutting action are identical to the predicate VICTUS Platform device (K141379), and therefore substantially equivalent to the legally marketed predicate device.

Performance Data

The VICTUS Femtosecond Laser Platform has undergone testing and is in compliance with applicable safety standards as listed in the following table.

Standard	Title
EN ISO 60601-1	Medical electrical equipment – Part I: General requirementsfor safety
EN ISO 60601-1-2	Medical electrical equipment – Part 1: General requirementsfor safety; 2. Collateral standard: electromagneticcompatibility; requirements and tests
EN ISO 60601-2-22	Medical electrical equipment – Part 2: Particular requirementsfor the safety of diagnostic and therapeutic laser equipment

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.

Non-Clinical Performance Data

A variety of test procedures were conducted to demonstrate that the performance of the lens fragmentation indication previously cleared via K140615 (using software version 2.7 SP3) provides substantially equivalent results when using software version 3.2 (previously cleared via K141379). The collected data were evaluated by comparing the mean values to the specified acceptance criteria and their 95% confidence intervals. Four different materials were used for the bench performance testing: porcine eyes, agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA). The acquired test data successfully verified that the various parameters meet their pre-defined acceptance criteria.

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Clinical Performance Data

Clinical performance data was collected using software version 3.2 with the new OCT subassembly (data provided and cleared via K141379). An open, controlled, multisurgeon, single-center clinical study was performed to confirm the intraoperative accuracy of biometry visualization performed by VICTUS optical coherence tomography (OCT) and its comparability with LENSTAR LS 900 by means of axial optical resolution accuracy comparison. Two groups of patients from two clinical applications i.e. femtosecond-laser flap creation (flap group - 58 eyes) and femtosecond laser assisted cataract surgery (cataract group - 113 eyes) were observed in this study. All 113 and 58 eyes assigned in the femto-cataract and flap group, respectively were available for a retrospective analysis of the correlation and agreement of the biometric data for lens thickness, anterior chamber depth (ACD) and central cornea thickness (CCT). The lens thickness, ACD and CCT measured by VICTUS OCT were compared with LENSTAR LS900 and the results are consistent.

All the enrolled cataract patients were treated with femtosecond laser assisted capsulotomy before the femtosecond laser assisted lens fragmentation by VICTUS femtosecond laser platform. The cataract group (113 eyes) represented cataract grades I through IV (Grade I = 76, Grade II = 16, Grade III = 16, Grade IV = 5). All laser assisted capsulotomy procedures were completed fully using the VICTUS laser platform with no need for manual intervention to complete the capsulotomy. There were no adverse or serious adverse events reported by the investigators during the clinical study for either the anterior capsulotomy or the lens fragmentation treatments. In addition, there were no device malfunctions which led or potentially led to adverse or serious adverse events.

Basis for Determination of Substantial Equivalence

The technological characteristics of the VICTUS Platform are substantially equivalent to the technological characteristics of the predicate VICTUS Platform which was cleared via K141379.

The indications for the VICTUS Platform remain unchanged from those cleared via K140615 and K141379.

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.