VICTUS FEMTOSECOND LASER PLATFORM

K132534 · Technolas Perfect Vision GmbH · OOE · Feb 14, 2014 · Ophthalmic

Device Facts

• Record ID: K132534
• Device Name: VICTUS FEMTOSECOND LASER PLATFORM
• Applicant: Technolas Perfect Vision GmbH
• Product Code: OOE · Ophthalmic
• Decision Date: Feb 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

VICTUS Femtosecond Laser Platform is a precision ophthalmic surgical laser. It uses femtosecond laser pulses to perform photodisruption of ocular tissue. Input consists of video images used to verify incision position and shape. The device uses a sterile disposable Patient Interface (contact lens and suction clip) to fix the eye and provide a reference surface for depth control. The system scans thousands of individual pulses to create continuous incisions, including primary and secondary corneal incisions for cataract surgery. Operated by a physician in a clinical setting. Output is visual verification of incision parameters. Benefits include highly reproducible and accurate depth, diameter, and angle of incisions, facilitating direct access into the eye during surgery.

Clinical Evidence

No clinical data provided. Bench testing only. Performance evaluated using porcine eyes, agarose gel, PETG, and PMMA. Testing confirmed that the modified system and new larger diameter patient interface (PI125) produce highly reproducible and accurate incision depth, diameter, and angle, with results substantially equivalent to predicate interfaces.

Technological Characteristics

Ophthalmic femtosecond laser; delivers pulses for tissue photodisruption. Features a sterile disposable Patient Interface (contact lens/suction clip). Connectivity: Not specified. Software version 2.7 SP2. Complies with EN ISO 60601-1, 60601-1-2, 60601-1-4, and 60601-2-22.

Indications for Use

Indicated for patients undergoing LASIK surgery (corneal flap creation), cataract surgery (anterior capsulotomy, corneal incisions), or other ophthalmic treatments requiring lamellar resection or corneal incisions.

Regulatory Classification

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.

Predicate Devices

• VICTUS Femtosecond Laser Platform (K120426)
• VICTUS Femtosecond Laser Platform (K122386)
• LenSx Laser System (K120732)

Submission Summary (Full Text)

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K132534

#### SECTION 5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

# FE3 1 4 2014

#### 510(k) Summary of safety and effectiveness ડ.

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 GmbH<br>Messerschmittstr. 1 +3<br>80992 Munich, Germany<br>Tel: [phone] |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Ken Nehmer<br>Sr. Manager, Regulatory Affairs<br>Technolas Perfect Vision<br>c/o 1025 Sanchez Street<br>San Francisco, CA 94114<br>Ph: 415-297-0408<br>Email: [e-mail] |
| TRADE NAME: | VICTUS Femtosecond Laser Platform |
| COMMON NAME: | Ophthalmic Laser |
| CLASSIFICATION<br>NAME: | Laser, Ophthalmic |
| DEVICE<br>CLASSIFICATION: | Class II |
| PRODUCT CODE | OOE (Ophthalmic Femtosecond Laser)<br>HQF (Laser, Ophthalmic) |
| PREDICATE<br>DEVICES: | VICTUS Femtosecond Laser Platform (K120426 and<br>K122386)<br>LenSx Laser System (K120732) |

#### SUBSTANTIALLY EQUIVALENT TO

| 510(k) NUMBER | PRODUCT TRADE NAME | MANUFACTURER |
|---------------|--------------------------|--------------------------|
| K120426 | VICTUS Femtosecond Laser | Technolas Perfect Vision |
| K122386 | Platform | GmbH |
| K120732 | LenSx Laser System | Alcon LenSx, Inc. |

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### Description of the Device Subject to Premarket Notification

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). In addition, the VICTUS has been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (via K122386).

This 510(k) expands the arcuate corneal incision by allowing the ability for primary and secondary corneal incisions. These cuts/incisions are performed for patients undergoing cataract surgery to allow direct access into the eye. The correct position and shape of the cuts is verified by the video image. The expansion of the corneal incision indication is supported by software version 2.7 SP2.

In addition, an increased diameter patient interface is being introduced (referred to as PI125). The PI125 is a universal PI that allows the use for either corneal or cataract procedures. User request for a smaller diameter patient interface that can be used for both cataract and corneal procedures resulted in the qualification of the existing cataract patient interface as a universal smaller diameter patient interface. Lastly, the bottom end of the pulse duration range has been modified to be lower than that previously cleared in K120426 and K122386.

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 eve relative to the delivery of the laser beam. 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 remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K120426 and K122386.

#### 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.

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### Technical Characteristics Comparison

The design principle of the VICTUS Platform is fundamentally the same as that previously cleared for VICTUS under K120426 and K122386. The VICTUS Platform mode of operation is the same as the previously cleared VICTUS Femtosecond Laser Platform cleared in KI20426 and K122386, and the LenSx Laser System cleared in K120732. all of which deliver femtosecond pulses to produce a pattern of photodisruption to create cuts / separation in ophthalmic tissue. The VICTUS Platform delivers femtosecond pulses to produce a pattern of photodisruption for creation of primary and secondary cuts / incisions in the cornea, as does the LenSx predicate system.

The means of fixation of the patient contact portion of the VICTUS Platform is substantially equivalent to that present in the VICTUS Femtosecond Laser Platform cleared in K120426 and K122386, and the LenSx Laser cleared in K120732. All of these predicate systems use suction vacuum to affix a suction ring to the corneal surface prior to use.

The VICTUS Platform mode of operation and the technology used to create the cutting action are similar or identical to these previously mentioned devices, and therefore substantially equivalent to these legally marketed predicate devices.

#### 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 requirements<br>for safety |
| EN ISO 60601-1-2 | Medical electrical equipment - Part 1: General requirements<br>for safety; 2. Collateral standard: electromagnetic<br>compatibility; requirements and tests |
| EN ISO 60601-1-4 | Medical electrical equipment - Part 1-4: General requirements<br>for safety: Collateral standard: Programmable electrical<br>medical systems |
| EN ISO 60601-2-22 | Medical electrical equipment - Part 2: Particular requirements<br>for the safety of diagnostic and therapeutic laser equipment |

The VICTUS Femtosecond Laser Platform has been found to perform equivalently to the predicate devices in patients undergoing ophthalmic surgery or other treatment requiring penetrating arcuate cuts / incisions in the cornea. The VICTUS Femtosecond Laser Platform and the predicate devices therefore have similar performance profiles.

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### Non-Clinical Performance Data

A variety of test procedures were conducted to demonstrate the performance of the modified VICTUS Platform in support of this premarket submission. 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). Testing was performed using the new larger diameter patient interface and results were substantially equivalent to the previously cleared patient interface. The new larger diameter patient interface is also representative for the existing cataract patient interface (use in corneal and cataract applications) as both have identical radius of curvature.

The testing showed that laser-assisted primary and secondary incisions performed with the VICTUS Femtosecond Laser Platform resulted in highly reproducible and accurate depth, diameter, and angle. Assessment of the larger diameter patient interface shows substantially equivalent results as compared to the predicate patient interfaces.

## Basis for Determination of Substantial Equivalence

The technological characteristics of the VICTUS Femtosecond Laser Platform are substantially equivalent to the technological characteristics of the VICTUS Femtosecond Laser Platform (K120426 and K122386), and the LenSx Laser (K120732).

The proposed expansion of the indication for use of primary and secondary incisions for the VICTUS Femtosecond Laser Platform is very similar to the indications for use cleared for the LenSx Laser in K120732: both include creation of corneal cuts/incisions during cataract surgery.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

February 14, 2014

Public Health Service

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

Technolas Perfect Vision GmbH % Mr. Ken Nehmer Sr. Manager, Regulatory Affairs, Americas 1025 Sanchez Street San Francisco, CA 94114

Re: K132534

Trade/Device Name: VICTUS Femtosecond Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: OOE. HOF Dated: January 9, 2013 Received: January 10, 2013

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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Page 2 - Mr. Ken Nehmer

(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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia YAlexander -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): K132534

Device Name: VICTUS Femtosecond Laser Platform

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.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

#### Date: Ka N. To 2014.02.11 17:18:48 -05'00'

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(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices K132534 510(k) Number:

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