TBD

K112098 · Lensar, Inc. · OOE · Oct 19, 2011 · Ophthalmic

Device Facts

• Record ID: K112098
• Device Name: TBD
• Applicant: Lensar, Inc.
• Product Code: OOE · Ophthalmic
• Decision Date: Oct 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LensAR-fs Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.

Device Story

Ophthalmic surgical laser system; utilizes mode-locked Yb:YAG laser (1030 nm wavelength, 1500 femtosecond pulse width). System performs anterior capsulotomy and lens fragmentation via plasma-mediated ablation and photodisruption. Input: computer-controlled scanning of laser beam focus in 3D. Output: precise incisions in lens and capsular tissue. Used in clinical settings by surgeons. Patient interface includes suction ring and Index Matching Eye Docking (IMED) device to optimize targeting. Laser cuts lens into radial sections and concentric cylinders, mimicking manual 'phaco chop' technique. Benefits include increased precision and predictability of incision patterns compared to manual methods.

Clinical Evidence

Bench testing only. Evaluated accuracy and reproducibility of capsulotomy incisions in ex vivo porcine eyes and human donor ocular globes. Results demonstrated incision patterns were accurate and predictable, consistent with predicate device performance. No clinical data required.

Technological Characteristics

Mode-locked Yb:YAG laser; 1030 nm wavelength; 1500 femtosecond pulse width. Plasma-mediated ablation and photodisruption mechanism. Computer-controlled 3D beam scanning. Includes disposable patient interface (suction ring and Index Matching Eye Docking device).

Indications for Use

Indicated for patients undergoing cataract surgery requiring anterior capsulotomy and/or laser phaco fragmentation.

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

• LensAR Laser System (K090633)
• LensAR Laser System (K102727)
• LenSx 550 Laser System Model 550 (K094052)
• LenSx 550 Laser System Model 550 (K082947)

Submission Summary (Full Text)

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

OCT 1 9 2011

# KILOGGE

## 510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS (SS&E)

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

#### SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED

- a. Applicant: LensAR. Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826 Tel: [phone] Fax: [phone]
- b. Contact Person: S.K. McGarvey Regulatory Consultant [e-mail] Cell: [phone] Fax: [phone]

## DATE SUMMARY PREPARED: July 20, 2011

# NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

| a. Trade/Proprietary Name: | LensAR-fs Laser System |
|----------------------------|---------------------------------------------|
| b. Common/Usual Name: | LensAR-fs Laser System |
| c. Classification Name: | Ophthalmic Laser, Phacofragmentation System |
| d. Classification Code(s): | 21 CFR 886.4390 OOE; 21 CFR 886.4670 HQC |

#### PREDICATE DEVICES

| 510(K) # | TRADE NAME | MANUFACTURER |
|------------------------|----------------------------------|--------------------|
| K090633 and<br>K102727 | LensAR Laser System | LensAR, Inc. |
| K094052 and<br>K082947 | LenSx 550 Laser System Model 550 | LenSx Lasers, Inc. |

#### DEVICE DESCRIPTION

The predicate LensAR Laser System is an ophthalmic surgical laser that has been cleared for use in anterior capsulotomy in cataract surgery (K090633) and anterior capsulotomy and laser phaco fragmentation performed individually or consecutively during the same surgery (K102727). In new laser device with modification to the pulse width of the laser (LensAR-fs Laser System) is intended for use in the same indication as cleared in K102727.

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

The system employs a mode-locked Yb:YAG laser which generates a high frequency series of ultrashort (1500 femtosecond), low energy pulses at a wavelength of 1030, my The system is technologically the same as defined for the predicate device, i.e., designed to cut the lens and lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted itssue at the beam focus. The precision capsulotomy and lens fragmentation is generated by computercontrolled scanning of the position of the laser beam focus in three dimensions at the target location. The laser energy is delivered to the eye through a disposable, patient interface device that consists of two separately packaged parts: a commercially wailable Suction Ring with Spring Loaded Syringe to fixate the eye and an Index Matching Eye Docking (IMED) device designed to match the refractive index of the comea to optimize beam targeting accuracy.

#### STATEMENT OF INTENDED USE

The LensAR-fs Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively diring the same surgery.

# TECHNOLOGICAL CHARACTERISTICS COMPARISON

The LensAR-fs Laser System is consistent with the technological characteristics of the predicate device LensAR Laser for use in Anterior Capsulotomy (K090633) and in Laser Phaco Fragmentation (K102727). This LensAR-fs Laser surgical device incorporates a change in pulse width and minor software and hardware changes for use in the same Indications for Use: Anterior Capsulotomy and Laser Phaco Fragmentation during cataract surgery.

The LensAR-fs Laser System is of comparable type and is substantially equivalent to the following predicate devices:

| 510(k) Number | Clearance Date | Device Description |
|----------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------|
| K102727<br>Anterior Capsulotomy &<br>Laser Phaco Fragmentation | 03/16/2011 | LensAR Laser System - Laser Technology<br>and Indications for Use predicate device |
| K090633<br>Anterior Capsulotomy | 05/13/2010 | LensAR Laser System - Laser Technology<br>and Indications for Use predicate device |
| K094052<br>Anterior Capsulotomy &<br>Lens Fragmentation | 04/23/2010 | LenSx 550 Laser System - Laser Technology<br>and Indications for Use predicate device |
| K082947<br>Anterior Capsulotomy | 08/14/2009 | LenSx 550 Laser System - Laser Technology<br>and Indications for Use predicate device |

{2}------------------------------------------------

- The activities used to evaluate the LensAR-fs Laser System (LLS-fs) and the . information and reports provided in this 510(k) submission do not identify any new issues of safety or effectiveness. The optical radiation hazard analysis done by Dry Sliney confirms the continuing ocular safety equivalence to the predicate device detailed in 510(k) K102727 for the predicate device.
- The LensAR-fs Laser technology and mechanism of laser-tissue interaction are . similar to other ultrashort pulse lasers identified in the table above.
- The indication for use statement for anterior capsulotomy and laser phaco . fragmentation for the LLS-fs is the same as that of the predicate devices detailed in the table above.
- The differences between the LLS-fs and the predicate devices are insignificant and do . not affect the safety or effectiveness of the device.

### BRIEF SUMMARY OF PRECLINICAL AND CLINICAL PERFORMANCE TEST RESULTS

The performance data supporting substantial equivalence of the LensAR-fs Laser System to the predicate LensAR device are summarized as follows:

# Summary of Pre-Clinical Testing

Testing and analyses performed included accuracy and reproducibility of capsulotomy incisions in ex vivo porcine eyes. The data demonstrated that the Lers on explanot produces anterior capsulotomy incision patterns that are accurate and predictable in size and shape, which confirm equivalence to those achieved with the predicate LensAR Laser device (K090633 and K102727).

Additional evaluations were done in human donor ocular globes to establish the equivalence of the geographical cutting patterns to those established for the predicate LensAR Laser in 510(k) K102727. In the same manner, as demonstrated by the LensAR predicate device use, the fs laser causes the lens to be divided, employing linear cuts, into a number of radial sections, similar in shape to those created by the conventional manual "phaco chop" surgical technique, and then further divided by applying a set of concentric cylindrical cuts through the radial sections.

The technical characteristics of the LensAR-fs Laser fall between those of the LensAR Laser and the LenSx Laser as seen in the comparative analysis supplied in the supporting documentation and raise no new issues with respect to the safety and effectiveness of the device in its intended use. Thus no new clinical evaluations were required.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

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

LensAR, Inc. c/o Ms. Shirley McGarvey Regulatory Consultant 2800 Discovery Drive, Suite 100 Orlando, FL 32826

Re: K112098

Trade/Device Name: LensAR-fs Laser System for Anterior Capsulotomy and Laser Phaco Fragmentation Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE, HOC Dated: September 27, 2011 Received: September 29, 2011

Dear Ms. McGarvey:

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.

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

Page 2 - Ms. Shirley McGarvey

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

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

Sincerely yours,
Kesia Alexander

Image /page/4/Picture/7 description: The image contains a handwritten word "for" in cursive script. The letter "f" has a long, curved descender extending below the baseline, and the "o" and "r" are connected with smooth strokes. The writing appears to be done with a pen or marker, and the lines are clear and legible.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

### Indications for Use Statement

| 510(k) Number (if known): | K112098 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | LensAR-fs Laser System for Anterior Capsulotomy and Laser Phaco Fragmentation |
| Indications for Use: | The LensAR-fs Laser System is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery. |

Prescription Use: X (Part 21 CFR 801 Subpart D) And/Or

Over-the-Counter Use: (Part 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)

Ors. C. Callaway for DLK
Dr. Vivian S. Cox

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112098

LensAR, Inc. - 510(k) for LensAR-fs Laser System for Anterior Capsulotomy and Laser Phaco Fragmentation