INFINITI(R) VISION SYSTEM

K120912 · Alcon Manufacturing, Ltd. · HQC · Jun 15, 2012 · Ophthalmic

Device Facts

• Record ID: K120912
• Device Name: INFINITI(R) VISION SYSTEM
• Applicant: Alcon Manufacturing, Ltd.
• Product Code: HQC · Ophthalmic
• Decision Date: Jun 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal. The following system modalities additionally support the described indications: - Ultrasound with UltraChopper Tip achieves the functionality of cataract separation. - AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells. - The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, and SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Device Story

INFINITI Vision System is a modular phacofragmentation platform for cataract surgery; used in clinical settings by ophthalmologists. System inputs include manual control and surgical parameters for ultrasound, irrigation/aspiration, and IOL injection. Device transforms inputs into mechanical energy for lens emulsification/separation via UltraChopper tip, cortical removal via AquaLase, and IOL delivery via INTREPID AutoSert handpiece. Output is the physical removal of lens material and controlled insertion of IOLs. Healthcare providers monitor system performance via console interface to adjust surgical parameters in real-time. Benefits include efficient cataract removal and standardized IOL implantation.

Clinical Evidence

Bench testing only. Compliance with EN ISO 11979-3, Section 5, was demonstrated for the compatibility of AcrySof IOL models SN6AT3 through SN6AT9 with Monarch II C and Monarch III D cartridges. No clinical data was required or provided.

Technological Characteristics

Modular phacofragmentation system. Components: UltraChopper tip, AquaLase tip, INTREPID AutoSert IOL Injector. Energy: Ultrasound. Sterilization: EtO (AAMI/ISO 11135-1:2007) for single-use accessories; reusable handpieces via validated reprocessing. Software: Unchanged from K112425. Standards: EN ISO 11979-3:2006 (mechanical properties), ISO 14971:2007 (risk management), 21 CFR 820 (GMP).

Indications for Use

Indicated for patients undergoing cataract surgery requiring emulsification, separation, and removal of cataracts, cortical material, and lens epithelial cells; anterior vitrectomy; bipolar coagulation; and intraocular lens (IOL) implantation. Compatible with specific AcrySof IOL models (SN60WF, SN6AD1, SN6AT3-SN6AT9).

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Predicate Devices

• INFINITI® Vision System (Evergreen II) (K112425)
• AquaLase Capsule Wash Tip (K093210)
• Alcon UltraChopper Tip (K091777)
• INFINITI® Vision System with OZil® IP (K082845)
• Monarch III Delivery System (K063155)
• INFINITI® Vision System (K021566)

Submission Summary (Full Text)

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510/1): k120912

# PREMARKET NOTIFICATION 510(k) SUMMARY

The submitter of the 510(k) is

JUN 1 5 2012

r

Martin A. Kaufman Director, Regulatory Affairs Alcon Research Ltd. 18500 Alton Parkway Irvine, CA 92618 Phone: [phone] Fax: [phone]

Device Subject to the 510(k)

Trade Name: Common Name: Classification Name: INFINITI® Vision System Phacofragmentation System Phacofragmentation System

per 21 CFR 886.4670

### Predicate Devices:

The legally marketed devices(s) to which we are claiming equivalence to are:

510(k) numberDevice

| K112425 | INFINITI® Vision System (Evergreen II) |
|---------|---------------------------------------------------------|
| K093210 | AquaLase Capsule Wash Tip |
| K091777 | Alcon UltraChopper Tip |
| K082845 | INFINITI® Vision System with OZil® IP |
| K063155 | Monarch III Delivery System (includes C & D cartridges) |
| K021566 | INFINITI® Vision System |

## Device Description

The INFINITI® Vision System is unchanged from the INFINITI® Vision System (Evergreen II - K112425) and maintains the modular design and incorporated features that include: Power Watch feature, UltraChopper tip, the AquaLase Capsule Wash Tip, the INTREPID® AutoSert™ IOL Injector Handpiece, and the system's associated software.

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### Indications for use:

The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

- Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
- AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells.
- The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, and SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

# Brief Summary of Nonclinical Tests and Results:

Safety tests of the INFINIT!® Vision System have been demonstrated its compliance with all applicable requirements that were covered in K112425. Additional testing that covers the additional AcrySoft intraocular lenses SN6AT3 through SN6AT9 was completed per EN ISO 11979-3, Section 5. Each AcrySoft iens was tested with the Monarch® II C Cartridge and the Monarch® III D Cartridge. This submission makes no changes whatsoever to the INFINITI® Vision System console, Sterilization parameters, Biocompatibility of materials, System Software, or the Electromagnetic and Electrical Safety.

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| Standard # | Title |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| EN ISO 11979-3:<br>2006 | Ophthalmic implants - Intraocular lenses-Part 3: Mechanical<br>Properties and Test Methods, Section 5. |

#### Accessories

Many INFINITI® accessories are provided sterile and are intended for single use only. These products are EtO sterilized and the process has been validated per AAMI/ISO 11135-1:2007: Medical Devices – Validation and routine control of Ethylene Oxide Sterilization. Reusable Handpieces are provided non-sterile. Validated reprocessing instruction for cleaning, sterilization, and re-use of the Handpieces are provided in the Directions for Use provided with the product.

# Conclusions

Technological characteristics affecting the clinical performance are unchanged to that of the predicate devices previously listed. The INFINITI® Vision System has been developed and will be manufactured in compliance with 21CFR 820 and ISO 14971:2007. Non-clinical testing noted above has demonstrated that functional requirements have been met and that this device is equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the logo in a circular fashion.

#### Public Health Service

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

Alcon Research, Ltd. c/o Mr. Martin Kaufman, RAC Director, Regulatory Affairs 15800 Alton Parkway Irvine. CA 92816

Re: K120912

Trade/Device Name: Infiniti Vision System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: II Product Codes: HQC, HQR, MLZ, KYB Dated: March 21, 2012 Received: March 26, 2012

Dear Mr. Kaufman:

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. Iisting 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

JUN 1 5 2012

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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 (OS) 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

ﺎﻝ

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known) _ ★ / 209 / 2 Device Name: INFINITI® Vision System

### Indications for Use:

The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectorny, bipolar coagulation, and intraocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

- Ultrasound with UltraChopper Tip achieves the functionality of cataract separation. -
- AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells
- The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Prescription use X AND/OR Over-The-Counter (21 CFR 801 Subpart C) (Pat 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

120912
510(k) Number