INFINITI

K021566 · Alcon Laboratories, Inc. · HQC · Jul 2, 2002 · Ophthalmic

Device Facts

• Record ID: K021566
• Device Name: INFINITI
• Applicant: Alcon Laboratories, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.

Device Story

Infiniti Cataract Extraction System is a phacofragmentation system used by ophthalmologists during anterior segment surgery. It performs simultaneous lens emulsification, irrigation, and aspiration, with ancillary functions including vitreous aspiration, cutting, and bipolar coagulation. The system is a modification of the Alcon Series 20000 Legacy system. It provides surgeons with a controlled environment for cataract removal, facilitating efficient lens extraction and associated surgical tasks. The device is intended for use in clinical settings by trained ophthalmic surgeons.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, and UL 2601-1 standards for electrical safety and electromagnetic compatibility. Biocompatibility testing performed per ISO 10993-1, 10993-5, 10993-7, and 10993-10. Sterilization validation performed per ISO 11135.

Technological Characteristics

Phacofragmentation system for anterior segment surgery. Includes irrigation, aspiration, and bipolar coagulation capabilities. Consumables are EtO sterilized (ISO 11135). Reusable handpieces require validated reprocessing. Electrical safety per IEC 60601-1 and UL 2601-1. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients undergoing cataract surgery requiring lens emulsification, removal, vitreous aspiration, cutting, and bipolar coagulation.

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

• Gemini Ophthalmic Surgery System (K911808)
• Sovereign Cataract Extraction System (K981116)
• Storz Premiere II Microsurgical System (K961310)
• Cataract Liquefracture Device (AquaLase) (K980292)
• Phacotron Gold Multifunction Ultrasonic (Tmesis) Handpiece (K925631)

Submission Summary (Full Text)

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K021566

# JUL - 2 2002

### Premarket Notification 510(k) Summary

This summary document is being prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Michael Buenger Associate Director, Regulatory Affairs Alcon Research, Inc. 6201 South Freeway Fort Worth, TX 76132 Phone: [phone] Fax: [phone]

Date Summary Prepared: May, 1, 2002

Device Subject to this 510(k)

| Trade Name: | <i>Infiniti</i> ™ Cataract Extraction System |
|----------------------|-------------------------------------------------|
| Common Name: | Phacofragmentation System |
| Classification Name: | Phacofragmentation System (per 21 CFR 886.4670) |

#### 1. Predicate Devices:

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

| 510(k) Number | Device |
|---------------|-------------------------------------------------------------------------------------------------|
| K911808 | Gemini Ophthalmic Surgery System<br>(Marketed as the Series 20000® Legacy® (STTL) and Accurus®) |
| K981116 | Sovereign* Cataract Extraction System |
| K961310 | Storz Premiere* II Microsurgical System |
| K980292 | Cataract Liquefracture Device (Marketed as AquaLase™) |
| K925631 | Phacotron Gold* Multifunction Ultrasonic (Tmesis*) Handpiece |

#### 2. Device Description

The Infiniti" is a cataract extraction system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting The Infiniti" system is a modification of the Alcon Series along with bipolar coagulation. 20000 " Legacy " system and is substantially equivalent to the predicate devices listed above.

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## 3. Indications for Use:

The intended use of the device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.

#### 4. Brief Summary of Nonclinical test and Results:

Safety tests of the Infinitit" Cataract Extraction System will demonstrate its compliance with applicable requirements of the following standards:

| IEC 60601-1: 1988 | Medical Electrical Equipment, Part 1 - General Requirements for<br>Safety. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:<br>A1:1991-11 +<br>A2:1995 -03 | Amendment - Medical Electrical Equipment, Part 1 - General<br>Requirements for Safety |
| IEC 60601-1-2 : 1993 | Medical electrical equipment Part 1: General Requirements for<br>Safety 2. Collateral Standard: ElectroMagnetic Compatibility -<br>Requirements and tests. |
| UL 2601-1: 1997 | Medical Electrical Equipment, Part 1 - General Requirements for<br>Safety |

Biocompatibility evaluations of materials coming in contact with the patient fluid path in the Infiniti" system will be performed to the following standards:

| AAMI/ ANSI/ ISO | Biological evaluation of medical devices, Part 1: Evaluation and |
|-----------------|-------------------------------------------------------------------------|
| 10993-1: 1997 | Testing |
| AAMI/ ANSI/ ISO | Biological evaluation of medical devices, Part 5: Test for |
| 10993-5: 1999 | cytotoxicity: in vitro methods. |
| AAMI/ ANSI/ ISO | Biological evaluation of medical devices, Part 7: Ethylene oxide |
| 10993-7: 1995 | sterilization methods. |
| AMI/ ANSI/ ISO | Biological evaluation of medical devices, Part 10: Tests for irritation |
| 10993-10: 1995 | and sensitization. |

The Infiniti" consumable products are provided sterile and intended for single use only. These products will be EtO sterilized and the process will be validated per the standard: AAMI/ ISO 11135:1994: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Reusable handpieces are not provided sterile. Validated reprocessing instructions for cleaning. sterilization and re-use will be provided in the Directions for Use of the product.

Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The Infiniti" Cataract Extraction System will be developed and manufactured in compliance with FDA and ISO quality system requirements. Testing will demonstrate that the functional requirements have been met and that the system specifications are fulfilled prior to commercial product release.

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#### Trademark References:

*PHACOTRON GOLD is a registered trademark of Chiron Corporation *PREMIERE is a registered trademark of Storz Ophthalmics, Inc. Corp. *SOVEREIGN is a registered trademark of Allergan, Inc. Corp. *TMESIS is a registered trademark of Azia Y. Anis *SYNERGIST is a registered trademark of Chiron Corporation

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Alcon Research, Ltd. c/o Mr. Michael Buenger Associate Director, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099

Re: K021566

Trade/Device Name: Infiniti™ Cataract Extraction System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HOC: HOR: MLZ Dated: May 10, 2002 Received: May 13, 2002

Dear Mr. Buenger:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Michael Buenger

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page _1_ of _1_

510(k) Number (if known): ¥021566

Device Name: _ Infiniti™ Cataract Extraction System___

Indications for Use:

The intended use of this device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Donna L. Vedner, for DMW/ARR
(Division Sign Off)

ision of Ophthaln Nose and Throat De

510(k) Number K021566

(Optional Format 3-10-98)