ALCON ULTRACHOPPER

K091777 · Alcon Research, Ltd. · HQC · Oct 20, 2009 · Ophthalmic

Device Facts

• Record ID: K091777
• Device Name: ALCON ULTRACHOPPER
• Applicant: Alcon Research, Ltd.
• Product Code: HQC · Ophthalmic
• Decision Date: Oct 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ALCON® UltraChopper is indicated to be used with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces. The ALCON® UltraChopper is intended for prescription use only.

Device Story

ALCON® UltraChopper is a modified ultrasonic phacofragmentation tip; used with existing INFINITI® or CONSTELLATION® system handpieces. Device functions as a mechanical tool to separate cataractous lenses into smaller fragments during phacoemulsification surgery. Operated by ophthalmologists in clinical settings. No software modifications required for host systems. Benefits include efficient lens fragmentation using established ultrasonic technology.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, -5, -10, -11, and -12. Functional testing demonstrated that the device meets requirements and performs equivalently to predicate devices.

Technological Characteristics

Material: Titanium 6AL-4V alloy. Principle: Ultrasonic phacofragmentation. Form factor: Modified phaco tip compatible with INFINITI®/CONSTELLATION® handpieces. Sterilization: Gamma radiation (SAL 10^-6) per EN ISO 11137-1:2006. Compliance: 21 CFR 820, ISO 14971:2003.

Indications for Use

Indicated for use with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces in patients undergoing cataract surgery.

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

• Bausch & Lomb Phaco Chop Needle (K041998)
• INFINITI® Cataract Extraction System (K021566)
• ALCON® Vision System (CONSTELLATION®) (K063583)

Submission Summary (Full Text)

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OCT 2 0 2009

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# k091777 Sick :

# 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:

Martin A. Kaufman Director, Regulatory Affairs Alcon Research, Ltd. 15800 Alton Parkway Irvine, CA 92618 Phone: [phone] Fax: [phone]

Device Subject to this 510(k):

ALCON® UltraChopper Trade Name: Common Name: Phacofragmentation tip Classification Name: Phacofragmentation tip (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 |
|---------------|---------------------------------------|
| K041998 | Bausch & Lomb Phaco Chop Needle |
| K021566 | INFINITI® Cataract Extraction System |
| K063583 | ALCON® Vision System (CONSTELLATION®) |

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## 2. Device Description

The ALCON® UltraChopper tip is a modified ultrasonic tip that will be added to the existing ALCON® Phaco tip family. The ALCON® UltraChopper tip is of a similar size and shape as existing Alcon phaco tips and is made with the same material (Titanium 6AL-4V alloy) as the Alcon phaco tips currently used on the INFINITI® System and CONSTELLATION® System. The ALCON® UltraChopper tip will utilize existing packaging configurations and have the same shelf life as existing phaco tips. It can be used with the same ultrasonic handpieces (INFINITI®, INFINITI® NeoSonix® or INFINITI® OZil) currently used on the Alcon systems such as the INFINITI® System and CONSTELLATION® System.

To use the ALCON® UltraChopper as intended, no modification to the existing INFINITI® System and CONSTELLATION® System software is required.

### 3. Indications for Use

The ALCON® UltraChopper is indicated to be used with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces.

### Brief Summary of Non-clinical test and Results 4.

Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:

| Standard # | Title |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 10993-1: 2003 AAMI/ANSI/ISO | Biological Evaluation of Medical Devices --<br>Part 1: Evaluation and testing |
| 10993-5: 1999 AAMI/ANSI/ISO | Biological Evaluation of medical devices --<br>Part 5: Tests for In Vitro cytotoxicity |
| 10993-10:2002/A1:2006 AAMI/<br>ANSI/ISO | Biological Evaluation of Medical Devices --<br>Part 10: Tests for irritation and delayed-type<br>hypersensitivity – Including A1:2006 |
| 10993-11:2006 AAMI/ANSI/ISO | Biological Evaluation of Medical Devices --<br>Part 11: Tests for systemic toxicity |
| 10993-12:2007 AAMI/ANSI/ISO | Biological Evaluation of Medical Devices --<br>Part 12: Sample Preparation and Reference<br>Materials |

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The ALCON® UltraChopper tip is provided sterile and intended for single use only. This product is Gamma sterilized and the process has been validated to a SAL of 10° per FDA Recognized Consensus Standard - "EN ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".

Technological characteristics affecting clinical performance are similar to those of predicate devices previously listed. The ALCON® UltraChopper tip has been developed and will be manufactured in compliance with section 21 CFR 820 and ISO 14971:2003. Non-clinical testing has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Mr. Martin Kaufman Director, Regulatory Affairs Alcon Research, Ltd. 15800 Alton Parkway Irvine CA 92618

OCT 2 0 2009

Re: K091777

Trade/Device Name: Alcon UltraChopper Regulation Number: 21 CFR 886.4670 Regulation Name: Phacoemulsification Tip Regulatory Class: II Product Code: HOC Dated: September 25, 2009 Received: September 29, 2009

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, 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 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); 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.

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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/CDRH0ffices/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/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.

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

Sincerely yours.

Kessà Alexander for

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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Alcon Research, Ltd. Traditional 510(k) Premarket Notification ALCON® UltraChopper

June 15, 2009

# Indications for Use Statement 4.

The Indications for Use statement is provided here and is also included in Attachment A. The ALCON® UltraChopper is intended for prescription use only.

510(k) Number (if known): _kua) 777 Device Name: ALCON® UltraChopper Indications for Use:

The ALCON® UltraChopper is indicated to be used with an Ultrasonic Phacofragmentation Handpiece to separate a cataractous lens into smaller pieces.

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)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number k091777