CATARACT LIQUEFRACTURE DEVICE

K980292 · Alcon Laboratories · MUS · May 19, 1998 · Ophthalmic

Device Facts

• Record ID: K980292
• Device Name: CATARACT LIQUEFRACTURE DEVICE
• Applicant: Alcon Laboratories
• Product Code: MUS · Ophthalmic
• Decision Date: May 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract

Device Story

Liquefracture device assists ophthalmic surgeons in cataract removal. Handpiece integrates irrigation, aspiration, and fluid heating functions. Device heats and pressurizes small volumes of Balanced Salt Solution (BSS) within handpiece; pulses of heated BSS are delivered to cataract. Pressure waves from heated fluid pulses fragment cataractous lens, similar to ultrasonic phacoemulsification. Emulsified material is simultaneously aspirated. Used in sterile field by surgeons during cataract surgery. System includes external user interface and low-power DC source for fluid heating. Benefits include efficient cataract softening and fragmentation, facilitating removal and restoring sight.

Clinical Evidence

Bench testing and in vivo calculations provided. Evaluated anterior chamber temperature rise, histological impact of heated BSS pulses, and cataract aspiration efficiency. Results show performance comparable to ultrasonic phacoemulsification.

Technological Characteristics

Handpiece-based system for BSS injection and aspiration. Employs heated fluid pulse technology for cataract fragmentation. Powered by Ophthalmic Surgery system with low-power DC source for heating. Sterile, surgical-use device.

Indications for Use

Indicated for patients requiring cataract removal 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

• Gemini Ophthalmic Surgery System (Series 20,000 Legacy® (STTL))
• Automated HydroSonics® (K902798)

Submission Summary (Full Text)

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

K980292

Image /page/0/Picture/2 description: The image shows the logo for Alcon Laboratories. The word "Alcon" is in large, bold, black letters. Below that, the word "LABORATORIES" is in smaller, black letters.

ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134-2099 [phone]

January 21, 1998

510(K) SUMMARY

Submitted by:

Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 [phone] (Phone) [phone] (Fax)

Trade Name: Common Name Classification Name

TBD Cataract Liquefracture Device Phacofragmentation System (per 21 CFR 886.4670)

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

K980292

# 1. Predicate Device

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

Phacoemulsification function associated with Alcon's: 11808, Gemini Ophthalmic Surgery System (being marketed as the Series 20,000 Legacy® (STTL)).

Automated HydroSonics® function: K902798

## 2. Device Description

The Liquefracture device is designed to assist ophthalmic surgeons in the removal of cateractous lenses (cataracts) for the purpose of restoration of impaired sight due to the formation of a cataract. Currently, their are two common methods used to complete this procedure. The first is to remove the lens in its entirety or in large sections by manually grasping and explanting (extracapsular cataract extraction or ECCE). The second is to use ultrasound to fragment the cataract into small pieces that are simultaneously drawn out of the eye through an aspiration tube (phacoemulsification). Alcon has developed and marketed a cataract pretreatment method (Automated HydroSonics") to Improve the efficiency of ultrasonic phacoemulsification.

The Liquefracture device combines the prefreatment and emulsification functions. It will be packaged into a handpiece used directly by the surgeon within the sterile field. The handpiece will be driven by a Ophthalmic Surgery system containing irrigation and aspiration functions as currently provided in cataract surgery equipment. In addition, a low power DC power source will be included in the Ophthalmic Surgery system to control the fluid heating function of the handpiece. A user interface will also be provided by the Ophthalmic Surgery system, which is placed external to the sterile environment (field) just as in most cataract surgery equipment.

#### 3. Intended Use of the Device

This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract.

# 4. Summary of the Technological Characteristics of the Device

The Automated HydroSonics® instrument is marketed and used to soften a cataract allowing easier ultrasonic emulsification. The mechanism for this softening is a delamination of the layers of the cataract. By increasing the temperature of the delivered fluid and by improving the efficiency of the fluid delivery, not only is the cataract delaminated, the layers are fragmented into portions that are easily aspirated using similar aspiration parameters currently used in phacoemulsification.

The Liquefracture handpiece containing BSS iniection and I/A capability is inserted into the eye. The heated BSS pulses are directed at the cataract while aspiration is engaged to remove emulsified material. Irrigation is also utilized to maintain space and pressure in the anterior segment of the eye.

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

K980292

The heated BSS pulses are created by heating and pressurizing a small volume of fluid within the handpiece. Controlled volumetric infusion of heated BSS is then expressed out of the handpiece when activated by the operator (surgeon).

The heated BSS pulses affect the cataract in the same manner as ultrasound. With ultrasound, the vibrating tip creates forward moving pressure waves which impact the cataract causing fragmentation. For the Liquefracture device, the heated BSS exils the handpiece lumen in pressure waves causing the same fragmentation result when they impact the cataract.

#### 5. Summary of the Performance Data

The testing and calculations provided in this Premarket notification show the device to be as safe and effective in the removal of cataracts as the predicate devices. Specifically, the anterior chamber temperature rise, the histological impact of hot BSS pulses in vivo and the efficiency of cataract aspiration are all comparable to U/S phacoemulsification.

## 8. Conclusions

Therefore, based on the data provided in this Premarket notification, the Alcon Cataract Liquefracture Device has been shown to be substantially equivalent to predicate devices such as those devices described in Item 1 (above).

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 1998

Mr. Martin A. Kaufman Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099

Re: K980292 Trade Name: Cataract Liquefracture Device Regulatory Class: II Product Code: 86 MUS Dated: March 20, 1998 Received: March 26, 1998

Dear Mr. Kaufman:

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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

# Page 2 - Mr. Martin A. Kaufman

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

A. Roepk. Lorenthel

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

Enclosure

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

4980292 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Cataract Liquefracture Device.

Indications For Use:

This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED). Concurrence of CDRH, Office of Device Evaluation (ODE)

Sta C. Clewory

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number. K980292

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)