ALCON SERIES 20000 LEGACY MACKOOL SYSTEM

K955789 · Alcon Laboratories · HQC · Mar 21, 1996 · Ophthalmic

Device Facts

• Record ID: K955789
• Device Name: ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
• Applicant: Alcon Laboratories
• Product Code: HQC · Ophthalmic
• Decision Date: Mar 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of this device is the automated phacoemulsification of a cataractous natural crystalline lens.

Device Story

Device is a phacoemulsification tip and sleeve assembly used during cataract surgery. System utilizes ultrasonic energy generated by a console, delivered to a handpiece, and converted into mechanical vibration via a hollow titanium needle to emulsify cataractous lens material. Irrigation fluid is delivered via an outer sleeve; emulsified material is aspirated through the needle center. New design incorporates an inner protective sleeve around the tip barrel to reduce heat transfer to the incision site. Operated by ophthalmic surgeons in an OR setting. Reduced heat transfer minimizes risk of corneal burns, allows for smaller incisions, improves wound stability, and reduces corneal endothelium hydration. Output is the physical emulsification and removal of the lens; surgeon monitors procedure via microscope and console feedback to guide clinical decision-making.

Clinical Evidence

Bench testing and post-mortem eye tests compared thermal, fluidic, and cutting performance against predicates. Thermal testing using thermocouples showed Mackool tips generated significantly lower temperatures than standard Alcon tips and lower temperatures than Storz MicroSeal tips. Fluidic testing confirmed similar infusion flow capabilities. Cutting performance was evaluated via bench-measured stroke length and surgeon evaluation, demonstrating performance equal to Alcon predicates and superior to Storz predicates.

Technological Characteristics

Phacoemulsification tip and sleeve assembly. Materials: hollow titanium needle, thin plastic inner sleeve, standard infusion sleeve. Energy: ultrasonic. Dimensions: available in two tip diameters and three edge bevel angles. Function: inner sleeve isolates tip from incision site to reduce heat transfer. Standalone accessory for phacoemulsification systems.

Indications for Use

Indicated for patients requiring phacoemulsification for the removal of cataractous natural crystalline lenses.

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

• Storz Modified Phaco Needle with Insulation Sleeve (K926512)
• Epsilon Ultrasonic Tips & Accessories (K831836)
• Alcon Gemini Ophthalmic Surgery System (Series 20,000 Legacy) (K911808)
• Alcon Series Ten Thousand Master (K861380)

Submission Summary (Full Text)

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K955789
Alcon
LABORATORIES

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

December 15, 1995

# 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: Alcon Series 20000® LEGACY® Mackool™ System
Common Name: Phacoemulsification Tip and Sleeve
Classification Name: Phacofragmentation System (per 21 CFR 886.4670)

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# 1. Predicate Device

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

a. K926512, Storz Modified Phaco Needle with Insulation Sleeve, (Storz Instrument Company)
b. K831836, Epsilon Ultrasonic Tips & Accessories, (CooperVision/Alcon Laboratories)
c. Phacoemulsification tips associated with Alcon’s:
K911808, Gemini Ophthalmic Surgery System (Series 20,000® Legacy®)
K861380, Series Ten Thousand Master

# 2. Device Description

The Series 20000 Legacy System and its predicate devices use ultrasonic energy to emulsify cataractous lens material and remove it from the eye (phacoemulsification). Electronic energy is generated in the machine, delivered to a handpiece and converted to ultrasonic energy delivered through a hollow titanium needle, or tip. Irrigation fluid is delivered to the eye via the combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the handpiece/tip assembly.

In this new system, an inner protective sleeve has been attached around the barrel of the ultrasonic tip in order to reduce the amount of undesirable heat transferred to the wound site. These ultrasonic tips will be available in three (3) styles each consisting of combinations of two (2) tip diameters and three (3) tip edge bevel angles.

# 3. Intended Use of the Device

The intended use of this device is the automated phacoemulsification of a cataractous natural crystalline lens.

# 4. Summary of the Technological Characteristics of the Device

The Alcon Mackool System Tip Sleeve Combination (TSC) utilizes the same technology (and patents) as the Storz MicroSeal Ultrasonic Tip Sleeve Combination in that a portion the ultrasonic tip is covered by a thin plastic inner sleeve under the standard infusion sleeve. The inner sleeve reduces the unwanted heat generated, isolates the tip from the incision site, and reduces the chance of corneal burn during surgery. This improvement will also allow surgeons to use smaller surgical incisions, reduce wound leakage, promote a more stable eye chamber, and result in less corneal endothelium hydration.

# 5. Summary of the Performance Data

Performance of Alcon’s Mackool system TSC’s was compared to the predicate devices in three areas: thermal performance, fluidics performance and cutting performance.

Thermal performance was evaluated in bench tests and in post mortem eye tests by using thermocouples to measure the temperature at the wound site in simulated use tests. Alcon Mackool™ tips showed significantly lower temperature than Alcon standard 0.9 mm, and somewhat lower temperature than Storz MicroSeal tips.

Fluidics performance was evaluated by measuring the infusion flow capability of the new device compared to the predicate devices. All TSC were found to have similar flow capability. The clinical relevance of this is that intraocular pressure during phacoemulsification procedures will be similar for all the devices, assuming the same steady aspiration flow rate.

Cutting performance was evaluated in bench tests by measuring tip stroke length and in the clinic by surgeon evaluation. Both tests showed Mackool tips have an acceptable cutting performance which is equal to (Alcon tips) or superior to (Storz tips) the cutting performance of the predicate devices.

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The performance testing has shown that Alcon’s Mackool system has similar or better thermal, fluidic, and cutting performance than the predicate devices.

## 6. Conclusions

Therefore, based on the data provided in this Premarket notification, the Alcon Mackool System has been proven to be substantially equivalent to predicate devices such as the Storz Modified Phaco Needle with Insulation Sleeve and other devices detailed in Item 1 (above).

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