MONARCH IOL DELIVERY SYSTEM

K981571 · Alcon Laboratories · KYB · Jul 9, 1998 · Ophthalmic

Device Facts

• Record ID: K981571
• Device Name: MONARCH IOL DELIVERY SYSTEM
• Applicant: Alcon Laboratories
• Product Code: KYB · Ophthalmic
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of this device is to fold and deliver Alcon ACRYSOF intraocular lenses into the eye for replacement of the human crystalline lens.

Device Story

The MONARCH IOL Delivery System is a surgical instrument used by ophthalmologists to fold and inject ACRYSOF intraocular lenses (IOLs) into the eye during cataract surgery. The system comprises a reusable titanium handpiece and a sterile, single-use cartridge. The surgeon loads the IOL into the cartridge, which is then inserted into the handpiece. A screw-driven plunger mechanism advances the lens through the cartridge, folding it for delivery through a small incision into the capsular bag. The plunger head is contoured to ensure smooth delivery while maintaining clearance for the trailing haptic. This controlled delivery mechanism allows for precise IOL placement, minimizing surgical trauma and ensuring the lens unfolds correctly without compromising its optical or physical integrity.

Clinical Evidence

Bench testing only. Performance data demonstrated that the delivery system successfully folds and delivers ACRYSOF IOLs without altering lens physical or optical properties (diameter, haptic angle, power, resolution, cosmetic attributes). Lenses were observed to unfold completely in a controlled fashion.

Technological Characteristics

System consists of a reusable titanium handpiece and a sterile, single-use cartridge. Operates via a manual screw-driven plunger mechanism to fold and express the lens. No electronic components, software, or external energy sources. Sterilization method for the cartridge is not specified; handpiece is autoclavable.

Indications for Use

Indicated for patients requiring replacement of the human crystalline lens via implantation of Alcon ACRYSOF intraocular lenses.

Regulatory Classification

Identification

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

Predicate Devices

• MONARCH IOL Delivery System (Alcon Laboratories, Inc.)
• ChiroFlex Lens Microsert (Chiron Ophthalmics Inc.)
• Softrans Injector (STAAR Surgical Company)

Submission Summary (Full Text)

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K 98/57/

JUL - 9 1998

LABORATORIES

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

May 1, 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)

MONARCH IOL Delivery System Trade Name: IOL Delivery System Common Name: Classification Name: Intraocular lens Guide, 21 CFR 886.4300

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K981571

#### 1. Predicate Device

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

- MONARCH IOL Delivery System, (Alcon Laboratories, Inc.) a.
- ChiroFlex Lens Microsert, (Chiron Ophthalmics Inc.) b.
- Softrans Injector, (STAAR Surgical Company) C.

### 2. Device Description

The MONARCH IOL Delivery System consists of two parts: an autoclavable, reusable titanium handbiece and a sterile, single-use cartridge. It is a device used for folding and delivering ACRYSOF intraocular lenses into the eye for replacement of the human crystalline lens. The system provides a controlled means to reliably place the ACRYSOF intraocular lens into the capsular bag.

# 3. Intended Use of the Device

The intended use of this device is to fold and deliver Alcon ACRYSOF intraocular lenses into the eye for replacement of the human crystalline lens.

# 4. Summary of the Technological Characteristics of the Device

The MONARCH IOL Delivery System utilizes a sterile, single use cartridge and a reusable handpiece to deliver ACRYSOF lenses. The cartridge is designed for easy loading and reliable folding of ACRYSOF lenses. The handpiece accepts the cartridge and delivers the lens by using a plunger to express the lens. The plunger head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by a screw mechanism to ensure a smooth and well controlled lens delivery.

#### 5. Summary of the Performance Data

The performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the overall diameter, haptic angle, power, resolution, or cosmetic attributes of the lenses. The test lenses were delivered smoothly and unfolded completely in a controlled fashion.

# 6. Conclusions

The MONARCH IOL Delivery System is easy to use, properly delivers the Alcon ACRYSOF intraocular lens, and is substantially equivalent to devices such as the Alcon MONARCH IOL Delivery System, the Softrans Injector (Model ET), or the ChiroFlex Lens Microsert system.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 1998

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

Re: K981571

Trade Name: MONARCH™ IOL Delivery System Regulatory Class: I Product Code: 86 KYB Dated: May 1, 1998 Received: May 4, 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 QS 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.

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#### 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 Ralph L. Rosenthal

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

Enclosure

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#### 3. Indication for Use

510(k) Number (if known):

Device Name: MONARCH™ IOL Delivery System

Indications For Use:

The intended use of this device is to fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens

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

Lawrence Romrell
DRL

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K981571

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _

(Optional Format 1-2-96).