MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)

K112977 · Alcon Research, Ltd. · MSS · Mar 27, 2012 · Ophthalmic

Device Facts

• Record ID: K112977
• Device Name: MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
• Applicant: Alcon Research, Ltd.
• Product Code: MSS · Ophthalmic
• Decision Date: Mar 27, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This Monarch® III C Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.

Device Story

Monarch® III C Cartridge IOL Delivery System consists of a disposable polypropylene cartridge and a reusable titanium handpiece. Device functions as an intraocular lens guide; cartridge folds and holds Alcon AcrySof® IOLs; handpiece uses a push-and-turn mechanism to advance the lens through a tapered nozzle into the posterior chamber of the eye. Used by ophthalmologists during cataract surgery. Modification from Monarch® II includes increased loading zone width for 6 mm lenses and modified exterior body for manufacturability. Device benefits patient by facilitating controlled, minimally invasive IOL implantation.

Clinical Evidence

Bench testing only. Device tested for delivery of AcrySof® IOLs in conformance with ISO 11979-3 (mechanical testing), ISO 10993 (biocompatibility), ISO 11135 (sterilization), and ISO 14971 (risk management).

Technological Characteristics

Components: Reusable titanium alloy handpiece; single-use polypropylene cartridge with polyvinylpyrrolidone (PVP) coating on inner lumen. Mechanism: Push-and-turn manual injection. Configuration: Barrel and plunger assembly with tapered nozzle. Sterilization: Handpiece via flash autoclave/steam; cartridge via EtO. Standards: ISO 11979-3, ISO 10993, ISO 11135, ISO 14971.

Indications for Use

Indicated for folding, holding, and inserting Alcon intraocular lenses (IOLs) into the posterior chamber of the eye, specifically for lenses approved for use with this inserter.

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® II (C Cartridge) IOL Delivery System (K001157)
• Monarch III (D Cartridge) IOL Delivery System (K063155)

Submission Summary (Full Text)

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March 2012 K112977

MAR 2 7 2012

### 6. 510(K) SUMMARY

### 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:

Catherine Goble Assistant Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134 Phone: [phone] Fax: [phone]

Date Summary Prepared: February 24, 2012

Device Subject to this 510(k):

| Trade Name: | Monarch® III IOL Delivery System |
|----------------------|----------------------------------|
| | ( C Cartridge) |
| Common Name: | Intraocular Lens Guide |
| Classification Name: | 21 CFR 886.4300 |

### 1. Predicate Devices:

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

| 510(k) Number | Device |
|---------------|-----------------------------------------------|
| K001157 | Monarch® II (C Cartridge) IOL Delivery System |
| K063155 | Monarch III (D Cartridge) IOL Delivery System |

### 2. Device Description:

The Monarch® III IOL Delivery System (C Cartridge), hereafter referred to as the Monarch® III C Cartridge, is a modification to the previously cleared Alcon Monarch® II IOL Delivery System (C Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III C Cartridge features nozzle tip sizing like the currently marketed Monarch® II C Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the posterior chamber of the width of the loading zone has

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been increased to ease loading of 6 mm lenses. The exterior body has been modified, similar to Monarch® III D cartridge to improve manufacturability. It is designed to work with the currently marketed Monarch® III handpiece, and has been qualified for use with Alcon's AcrySof® Intraocular Lens models.

## 3. Indications for Use:

This Monarch® III C Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.

# 4. Brief Summary of Nonclinical Test and Results:

The Monarch® III C Cartridge, in conjunction with the currently marketed Monarch® III handpiece, has been tested and found to deliver the AcrySof® Intraocular Lens in conformance with the requirements set forth in ISO 11979-3, ISO 10993, ISO 11135, and ISO 14971.

| Device Name | Proposed<br>Monarch® III IOL<br>Delivery System (C<br>Cartridge) | Monarch® II IOL<br>Delivery System (C<br>Cartridge) | Monarch® III IOL<br>Delivery System (D<br>Cartridge) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K112977 | K003768 | K063155 |
| Substantial Equivalence Characteristics | | | |
| Intended Use | Folding and injection<br>of AcrySof®<br>intraocular lenses into<br>the posterior chamber<br>of the eye | Folding and injection<br>of AcrySof®<br>intraocular lenses<br>into the posterior<br>chamber of the eye | Folding and injection<br>of AcrySof®<br>intraocular lenses into<br>the posterior chamber<br>of the eye |
| Anatomical Site of Use | Posterior chamber of<br>the eye | Posterior chamber of<br>the eye | Posterior chamber of<br>the eye |
| Components | Identical reusable<br>handpiece and single-<br>use, sterile coated<br>cartridge | Identical reusable<br>handpiece and single-<br>use, sterile coated<br>cartridge | Reusable handpiece<br>and single-use, sterile<br>coated cartridge |
| Device Name | Proposed<br>Monarch® III IOL<br>Delivery System (C<br>Cartridge) | Monarch® II IOL<br>Delivery System (C<br>Cartridge) | Monarch® III IOL<br>Delivery System (D<br>Cartridge) |
| 510(k) Number | K112977 | K003768 | K063155 |
| Substantial Equivalence Characteristics | | | |
| Handpiece (Identical) | | | |
| Material | Titanium alloy | Titanium alloy | Titanium alloy |
| Lens Injecting<br>Mechanism | Push and turn | Push and turn | Push and turn |
| Configuration | Barrel and plunger<br>assembly, the barrel<br>has a chamber to<br>accept the cartridge<br>and the plunger<br>advances the lens for<br>injection | Barrel and plunger<br>assembly, the barrel<br>has a chamber to<br>accept the cartridge<br>and the plunger<br>advances the lens for<br>injection | Barrel and plunger<br>assembly, the barrel<br>has a chamber to<br>accept the cartridge<br>and the plunger<br>advances the lens for<br>injection |
| Sterilization | Flash autoclave or<br>steam sterilization by<br>user | Flash autoclave or<br>steam sterilization by<br>user | Flash autoclave or<br>steam sterilization by<br>user |
| Cartridge | | | |
| Material | Polypropylene with a<br>polyvinylpyrolidione<br>(PVP) coating on the<br>inner lumen | Polypropylene with a<br>polyvinylpyrolidione<br>(PVP) coating on the<br>inner lumen | Polypropylene with a<br>polyvinylpyrolidione<br>(PVP) coating on the<br>inner lumen |
| Lens Folding<br>Mechanism | Internal cartridge<br>geometry | Internal cartridge<br>geometry | Internal cartridge<br>geometry |
| Nozzle | Tapered lumen | Tapered lumen | Tapered lumen |
| Configuration | Lens loading and<br>folding area<br>connected to a lens<br>injecting nozzle | Lens loading and<br>folding area<br>connected to a lens<br>injecting nozzle | Lens loading and<br>folding area<br>connected to a lens<br>injecting nozzle |
| Sterilization | EtO | EtO | EtO |

# 5. Comparison of Technological Characteristics to Predicate Device:

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#### Public Health Service

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

Ms. Catherine Goble Assistant Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134

MAR 2 7 2012

### Re: K112977

Trade/Device Name: Monarch® III IOL Delivery System (C Cartridge) Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, Reserved Product Code: MSS Dated: March 6, 2012 Received: March 7, 2012

Dear Ms. Goble:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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# Page 2 - Ms. Catherine Goble

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.

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/CDRH/CDRHOffices/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.

Sincerely yours.

Kesia Alexander

Malvina B. Evdelman, 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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# Monarch III C Cartridge 510(k)

Page 1 of 1

# 5. INDICATIONS FOR USE STATEMENT

K112977 510(k) Number (if known):

Monarch III IOL Delivery System Device Name: (C Cartridge)

Indications for Use:

This Monarch® III C Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.

Prescription Use X (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)

Jennifer H. Brown
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_KIJ 297