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 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 eye. The width of the loading zone has 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Monarch® III IOL Delivery System (C Cartridge). It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device "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." However, the specific acceptance criteria (e.g., maximum force, minimum delivery success rate) from these ISO standards and the reported device performance against those criteria are not detailed in the summary.

Since specific criteria and numerical performance are not provided, a table cannot be constructed with this information.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "tested," but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This was likely part of the detailed test reports submitted with the 510(k), but not included in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the testing described relates to the physical performance of an intraocular lens delivery system against industrial standards (ISO), not the interpretation of medical images or diagnostic outputs requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted and is not applicable. This device is a delivery system, not a diagnostic or interpretive tool that would involve human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This information is not applicable. The device is not an algorithm; it is a physical medical device. The "performance" described relates to its ability to deliver an IOL in conformance with ISO standards, which is inherently a standalone physical test.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is compliance with international ISO standards (ISO 11979-3, ISO 10993, ISO 11135, and ISO 14971) which dictate requirements for intraocular lenses and their delivery systems, biocompatibility, sterilization, and risk management.

8. Sample Size for the Training Set:

This information is not applicable as the device is a mechanical delivery system, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as #8.

Summary

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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: (817) 551-6816 Fax: (817) 551-4630

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:

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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	ProposedMonarch® III IOLDelivery System (CCartridge)	Monarch® II IOLDelivery System (CCartridge)	Monarch® III IOLDelivery System (DCartridge)
510(k) Number	K112977	K003768	K063155
Substantial Equivalence Characteristics
Intended Use	Folding and injectionof AcrySof®intraocular lenses intothe posterior chamberof the eye	Folding and injectionof AcrySof®intraocular lensesinto the posteriorchamber of the eye	Folding and injectionof AcrySof®intraocular lenses intothe posterior chamberof the eye
Anatomical Site of Use	Posterior chamber ofthe eye	Posterior chamber ofthe eye	Posterior chamber ofthe eye
Components	Identical reusablehandpiece and single-use, sterile coatedcartridge	Identical reusablehandpiece and single-use, sterile coatedcartridge	Reusable handpieceand single-use, sterilecoated cartridge
Device Name	ProposedMonarch® III IOLDelivery System (CCartridge)	Monarch® II IOLDelivery System (CCartridge)	Monarch® III IOLDelivery System (DCartridge)
510(k) Number	K112977	K003768	K063155
Substantial Equivalence Characteristics
Handpiece (Identical)
Material	Titanium alloy	Titanium alloy	Titanium alloy
Lens InjectingMechanism	Push and turn	Push and turn	Push and turn
Configuration	Barrel and plungerassembly, the barrelhas a chamber toaccept the cartridgeand the plungeradvances the lens forinjection	Barrel and plungerassembly, the barrelhas a chamber toaccept the cartridgeand the plungeradvances the lens forinjection	Barrel and plungerassembly, the barrelhas a chamber toaccept the cartridgeand the plungeradvances the lens forinjection
Sterilization	Flash autoclave orsteam sterilization byuser	Flash autoclave orsteam sterilization byuser	Flash autoclave orsteam sterilization byuser
Cartridge
Material	Polypropylene with apolyvinylpyrolidione(PVP) coating on theinner lumen	Polypropylene with apolyvinylpyrolidione(PVP) coating on theinner lumen	Polypropylene with apolyvinylpyrolidione(PVP) coating on theinner lumen
Lens FoldingMechanism	Internal cartridgegeometry	Internal cartridgegeometry	Internal cartridgegeometry
Nozzle	Tapered lumen	Tapered lumen	Tapered lumen
Configuration	Lens loading andfolding areaconnected to a lensinjecting nozzle	Lens loading andfolding areaconnected to a lensinjecting nozzle	Lens loading andfolding areaconnected to a lensinjecting nozzle
Sterilization	EtO	EtO	EtO

5. Comparison of Technological Characteristics to Predicate Device:

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and the commended to the

. .

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.

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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 886.4300 Intraocular lens guide.

(a)
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.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.