(161 days)
The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
The Monarch© III IOL Delivery System is a modification to the previously cleared Alcon Monarch(r) II IOL Delivery System (K003768) consisting of a disposable cartridge and reusable handpiece. The Monarch II cartridges are designated as A, B, and C, and feature various nozzle tip sizes that correspond to the various AcrySof® IOL models. As with the cleared cartridges, the Monarch© III IOL Delivery System presented in this submission utilizes a one-piece disposable cartridge (designated as D) with progressive folding in combination with a reusable handpiece (H4). This new cartridge possesses the same basic inner lumen design and lens guiding mechanisms as the existing Monarch*) II A, B, and C cartridges, but differs in nozzle tip sizing.
The document provided is a 510(k) summary for the Alcon Monarch® III IOL Delivery System. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed devices. The summary outlines the device description, indications for use, and a brief summary of nonclinical tests. However, it does not contain detailed acceptance criteria, specific study results proving device performance against those criteria, or the other specific information requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details).
This document is a regulatory submission, not a detailed scientific study report. It states that Alcon will conform to requirements but doesn't provide the test results or the specific acceptance criteria themselves.
Therefore, I cannot provide the requested table and detailed study information based on this document.
Here's an explanation of why the requested information is absent:
- Acceptance Criteria & Reported Performance: The document states that the device "will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product." This is a statement of intent to conform to guidance, not a set of specific, quantified acceptance criteria or a report of the device's performance against them.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): This type of detailed information would typically be found in a comprehensive test report or clinical study report, which is usually part of the full 510(k) submission but not typically included in the public 510(k) summary. For a device like an IOL delivery system, the "ground truth" often relates to mechanical integrity, successful delivery without damage to the IOL or ocular structures, and consistent performance, rather than expert consensus on images.
- Training Set Information: This device is a mechanical delivery system, not an AI or image-based diagnostic tool. Therefore, concepts like "training set," "ground truth for the training set," "experts," and "MRMC studies" are generally not applicable in the context of this type of medical device submission.
In summary, the provided text confirms:
- Device Name: Monarch® III IOL Delivery System (D Cartridge and H4 Handpiece)
- Indication for Use: Implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
- Regulatory Clearance: K063155, cleared March 27, 2007.
- Nonclinical Test Summary: "Alcon has provided a Statement of Conformance... that the Monarch® III IOL Delivery System... will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product."
No further details regarding specific acceptance criteria, study methodologies, statistical results, or expert involvement are present in this 510(k) summary.
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5. 510(K) SUMMARY
MAR 2 7 2007
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 G. Goble Senior Manager, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134 Phone: (817) 551-6816 Fax: (817) 551-4630
Date Summary Prepared: October 9, 2006
Device Subject to this 510(k):
| Trade Name: | Monarch® III IOL Delivery System(D Cartridge and H4 Handpiece) |
|---|---|
| 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 |
|---|---|
| K003768 | Monarch® II IOL Delivery System (A & C Cartridges) |
| K001157 | Monarch® II IOL Delivery System (B Cartridge) |
2. Device Description:
The Monarch© III IOL Delivery System is a modification to the previously cleared Alcon Monarch(r) II IOL Delivery System (K003768) consisting of a disposable cartridge and reusable handpiece. The Monarch II cartridges are designated as A, B, and C, and feature various nozzle tip sizes that correspond to the various AcrySof® IOL models. As with the cleared cartridges, the
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Monarch© III IOL Delivery System presented in this submission utilizes a one-piece disposable cartridge (designated as D) with progressive folding in combination with a reusable handpiece (H4). This new cartridge possesses the same basic inner lumen design and lens guiding mechanisms as the existing Monarch*) II A, B, and C cartridges, but differs in nozzle tip sizing.
3. Indications for Use:
The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
4. Brief Summary of Nonclinical Test and Results:
Alcon has provided a Statement of Conformance (Attachment J) that the Monarch® III IOL Delivery System Cartridge D and Handpiece H4 intended to be introduced, will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alcon Research, Ltd. Ms. Catherine G. Goble Senior Manager, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134
Re: K063155
Trade Name: · Monarch® III IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: KYB Dated: February 28, 2007 Received: March 1, 2007
MAR 2 7 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Catherine G. Goble
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
M.B. Eichler, M.D.
Malvina B. Evdelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 -- Ms. Catherine G. Goble
Indications for Use
510(k) Number (if known): K063155
Device Name: Monarch III IOL Delivery System
Indications For Use:
The MONARCH® III IOL Delivery System is used for implantation of
ALCON® qualified ACRYSOF® intraocular lenses into the eye
following cataract removal.
Prescription Use YES AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Keria Alexander
(Division Sign-Off)
Division of Ophthalmic Ear
Nose and Throat Devises
510(k) Number K6/3155
Page 1 of 1
§ 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.