(41 days)
To fold and deliver AMO® Acrylic OptiEdge intraocular lenses into the eye for the replacement of the human crystalline lens.
Not Found
The provided text is a 510(k) summary for a medical device (Lens Delivery System) and does not contain any information about acceptance criteria or a study proving device performance against such criteria.
The document is a regulatory letter from the FDA stating that the device has been found substantially equivalent to a predicate device and can be marketed. It discusses:
- Device Name: Duckworth & Kent Ltd, Lens Delivery System, Model DK7788
- Regulation Number/Name: 21 CFR 886.4300, Intraocular Lens Guide
- Regulatory Class: Class I
- Product Code: MSS
- Indications for Use: To fold and deliver AMO® Acrylic OptiEdge intraocular lenses into the eye for the replacement of the human crystalline lens.
Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2006
Duckworth & Kent c/o Mr. Martin Lock Head of Quality Systems Terence House 7 Marquis Business Centre Royston Road Baldock, Hertfordshire United Kindgom SG7 6XL
Re: K060995
Trade/Device Name: Duckworth & Kent Ltd, Lens Delivery System.
Model DK7788
Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: March 28, 2006 Received: April 11, 2006
Dear Mr. Lock:
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.
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Page 2- Mr. Martin Lock
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 (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. 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 (301) 594 - 4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jenette R. Bono PhD
Malvina B. Eydelman, M.D. Acting Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K060995
Device Name: Duckworth & Kent Ltd, Cartridge Lens Delivery System, Model DK7788
Indications for Use:
To fold and deliver AMO® Acrylic OptiEdge intraocular lenses into the eye for the replacement of the human crystalline lens.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR :
Over-The-Counter Use (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)
Bueltoma
ion of Onrithalmic Ear and Throat Devise
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§ 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.