CAPSULE TENSION RING INSERTER, MODEL 7-810

K042478 · Duckworth & Kent, Ltd. · NCE · Dec 28, 2004 · Ophthalmic

Device Facts

• Record ID: K042478
• Device Name: CAPSULE TENSION RING INSERTER, MODEL 7-810
• Applicant: Duckworth & Kent, Ltd.
• Product Code: NCE · Ophthalmic
• Decision Date: Dec 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

When a "Morcher Capsular Tension Ring" is to be implanted as part of a cataract procedure. This injector will facilitate the insertion and proper placement of the ring in the capsular bag.

Device Story

Capsule Tension Ring Inserter (7-810) is a manual surgical instrument used by ophthalmologists during cataract procedures. Device facilitates insertion and placement of Morcher Capsular Tension Ring into capsular bag. Operated manually by surgeon in OR setting. Provides mechanical assistance for ring delivery; improves surgical precision during lens implantation. Benefits patient by ensuring proper ring positioning within capsular bag.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument; non-sterile; designed for insertion of Morcher Capsular Tension Ring. No electronic components, software, or energy sources.

Indications for Use

Indicated for use in patients undergoing cataract surgery requiring implantation of a Morcher Capsular Tension Ring to facilitate insertion and placement of the ring into the capsular bag.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2004

Duckworth & Kent, Ltd. c/o Mr. Martin Lock Head of Quality Systems Terrence House, 7 Marquis Baldock, Hertsfordshire, United Kingdom, SG7 6XL

Re: K042478

Trade/Device Name: Capsule Tension Ring Inserter Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: NCE Dated: December 9, 2004 Received: December 13, 2004

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.

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.

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Page 2 - Mr. Martin Lock

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Akaliji forenthal

A. Ralph Rosenthal, 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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## STATEMENT OF INDICATIONS FOR USE

K042478 510K Number (if known):

Device Name: Duckworth & Kent Ltd Capsule Tension Ring Inserter 7-810

Indications for Use:

When a "Morcher Capsular Tension Ring" is to be implanted as part of a cataract procedure.

This injector will facilitate the insertion and proper placement of the ring in the capsular bag.

Indications for Use Labelling:

INDICATION FOR USE

Injector for Morcher Capsule Tension Ring.

Capsule Tension Ring Ins 7-810 NON-STERILE Duckworth & Kent Ltd, Baldock, SG7 SXL, England

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Raoul Cunningham

510(k) Number K942478