OPHTEC ENCLAVATION NEEDLE

K030471 · Ophtec, USA · HNQ · Apr 17, 2003 · Ophthalmic

Device Facts

• Record ID: K030471
• Device Name: OPHTEC ENCLAVATION NEEDLE
• Applicant: Ophtec, USA
• Product Code: HNQ · Ophthalmic
• Decision Date: Apr 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4350
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

An OPHTEC Enclavation Needle is a hand held, non powered, single-use ophthalmic instrument used to manipulate iris tissue during the surgical procedure to fixate an ARTISAN™ phakic or aphakic intraocular lens in a human eye.

Device Story

OPHTEC Enclavation Needle is a manual, non-powered, single-use surgical instrument. Device consists of an acrylic handle with two stainless steel needles, one at each end, configured as right-hand and left-hand designs. Used by ophthalmic surgeons in an operating room setting to manipulate iris tissue during the fixation of ARTISAN™ phakic or aphakic intraocular lenses. The instrument assists the surgeon in the mechanical enclavation process, facilitating precise tissue handling required for lens implantation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual, non-powered, single-use ophthalmic instrument. Materials: surgical stainless steel needles, acrylic handle. Design: dual-ended with specific right/left configurations for tissue manipulation. Sterilization: not specified.

Indications for Use

Indicated for use by surgeons to manipulate iris tissue during the surgical fixation of ARTISAN™ phakic or aphakic intraocular lenses in human eyes.

Regulatory Classification

Identification

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Predicate Devices

• Stephens Disposable Hooks (K022842)

Submission Summary (Full Text)

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K030471/

OPHTEC Enclavation Needle 510(k), February 10, 2003

Section B

## 510(k) Premarket Notification Summary for OPHTEC Enclavation Needles

APR 1 7 2003

| Trade name: | OPHTEC Enclavation Needle |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Enclavation Needle |
| Classification name: | 86HNQ, Ophthalmic Hook |
| Substantially Equivalent to: | Stephens Disposable Hooks (K022842) |
| Description of Device: | Enclavation Needles are surgical stainless steel needles that have been dulled and molded into a configuration so as to assist in tissue manipulation during ARTISAN™ Lens implant surgery. The instrument has an acrylic handle and one needle at each end. Each end is uniquely designed to create a right-hand end and a left-hand end to aid the surgeon during the procedure. |

| Submitted by: | Rick McCarley<br>President & CEO<br>OPHTEC USA |
|-----------------|-----------------------------------------------------------------------|
| Address: | OPHTEC USA<br>6421 Congress Avenue, Suite 112<br>Boca Raton, FL 22487 |
| Telephone: | [phone] |
| Contact Person: | Rick McCarley |
| Date Prepared: | February 10, 2003 |

.)000006

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 7 2003

OPHTEC USA c/o Mr. Rick McCarley 6421 Congress Avenue, Suite 112 Boca Raton, FL 22487

Re: K030471

> Trade/Device Name: OPHTEC Enclavation Needle Regulation Number: 886.4350 Regulation Name: Ophthalmic Hook Regulatory Class: I Product Code: HNO Dated: February 10, 2003 Received: February 12, 2003

Dear Mr. McCarley:

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. Rick McCarley

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,

A. halpi korenthal

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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510(k) Number (if known): K030471

Device Name: OPHTEC Enclavation Needle

Indications For Use:

An OPHTEC Enclavation Needle is a hand held, non powered, single-use ophthalmic instrument used to manipulate iris tissue during the surgical procedure to fixate an ARTISAN™ phakic or aphakic intraocular lens in a human eye.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

| (Division Sign-Off) | |
|-----------------------------|---------|
| Division of Ophthalmic Ear, | |
| Nose and Throat Devises | |
| 510(k) Number | K030471 |

(Optional Format 3-10-98)