DYNA INTRA-LIMBAL LENS

K020006 · Lens Dynamics, Inc. · HQD · Mar 29, 2002 · Ophthalmic

Device Facts

• Record ID: K020006
• Device Name: DYNA INTRA-LIMBAL LENS
• Applicant: Lens Dynamics, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Mar 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty. The lens may be disinfected using a chemical disinfection system.

Device Story

Dyna Intra-Limbal Lens is a rigid gas permeable (RGP) contact lens; manufactured from enflufocon A or hexafocon A materials. Lens features 11.2 mm diameter; designed to fit within limbus; utilizes spherical peripheral system to facilitate tear exchange and corneal cleansing. Intended for daily wear; prescribed by eye care professionals for patients with refractive ametropia or irregular corneal conditions (e.g., keratoconus, post-surgical complications). Lens provides physical correction of vision; improves patient outcomes by managing irregular corneal topography. Disinfection performed via chemical systems.

Clinical Evidence

Clinical data presented for 20 patients randomly selected for various corneal conditions to support efficacy of the new indication. No further statistical metrics provided.

Technological Characteristics

Rigid gas permeable contact lens; materials: enflufocon A or hexafocon A; <1% water content (hydrophobic). Diameter: 11.2 mm. Design: spherical peripheral system. Manufacturing follows ANSI Z80.20-1998 and cGMP quality assurance programs.

Indications for Use

Indicated for daily wear in aphakic and non-aphakic patients for correction of myopia, hyperopia, and astigmatism. Also indicated for patients with irregular corneal conditions including keratoconus, pellucid marginal degeneration, or post-penetrating keratoplasty.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Predicate Devices

• Boston ES (enflufocon A) (K943177)
• Boston XO (hexafocon A) (K000795)

Submission Summary (Full Text)

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### MAR 2 9 2002

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### The assigned 510(k) number is: K020006

#### Applicant information:

March 26, 2002 Date Prepared:

Name: Address Lens Dynamics, Inc. 8600 W 14th Ave. Suite 2 Lakewood, CO 80215

Contact Person: Phone number:

Mr. Al Vaske [phone]

Reason for 510(k) submission:

New Indication

#### Device Information:

Device Classification:

Class II

Classification Name:

Classification #:

Trade Name:

Material Covered By:

Rigid gas permeable (hydrophobic) contact lens; Class II for daily Wear.

21 CFR 886.5916, Ophthalmic: 86 HQD

Dyna Intra-Limbal Lens

enflufocon A; approved, 510(k) K943177 hexafocon A; approved, 510(k) K000795

#### Predicate Device:

The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable lens is substantially equivalent to the Boston ES (enflufocon A) and Boston XO (hexafocon A) RGP contact lens, which were cleared in 510(k) Premarket Notifications K943177 and K000795 respectively.

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#### Device Description:

The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable spherical contact lens is intended for the correction of highly irregular comeas occurring naturally or from disease such as Pellucid Marginal Degeneration and keratoconus or from post surgery complications such as tilted grafts.

The design is larger in diameter, with a 11.2 mm standard diameter that is sized to fit within the limbus. A spherical peripheral system is employed to insure maximum exchange of tears and adequate cleansing of the cornea from flushing action behind the lens.

The lens material attributes and lens parameters are found in the package insert.

#### Intended Use:

The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty. The lens may be disinfected using a chemical disinfection system.

#### Description of Safety and Substantial Equivalence:

The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable lens will be manufactured according to specified process controls and standards as identified in ANSI standard Z80.20-1998, and a cGMP quality assurance program currently in place.

The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the Dyna Intra-Limbal Lens manufactured in either (entlufocon A) or (hexafocon A) rigid gas permeable lens material is equivalent to the predicate devices identified previously. Authorization letters from Polymer Technology allowing the FDA to access all of their pre clinical and clinical data for these materials are enclosed. Reference 510(k) K943177 and K000795 respectively.

Shelf Life ~ The Dyna Intra-Limbal Lens is a hydrophobic rigid gas permeable contact lens material with <1% water content. Based on the Premarket Notification Guidance document for Daily Wear Lenses, shelf-life studies are not required for clearance of the Dyna Intra-Limbal Lens.

Solution Compatibility ~ The lens care regimes approved by Polymer Technology will be followed in the Dyna Intra-Limbal labeling.

The sponsor concludes data presented supports substantial equivalence of the Dyna Intra-Limbal Lens to the predicate devices and meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above. The difference between the predicates devices and the Dyna Intra-Limbal Lens is the addition of a new indication for use. Clinical data presented of 20 patients randomly selected for various corneal conditions supports efficacy of the Dyna Intra-Limbal Lens.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAR 2 9 2002

Lens Dynamics, Inc. c/o Al Vaske, President 8600 West 14th Ave., Suite 2 Lakewood, CO 80215

Re: K020006

Trade/Device Name: Dyna Intra-Limbal Lens Regulation Number: CFR 886.5916 Regulation Name: Daily Wear RGP Contact Lens Regulatory Class: Class II Product Code: HQD Dated: December 24, 2001 Received: January 2, 2002

Dear Mr. Vaske:

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 - Al Vaske, President

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph Rosenthal

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

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## INDICATIONS FOR USE STATEMENT

Device Name:

Dyna Intra-Limbal Lens

#### INDICATIONS FOR USE:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Norris. C. Brown, Ph.D.

Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

K020006 510(k) Number.

Prescription Use X (Per 21 CFR 801.109)

Or

Over-The-Counter Use _

(Optional Format 1-2-96)