LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)

K991015 · Lamda Polytech , Ltd. · LPL · Nov 2, 1999 · Ophthalmic

Device Facts

• Record ID: K991015
• Device Name: LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
• Applicant: Lamda Polytech , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The LM-70 (lidofilcon A) Spherical Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system. The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.

Device Story

LM-70 is a lathe-cut, soft hydrophilic contact lens fabricated from lidofilcon A (terpolymer of N-vinyl-2-pyrrolidone and methyl methacrylate, cross-linked with ethylene glycol dimethacrylate and Allyl methacrylate). In dry state, material is machined and polished; in hydrated state (70% water), lens becomes soft and pliable, conforming to corneal curvature. Used for daily wear to correct myopia, hyperopia, and astigmatism. Lens acts as refractive medium to focus light on retina. Requires maintenance in fully hydrated state using compatible storage solution; compatible with chemical or heat disinfection systems.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on material chemistry, physical properties, and manufacturing process comparisons to the predicate device.

Technological Characteristics

Material: Lidofilcon A (NVP/MMA terpolymer cross-linked with EGDMA/AMA). Water content: 70% ± 2%. Refractive index: 1.41 (hydrated). Oxygen permeability: 38.5 x 10^-11 (cm²/sec)(ml O2/ml x mmHg @ 35°C). Specific gravity: 1.061. Form factor: Spherical and Toric soft contact lens. Manufacturing: Lathe-cut. Disinfection: Chemical or heat.

Indications for Use

Indicated for correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes who are myopic or hyperopic. Spherical lens indicated for refractive astigmatism ≤ 0.75 diopters. Toric lens indicated for refractive astigmatism ≤ 10 diopters.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Predicate Devices

• LL-70 (Lombart Lenses, LTD)

Submission Summary (Full Text)

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# 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: K991015

#### Applicant information:

| Date Prepared: | March 24, 1999 |
|----------------|----------------|
|----------------|----------------|

| Name:<br>Address | Lamda Polytech Limited<br>1 Lincoln Park Borough Road<br>Brackley Northants<br>England NN13 7BE |
|----------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person:<br>Phone number: | Ian Atkins<br>44-1280 705500 |
| USA Consultant: | Med-Vice Consulting Inc. |

| USA Consultant. | Med-vice Consulting, inc. |
|-----------------|---------------------------|
| Phone number | [phone] |
| Fax number | [phone] |
| | Martin Dalsing |

#### Device Information:

| Device Classification: | Class II |
|------------------------|-------------------------------------------------------------------------------------------------|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens<br>for Daily Wear (clear, lathe-cut) |

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#### Equivalent Devices:

The LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens is substantially equivalent to the following predicate device in terms of intended use and design. Predicate device: "LL-70" manufactured/distributed by Lombart Lenses, LTD.

#### Device Description:

The LM-70 Spherical and Toric Soft Contact Lens is fabricated from lidofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (lidofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warned however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The non-ionic lens material, (lidofilcon A) is a terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and Allyl methacrylate (AMA). It consists of 30% lidofilcon A and 70% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 70% water by weight. The physical properties of the lens are:

| Refractive Index | 1.52 (dry) 1.41 (hydrated) |
|---------------------|--------------------------------------------------------------------------|
| Light Transmission | greater than 95% |
| Water Content | 70% ±2% |
| Specific Gravity | 1.061 (hydrated) |
| Oxygen Permeability | 38.5 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method). |

#### Intended Use:

The LM-70 (Udofilcon A) Spherical Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.

The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.

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#### Substantial Equivalence:

The LM-70 Soft Contact Lens will be manufactured according to specified process controls and an ISO 9001/9002 and CGMP quality assurance program currently in place. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the LM-70 material is equivalent to the predicate device identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate device, this 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 device identified above.

The following matrix illustrates the production method, lens function and material characteristics of the LM-70 Spherical and Toric Soft Contact Lens, as well as the predicate device.

| | General S.E. Areas | Lamda Polytech<br>LM-70 (lidofilcon A) | Predicate Device<br>LL-70 (lidofilcon A) |
|-----|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | Intended Use | Visual correction in Not-aphakic<br>persons with non-diseased eyes<br>that myopic or hyperopic | Visual correction in Not-aphakic<br>persons with non-diseased eyes<br>that myopic or hyperopic |
| 2.) | Functionality | After machining from the optical<br>blank, the contact lenses act as a<br>refractive medium that focus light<br>rays from near and distant objects<br>on the retina. | After machining from the optical<br>blank, the contact lenses act as a<br>refractive medium that focus light<br>rays from near and distant objects<br>on the retina. |
| 3.) | Indications | Daily wear, Soft (hydrophilic)<br>contact lens | Daily wear, Soft (hydrophilic)<br>contact lens |
| 4.) | Production Method | Lathe-cut | Lathe-cut |
| 5.) | FDA Group # | Group # 2 >50% Water, Nonionic<br>Polymers | Group # 2 >50% Water, Nonionic<br>Polymers |
| 6.) | Water Content | 70% ± 2 % | 70% ± 2 % |
| 7.) | Oxygen Permeability | 38.5 X 10-11 (cm2/sec)<br>(ml 02/ml x mm Hg @ 35 degrees<br>C), (revised Fatt method). | 34.7 X 10-11 (cm2/sec)<br>(ml 02/ml x mm Hg @ 35 degrees<br>C), (revised Fatt method). |
| 8.) | Specific Gravity | 1.061 | 1.073 |

### Substantial Equivalence Matrix

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 1999

Lamda Polytech Limited c/o Mr. Martin Dalsing Offical Representative and Consultant for Lamda Polytech Limited MedVice Consulting, Inc. 623 Glacier Drive Grand Junction, Co 81503

Re: K991015

Trade Name: LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens for Daily Wear (clear, lathe-cut) Regulatory Class: II Product Code: 86 LPL Dated: October 5, 1999 Received: October 8, 1999

Dear Mr. Dalsing:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect

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Page 2 - Mr. Martin Dalsing

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

#### LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens for Daily Wear Device Name: (clear, lathe-cut)

#### INDICATIONS FOR USE:

The LM-70 (lidofilcon A) Spherical Soft Contact Lens for daily wear aisre indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.

The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Orus

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_k 9905

Image /page/5/Picture/11 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font. There is a line through the text, indicating that it is not applicable. The text is likely related to the regulatory requirements for prescription drug labeling.

or

Over-The-Counter Use

(Optional Format 1-2-96)