S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS

K990281 · Nissel , Ltd. · LPL · Apr 16, 1999 · Ophthalmic

Device Facts

• Record ID: K990281
• Device Name: S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
• Applicant: Nissel , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The S-38™ (polymacon) Soft (hydrophilic) Contact Lens with blue tint is indicated for daily wear 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 may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic The lens may be worn by persons who may presbyopes. exhibit astigmatism of not more than 2.00 diopters that does not interfere with visual acuity. The Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and/or marqinally presbyopic requiring up to +1.00 D of The lens may be worn by persons who exhibit add. astiqmatism of 1.50 diopters or less but may not be suitable for higher degrees of astigmatism.

Device Story

Hydrophilic contact lenses (polymacon) designed for daily wear; function as corrective refracting medium on human cornea to focus light on retina. Subject devices are identical to previously cleared S-38, Esstech PS, and Esstech SV lenses, with addition of Procion Blue MX-R (Reactive Dye Blue #4) tint. Lenses are worn by patients to correct myopia, hyperopia, and/or marginal presbyopia. No change in optical or physical properties (water content, refractive index, oxygen permeability) compared to clear versions. Tinting process added to manufacturing. No new clinical data generated; safety established via prior clinical data and successful toxicology testing (cytotoxicity, systemic toxicity, ocular irritation).

Clinical Evidence

No clinical data generated for this submission. Safety and efficacy rely on prior clinical data contained in P920036. Bench testing included toxicology (cytotoxicity, systemic toxicity, ocular irritation), which the lenses passed.

Technological Characteristics

Hydrophilic polymer of 2-hydroxyethyl methacrylate cross-linked with ethyleneglycol dimethacrylate; 38% water content; refractive index 1.43 (hydrated); oxygen permeability Dk=8.5 (Fatt method at 35°C); visible light transmittance >95%; contains Procion Blue MX-R dye. Dimensions: chord diameter 12.5-15.0 mm, center thickness 0.07-0.97 mm, base curve 7.40-9.60 mm. Powers: -20.00 to +20.00 D.

Indications for Use

Indicated for daily wear for visual acuity correction in aphakic/not-aphakic persons with non-diseased eyes (myopic/hyperopic). S-38: astigmatism ≤1.50D. Esstech PS: not-aphakic, myopic/hyperopic, presbyopes, astigmatism ≤2.00D. Esstech SV: not-aphakic, myopic/hyperopic, marginally presbyopic (up to +1.00D add), astigmatism ≤1.50D.

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

• S-38™ Soft (polymacon) Contact Lens (P920036)
• Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens (K942186)
• Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens (K942187)

Submission Summary (Full Text)

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APR 16 100

K990281, FOI Summary

# 510(k) SUMMARY FOR FOI

S-38™ (polymacon) Soft (hydrophilic) Contact Lens, blue tint

- Contact Lens Classification Name:
Contact Lens Common/Usual Name:

- 5-38m (polymacon) Soft (hydrophilic) Proprietary Name: Contact Lens, the Esstech® PS Concact Bens) Soft (hydrophilic) Contact (polymacon) SEsstech® SV (polymacon) Soft (hydrophilic) Contact Lens
Establishment Registration Number: 9610790 Owner/Operator No: 8010037

- Contact lenses were reclassified as Class II Classification: devices in November, 1993. 21 CFR 886.5925, 86LPL
Performance Standards: None

Copies of labeling, revised to include the Labeling: Copies of rabeling, " the blue tint, were included in this submission.

Substantial Equivalence: The sponsor considers these to be substantially equivalent to the S-38™ Soft (polymacon) Contact Lens covered in Sort (porymacon) 920036 and the Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV Contact on) Soft (hydrophilic) Contact (porymateen) bon the 510(k)'s K942186 and K942187, respectively.

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# SUBSTANTIAL EQUIVALENCE S-38™

| Material | S-38™ Clear Untinted | S-38™ Blue Tinted |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | hydrophilic polymer<br>of 2-hydroxyethyl<br>methacrylate cross-<br>linked with<br>ethyleneglycol<br>dimethacrylate | hydrophilic polymer<br>of 2-hydroxyethyl<br>methacrylate cross-<br>linked with<br>ethyleneglycol<br>dimethacrylate<br>containing the dye<br>Procion blue MX-R. |
| Water Content | 38% | same |
| Refractive<br>Index | 1.43, hydrated | same |
| Light<br>Transmittance<br>(visible) | >97% | >95% |
| Oxygen<br>permeability | Dk = 8.5(cm/sec)(ml<br>O2/mlxmm Hg)<br>Measured at 35°C<br>(Fatt method). | same |
| Actions | When placed on the<br>human cornea, the<br>hydrated lens<br>acts as a corrective<br>refracting medium to<br>focus light<br>rays on the retina. | same |
| Chord Diameter | 12.5 to 15.0 mm | same |
| Center<br>thickness | 0.07 to 0.97 mm | same |
| Base Curve | 7.40 to 9.60 mm | same |
| Powers | -20.00 to +20.00 D | same |
| Material | ESSTECH® PS Clear<br>Untinted | ESSTECH® PS Blue<br>Tinted |
| Description | hydrophilic polymer<br>of 2-hydroxyethyl<br>methacrylate cross-<br>linked with<br>ethyleneglycol<br>dimethacrylate | hydrophilic polymer<br>of 2-hydroxyethyl<br>methacrylate cross-<br>linked with<br>ethyleneglycol<br>dimethacrylate<br>containing the dye<br>Procion blue MX-R. |
| Water Content | 38% | same |
| Refractive<br>Index | 1.43, hydrated | same |
| Light<br>Transmittance<br>(visible) | > 97% | > 95% |
| Oxygen<br>permeability | $D_k = 8.5 (cm/sec) (ml O_2/ ml x mm Hg)$<br>Measured at 35°C<br>(Fatt method). | same |
| Actions | When placed on the<br>human cornea, the<br>hydrated lens acts<br>as a corrective<br>refracting medium to<br>focus light rays on<br>the retina. | same |
| Chord Diameter | $14.00 \pm 0.20$ mm | same |
| Center<br>thickness | 0.17 $\pm 0.02$ mm | same |
| Base Curve | 8.30, 8.70, and 9.10<br>$\pm 0.10$ mm | same |
| Powers | +10.00 to -10.00D in<br>0.25 dioptric steps | same |
| | | |
| Material | ESSTECH® SV Clear<br>Untinted | ESSTECH® SV Blue<br>Tinted |
| Description | hydrophilic polymer<br>of 2-hydroxyethyl<br>methacrylate cross-<br>linked with<br>ethyleneglycol<br>dimethacrylate | hydrophilic polymer<br>of 2-hydroxyethyl<br>methacrylate cross-<br>linked with<br>ethyleneglycol<br>dimethacrylate<br>containing the dye<br>Procion blue MX-R. |
| Water Content | 38% | same |
| Refractive<br>Index | 1.43, hydrated | same |
| Light<br>Transmittance | >97% | >95% |
| Oxygen<br>permeability | Dk = 8.5(cm/sec)(ml<br>O2/ml x mm Hg)<br>Measured at 35°C<br>(Fatt method). | same |
| Actions | When placed on the<br>human cornea, the<br>hydrated lens<br>acts as a corrective<br>refracting medium to<br>focus light<br>rays on the retina. | same |
| Chord Diameter | 14.00 ± 0.20 mm | same |
| Center<br>thickness<br>Minus powers: | 0.07 to<br>0.14 ± 0.02 mm | same<br>same |
| Variable from<br>Plus powers:<br>Variable from | 0.15 to<br>0.30 ± 0.02 mm | same |
| Base Curve | 8.30, 8.70, and 9.10<br>±0.10 mm | same |
| Powers | +10.00 to -10.00D in<br>0.25 diopter steps | same |

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# SUBSTANTIAL EQUIVALENCE ESSTECH® PS

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## SUBSTANTIAL EQUIVALENCE ESSTECH® SV

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#### SUMMARY

## PRODUCT DESCRIPTION AND CHEMISTRY

The lenses are identical to the already approved and cleared products S-38™ (polymacon) Soft (hydrophilic) Contact Lens, the Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, except for the addition of the listed color additive Procion Blue MX-R (Reactive Dye Blue #4).

### TOXICOLOGY:

The lenses passed cytotoxicity, systemic toxicity and ocular irritation testing.

#### MICROBIOLOGY

All microbiological testing is contained in P920036.

#### CLINICAL DATA

Since there is no change other than the addition of a listed color additive, no new clinical data was generated. All prior clinical data is contained in P920036.

#### MANUFACTURING

The blue tinted lenses are manufactured in a manner identical to that described in P920036, K942186 and K942187, with the addition of the tinting process.

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Image /page/5/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 or bird-like figure with three heads, suggesting a sense of unity or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

APR 16 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NISSEL LIMITED c/o John M. Szabocsik, Ph.D. 203 North Wabash Avenue Suite 1200 Chicago, IL 60601

Re: K990281

Trade Name: S-38™ (polymacon) Soft (hydrophilic) Contact Lens, the Esstech® PS Lens and the Esstech ® SV (polymacon) Soft (hydrophilic) Contact Lens, With blue tint Regulatory Class: II Product Code: 86 LPL

Dated: January 26, 1999 Received: January 28, 1999

Dear Dr. Szabocsik:

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 any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - John M. Szabocsik, Ph.D.

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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January 26, 1999

Page 1 of 1

510(k) NUMBER (IF KNOWN) K990281

S-38™ (polymacon) Soft (hydrophilic) DEVICE NAME Contact Lens, the Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens and the Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, with blue tint

## INDICATIONS FOR USE

The S-38™ (polymacon) Soft (hydrophilic) Contact Lens with blue tint is indicated for daily wear 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 may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The Esstech® PS (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic The lens may be worn by persons who may presbyopes. exhibit astigmatism of not more than 2.00 diopters that does not interfere with visual acuity.

The Esstech® SV (polymacon) Soft (hydrophilic) Contact Lens, with blue tint is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and/or marqinally presbyopic requiring up to +1.00 D of The lens may be worn by persons who exhibit add. astiqmatism of 1.50 diopters or less but may not be suitable for higher degrees of astigmatism.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter-Use OR (Optional Format 1-2-96)

Marcel W. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K990281

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