PMMA CLASIC
K955777 · Rand Scientific Corp. · HPX · May 16, 1996 · OP
Device Facts
| Record ID | K955777 |
|---|
| Device Name | PMMA CLASIC |
|---|
| Applicant | Rand Scientific Corp. |
|---|
| Product Code | HPX · OP |
|---|
| Decision Date | May 16, 1996 |
|---|
| Decision | SESE |
|---|
| Submission Type | Traditional |
|---|
| Device Class | Class U |
|---|
Indications for Use
The PMMA Classic contact lenses are indicated for the correction of refractive errors (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who may exhibit refractive astigmatism of 1.50 diopters or less.
Device Story
PMMA Classic contact lenses; spherical or aspheric design; lathe-cut polymethyl methacrylate (PMMA) material. Intended for vision correction in aphakic/non-aphakic patients. Device provides refractive correction via physical lens geometry. Used by patients under eye care professional guidance. Safety established via biocompatibility testing (USP Systemic Injection, Primary Eye Irritation, Agar Diffusion Cytotoxicity) and historical clinical use of PMMA materials.
Clinical Evidence
Bench testing only. Biocompatibility studies performed: USP Systemic Injection Test (no toxic signs, weight gain observed), USP Primary Eye Irritation Test (no irritation in New Zealand rabbits), and Agar Diffusion Cytotoxicity (no reactivity per USP 23/ISO 10993-5).
Technological Characteristics
Material: Polymethyl methacrylate (PMMA). Manufacturing: Lathe cut. Physical properties: Non-gas permeable, <2% water content, refractive index 1.49, hardness 95 (Shore D). Design: Spherical or aspheric base curves. Standards: ANSI Z80.2 for tolerances.
Indications for Use
Indicated for correction of refractive errors (myopia/hyperopia) in aphakic and non-aphakic persons with non-diseased eyes; suitable for patients with refractive astigmatism of 1.50 diopters or less.
Submission Summary (Full Text)
{0}
R S Rand Scientific CORPORATION
MAY 16 1996
K955777 TRANS AIRE
4135 Northgate Blvd, Suite 9 • Sacramento, CA 95834 • 800/RPG-VIEW Phone: 916/921-5535 • Fax: 916/921-5927 • 800/747-8439
## A. SUMMARY OF SAFETY AND EFFECTIVENESS
### 1. TOXICOLOGY
**USP SYSTEMIC INJECTION TEST**
Clinical Observations: No toxic signs were observed during the 72 hour observation period.
Weights: All animals gained weight during the test.
Conclusion: This test material met the requirements of the USP Systemic Injection Test, using the extracting media.
### 2. USP PRIMARY EYE IRRITATION TEST
**EYE IRRITATION STUDY:** No irritation was observed during the study period.
Clinical Observations: All animals remained healthy throughout the study period.
Conclusion: The test material produced no irritation response in the eyes of the New Zealand rabbits.
### B. CYTOTOXICITY - AGAR DIFFUSION
Results: There was no reactivity with the tinted or clear PMMA contact lens buttons.
Conclusion: These samples meet the requirements of USP 23 and ISO 10993-5 for this Cytotoxicity Test.
### C. The spherical contact lens design will have a spherical front and back surface. The base curve (back surface) will contain one or more spherical curves on the periphery of the lens which will have a longer radius of curvature than the central section (optic zone).
### D. The low eccentricity aspheric contact lens will have a spherical front surface and an aspherical back surface (base curve). The eccentricity of the base curve will provide design more closely matching the curvature of the cornea. The design may or may not contain peripheral curves.
### E. Contact lenses were manufactured with a variety of prescriptions to demonstrate they could be manufactured. Rand uses ANSI Z80.2 as a standard for all contact lens tolerances.
{1}
F. STATEMENT OF SIMILARITIES AND DIFFERENCES
| CLASSIC PMMA | PREDICATE DEVICE |
| --- | --- |
| Polymethyl methacrylate | Polymethyl methacrylate and silicone |
| Lathe cut | Lathe cut |
| Not gas permeable | Not gas permeable |
| Less than 2% water content | Less than 2% water content |
| Index of refraction 1.49 | Index of refraction 1.49 |
| Hardness 95 (Shore D) | Hardness 95 (Shore D) |
G. THE RESULTS OF THE TOXICOLOGY TESTS AND THE FACT THAT PMMA CONTACT LENSES HAVE BEEN MARKETED FOR OVER THIRTY YEARS SHOWS THAT THE PMMA CLASSIC CONTACT LENSES ARE SAFE AND EFFECTIVE FOR THEIR INTENDED USE.
